From f292e9f4ca895a86427e5c1e7b96aa959e5f1b6c Mon Sep 17 00:00:00 2001 From: pendingintent <3921919+pendingintent@users.noreply.github.com> Date: Thu, 13 Aug 2026 09:24:16 -0400 Subject: [PATCH 1/4] Removed legact USDM and DDS JSON files. Added additional Claude workflows. --- .github/workflows/azure-deploy.yml | 114 +- .github/workflows/ci.yml | 11 +- .github/workflows/claude-changelog.yml | 58 + .github/workflows/claude-comment-review.yml | 24 +- .github/workflows/claude-review.yml | 33 + .github/workflows/claude-test-analysis.yml | 39 + output/json/H2Q-MC-LZZT-20260618T1509.json | 33893 ---------------- .../H2Q-MC-LZZT-define-20260618T1521.json | 33559 --------------- output/json/NCT01797120-20260618T1511.json | 11441 ------ output/json/NCT01797120-20260630T1221.json | 7754 ---- output/json/NCT01797120-dds-latest.json | 12419 +++--- .../NCT01797120-define-20260618T1514.json | 11197 ----- .../NCT01797120-define-20260630T1224.json | 4215 -- .../NCT01797120-define-20260716T1138.json | 11183 ----- output/json/NCT01797120-define-latest.json | 11183 ----- output/json/NCT01797120-latest.json | 1562 +- .../json/NCT01797120-usdm-20260716T1134.json | 14385 ------- .../NCT12345678-define-20260716T1133.json | 33435 --------------- output/json/NCT12345678-define-latest.json | 33435 --------------- output/json/NCT12345678-latest.json | 33031 --------------- .../json/NCT12345678-usdm-20260716T1124.json | 33031 --------------- 21 files changed, 6928 insertions(+), 279074 deletions(-) create mode 100644 .github/workflows/claude-changelog.yml create mode 100644 .github/workflows/claude-review.yml create mode 100644 .github/workflows/claude-test-analysis.yml delete mode 100644 output/json/H2Q-MC-LZZT-20260618T1509.json delete mode 100644 output/json/H2Q-MC-LZZT-define-20260618T1521.json delete mode 100644 output/json/NCT01797120-20260618T1511.json delete mode 100644 output/json/NCT01797120-20260630T1221.json delete mode 100644 output/json/NCT01797120-define-20260618T1514.json delete mode 100644 output/json/NCT01797120-define-20260630T1224.json delete mode 100644 output/json/NCT01797120-define-20260716T1138.json delete mode 100644 output/json/NCT01797120-define-latest.json delete mode 100644 output/json/NCT01797120-usdm-20260716T1134.json delete mode 100644 output/json/NCT12345678-define-20260716T1133.json delete mode 100644 output/json/NCT12345678-define-latest.json delete mode 100644 output/json/NCT12345678-latest.json delete mode 100644 output/json/NCT12345678-usdm-20260716T1124.json diff --git a/.github/workflows/azure-deploy.yml b/.github/workflows/azure-deploy.yml index a356007..1c52716 100644 --- a/.github/workflows/azure-deploy.yml +++ b/.github/workflows/azure-deploy.yml @@ -1,70 +1,72 @@ +--- name: Deploy to Azure App Service on: - push: - branches: - - master - # - release-* - workflow_dispatch: #Allow manual triggers + push: + branches: + - master + # - release-* + workflow_dispatch: # Allow manual triggers permissions: - contents: read - + contents: read + jobs: - build-and-test: - name: Build and Test - runs-on: ubuntu-latest + build-and-test: + name: Build and Test + runs-on: ubuntu-latest - steps: - - name: Checkout code - uses: actions/checkout@v4 - with: - submodules: recursive # Include cdisc-json-validation submodule + steps: + - name: Checkout code + uses: actions/checkout@v4 + with: + submodules: recursive # Include cdisc-json-validation submodule - - name: Set up Python 3.13 - uses: actions/setup-python@v5 - with: - python-version: '3.13' - cache: 'pip' - cache-dependency-path: | - pyproject.toml - requirements.txt + - name: Set up Python 3.13 + uses: actions/setup-python@v5 + with: + python-version: "3.13" + cache: "pip" + cache-dependency-path: | + pyproject.toml + requirements.txt - - name: Install dependencies - run: | - python -m pip install --upgrade pip - pip install -e ".[dev]" + - name: Install dependencies + run: | + python -m pip install --upgrade pip + pip install -e ".[dev]" - - name: Run tests - run: | - pytest -q tests --disable-warnings --tb=short - env: - CDISC_CONCEPTS_JSON: '[]' # Bypass CDISC API for tests + - name: Run tests + run: | + pytest -q tests --disable-warnings --tb=short + env: + CDISC_CONCEPTS_JSON: "[]" # Bypass CDISC API for tests - - name: Create deployment package - run: | - # Nothing special needed - Azure will handle pip install - echo "Build successful" + - name: Create deployment package + run: | + # Nothing special needed - Azure will handle pip install + echo "Build successful" - deploy: - name: Deploy to Azure - needs: build-and-test - runs-on: ubuntu-latest - environment: production # Optional: requires manual approval + deploy: + name: Deploy to Azure + needs: build-and-test + runs-on: ubuntu-latest + environment: production # Optional: requires manual approval - steps: - - name: Checkout code - uses: actions/checkout@v4 - with: - submodules: recursive - - name: Deploy to Azure Web App - uses: azure/webapps-deploy@v2 - with: - app-name: ${{ secrets.AZURE_WEBAPP_NAME }} - publish-profile: ${{ secrets.AZURE_WEBAPP_PUBLISH_PROFILE }} - package: . + steps: + - name: Checkout code + uses: actions/checkout@v4 + with: + submodules: recursive + - name: Deploy to Azure Web App + uses: azure/webapps-deploy@v2 + with: + app-name: ${{ secrets.AZURE_WEBAPP_NAME }} + publish-profile: ${{ secrets.AZURE_WEBAPP_PUBLISH_PROFILE }} + package: . - - name: Verify deployment - run: | - echo "Deployment complete!" - echo "App URL: https://${{ secrets.AZURE_WEBAPP_NAME }}.azurewebsites.net" \ No newline at end of file + - name: Verify deployment + run: | + echo "Deployment complete!" + echo "App URL: + https://${{ secrets.AZURE_WEBAPP_NAME }}.azurewebsites.net" diff --git a/.github/workflows/ci.yml b/.github/workflows/ci.yml index 84d86c0..0343259 100644 --- a/.github/workflows/ci.yml +++ b/.github/workflows/ci.yml @@ -1,11 +1,12 @@ -# yaml-language-server: $schema=https://json.schemastore.org/github-workflow.json +# yaml-language-server: +# $schema=https://json.schemastore.org/github-workflow.json name: CI (Python) on: push: - branches: [ "master" ] + branches: ["master"] pull_request: - branches: [ "master" ] + branches: ["master"] permissions: contents: read @@ -21,7 +22,7 @@ jobs: strategy: fail-fast: false matrix: - python-version: [ "3.11", "3.12", "3.13", "3.14" ] + python-version: ["3.11", "3.12", "3.13", "3.14"] steps: - name: Checkout @@ -62,4 +63,4 @@ jobs: with: name: test-reports-py${{ matrix.python-version }} path: reports/ - if-no-files-found: ignore \ No newline at end of file + if-no-files-found: ignore diff --git a/.github/workflows/claude-changelog.yml b/.github/workflows/claude-changelog.yml new file mode 100644 index 0000000..47c31f4 --- /dev/null +++ b/.github/workflows/claude-changelog.yml @@ -0,0 +1,58 @@ +--- +name: Generate Changelog + +on: + push: + tags: + - 'release-v*' + +jobs: + changelog: + runs-on: ubuntu-latest + permissions: + contents: write + steps: + - uses: actions/checkout@v4 + with: + fetch-depth: 0 + + - name: Get commits since last tag + id: commits + run: | + PREVIOUS_TAG=$(git describe --tags + --abbrev=0 HEAD^ 2>/dev/null || echo "") + if [ -n "$PREVIOUS_TAG" ]; then + COMMITS=$(git log ${PREVIOUS_TAG}..HEAD --oneline) + else + COMMITS=$(git log --oneline -20) + fi + echo "commits<> $GITHUB_OUTPUT + echo "$COMMITS" >> $GITHUB_OUTPUT + echo "EOF" >> $GITHUB_OUTPUT + + - name: Generate changelog with Claude + uses: anthropics/claude-code-action@v1 + with: + anthropic_api_key: ${{ secrets.ANTHROPIC_API_KEY }} + github_token: ${{ secrets.GITHUB_TOKEN }} + prompt: | + Generate a changelog for release ${{ github.ref_name }}. + + Commits since last release: + ${{ steps.commits.outputs.commits }} + + Format: + ## What's New in ${{ github.ref_name }} + + ### Features + - ... + + ### Bug Fixes + - ... + + ### Breaking Changes + - ... (only if any) + + Write the changelog to CHANGELOG.md (prepared before existing + content). + Then commit and push the updated CHANGELOG.md. diff --git a/.github/workflows/claude-comment-review.yml b/.github/workflows/claude-comment-review.yml index 70d96fc..100416b 100644 --- a/.github/workflows/claude-comment-review.yml +++ b/.github/workflows/claude-comment-review.yml @@ -1,3 +1,4 @@ +--- name: Claude PR Comment Review on: @@ -18,15 +19,16 @@ jobs: github.event.pull_request != null) }} runs-on: ubuntu-latest steps: - - name: Checkout - uses: actions/checkout@v4 + - name: Checkout + uses: actions/checkout@v4 - - name: Run Claude Code Action (comment-triggered) - uses: anthropics/claude-code-action@v1 - with: - anthropic_api_key: ${{ secrets.ANTHROPIC_API_KEY}} - prompt: | - You are reviewing a GitHub Pull Request. Focus on security, correctness, clarity. - - Only comment on files that changed in this PR. - - Prioritize actionable fixes and cite specific lines. - - Keep comments concise; avoid restating code. + - name: Run Claude Code Action (comment-triggered) + uses: anthropics/claude-code-action@v1 + with: + anthropic_api_key: ${{ secrets.ANTHROPIC_API_KEY}} + prompt: | + You are reviewing a GitHub Pull Request. Focus on + security, correctness, clarity. + - Only comment on files that changed in this PR. + - Prioritize actionable fixes and cite specific lines. + - Keep comments concise; avoid restating code. diff --git a/.github/workflows/claude-review.yml b/.github/workflows/claude-review.yml new file mode 100644 index 0000000..ec39cf3 --- /dev/null +++ b/.github/workflows/claude-review.yml @@ -0,0 +1,33 @@ +--- +name: Claude Code Review + +on: + pull_request: + types: [opened, synchronize, reopened] + +permissions: + contents: read + pull-requests: write + +jobs: + claude-review: + runs-on: ubuntu-latest + steps: + - name: Checkout + uses: actions/checkout@v4 + with: + fetch-depth: 0 # Full history needed for diff analysis + + - name: Claude Code claude-review + uses: anthropics/claude-code-action@v1 + with: + anthropic_api_key: ${{ secrets.ANTHROPIC_API_KEY }} + prompt: | + Review this pull request and post inline comments for: + 1. Logic errors and edge cases + 2. Security vulnerabilities (SQL injection, XSS, auth bypasses) + 3. Performance issues (N+1 queries, blocking calls, memory leaks) + 4. Missing error handling + 5. Missing unit tests + 6. Non conformance with USDM v4.0 schema (schema/dataStructure.yml) + Focus on changed files only, Be specific - cite line numbers diff --git a/.github/workflows/claude-test-analysis.yml b/.github/workflows/claude-test-analysis.yml new file mode 100644 index 0000000..d5beeb6 --- /dev/null +++ b/.github/workflows/claude-test-analysis.yml @@ -0,0 +1,39 @@ +--- +name: Claude Anaylze Test Failures + +on: + workflow_run: + workflows: ["Tests"] + types: [completed] + +jobs: + analyze: + if: ${{ github.event.workflow_run.conclusion == 'failure' }} + runs-on: ubuntu-latest + permissions: + contents: read + issues: write + pull-requests: write + steps: + - uses: actions/checkout@v4 + + - name: Download test artifacts + uses: actions/download-artifact@v4 + with: + name: test-results + run-id: ${{ github.event.workflow_run.id }} + github-token: ${{ secrets.GITHUB_TOKEN }} + + - name: Analyze with Claude + uses: anthropics/claude-code-action@v1 + with: + anthropic_api_key: ${{ secrets.ANTHROPIC_API_KEY }} + github_token: ${{ secrets.GITHUB_TOKEN }} + prompt: | + Tests failed on the latest push. + Analyze the failures and: + 1. Identify the root cause (not just which test failed) + 2. Point to the specific file and line that likely caused it + 3. Suggest a fix or investigation path + + Post this as a comment on the PR that triggered these tests. diff --git a/output/json/H2Q-MC-LZZT-20260618T1509.json b/output/json/H2Q-MC-LZZT-20260618T1509.json deleted file mode 100644 index ceb7e90..0000000 --- a/output/json/H2Q-MC-LZZT-20260618T1509.json +++ /dev/null @@ -1,33893 +0,0 @@ -{ - "study": { - "id": null, - "extensionAttributes": [], - "name": "H2Q-MC-LZZT", - "description": "Patients with probable mild to moderate AD will be studied in a randomized, double-blind, parallel (3 arm), placebo-controlled trial of 26 weeks duration. The study will be conducted on an outpatient basis. Approximately 300 patients will be enrolled", - "label": "Alzheimer Study", - "versions": [ - { - "id": "StudyVersion_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_153", - "url": "http://www.cdisc.org/usdm/extensions/studyDesignSolution", - "valueExtensionClass": { - "id": "ExtensionClass_1", - "url": "http://www.cdisc.org/usdm/extensions/StudyDesignSolution", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_154", - "url": "tool-name", - "valueString": "SoA Workbench", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_155", - "url": "tool-version", - "valueString": "1.4.0", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_156", - "url": "usdm-creation-date", - "valueString": "20260618T15:09", - "instanceType": "ExtensionAttribute" - } - ], - "instanceType": "ExtensionClass" - }, - "instanceType": "ExtensionAttribute" - } - ], - "versionIdentifier": "1", - "rationale": "", - "studyIdentifiers": [ - { - "id": "StudyIdentifier_1", - "extensionAttributes": [], - "text": "H2Q-MC-LZZT", - "scopeId": "Organization_1", - "instanceType": "StudyIdentifier" - } - ], - "referenceIdentifiers": [], - "studyDesigns": [ - { - "id": "InterventionalStudyDesign_1", - "extensionAttributes": [], - "name": "Darren", - "label": "Alzheimer Study", - "description": "Patients with probable mild to moderate AD will be studied in a randomized, double-blind, parallel (3 arm), placebo-controlled trial of 26 weeks duration. The study will be conducted on an outpatient basis. Approximately 300 patients will be enrolled", - "studyType": null, - "studyPhase": null, - "therapeuticAreas": [], - "characteristics": [], - "encounters": [ - { - "id": "Encounter_1", - "extensionAttributes": [], - "name": "SCREEN1", - "label": "Screening 1", - "description": "Screening encounter", - "type": { - "id": "Code_55", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "Encounter_2", - "scheduledAtId": "Timing_1", - "environmentalSettings": [ - { - "id": "Code_84", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_164", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_17", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_1", - "label": null, - "description": null, - "text": "Subject identifier", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_18", - "extensionAttributes": [], - "name": "ENCOUNTER_END_RULE_2", - "label": null, - "description": null, - "text": "completion of screening activities", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_2", - "extensionAttributes": [], - "name": "SCREEN2", - "label": "Screening 2", - "description": "Screening encounter - Ambulatory ECG Placement", - "type": { - "id": "Code_56", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_1", - "nextId": "Encounter_3", - "scheduledAtId": "Timing_2", - "environmentalSettings": [ - { - "id": "Code_85", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_165", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": { - "id": "TransitionRule_19", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_2", - "label": null, - "description": null, - "text": "subject leaves clinic after connection of ambulatory ECG machine", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_3", - "extensionAttributes": [], - "name": "DOSE", - "label": "Baseline", - "description": "Baseline encounter - Ambulatory ECG Removal", - "type": { - "id": "Code_57", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_2", - "nextId": "Encounter_4", - "scheduledAtId": "Timing_3", - "environmentalSettings": [ - { - "id": "Code_86", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_166", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_20", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_3", - "label": null, - "description": null, - "text": "subject has connection of ambulatory ECG machine removed", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_21", - "extensionAttributes": [], - "name": "ENCOUNTER_END_RULE_5", - "label": null, - "description": null, - "text": "Radomized", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_4", - "extensionAttributes": [], - "name": "WEEK2", - "label": "Week 2", - "description": "Day 14", - "type": { - "id": "Code_58", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_3", - "nextId": "Encounter_5", - "scheduledAtId": "Timing_4", - "environmentalSettings": [ - { - "id": "Code_87", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_167", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_5", - "extensionAttributes": [], - "name": "WEEK4", - "label": "Week 4", - "description": "Day 28", - "type": { - "id": "Code_59", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_4", - "nextId": "Encounter_6", - "scheduledAtId": "Timing_5", - "environmentalSettings": [ - { - "id": "Code_88", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_168", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_6", - "extensionAttributes": [], - "name": "WEEK6", - "label": "Week 6", - "description": "Day 42", - "type": { - "id": "Code_60", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_5", - "nextId": "Encounter_7", - "scheduledAtId": "Timing_6", - "environmentalSettings": [ - { - "id": "Code_89", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_169", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_7", - "extensionAttributes": [], - "name": "WEEK8", - "label": "Week 8", - "description": "Day 56", - "type": { - "id": "Code_61", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_6", - "nextId": "Encounter_9", - "scheduledAtId": "Timing_7", - "environmentalSettings": [ - { - "id": "Code_90", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_170", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_9", - "extensionAttributes": [], - "name": "WEEK12", - "label": "Week 12", - "description": "Day 84", - "type": { - "id": "Code_63", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_7", - "nextId": "Encounter_11", - "scheduledAtId": "Timing_8", - "environmentalSettings": [ - { - "id": "Code_92", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_171", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_11", - "extensionAttributes": [], - "name": "WEEK16", - "label": "Week 16", - "description": "Day 112", - "type": { - "id": "Code_65", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_9", - "nextId": "Encounter_13", - "scheduledAtId": "Timing_9", - "environmentalSettings": [ - { - "id": "Code_94", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_172", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_13", - "extensionAttributes": [], - "name": "WEEK20", - "label": "Week 20", - "description": "Day 140", - "type": { - "id": "Code_67", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_11", - "nextId": "Encounter_15", - "scheduledAtId": "Timing_10", - "environmentalSettings": [ - { - "id": "Code_96", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_173", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_15", - "extensionAttributes": [], - "name": "WEEK24", - "label": "Week 24", - "description": "Day 168", - "type": { - "id": "Code_69", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_13", - "nextId": "Encounter_16", - "scheduledAtId": "Timing_11", - "environmentalSettings": [ - { - "id": "Code_98", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_174", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_16", - "extensionAttributes": [], - "name": "WEEK26", - "label": "Week 26", - "description": "Day 182", - "type": { - "id": "Code_70", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_15", - "nextId": null, - "scheduledAtId": "Timing_12", - "environmentalSettings": [ - { - "id": "Code_99", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_175", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": { - "id": "TransitionRule_22", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_12", - "label": null, - "description": null, - "text": "End of treatment", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - } - ], - "activities": [ - { - "id": "Activity_1", - "extensionAttributes": [], - "name": "Informed Consent", - "label": "Informed Consent", - "description": "Informed consent activity", - "previousId": null, - "nextId": "Activity_2", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_1" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_2", - "extensionAttributes": [], - "name": "Inclusion/Exclusion Criteria", - "label": "Inclusion/Exclusion Criteria", - "description": "Inclusion/Exclusion Criteria activity", - "previousId": "Activity_1", - "nextId": "Activity_3", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_2", - "BiomedicalConcept_3", - "BiomedicalConcept_4" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_3", - "extensionAttributes": [], - "name": "Patient number assigned", - "label": "Patient Number assigned", - "description": "Patient Number assigned activity", - "previousId": "Activity_2", - "nextId": "Activity_4", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_5" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_4", - "extensionAttributes": [], - "name": "Demographics", - "label": "Demographics", - "description": "Demographics activity", - "previousId": "Activity_3", - "nextId": "Activity_5", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_6", - "BiomedicalConcept_7", - "BiomedicalConcept_8", - "BiomedicalConcept_9", - "BiomedicalConcept_10" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_5", - "extensionAttributes": [], - "name": "Education", - "label": "Education", - "description": "Education activity", - "previousId": "Activity_4", - "nextId": "Activity_6", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_11", - "BiomedicalConcept_12" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_6", - "extensionAttributes": [], - "name": "Hachinski", - "label": "Hachinski", - "description": "Hachinski test", - "previousId": "Activity_5", - "nextId": "Activity_7", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_10", - "BiomedicalConceptSurrogate_11", - "BiomedicalConceptSurrogate_12", - "BiomedicalConceptSurrogate_13", - "BiomedicalConceptSurrogate_14", - "BiomedicalConceptSurrogate_15", - "BiomedicalConceptSurrogate_16", - "BiomedicalConceptSurrogate_17", - "BiomedicalConceptSurrogate_18", - "BiomedicalConceptSurrogate_9" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_7", - "extensionAttributes": [], - "name": "MMSE", - "label": "MMSE", - "description": "MMSE test", - "previousId": "Activity_6", - "nextId": "Activity_8", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_20", - "BiomedicalConceptSurrogate_21", - "BiomedicalConceptSurrogate_22", - "BiomedicalConceptSurrogate_23", - "BiomedicalConceptSurrogate_24", - "BiomedicalConceptSurrogate_25", - "BiomedicalConceptSurrogate_26" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_8", - "extensionAttributes": [], - "name": "Physical examination", - "label": "Physical examination", - "description": "Physical examination results", - "previousId": "Activity_7", - "nextId": "Activity_9", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_159", - "BiomedicalConcept_160", - "BiomedicalConcept_161" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_9", - "extensionAttributes": [], - "name": "Medical History", - "label": "Medical History", - "description": "Medical History response", - "previousId": "Activity_8", - "nextId": "Activity_10", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_14" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_10", - "extensionAttributes": [], - "name": "Habits", - "label": "Habits", - "description": "List of habits", - "previousId": "Activity_9", - "nextId": "Activity_11", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_15", - "BiomedicalConcept_16", - "BiomedicalConcept_17" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_11", - "extensionAttributes": [], - "name": "Chest X-ray", - "label": "Chest X-ray", - "description": "Chest X-ray result", - "previousId": "Activity_10", - "nextId": "Activity_12", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_18" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_12", - "extensionAttributes": [], - "name": "Apo E genotyping", - "label": "Apo E genotyping", - "description": "Apo E genotyping test", - "previousId": "Activity_11", - "nextId": "Activity_13", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_19" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_13", - "extensionAttributes": [], - "name": "Patient randomised", - "label": "Patient randomized", - "description": "Patient randomized activity", - "previousId": "Activity_12", - "nextId": "Activity_14", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_19" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_14", - "extensionAttributes": [], - "name": "Vital Signs", - "label": "Vital Signs", - "description": "Vital Signs result", - "previousId": "Activity_13", - "nextId": "Activity_15", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_20", - "BiomedicalConcept_21", - "BiomedicalConcept_22", - "BiomedicalConcept_23", - "BiomedicalConcept_24", - "BiomedicalConcept_25", - "BiomedicalConcept_26" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_15", - "extensionAttributes": [], - "name": "Ambulatory ECG placed", - "label": "Ambulatory ECG placed", - "description": "Ambulatory ECG placed activity", - "previousId": "Activity_14", - "nextId": "Activity_16", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_162" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_16", - "extensionAttributes": [], - "name": "Ambulatory ECG removed", - "label": "Ambulatory ECG removed", - "description": "Ambulatory ECG removed activity", - "previousId": "Activity_15", - "nextId": "Activity_17", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_163" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_17", - "extensionAttributes": [], - "name": "ECG", - "label": "ECG", - "description": "ECG results", - "previousId": "Activity_16", - "nextId": "Activity_18", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_27", - "BiomedicalConcept_28", - "BiomedicalConcept_29", - "BiomedicalConcept_30", - "BiomedicalConcept_31", - "BiomedicalConcept_32", - "BiomedicalConcept_33", - "BiomedicalConcept_34", - "BiomedicalConcept_35", - "BiomedicalConcept_36", - "BiomedicalConcept_37", - "BiomedicalConcept_38", - "BiomedicalConcept_39", - "BiomedicalConcept_40", - "BiomedicalConcept_41", - "BiomedicalConcept_42", - "BiomedicalConcept_43", - "BiomedicalConcept_44", - "BiomedicalConcept_45", - "BiomedicalConcept_46", - "BiomedicalConcept_47", - "BiomedicalConcept_48", - "BiomedicalConcept_49", - "BiomedicalConcept_50" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_18", - "extensionAttributes": [], - "name": "Placebo TTS Test", - "label": "Placebo TTS Test", - "description": "Placebo TTS Test results", - "previousId": "Activity_17", - "nextId": "Activity_19", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_164" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_19", - "extensionAttributes": [], - "name": "CT Scan", - "label": "CT Scan", - "description": "CT Scan results", - "previousId": "Activity_18", - "nextId": "Activity_20", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_51" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_20", - "extensionAttributes": [], - "name": "MRI", - "label": "MRI", - "description": "MRI results", - "previousId": "Activity_19", - "nextId": "Activity_21", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_52" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_21", - "extensionAttributes": [], - "name": "MRI, CT Scan", - "label": "MRI, CT Scan", - "description": "MRI, CT Scan results", - "previousId": "Activity_20", - "nextId": "Activity_22", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_165", - "BiomedicalConcept_166" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_22", - "extensionAttributes": [], - "name": "Concomitant medications", - "label": "Concomitant medications", - "description": "Concomitant medications information", - "previousId": "Activity_21", - "nextId": "Activity_23", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_54", - "BiomedicalConcept_55" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_23", - "extensionAttributes": [], - "name": "Hematology", - "label": "Hematology", - "description": "Hematology results", - "previousId": "Activity_22", - "nextId": "Activity_24", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_56", - "BiomedicalConcept_57", - "BiomedicalConcept_58", - "BiomedicalConcept_59", - "BiomedicalConcept_60", - "BiomedicalConcept_61", - "BiomedicalConcept_62", - "BiomedicalConcept_63", - "BiomedicalConcept_64", - "BiomedicalConcept_65", - "BiomedicalConcept_66", - "BiomedicalConcept_67", - "BiomedicalConcept_68", - "BiomedicalConcept_69", - "BiomedicalConcept_70", - "BiomedicalConcept_71", - "BiomedicalConcept_72", - "BiomedicalConcept_73" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_24", - "extensionAttributes": [], - "name": "Chemistry", - "label": "Chemistry", - "description": "Chemistry test results", - "previousId": "Activity_23", - "nextId": "Activity_25", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_74", - "BiomedicalConcept_75", - "BiomedicalConcept_76", - "BiomedicalConcept_77", - "BiomedicalConcept_78", - "BiomedicalConcept_79", - "BiomedicalConcept_80", - "BiomedicalConcept_81", - "BiomedicalConcept_82", - "BiomedicalConcept_83", - "BiomedicalConcept_84", - "BiomedicalConcept_85", - "BiomedicalConcept_86", - "BiomedicalConcept_87", - "BiomedicalConcept_88", - "BiomedicalConcept_89", - "BiomedicalConcept_90", - "BiomedicalConcept_91", - "BiomedicalConcept_92", - "BiomedicalConcept_93", - "BiomedicalConcept_94", - "BiomedicalConcept_95", - "BiomedicalConcept_96", - "BiomedicalConcept_97", - "BiomedicalConcept_98", - "BiomedicalConcept_99", - "BiomedicalConcept_100" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_25", - "extensionAttributes": [], - "name": "Urinalysis", - "label": "Urinalysis", - "description": "Urinalysis results", - "previousId": "Activity_24", - "nextId": "Activity_26", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_101", - "BiomedicalConcept_102", - "BiomedicalConcept_103", - "BiomedicalConcept_104", - "BiomedicalConcept_105", - "BiomedicalConcept_106", - "BiomedicalConcept_107", - "BiomedicalConcept_108", - "BiomedicalConcept_109" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_26", - "extensionAttributes": [], - "name": "Plasma Specimen (Xanomeline)", - "label": "Plasma Specimen (Xanomeline)", - "description": "Plasma Specimen (Xanomeline) results", - "previousId": "Activity_25", - "nextId": "Activity_27", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_27", - "extensionAttributes": [], - "name": "Hemoglobin A1C", - "label": "Hemoglobin A1C", - "description": "Hemoglobin A1C results", - "previousId": "Activity_26", - "nextId": "Activity_28", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_110", - "BiomedicalConcept_111" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_28", - "extensionAttributes": [], - "name": "Study Drug", - "label": "Study Drug", - "description": "Study Drug activity", - "previousId": "Activity_27", - "nextId": "Activity_29", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_112" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_29", - "extensionAttributes": [], - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "description": "TTS Acceptability Survey results", - "previousId": "Activity_28", - "nextId": "Activity_30", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_113", - "BiomedicalConcept_114", - "BiomedicalConcept_115", - "BiomedicalConcept_116", - "BiomedicalConcept_117" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_30", - "extensionAttributes": [], - "name": "ADAS-Cog", - "label": "ADAS-Cog", - "description": "ADAS-Cog results", - "previousId": "Activity_29", - "nextId": "Activity_31", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_172", - "BiomedicalConcept_173", - "BiomedicalConcept_174", - "BiomedicalConcept_175", - "BiomedicalConcept_176", - "BiomedicalConcept_177", - "BiomedicalConcept_178", - "BiomedicalConcept_179", - "BiomedicalConcept_180", - "BiomedicalConcept_181", - "BiomedicalConcept_182", - "BiomedicalConcept_183", - "BiomedicalConcept_184", - "BiomedicalConcept_185", - "BiomedicalConcept_186", - "BiomedicalConcept_187" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_31", - "extensionAttributes": [], - "name": "CIBIC+", - "label": "CIBIC+", - "description": "CIBIC+ results", - "previousId": "Activity_30", - "nextId": "Activity_32", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_27" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_32", - "extensionAttributes": [], - "name": "DAD", - "label": "DAD", - "description": "DAD results", - "previousId": "Activity_31", - "nextId": "Activity_33", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_28" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_33", - "extensionAttributes": [], - "name": "NPI-X", - "label": "NPI-X", - "description": "NPI-X results", - "previousId": "Activity_32", - "nextId": "Activity_34", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_29", - "BiomedicalConceptSurrogate_30", - "BiomedicalConceptSurrogate_31", - "BiomedicalConceptSurrogate_32", - "BiomedicalConceptSurrogate_33", - "BiomedicalConceptSurrogate_34" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_34", - "extensionAttributes": [], - "name": "Adverse Events", - "label": "Adverse Events", - "description": "Activities to conduct if occurence of Adverse Event", - "previousId": "Activity_33", - "nextId": "Activity_35", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_134", - "BiomedicalConcept_135" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_35", - "extensionAttributes": [], - "name": "Check Adverse Events", - "label": "Check Adverse Events", - "description": "TL: Adverse Event Timeline", - "previousId": "Activity_34", - "nextId": "Activity_36", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_170", - "BiomedicalConcept_171" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_36", - "extensionAttributes": [], - "name": "Patient Summary", - "label": "Patient Summary", - "description": "Patient Summary (Study Conclusion)", - "previousId": "Activity_35", - "nextId": "Activity_37", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_136", - "BiomedicalConcept_137", - "BiomedicalConcept_138", - "BiomedicalConcept_139", - "BiomedicalConcept_140", - "BiomedicalConcept_141", - "BiomedicalConcept_142", - "BiomedicalConcept_143", - "BiomedicalConcept_144", - "BiomedicalConcept_145", - "BiomedicalConcept_146", - "BiomedicalConcept_147", - "BiomedicalConcept_148", - "BiomedicalConcept_149", - "BiomedicalConcept_150", - "BiomedicalConcept_151", - "BiomedicalConcept_152" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_37", - "extensionAttributes": [], - "name": "Supine", - "label": "Supine", - "description": "Supine", - "previousId": "Activity_36", - "nextId": "Activity_38", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_168" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_38", - "extensionAttributes": [], - "name": "Vital Signs Supine", - "label": "Vital Signs Supine", - "description": "Vital Signs Supine", - "previousId": "Activity_37", - "nextId": "Activity_39", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_153", - "BiomedicalConcept_154", - "BiomedicalConcept_155" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_39", - "extensionAttributes": [], - "name": "Stand", - "label": "Stand", - "description": "Stand", - "previousId": "Activity_38", - "nextId": "Activity_40", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_169" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_40", - "extensionAttributes": [], - "name": "Vital Signs Standing", - "label": "Vital Signs Standing", - "description": "Vital Signs Standing", - "previousId": "Activity_39", - "nextId": null, - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_156", - "BiomedicalConcept_157", - "BiomedicalConcept_158" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - } - ], - "arms": [ - { - "id": "StudyArm_1", - "extensionAttributes": [], - "name": "Placebo", - "label": "Placebo", - "description": "Placebo ARM", - "type": { - "id": "Code_1", - "extensionAttributes": [], - "code": "C174268", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Placebo Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_2", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - }, - { - "id": "StudyArm_2", - "extensionAttributes": [], - "name": "Xanomeline Low Dose", - "label": "Xanomeline Low Dose", - "description": "Active substance low dose", - "type": { - "id": "Code_3", - "extensionAttributes": [], - "code": "C174267", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Active Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_4", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - }, - { - "id": "StudyArm_3", - "extensionAttributes": [], - "name": "Xanomeline High Dose", - "label": "Xanomeline High Dose", - "description": "Active Substance high dose", - "type": { - "id": "Code_5", - "extensionAttributes": [], - "code": "C174267", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Active Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_6", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - } - ], - "studyCells": [ - { - "id": "StudyCell_1", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_2", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_3", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_4", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_5", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_5", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_7" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_11", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_12", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_4" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_13", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_5" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_14", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_5", - "elementIds": [ - "StudyElement_6" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_15", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_7" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_16", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_17", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_18", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_19", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_5", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_20", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_7" - ], - "instanceType": "StudyCell" - } - ], - "rationale": "", - "epochs": [ - { - "id": "StudyEpoch_1", - "extensionAttributes": [], - "name": "Screening", - "label": "Screening", - "description": "Screening Epoch", - "type": { - "id": "Code_10", - "extensionAttributes": [], - "code": "C202487", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "SCREENING", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "StudyEpoch_3", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_3", - "extensionAttributes": [], - "name": "Treatment 1", - "label": "Treatment 1", - "description": "Treatment 1 Epoch", - "type": { - "id": "Code_11", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_1", - "nextId": "StudyEpoch_4", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_4", - "extensionAttributes": [], - "name": "Treatment 2", - "label": "Treatment 2", - "description": "Treatment 2 Epoch", - "type": { - "id": "Code_13", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_3", - "nextId": "StudyEpoch_5", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_5", - "extensionAttributes": [], - "name": "Treatment 3", - "label": "Treatment 3", - "description": "Treatment 3 Epoch", - "type": { - "id": "Code_14", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_4", - "nextId": "StudyEpoch_2", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_2", - "extensionAttributes": [], - "name": "Follow-up", - "label": "Follow-up", - "description": "Follow-up Epoch", - "type": { - "id": "Code_12", - "extensionAttributes": [], - "code": "C202578", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "FOLLOW-UP", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_5", - "nextId": null, - "notes": [], - "instanceType": "StudyEpoch" - } - ], - "elements": [ - { - "id": "StudyElement_1", - "extensionAttributes": [], - "name": "EL1", - "label": "Screening", - "description": "Screening Element", - "transitionStartRule": { - "id": "TransitionRule_23", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_1", - "label": null, - "description": null, - "text": "Informed consent", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_24", - "extensionAttributes": [], - "name": "ELEMENT_END_RULE_1", - "label": null, - "description": null, - "text": "Completion of all screening activities and no more than 2 weeks from informed consent", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_2", - "extensionAttributes": [], - "name": "EL2", - "label": "Placebo", - "description": "Placebo TTS (adhesive patches)", - "transitionStartRule": { - "id": "TransitionRule_27", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_2", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_3", - "extensionAttributes": [], - "name": "EL3", - "label": "Low", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "transitionStartRule": { - "id": "TransitionRule_28", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_3", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_4", - "extensionAttributes": [], - "name": "EL4", - "label": "High - Start", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "transitionStartRule": { - "id": "TransitionRule_29", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_4", - "label": null, - "description": null, - "text": "Randomized", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_5", - "extensionAttributes": [], - "name": "EL5", - "label": "High - Middle", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg + 25 cm2, 27 mg", - "transitionStartRule": { - "id": "TransitionRule_30", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_5", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose\\u00a0(from\\u00a0patches\\u00a0supplied\\u00a0at\\u00a0Visit\\u00a04)", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_6", - "extensionAttributes": [], - "name": "EL6", - "label": "High - End", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "transitionStartRule": { - "id": "TransitionRule_31", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_6", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose\\u00a0(from\\u00a0patches\\u00a0supplied\\u00a0at\\u00a0Visit\\u00a012)", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_7", - "extensionAttributes": [], - "name": "EL7", - "label": "Follow up", - "description": "Follow up Element", - "transitionStartRule": { - "id": "TransitionRule_25", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_7", - "label": null, - "description": null, - "text": "End\\u00a0of\\u00a0last\\u00a0scheduled\\u00a0visit\\u00a0on\\u00a0study\\u00a0(including\\u00a0early\\u00a0termination)", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_26", - "extensionAttributes": [], - "name": "ELEMENT_END_RULE_7", - "label": null, - "description": null, - "text": "Completion\\u00a0of\\u00a0all\\u00a0specified\\u00a0followup\\u00a0activities\\u00a0(which\\u00a0vary\\u00a0on\\u00a0a\\u00a0patient-by-patient\\u00a0basis)", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - } - ], - "estimands": [ - { - "id": "Estimand_1", - "extensionAttributes": [], - "name": "Estimand 1", - "label": "Estimand 1", - "description": "Estimand 1", - "populationSummary": "Group mean changes from baseline in the primary efficacy parameters", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_1", - "interventionIds": [ - "StudyIntervention_1" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_1", - "extensionAttributes": [], - "name": "Disruption", - "label": "Disruption", - "description": "The disruption of treatment to the subject", - "text": "Temporary Treatment Interruption", - "strategy": "Treatment Policy. Continue to measure effect of treatment assignment regardless of interruption.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - } - ], - "indications": [ - { - "id": "Indication_1", - "extensionAttributes": [], - "name": "Indication 1", - "label": "Alzheimer's disease", - "description": "Alzheimer's disease", - "isRareDisease": false, - "codes": [ - { - "id": "Code_36968", - "extensionAttributes": [], - "code": "G30.9", - "codeSystem": "ICD-10-CM", - "codeSystemVersion": "1", - "decode": "Alzheimer's disease; unspecified", - "instanceType": "Code" - } - ], - "notes": [], - "instanceType": "Indication" - }, - { - "id": "Indication_2", - "extensionAttributes": [], - "name": "Indication 2", - "label": "Alzheimer's disease", - "description": "Alzheimer's disease", - "isRareDisease": false, - "codes": [ - { - "id": "Code_36969", - "extensionAttributes": [], - "code": "26929004", - "codeSystem": "SNOMED", - "codeSystemVersion": "2018-01-31", - "decode": "Alzheimer's disease", - "instanceType": "Code" - } - ], - "notes": [], - "instanceType": "Indication" - } - ], - "studyInterventionIds": [ - "StudyIntervention_1" - ], - "objectives": [ - { - "id": "Objective_1", - "extensionAttributes": [], - "name": "OBJ1", - "label": "Objective 1", - "description": "Main Objective", - "text": "To determine if there is a statistically significant relationship (overall Type 1 erroralpha=0.05) between the change in both the ADAS-Cog (11) and CIBIC+ scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2508", - "extensionAttributes": [], - "code": "C85826", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85826", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_1", - "extensionAttributes": [], - "name": "ENDPT1", - "label": "Endpoint 1", - "description": "ADAS-Cog Week 24 Endpoint", - "text": "Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] at Week 24", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2514", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_2", - "extensionAttributes": [], - "name": "ENDPT2", - "label": "Endpoint 2", - "description": "Clinician Week 24 impression of change", - "text": "Video-referenced Clinician\\u2019s Interview-based Impression of Change (CIBIC+) at Week 24", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2515", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_2", - "extensionAttributes": [], - "name": "OBJ2", - "label": "Objective 2", - "description": "Safety", - "text": "To document the safety profile of the xanomeline TTS.", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2509", - "extensionAttributes": [], - "code": "C85826", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85826", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_3", - "extensionAttributes": [], - "name": "ENDPT3", - "label": "Endpoint 3", - "description": "Adverse events", - "text": "Adverse events", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2516", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_4", - "extensionAttributes": [], - "name": "ENDPT4", - "label": "Endpoint 4", - "description": "Vital Signs", - "text": "Vital signs (weight, standing and supine blood pressure, heart rate)", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2517", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_5", - "extensionAttributes": [], - "name": "ENDPT5", - "label": "Endpoint 5", - "description": "Baseline", - "text": "The change from baseline laboratory value will be calculated as the difference between the baseline lab value and the endpoint value (i.e., the value at the specified visit) or the end of treatment observation\", \"text\": \"Laboratory evaluations (Change from Baseline)", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2518", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_3", - "extensionAttributes": [], - "name": "OBJ3", - "label": "Objective 3", - "description": "Behaviour", - "text": "To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2510", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_6", - "extensionAttributes": [], - "name": "ENDPT6", - "label": "Endpoint 6", - "description": "Cognitive Scale", - "text": "Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] at Weeks 8 and 16", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2519", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_7", - "extensionAttributes": [], - "name": "ENDPT7", - "label": "Endpoint 7", - "description": "Clinician impression at Week8 and Week16", - "text": "Video-referenced Clinician\\u2019s Interview-based Impression of Change (CIBIC+) at Weeks 8 and 16", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2520", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_8", - "extensionAttributes": [], - "name": "ENDPT8", - "label": "Endpoint 8", - "description": "NPI-X", - "text": "Mean Revised Neuropsychiatric Inventory (NPI-X) from Week 4 to Week 24", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2521", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_4", - "extensionAttributes": [], - "name": "OBJ4", - "label": "Objective 4", - "description": "Improvements", - "text": "To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas (see Attachment LZZT.5).", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2511", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_9", - "extensionAttributes": [], - "name": "ENDPT9", - "label": "Endpoint 9", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2522", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_5", - "extensionAttributes": [], - "name": "OBJ5", - "label": "Objective 5", - "description": "Improvements", - "text": "To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer's Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment (see Attachment LZZT.2).", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2512", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_10", - "extensionAttributes": [], - "name": "ENDPT10", - "label": "Endpoint 10", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2523", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_6", - "extensionAttributes": [], - "name": "OBJ6", - "label": "Objective 6", - "description": "Response", - "text": "To assess the treatment response as a function of Apo E genotype.", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2513", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_11", - "extensionAttributes": [], - "name": "ENDPT11", - "label": "Endpoint 11", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2524", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - } - ], - "population": { - "id": "StudyDesignPopulation_1", - "extensionAttributes": [], - "name": "Population_1", - "label": null, - "description": null, - "includesHealthySubjects": false, - "plannedEnrollmentNumber": null, - "plannedCompletionNumber": null, - "plannedSex": [], - "criterionIds": [], - "plannedAge": null, - "notes": [], - "cohorts": [], - "instanceType": "StudyDesignPopulation" - }, - "scheduleTimelines": [ - { - "id": "ScheduleTimeline_1", - "extensionAttributes": [], - "name": "Main Timeline", - "label": "Main Timeline", - "description": "This is the main timeline for the study design", - "mainTimeline": true, - "entryCondition": "Potential subject identified", - "entryId": "ScheduledActivityInstance_1", - "exits": [], - "timings": [ - { - "id": "Timing_1", - "extensionAttributes": [], - "name": "TIM1", - "label": "Screening", - "description": "Screening Timing", - "type": { - "id": "Code_20", - "extensionAttributes": [], - "code": "C201357", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Before", - "instanceType": "Code" - }, - "value": "-P2W", - "valueLabel": "2 Weeks Before Dose", - "relativeToFrom": { - "id": "Code_27", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_1", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_2", - "extensionAttributes": [], - "name": "TIM2", - "label": "Pre-dose", - "description": "Pre-dose Timing", - "type": { - "id": "Code_22", - "extensionAttributes": [], - "code": "C201357", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Before", - "instanceType": "Code" - }, - "value": "-P2D", - "valueLabel": "2 Days Before Dose", - "relativeToFrom": { - "id": "Code_28", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "PT4H", - "windowUpper": "PT0H", - "windowLabel": "-4..0 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_3", - "extensionAttributes": [], - "name": "TIM3", - "label": "Dosing", - "description": "Dosing Anchor", - "type": { - "id": "Code_18", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "P1D", - "valueLabel": "1 Day", - "relativeToFrom": { - "id": "Code_19", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_3", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_4", - "extensionAttributes": [], - "name": "TIM4", - "label": "Week 2", - "description": "Week 2 timing", - "type": { - "id": "Code_29", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_25", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_4", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_5", - "extensionAttributes": [], - "name": "TIM5", - "label": "Week 4", - "description": "Week 4 Timing", - "type": { - "id": "Code_30", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P4W", - "valueLabel": "4 Weeks", - "relativeToFrom": { - "id": "Code_31", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_5", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_6", - "extensionAttributes": [], - "name": "TIM6", - "label": "Week 6", - "description": "Week 6 Timing", - "type": { - "id": "Code_32", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P6W", - "valueLabel": "6 Weeks", - "relativeToFrom": { - "id": "Code_33", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_6", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_7", - "extensionAttributes": [], - "name": "TIM7", - "label": "Week 8", - "description": "Week 8 Timing", - "type": { - "id": "Code_34", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P8W", - "valueLabel": "8 Weeks", - "relativeToFrom": { - "id": "Code_35", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_7", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_8", - "extensionAttributes": [], - "name": "TIM9", - "label": "Week 12", - "description": "Week 12 Timing", - "type": { - "id": "Code_36", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P12W", - "valueLabel": "12 Weeks", - "relativeToFrom": { - "id": "Code_37", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_19", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_9", - "extensionAttributes": [], - "name": "TIM11", - "label": "Week 16", - "description": "Week 16 Timing", - "type": { - "id": "Code_38", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P16W", - "valueLabel": "16 Weeks", - "relativeToFrom": { - "id": "Code_39", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_21", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_10", - "extensionAttributes": [], - "name": "TIM13", - "label": "Week 20", - "description": "Week 20 Timing", - "type": { - "id": "Code_40", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P20W", - "valueLabel": "20 Weeks", - "relativeToFrom": { - "id": "Code_41", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_23", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_11", - "extensionAttributes": [], - "name": "TIM15", - "label": "Week 24", - "description": "Week 24 Timing", - "type": { - "id": "Code_42", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P24W", - "valueLabel": "24 Weeks", - "relativeToFrom": { - "id": "Code_43", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_25", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_12", - "extensionAttributes": [], - "name": "TIM16", - "label": "Week 26", - "description": "Week 26 Timing", - "type": { - "id": "Code_44", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P26W", - "valueLabel": "26 Weeks", - "relativeToFrom": { - "id": "Code_45", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_26", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_13", - "extensionAttributes": [], - "name": "TIM8", - "label": "Week 8 Home", - "description": "Week 8 Home Timing", - "type": { - "id": "Code_46", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_47", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_8", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_7", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_14", - "extensionAttributes": [], - "name": "TIM10", - "label": "Week 12 Home", - "description": "Week 12 Home Timing", - "type": { - "id": "Code_48", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_49", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_20", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_19", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_15", - "extensionAttributes": [], - "name": "TIM12", - "label": "Week 16 Home", - "description": "Week 16 Home Timing", - "type": { - "id": "Code_50", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_51", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_22", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_21", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_16", - "extensionAttributes": [], - "name": "TIM14", - "label": "Week 20 Home", - "description": "Week 20 Home Timing", - "type": { - "id": "Code_52", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_53", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_24", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_23", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_1", - "extensionAttributes": [], - "name": "SCREEN1", - "label": "Screen 1", - "description": "Screen 1 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_2", - "epochId": "StudyEpoch_1", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_1", - "Activity_2", - "Activity_3", - "Activity_4", - "Activity_5", - "Activity_6", - "Activity_7", - "Activity_8", - "Activity_9", - "Activity_10", - "Activity_11", - "Activity_14", - "Activity_17", - "Activity_18", - "Activity_19", - "Activity_20", - "Activity_21", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_25", - "Activity_27", - "Activity_31", - "Activity_32", - "Activity_30", - "Activity_33" - ], - "encounterId": "Encounter_1" - }, - { - "id": "ScheduledActivityInstance_2", - "extensionAttributes": [], - "name": "SCREEN2", - "label": "Screen 2", - "description": "Screen 2 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_3", - "epochId": "StudyEpoch_1", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_15", - "Activity_33" - ], - "encounterId": "Encounter_2" - }, - { - "id": "ScheduledActivityInstance_3", - "extensionAttributes": [], - "name": "DOSE", - "label": "Dose", - "description": "Dose Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_4", - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_13", - "Activity_14", - "Activity_16", - "Activity_22", - "Activity_28", - "Activity_26", - "Activity_30", - "Activity_31", - "Activity_32", - "Activity_33" - ], - "encounterId": "Encounter_3" - }, - { - "id": "ScheduledActivityInstance_4", - "extensionAttributes": [], - "name": "WEEK2", - "label": "Week 2", - "description": "Week 2 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_5", - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_12", - "Activity_14", - "Activity_22", - "Activity_23", - "Activity_25", - "Activity_26", - "Activity_28", - "Activity_17", - "Activity_24", - "Activity_33" - ], - "encounterId": "Encounter_4" - }, - { - "id": "ScheduledActivityInstance_5", - "extensionAttributes": [], - "name": "WEEK4", - "label": "Week 4", - "description": "Week 4 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_6", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_26", - "Activity_28", - "Activity_33" - ], - "encounterId": "Encounter_5" - }, - { - "id": "ScheduledActivityInstance_6", - "extensionAttributes": [], - "name": "WEEK6", - "label": "Week 6", - "description": "Week 6 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_7", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_26", - "Activity_28", - "Activity_33" - ], - "encounterId": "Encounter_6" - }, - { - "id": "ScheduledActivityInstance_7", - "extensionAttributes": [], - "name": "WEEK8", - "label": "Week 8", - "description": "Week 8 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_8", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_31", - "Activity_31", - "Activity_32", - "Activity_32", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_7" - }, - { - "id": "ScheduledActivityInstance_8", - "extensionAttributes": [], - "name": "WEEK8N", - "label": "Week 8 NPI", - "description": "Week 8 NPI Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_19", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_31", - "Activity_31", - "Activity_32", - "Activity_32", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_7" - }, - { - "id": "ScheduledActivityInstance_19", - "extensionAttributes": [], - "name": "WEEK12", - "label": "Week 12", - "description": "Week 12", - "defaultConditionId": "ScheduledActivityInstance_20", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_25", - "Activity_25", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_9" - }, - { - "id": "ScheduledActivityInstance_20", - "extensionAttributes": [], - "name": "WEEK12N", - "label": "Week 12 NPI", - "description": "Week 12 NPI", - "defaultConditionId": "ScheduledActivityInstance_21", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_25", - "Activity_25", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_9" - }, - { - "id": "ScheduledActivityInstance_21", - "extensionAttributes": [], - "name": "WEEK16", - "label": "Week 16", - "description": "Week 16", - "defaultConditionId": "ScheduledActivityInstance_22", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_32", - "Activity_32", - "Activity_31", - "Activity_31", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_11" - }, - { - "id": "ScheduledActivityInstance_22", - "extensionAttributes": [], - "name": "WEEK16N", - "label": "Week 16 NPI", - "description": "Week 16 NPI", - "defaultConditionId": "ScheduledActivityInstance_23", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_32", - "Activity_32", - "Activity_31", - "Activity_31", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_11" - }, - { - "id": "ScheduledActivityInstance_23", - "extensionAttributes": [], - "name": "WEEK20", - "label": "Week 20", - "description": "Week 20", - "defaultConditionId": "ScheduledActivityInstance_24", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_13" - }, - { - "id": "ScheduledActivityInstance_24", - "extensionAttributes": [], - "name": "WEEK20N", - "label": "Week 20 NPI", - "description": "Week 20 NPI", - "defaultConditionId": "ScheduledActivityInstance_25", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_13" - }, - { - "id": "ScheduledActivityInstance_25", - "extensionAttributes": [], - "name": "WEEK24", - "label": "Week 24", - "description": "Week 24", - "defaultConditionId": "ScheduledActivityInstance_26", - "epochId": "StudyEpoch_5", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_25", - "Activity_28", - "Activity_30", - "Activity_32", - "Activity_31" - ], - "encounterId": "Encounter_15" - }, - { - "id": "ScheduledActivityInstance_26", - "extensionAttributes": [], - "name": "WEEK26", - "label": "Week 26", - "description": "Week 26", - "defaultConditionId": null, - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_28", - "Activity_29" - ], - "encounterId": "Encounter_16" - }, - { - "id": "ScheduledDecisionInstance_1", - "extensionAttributes": [], - "name": "testDecisionInstance", - "label": "testDecisionInstance", - "description": "testDecisionInstance", - "defaultConditionId": null, - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [ - { - "id": "Condition_1", - "extensionAttributes": [], - "condition": "is not null", - "conditionTargetId": "ScheduledActivityInstance_3", - "instanceType": "Condition" - } - ] - }, - { - "id": "ScheduledDecisionInstance_2", - "extensionAttributes": [], - "name": "test_2", - "label": "test_2", - "description": "test_2", - "defaultConditionId": "blahblahblah", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [] - }, - { - "id": "ScheduledDecisionInstance_3", - "extensionAttributes": [], - "name": "test3", - "label": "test3", - "description": "test3", - "defaultConditionId": "ScheduledActivityInstance_11", - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [] - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - }, - { - "id": "ScheduleTimeline_6", - "extensionAttributes": [], - "name": "Adverse Event Timeline", - "label": "Adverse Event Timeline", - "description": "This is the adverse event timeline", - "mainTimeline": false, - "entryCondition": "Subject suffers an adverse event", - "entryId": "ScheduledActivityInstance_11", - "exits": [], - "timings": [ - { - "id": "Timing_17", - "extensionAttributes": [], - "name": "TIM17", - "label": "Adverse Event", - "description": "Adverse Event Timing", - "type": { - "id": "Code_105", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "P1D", - "valueLabel": "1 Day", - "relativeToFrom": { - "id": "Code_106", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_11", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_11", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_11", - "extensionAttributes": [], - "name": "AE", - "label": "Adverse Event", - "description": "Occurrence of Adverse Event", - "defaultConditionId": null, - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - }, - { - "id": "ScheduleTimeline_7", - "extensionAttributes": [], - "name": "Early Termination Timeline", - "label": "Early Termination Timeline", - "description": "This is the early termination processing", - "mainTimeline": false, - "entryCondition": "Subject terminates the study early", - "entryId": "ScheduledActivityInstance_12", - "exits": [], - "timings": [ - { - "id": "Timing_18", - "extensionAttributes": [], - "name": "TIM18", - "label": "Early Termination", - "description": "Early Termination Timing", - "type": { - "id": "Code_107", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "P1D", - "valueLabel": "1 Day", - "relativeToFrom": { - "id": "Code_108", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_12", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_12", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_12", - "extensionAttributes": [], - "name": "ET", - "label": "Early Termination", - "description": "Early Termination", - "defaultConditionId": null, - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - }, - { - "id": "ScheduleTimeline_8", - "extensionAttributes": [], - "name": "Vital Sign Blood Pressure Timeline", - "label": "Vital Sign Blood Pressure Timeline", - "description": "BP Profile", - "mainTimeline": false, - "entryCondition": "Automatic execution", - "entryId": "ScheduledActivityInstance_13", - "exits": [], - "timings": [ - { - "id": "Timing_19", - "extensionAttributes": [], - "name": "TIM19", - "label": "Supine", - "description": "VS Supine", - "type": { - "id": "Code_109", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "PT0M", - "valueLabel": "0 mins", - "relativeToFrom": { - "id": "Code_110", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_13", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_13", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_20", - "extensionAttributes": [], - "name": "TIM20", - "label": "VS while supine", - "description": "VS while supine", - "type": { - "id": "Code_111", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT5M", - "valueLabel": "5 mins", - "relativeToFrom": { - "id": "Code_112", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_14", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_13", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_21", - "extensionAttributes": [], - "name": "TIM21", - "label": "Standing", - "description": "VS Standing", - "type": { - "id": "Code_113", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT0M", - "valueLabel": "0 mins", - "relativeToFrom": { - "id": "Code_114", - "extensionAttributes": [], - "code": "C201353", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "End to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_15", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_14", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_22", - "extensionAttributes": [], - "name": "TIM22", - "label": "VS while standing", - "description": "VS while standing", - "type": { - "id": "Code_115", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT1M", - "valueLabel": "1 min", - "relativeToFrom": { - "id": "Code_116", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_16", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_15", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_23", - "extensionAttributes": [], - "name": "TIM23", - "label": "Standing", - "description": "VS Standing", - "type": { - "id": "Code_117", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT0M", - "valueLabel": "0 min", - "relativeToFrom": { - "id": "Code_118", - "extensionAttributes": [], - "code": "C201353", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "End to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_17", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_16", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_24", - "extensionAttributes": [], - "name": "TIM24", - "label": "VS while standing", - "description": "VS while standing", - "type": { - "id": "Code_119", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT2M", - "valueLabel": "2 min", - "relativeToFrom": { - "id": "Code_120", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_18", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_17", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_13", - "extensionAttributes": [], - "name": "VS_5MIN", - "label": "5 minute supine", - "description": "VS 5 minute supine", - "defaultConditionId": "ScheduledActivityInstance_14", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_14", - "extensionAttributes": [], - "name": "VS_SUPINE", - "label": "Vital signs supine", - "description": "VS Vital signs supine", - "defaultConditionId": "ScheduledActivityInstance_15", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_15", - "extensionAttributes": [], - "name": "VS_1MIN", - "label": "1 minute standing", - "description": "VS 1 minute standing", - "defaultConditionId": "ScheduledActivityInstance_16", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_16", - "extensionAttributes": [], - "name": "VS_STAND1", - "label": "Vital signs after 1 min standing", - "description": "VS Vital signs after 1 min standing", - "defaultConditionId": "ScheduledActivityInstance_17", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_17", - "extensionAttributes": [], - "name": "VS_2MIN", - "label": "2 minute standing", - "description": "VS 2 minute standing", - "defaultConditionId": "ScheduledActivityInstance_18", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_18", - "extensionAttributes": [], - "name": "VS_STAND3", - "label": "Vital signs after 3 min standing", - "description": "VS Vital signs after 3 min standing", - "defaultConditionId": null, - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - } - ], - "biospecimenRetentions": [], - "documentVersionIds": [], - "eligibilityCriteria": [], - "analysisPopulations": [], - "notes": [], - "subTypes": [], - "model": { - "id": "Code_StudyDesignModel", - "extensionAttributes": [], - "code": "", - "codeSystem": "", - "codeSystemVersion": "", - "decode": "", - "instanceType": "Code" - }, - "intentTypes": [], - "blindingSchema": null, - "instanceType": "InterventionalStudyDesign" - } - ], - "titles": [ - { - "id": "StudyTitle_1", - "extensionAttributes": [], - "text": "LZZT - Pilot", - "type": { - "id": "Code_27557", - "extensionAttributes": [], - "code": "C207646", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Study Acronym", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - }, - { - "id": "StudyTitle_2", - "extensionAttributes": [], - "text": "Xanomeline (LY246708)", - "type": { - "id": "Code_27601", - "extensionAttributes": [], - "code": "C207615", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Brief Study Title", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - }, - { - "id": "StudyTitle_3", - "extensionAttributes": [], - "text": "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease", - "type": { - "id": "Code_27813", - "extensionAttributes": [], - "code": "C207616", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Official Study Title", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - } - ], - "documentVersionIds": [], - "dateValues": [], - "amendments": [ - { - "id": "StudyAmendment_1", - "extensionAttributes": [], - "notes": [], - "name": "AMEND_1", - "label": "Amendment 1", - "description": "First amendment", - "number": "1", - "summary": "Updated inclusion criteria", - "primaryReason": { - "id": "StudyAmendmentReason_1", - "extensionAttributes": [], - "code": { - "id": "Code_2525", - "extensionAttributes": [], - "code": "C207605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "IRB/IEC Feedback", - "instanceType": "Code" - }, - "otherReason": null, - "instanceType": "StudyAmendmentReason" - }, - "secondaryReasons": [ - { - "id": "StudyAmendmentReason_2", - "extensionAttributes": [], - "code": { - "id": "Code_2526", - "extensionAttributes": [], - "code": "C17649", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "OTHER", - "instanceType": "Code" - }, - "otherReason": "Fix typographical errors", - "instanceType": "StudyAmendmentReason" - } - ], - "changes": [ - { - "id": "StudyChange_2", - "extensionAttributes": [], - "name": "AMEND_CHG_1", - "label": "Change 1", - "description": "Typographical errors lead to ambiguity when interpreting Inclusion Criteria", - "summary": "Fixed inclusion criteria text", - "rationale": "Subject safety", - "changedSections": [ - { - "id": "DocumentContentReference_2", - "extensionAttributes": [], - "sectionNumber": "1.5", - "sectionTitle": "Header 1.5", - "appliesToId": "StudyDefinitionDocument_1", - "instanceType": "DocumentContentReference" - } - ], - "instanceType": "StudyChange" - } - ], - "impacts": [ - { - "id": "StudyAmendmentImpact_1", - "extensionAttributes": [], - "notes": [], - "type": { - "id": "Code_2527", - "extensionAttributes": [], - "code": "C215665", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Study Subject Safety", - "instanceType": "Code" - }, - "text": "Enhance subject safety", - "isSubstantial": false, - "instanceType": "StudyAmendmentImpact" - } - ], - "geographicScopes": [ - { - "id": "GeographicScope_1", - "extensionAttributes": [], - "type": { - "id": "Code_12462", - "extensionAttributes": [], - "code": "C68846", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Global", - "instanceType": "Code" - }, - "code": null, - "instanceType": "GeographicScope" - }, - { - "id": "GeographicScope_5", - "extensionAttributes": [], - "type": { - "id": "Code_20010", - "extensionAttributes": [], - "code": "C41129", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Region", - "instanceType": "Code" - }, - "code": { - "id": "AliasCode_20011", - "extensionAttributes": [], - "standardCode": { - "id": "Code_20011", - "extensionAttributes": [], - "code": "150", - "codeSystem": "UN M49", - "codeSystemVersion": "2026", - "decode": "Europe", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "GeographicScope" - } - ], - "enrollments": [ - { - "id": "SubjectEnrollment_1", - "extensionAttributes": [], - "name": "Enrollment 1", - "label": null, - "description": null, - "quantity": { - "id": "SubjectEnrollment_1_Qty", - "extensionAttributes": [], - "value": 15.0, - "unit": null, - "instanceType": "Quantity" - }, - "forGeographicScope": { - "id": "GeographicScope_5", - "extensionAttributes": [], - "type": { - "id": "Code_20010", - "extensionAttributes": [], - "code": "C41129", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Region", - "instanceType": "Code" - }, - "code": { - "id": "AliasCode_20011", - "extensionAttributes": [], - "standardCode": { - "id": "Code_20011", - "extensionAttributes": [], - "code": "150", - "codeSystem": "UN M49", - "codeSystemVersion": "2026", - "decode": "Europe", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "GeographicScope" - }, - "forStudyCohortId": null, - "forStudySiteId": null, - "instanceType": "SubjectEnrollment" - } - ], - "dateValues": [ - { - "id": "GovernanceDate_1", - "extensionAttributes": [], - "name": "Protocol Approval", - "label": null, - "description": null, - "type": { - "id": "Code_13051", - "extensionAttributes": [], - "code": "C215663", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Effective Date", - "instanceType": "Code" - }, - "dateValue": "2006-06-01", - "geographicScopes": [ - { - "id": "GeographicScope_1", - "extensionAttributes": [], - "type": { - "id": "Code_12462", - "extensionAttributes": [], - "code": "C68846", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Global", - "instanceType": "Code" - }, - "code": null, - "instanceType": "GeographicScope" - } - ], - "instanceType": "GovernanceDate" - } - ], - "instanceType": "StudyAmendment" - } - ], - "organizations": [ - { - "id": "Organization_1", - "extensionAttributes": [], - "name": "LILLY", - "label": "Eli Lilly", - "identifier": "00-642-1325", - "identifierScheme": "DUNS", - "type": { - "id": "Code_28637", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_1", - "extensionAttributes": [], - "text": "Lilly Corporate Ctr, Indianapolis, , IN, 4628, United States of America", - "lines": [ - "Lilly Corporate Ctr" - ], - "city": "Indianapolis", - "district": null, - "state": "IN", - "postalCode": "4628", - "country": { - "id": "Code_28638", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_2", - "extensionAttributes": [], - "name": "CT-GOV", - "label": "ClinicalTrials.gov", - "identifier": "CT-GOV", - "identifierScheme": "USGOV", - "type": { - "id": "Code_28639", - "extensionAttributes": [], - "code": "C142578", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Independent Data Monitoring Committee", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_2", - "extensionAttributes": [], - "text": "National Library of Medicine, Bethesda, 8600 Rockville Pike, MD, 20894, United States of America", - "lines": [ - "National Library of Medicine" - ], - "city": "Bethesda", - "district": "8600 Rockville Pike", - "state": "MD", - "postalCode": "20894", - "country": { - "id": "Code_28640", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_3", - "extensionAttributes": [], - "name": "MLM Medical Labs", - "label": "Central Labu", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_39641", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_3", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_39642", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - } - ], - "roles": [ - { - "id": "StudyRole_1", - "extensionAttributes": [], - "name": "Role 1", - "label": "Sponsor", - "description": "Study Sponsor", - "code": { - "id": "Code_35642", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": { - "id": "Masking_1", - "extensionAttributes": [], - "text": "Masked", - "isMasked": true, - "instanceType": "Masking" - }, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_3", - "extensionAttributes": [], - "name": "Laboratory Contact", - "label": "Lab Primary Contact", - "description": "The primary person to contact at the Central Lab", - "code": { - "id": "Code_40467", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_3" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_2", - "extensionAttributes": [], - "name": "John Smith", - "label": null, - "description": null, - "personName": { - "id": "PersonName_2", - "extensionAttributes": [], - "text": null, - "familyName": "Smith", - "givenNames": [ - "John" - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "PhD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - } - ], - "studyInterventions": [ - { - "id": "StudyIntervention_1", - "extensionAttributes": [], - "name": "XINONILINE", - "label": "Xinomiline", - "description": "Xinomiline", - "role": { - "id": "Code_36026", - "extensionAttributes": [], - "code": "C41161", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Experimental Intervention", - "instanceType": "Code" - }, - "type": { - "id": "Code_36027", - "extensionAttributes": [], - "code": "C1909", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Pharmacologic Substance", - "instanceType": "Code" - }, - "minimumResponseDuration": { - "id": "Quantity_1", - "extensionAttributes": [], - "value": 1.0, - "unit": { - "id": "AliasCode_30645", - "extensionAttributes": [], - "standardCode": { - "id": "Code_36028", - "extensionAttributes": [], - "code": "C25301", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Day", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "Quantity" - }, - "codes": [ - { - "id": "Code_36144", - "extensionAttributes": [], - "code": "XIN", - "codeSystem": "SPONSOR", - "codeSystemVersion": "12", - "decode": "XIN", - "instanceType": "Code" - } - ], - "administrations": [], - "notes": [], - "instanceType": "StudyIntervention" - } - ], - "businessTherapeuticAreas": [], - "biomedicalConcepts": [ - { - "id": "BiomedicalConcept_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_126", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Informed Consent", - "label": null, - "synonyms": [ - "Informed Consent Obtained" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "id": "BiomedicalConceptProperty_1", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3021", - "instanceType": "ResponseCode", - "name": "INFORMED CONSENT OBTAINED", - "label": "INFORMED CONSENT OBTAINED", - "isEnabled": true, - "code": { - "id": "Code_42410", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37048", - "standardCode": { - "id": "Code_44335", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_2", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37049", - "standardCode": { - "id": "Code_44336", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_3", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37050", - "standardCode": { - "id": "Code_44337", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3151", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3361", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_2", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_127", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/INCL01", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Inclusion Criteria", - "label": "Inclusion Criteria", - "synonyms": [ - "Inclusion" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25532", - "properties": [ - { - "id": "BiomedicalConceptProperty_4", - "extensionAttributes": [], - "name": "TIVERS", - "label": "TIVERS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37051", - "standardCode": { - "id": "Code_44338", - "extensionAttributes": [], - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_5", - "extensionAttributes": [], - "name": "IEORRES", - "label": "IEORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37052", - "standardCode": { - "id": "Code_44339", - "extensionAttributes": [], - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_6", - "extensionAttributes": [], - "name": "IEDTC", - "label": "IEDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37053", - "standardCode": { - "id": "Code_44340", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24523", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28641", - "extensionAttributes": [], - "code": "C25532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Inclusion Criteria", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_3", - "extensionAttributes": [], - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "synonyms": [ - "Inclusion Exclusion Criteria Yes No Indicator", - "IEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83063", - "properties": [ - { - "id": "BiomedicalConceptProperty_7", - "extensionAttributes": [], - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37054", - "standardCode": { - "id": "Code_44341", - "extensionAttributes": [], - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_8", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37055", - "standardCode": { - "id": "Code_44342", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_31819", - "extensionAttributes": [], - "standardCode": { - "id": "Code_38143", - "extensionAttributes": [], - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_4", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_1", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EXCL01", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Exclusion Criteria", - "label": "Exclusion Criteria", - "synonyms": [ - "Exclusion" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25370", - "properties": [ - { - "id": "BiomedicalConceptProperty_9", - "extensionAttributes": [], - "name": "TIVERS", - "label": "TIVERS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2841", - "instanceType": "ResponseCode", - "name": "INFORMED CONSENT OBTAINED", - "label": "INFORMED CONSENT OBTAINED", - "isEnabled": true, - "code": { - "id": "Code_40605", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37056", - "standardCode": { - "id": "Code_44343", - "extensionAttributes": [], - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_10", - "extensionAttributes": [], - "name": "IEORRES", - "label": "IEORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37057", - "standardCode": { - "id": "Code_44344", - "extensionAttributes": [], - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_11", - "extensionAttributes": [], - "name": "IEDTC", - "label": "IEDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37058", - "standardCode": { - "id": "Code_44345", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3153", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3363", - "extensionAttributes": [], - "code": "C25370", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Exclusion Criteria", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_5", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_2", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RAND", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Subject is Randomized", - "label": "Subject is Randomized", - "synonyms": [ - "Randomized" - ], - "reference": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "id": "BiomedicalConceptProperty_12", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3022", - "instanceType": "ResponseCode", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "isEnabled": true, - "code": { - "id": "Code_42422", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37059", - "standardCode": { - "id": "Code_44346", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_13", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37060", - "standardCode": { - "id": "Code_44347", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_14", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37061", - "standardCode": { - "id": "Code_44348", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3160", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3370", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_6", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_125", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RACE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Race", - "label": "Race", - "synonyms": [ - "Racial Group" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17049", - "properties": [ - { - "id": "BiomedicalConceptProperty_15", - "extensionAttributes": [], - "name": "RACE", - "label": "RACE", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37062", - "standardCode": { - "id": "Code_44349", - "extensionAttributes": [], - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Race", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_16", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37063", - "standardCode": { - "id": "Code_44350", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_31820", - "extensionAttributes": [], - "standardCode": { - "id": "Code_38144", - "extensionAttributes": [], - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Race", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_7", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_3", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ETHNIC", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ethnic Group", - "label": "Ethnic Group", - "synonyms": [ - "Ethnicity", - "Ethnic Origin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16564", - "properties": [ - { - "id": "BiomedicalConceptProperty_17", - "extensionAttributes": [], - "name": "ETHNIC", - "label": "ETHNIC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37064", - "standardCode": { - "id": "Code_44351", - "extensionAttributes": [], - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ethnic Group", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_18", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37065", - "standardCode": { - "id": "Code_44352", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_31821", - "extensionAttributes": [], - "standardCode": { - "id": "Code_38145", - "extensionAttributes": [], - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Ethnic Group", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_8", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_4", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AGE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Subject Age", - "label": "Subject Age", - "synonyms": [ - "Age" - ], - "reference": "/mdr/bc/biomedicalconcepts/C69260", - "properties": [ - { - "id": "BiomedicalConceptProperty_19", - "extensionAttributes": [], - "name": "AGE", - "label": "AGE", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37066", - "standardCode": { - "id": "Code_44353", - "extensionAttributes": [], - "code": "C170981", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Numeric Age for Data Tabulation", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_20", - "extensionAttributes": [], - "name": "AGEU", - "label": "AGEU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37067", - "standardCode": { - "id": "Code_44354", - "extensionAttributes": [], - "code": "C50400", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Age Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_21", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37068", - "standardCode": { - "id": "Code_44355", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24524", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28642", - "extensionAttributes": [], - "code": "C69260", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Subject Age", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_9", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_5", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BRTHDTC", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Birth Date and Time", - "label": "Birth Date and Time", - "synonyms": [ - "BRTHDTC", - "Date/Time of Birth" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83217", - "properties": [ - { - "id": "BiomedicalConceptProperty_22", - "extensionAttributes": [], - "name": "BRTHDTC", - "label": "BRTHDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37069", - "standardCode": { - "id": "Code_44356", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_23", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37070", - "standardCode": { - "id": "Code_44357", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3155", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3365", - "extensionAttributes": [], - "code": "C83217", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Birth Date and Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_10", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_6", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SEX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sex", - "label": null, - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C28421", - "properties": [ - { - "id": "BiomedicalConceptProperty_24", - "extensionAttributes": [], - "name": "SEX", - "label": "SEX", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37071", - "standardCode": { - "id": "Code_44358", - "extensionAttributes": [], - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_25", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37072", - "standardCode": { - "id": "Code_44359", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24525", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28643", - "extensionAttributes": [], - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_11", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_7", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EDULEVEL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Education Level", - "label": "Education Level", - "synonyms": [ - "EDULEVEL", - "Education Level Completed", - "Education" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17953", - "properties": [ - { - "id": "BiomedicalConceptProperty_26", - "extensionAttributes": [], - "name": "SCORRES", - "label": "SCORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37073", - "standardCode": { - "id": "Code_44360", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_27", - "extensionAttributes": [], - "name": "SCDTC", - "label": "SCDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37074", - "standardCode": { - "id": "Code_44361", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24526", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28644", - "extensionAttributes": [], - "code": "C17953", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Education Level", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_12", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_8", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EDUYRNUM", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Number of Years of Education", - "label": "Number of Years of Education", - "synonyms": [ - "EDUYRNUM", - "Education" - ], - "reference": "/mdr/bc/biomedicalconcepts/C122393", - "properties": [ - { - "id": "BiomedicalConceptProperty_28", - "extensionAttributes": [], - "name": "SCORRES", - "label": "SCORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [ - { - "id": "ResponseCode_2850", - "instanceType": "ResponseCode", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "isEnabled": true, - "code": { - "id": "Code_40810", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37075", - "standardCode": { - "id": "Code_44362", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_29", - "extensionAttributes": [], - "name": "SCORRESU", - "label": "SCORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3023", - "instanceType": "ResponseCode", - "name": "YEARS", - "label": "YEARS", - "isEnabled": true, - "code": { - "id": "Code_42452", - "extensionAttributes": [], - "code": "C29848", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "YEARS", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37076", - "standardCode": { - "id": "Code_44363", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_30", - "extensionAttributes": [], - "name": "SCDTC", - "label": "SCDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_2842", - "instanceType": "ResponseCode", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "isEnabled": true, - "code": { - "id": "Code_40628", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37077", - "standardCode": { - "id": "Code_44364", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24527", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28645", - "extensionAttributes": [], - "code": "C122393", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Number of Years of Education", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_14", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_123", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MEDHISTFREE", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_124", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MHALZHEIMERS", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_128", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MHVISUALHALLUCINATIONS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Solicited Medical History", - "label": "Solicited Medical History", - "synonyms": [ - "Medical History", - "Medical History Collection" - ], - "reference": "/mdr/bc/biomedicalconcepts/C200145", - "properties": [ - { - "id": "BiomedicalConceptProperty_31", - "extensionAttributes": [], - "name": "MHTERM", - "label": "MHTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37078", - "standardCode": { - "id": "Code_44365", - "extensionAttributes": [], - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_32", - "extensionAttributes": [], - "name": "MHDECOD", - "label": "MHDECOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37079", - "standardCode": { - "id": "Code_44366", - "extensionAttributes": [], - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_33", - "extensionAttributes": [], - "name": "MHSTDTC", - "label": "MHSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37080", - "standardCode": { - "id": "Code_44367", - "extensionAttributes": [], - "code": "C83338", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_34", - "extensionAttributes": [], - "name": "MHENDTC", - "label": "MHENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37081", - "standardCode": { - "id": "Code_44368", - "extensionAttributes": [], - "code": "C83330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_35", - "extensionAttributes": [], - "name": "MHENRF", - "label": "MHENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37082", - "standardCode": { - "id": "Code_44369", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_36", - "extensionAttributes": [], - "name": "MHENRTPT", - "label": "MHENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37083", - "standardCode": { - "id": "Code_44370", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_37", - "extensionAttributes": [], - "name": "MHENTPT", - "label": "MHENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37084", - "standardCode": { - "id": "Code_44371", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3156", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3366", - "extensionAttributes": [], - "code": "C200145", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Medical History", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_15", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_134", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALCOHOLHX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alcohol Use History", - "label": "Alcohol Use History", - "synonyms": [ - "Alcohol History", - "Alcohol Use" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81229", - "properties": [ - { - "id": "BiomedicalConceptProperty_38", - "extensionAttributes": [], - "name": "SUTRT", - "label": "SUTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37085", - "standardCode": { - "id": "Code_44372", - "extensionAttributes": [], - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_39", - "extensionAttributes": [], - "name": "SUPRESP", - "label": "SUPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37086", - "standardCode": { - "id": "Code_44373", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_40", - "extensionAttributes": [], - "name": "SUOCCUR", - "label": "SUOCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37087", - "standardCode": { - "id": "Code_44374", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_41", - "extensionAttributes": [], - "name": "SUDOSE", - "label": "SUDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37088", - "standardCode": { - "id": "Code_44375", - "extensionAttributes": [], - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_42", - "extensionAttributes": [], - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37089", - "standardCode": { - "id": "Code_44376", - "extensionAttributes": [], - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_43", - "extensionAttributes": [], - "name": "SUDOSU", - "label": "SUDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37090", - "standardCode": { - "id": "Code_44377", - "extensionAttributes": [], - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_44", - "extensionAttributes": [], - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37091", - "standardCode": { - "id": "Code_44378", - "extensionAttributes": [], - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_45", - "extensionAttributes": [], - "name": "SUSTDTC", - "label": "SUSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37092", - "standardCode": { - "id": "Code_44379", - "extensionAttributes": [], - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_46", - "extensionAttributes": [], - "name": "SUENDTC", - "label": "SUENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37093", - "standardCode": { - "id": "Code_44380", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_47", - "extensionAttributes": [], - "name": "SUSTRF", - "label": "SUSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37094", - "standardCode": { - "id": "Code_44381", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_48", - "extensionAttributes": [], - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37095", - "standardCode": { - "id": "Code_44382", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_49", - "extensionAttributes": [], - "name": "SUSTTPT", - "label": "SUSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37096", - "standardCode": { - "id": "Code_44383", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_50", - "extensionAttributes": [], - "name": "SUENRF", - "label": "SUENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37097", - "standardCode": { - "id": "Code_44384", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_51", - "extensionAttributes": [], - "name": "SUENRTPT", - "label": "SUENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37098", - "standardCode": { - "id": "Code_44385", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_52", - "extensionAttributes": [], - "name": "SUENTPT", - "label": "SUENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37099", - "standardCode": { - "id": "Code_44386", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24528", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28646", - "extensionAttributes": [], - "code": "C81229", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alcohol Use History", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_16", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_135", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CAFFEINEHX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Caffeine Use History", - "label": "Caffeine Use History", - "synonyms": [ - "Caffeine History", - "Caffeine Use" - ], - "reference": "/mdr/bc/biomedicalconcepts/C201990", - "properties": [ - { - "id": "BiomedicalConceptProperty_53", - "extensionAttributes": [], - "name": "SUTRT", - "label": "SUTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37100", - "standardCode": { - "id": "Code_44387", - "extensionAttributes": [], - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_54", - "extensionAttributes": [], - "name": "SUPRESP", - "label": "SUPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37101", - "standardCode": { - "id": "Code_44388", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_55", - "extensionAttributes": [], - "name": "SUOCCUR", - "label": "SUOCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37102", - "standardCode": { - "id": "Code_44389", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_56", - "extensionAttributes": [], - "name": "SUDOSE", - "label": "SUDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37103", - "standardCode": { - "id": "Code_44390", - "extensionAttributes": [], - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_57", - "extensionAttributes": [], - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37104", - "standardCode": { - "id": "Code_44391", - "extensionAttributes": [], - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_58", - "extensionAttributes": [], - "name": "SUDOSU", - "label": "SUDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37105", - "standardCode": { - "id": "Code_44392", - "extensionAttributes": [], - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_59", - "extensionAttributes": [], - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37106", - "standardCode": { - "id": "Code_44393", - "extensionAttributes": [], - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_60", - "extensionAttributes": [], - "name": "SUSTDTC", - "label": "SUSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37107", - "standardCode": { - "id": "Code_44394", - "extensionAttributes": [], - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_61", - "extensionAttributes": [], - "name": "SUENDTC", - "label": "SUENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37108", - "standardCode": { - "id": "Code_44395", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_62", - "extensionAttributes": [], - "name": "SUSTRF", - "label": "SUSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37109", - "standardCode": { - "id": "Code_44396", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_63", - "extensionAttributes": [], - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37110", - "standardCode": { - "id": "Code_44397", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_64", - "extensionAttributes": [], - "name": "SUSTTPT", - "label": "SUSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37111", - "standardCode": { - "id": "Code_44398", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_65", - "extensionAttributes": [], - "name": "SUENRF", - "label": "SUENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37112", - "standardCode": { - "id": "Code_44399", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_66", - "extensionAttributes": [], - "name": "SUENRTPT", - "label": "SUENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2843", - "instanceType": "ResponseCode", - "name": "YEARS", - "label": "YEARS", - "isEnabled": true, - "code": { - "id": "Code_40666", - "extensionAttributes": [], - "code": "C29848", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "YEARS", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37113", - "standardCode": { - "id": "Code_44400", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_67", - "extensionAttributes": [], - "name": "SUENTPT", - "label": "SUENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37114", - "standardCode": { - "id": "Code_44401", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3157", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3367", - "extensionAttributes": [], - "code": "C201990", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Caffeine Use History", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_17", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_130", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CIGARHX", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_131", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CIGARETTEHX", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_132", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PIPEHX", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_133", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TOBACCOHX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "History of Tobacco Use", - "label": "History of Tobacco Use", - "synonyms": [ - "Tobacco Use", - "Tobacco Use History" - ], - "reference": "/mdr/bc/biomedicalconcepts/C181760", - "properties": [ - { - "id": "BiomedicalConceptProperty_68", - "extensionAttributes": [], - "name": "SUTRT", - "label": "SUTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37115", - "standardCode": { - "id": "Code_44402", - "extensionAttributes": [], - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_69", - "extensionAttributes": [], - "name": "SUPRESP", - "label": "SUPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37116", - "standardCode": { - "id": "Code_44403", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_70", - "extensionAttributes": [], - "name": "SUOCCUR", - "label": "SUOCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37117", - "standardCode": { - "id": "Code_44404", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_71", - "extensionAttributes": [], - "name": "SUDOSE", - "label": "SUDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37118", - "standardCode": { - "id": "Code_44405", - "extensionAttributes": [], - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_72", - "extensionAttributes": [], - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37119", - "standardCode": { - "id": "Code_44406", - "extensionAttributes": [], - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_73", - "extensionAttributes": [], - "name": "SUDOSU", - "label": "SUDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37120", - "standardCode": { - "id": "Code_44407", - "extensionAttributes": [], - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_74", - "extensionAttributes": [], - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37121", - "standardCode": { - "id": "Code_44408", - "extensionAttributes": [], - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_75", - "extensionAttributes": [], - "name": "SUSTDTC", - "label": "SUSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37122", - "standardCode": { - "id": "Code_44409", - "extensionAttributes": [], - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_76", - "extensionAttributes": [], - "name": "SUENDTC", - "label": "SUENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37123", - "standardCode": { - "id": "Code_44410", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_77", - "extensionAttributes": [], - "name": "SUDUR", - "label": "SUDUR", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37124", - "standardCode": { - "id": "Code_44411", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_78", - "extensionAttributes": [], - "name": "SUSTRF", - "label": "SUSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37125", - "standardCode": { - "id": "Code_44412", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_79", - "extensionAttributes": [], - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37126", - "standardCode": { - "id": "Code_44413", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_80", - "extensionAttributes": [], - "name": "SUSTTPT", - "label": "SUSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37127", - "standardCode": { - "id": "Code_44414", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_81", - "extensionAttributes": [], - "name": "SUENRF", - "label": "SUENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37128", - "standardCode": { - "id": "Code_44415", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_82", - "extensionAttributes": [], - "name": "SUENRTPT", - "label": "SUENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37129", - "standardCode": { - "id": "Code_44416", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_83", - "extensionAttributes": [], - "name": "SUENTPT", - "label": "SUENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37130", - "standardCode": { - "id": "Code_44417", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3158", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3368", - "extensionAttributes": [], - "code": "C181760", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "History of Tobacco Use", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_18", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_136", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/XRAY", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_137", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/XRAYCHEST", - "instanceType": "ExtensionAttribute" - } - ], - "name": "X-Ray Imaging", - "label": "X-Ray Imaging", - "synonyms": [ - "Conventional X-Ray", - "Medical Imaging", - "X-Ray", - "Static X-Ray" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38101", - "properties": [ - { - "id": "BiomedicalConceptProperty_84", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37131", - "standardCode": { - "id": "Code_44418", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_85", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3024", - "instanceType": "ResponseCode", - "name": "X-RAY", - "label": "X-RAY", - "isEnabled": true, - "code": { - "id": "Code_42509", - "extensionAttributes": [], - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "X-RAY", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37132", - "standardCode": { - "id": "Code_44419", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_86", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37133", - "standardCode": { - "id": "Code_44420", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_87", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37134", - "standardCode": { - "id": "Code_44421", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_88", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37135", - "standardCode": { - "id": "Code_44422", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_89", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37136", - "standardCode": { - "id": "Code_44423", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_90", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37137", - "standardCode": { - "id": "Code_44424", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_33681", - "extensionAttributes": [], - "standardCode": { - "id": "Code_40968", - "extensionAttributes": [], - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "X-RAY", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_19", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_138", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RAND", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Subject is Randomized", - "label": null, - "synonyms": [ - "Randomized" - ], - "reference": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "id": "BiomedicalConceptProperty_91", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3025", - "instanceType": "ResponseCode", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "isEnabled": true, - "code": { - "id": "Code_42516", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37138", - "standardCode": { - "id": "Code_44425", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_92", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37139", - "standardCode": { - "id": "Code_44426", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_93", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37140", - "standardCode": { - "id": "Code_44427", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3160", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3370", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_20", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_9", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TEMP", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_145", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/TEMP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Temperature", - "label": "Body Temperature", - "synonyms": [ - "Temperature" - ], - "reference": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ - { - "id": "BiomedicalConceptProperty_94", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37141", - "standardCode": { - "id": "Code_44428", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_95", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37142", - "standardCode": { - "id": "Code_44429", - "extensionAttributes": [], - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_96", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37143", - "standardCode": { - "id": "Code_44430", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_97", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37144", - "standardCode": { - "id": "Code_44431", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2640", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2850", - "extensionAttributes": [], - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_21", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_10", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WEIGHT", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_146", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/WEIGHT_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Weight", - "label": "Body Weight", - "synonyms": [ - "WEIGHT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ - { - "id": "BiomedicalConceptProperty_98", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37145", - "standardCode": { - "id": "Code_44432", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_99", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37146", - "standardCode": { - "id": "Code_44433", - "extensionAttributes": [], - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_100", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37147", - "standardCode": { - "id": "Code_44434", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3161", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3371", - "extensionAttributes": [], - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_22", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_11", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HEIGHT", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_147", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/HEIGHT_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Height", - "label": "Body Height", - "synonyms": [ - "HEIGHT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C164634", - "properties": [ - { - "id": "BiomedicalConceptProperty_101", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37148", - "standardCode": { - "id": "Code_44435", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_102", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37149", - "standardCode": { - "id": "Code_44436", - "extensionAttributes": [], - "code": "C168688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Height", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_103", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37150", - "standardCode": { - "id": "Code_44437", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24529", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28647", - "extensionAttributes": [], - "code": "C164634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Height", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_23", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_12", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PULSE", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_148", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/PULSE_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Pulse Rate", - "label": "Pulse Rate", - "synonyms": [ - "Pulse" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49676", - "properties": [ - { - "id": "BiomedicalConceptProperty_104", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37151", - "standardCode": { - "id": "Code_44438", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_105", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3026", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_42622", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37152", - "standardCode": { - "id": "Code_44439", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_106", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37153", - "standardCode": { - "id": "Code_44440", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_107", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37154", - "standardCode": { - "id": "Code_44441", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_108", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37155", - "standardCode": { - "id": "Code_44442", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_109", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37156", - "standardCode": { - "id": "Code_44443", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2664", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2874", - "extensionAttributes": [], - "code": "C49676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_24", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_13", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RESP", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_149", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/RESP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Respiratory Rate", - "label": "Respiratory Rate", - "synonyms": [ - "RESP", - "RESPRATE" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49678", - "properties": [ - { - "id": "BiomedicalConceptProperty_110", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37157", - "standardCode": { - "id": "Code_44444", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_111", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3027", - "instanceType": "ResponseCode", - "name": "breaths/min", - "label": "breaths/min", - "isEnabled": true, - "code": { - "id": "Code_42629", - "extensionAttributes": [], - "code": "C49674", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "breaths/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37158", - "standardCode": { - "id": "Code_44445", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_112", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37159", - "standardCode": { - "id": "Code_44446", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2680", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2890", - "extensionAttributes": [], - "code": "C49678", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_25", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_14", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BMI", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_150", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/BMI_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Mass Index", - "label": "Body Mass Index", - "synonyms": [ - "BMI", - "Quetelet Index" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16358", - "properties": [ - { - "id": "BiomedicalConceptProperty_113", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37160", - "standardCode": { - "id": "Code_44447", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_114", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37161", - "standardCode": { - "id": "Code_44448", - "extensionAttributes": [], - "code": "C42575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Density", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_115", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37162", - "standardCode": { - "id": "Code_44449", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24530", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28648", - "extensionAttributes": [], - "code": "C16358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Mass Index", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_26", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_151", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/DIABP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_152", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/packages/2026-06-30/specializations/SYSBP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Blood Pressure", - "label": "Blood Pressure", - "synonyms": [ - "BP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C54706", - "properties": [], - "code": { - "id": "AliasCode_3162", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3372", - "extensionAttributes": [], - "code": "C54706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_27", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_15", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGINTP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Electrocardiogram Analysis", - "label": "Electrocardiogram Analysis", - "synonyms": [ - "ECG Analysis", - "EKG Analysis", - "Electrocardiogram Interpretation", - "ECG Interpretation", - "EKG Interpretation" - ], - "reference": "/mdr/bc/biomedicalconcepts/C181655", - "properties": [ - { - "id": "BiomedicalConceptProperty_116", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37163", - "standardCode": { - "id": "Code_44450", - "extensionAttributes": [], - "code": "C125009", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Interpretation", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_117", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37164", - "standardCode": { - "id": "Code_44451", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_118", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37165", - "standardCode": { - "id": "Code_44452", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_119", - "extensionAttributes": [], - "name": "EGCLSIG", - "label": "EGCLSIG", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37166", - "standardCode": { - "id": "Code_44453", - "extensionAttributes": [], - "code": "C93532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinically Significant Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_120", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37167", - "standardCode": { - "id": "Code_44454", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24531", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28649", - "extensionAttributes": [], - "code": "C181655", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Electrocardiogram Analysis", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_28", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_16", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AVCOND", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Atrioventricular Conduction ECG Assessment", - "label": "Atrioventricular Conduction ECG Assessment", - "synonyms": [ - "AVCOND", - "Atrioventricular Conduction" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111131", - "properties": [ - { - "id": "BiomedicalConceptProperty_121", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37168", - "standardCode": { - "id": "Code_44455", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_122", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37169", - "standardCode": { - "id": "Code_44456", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_123", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37170", - "standardCode": { - "id": "Code_44457", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_124", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37171", - "standardCode": { - "id": "Code_44458", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_125", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37172", - "standardCode": { - "id": "Code_44459", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24532", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28650", - "extensionAttributes": [], - "code": "C111131", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Atrioventricular Conduction ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_29", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_17", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AXISVOLT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Axis and Voltage ECG Assessment", - "label": "Axis and Voltage ECG Assessment", - "synonyms": [ - "AXISVOLT", - "Axis and Voltage" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111132", - "properties": [ - { - "id": "BiomedicalConceptProperty_126", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37173", - "standardCode": { - "id": "Code_44460", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_127", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37174", - "standardCode": { - "id": "Code_44461", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_128", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37175", - "standardCode": { - "id": "Code_44462", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_129", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37176", - "standardCode": { - "id": "Code_44463", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_130", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37177", - "standardCode": { - "id": "Code_44464", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24533", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28651", - "extensionAttributes": [], - "code": "C111132", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Axis and Voltage ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_30", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_18", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHYPTENL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Chamber Hypertrophy or Enlargement ECG Assessment", - "label": "Chamber Hypertrophy or Enlargement ECG Assessment", - "synonyms": [ - "CHYPTENL", - "Chamber Hypertrophy or Enlargement" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111155", - "properties": [ - { - "id": "BiomedicalConceptProperty_131", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37178", - "standardCode": { - "id": "Code_44465", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_132", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37179", - "standardCode": { - "id": "Code_44466", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_133", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37180", - "standardCode": { - "id": "Code_44467", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_134", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37181", - "standardCode": { - "id": "Code_44468", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_135", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37182", - "standardCode": { - "id": "Code_44469", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24534", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28652", - "extensionAttributes": [], - "code": "C111155", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Chamber Hypertrophy or Enlargement ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_31", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_19", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TECHQUAL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECG Technical Quality", - "label": "ECG Technical Quality", - "synonyms": [ - "TECHQUAL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117807", - "properties": [ - { - "id": "BiomedicalConceptProperty_136", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37183", - "standardCode": { - "id": "Code_44470", - "extensionAttributes": [], - "code": "C114120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ECG Recording Quality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_137", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37184", - "standardCode": { - "id": "Code_44471", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_138", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37185", - "standardCode": { - "id": "Code_44472", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_139", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37186", - "standardCode": { - "id": "Code_44473", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24535", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28653", - "extensionAttributes": [], - "code": "C117807", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "ECG Technical Quality", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_32", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_20", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/IVTIACD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Intraventricular and Intraatrial Conduction ECG Assessment", - "label": "Intraventricular and Intraatrial Conduction ECG Assessment", - "synonyms": [ - "IVTIACD", - "Intraventricular-Intraatrial Conduction" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111238", - "properties": [ - { - "id": "BiomedicalConceptProperty_140", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37187", - "standardCode": { - "id": "Code_44474", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_141", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37188", - "standardCode": { - "id": "Code_44475", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_142", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37189", - "standardCode": { - "id": "Code_44476", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_143", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37190", - "standardCode": { - "id": "Code_44477", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_144", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37191", - "standardCode": { - "id": "Code_44478", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24536", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28654", - "extensionAttributes": [], - "code": "C111238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Intraventricular and Intraatrial Conduction ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_33", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_21", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MI", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Myocardial Infarction ECG Assessment", - "label": "Myocardial Infarction ECG Assessment", - "synonyms": [ - "MI", - "Myocardial Infarction" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111280", - "properties": [ - { - "id": "BiomedicalConceptProperty_145", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37192", - "standardCode": { - "id": "Code_44479", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_146", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37193", - "standardCode": { - "id": "Code_44480", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_147", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37194", - "standardCode": { - "id": "Code_44481", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_148", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37195", - "standardCode": { - "id": "Code_44482", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24537", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28655", - "extensionAttributes": [], - "code": "C111280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Myocardial Infarction ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_34", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_22", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PACEMAKR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Pacemaker ECG Assessment", - "label": "Pacemaker ECG Assessment", - "synonyms": [ - "PACEMAKR", - "Pacemaker" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111285", - "properties": [ - { - "id": "BiomedicalConceptProperty_149", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37196", - "standardCode": { - "id": "Code_44483", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_150", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37197", - "standardCode": { - "id": "Code_44484", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_151", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37198", - "standardCode": { - "id": "Code_44485", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_152", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37199", - "standardCode": { - "id": "Code_44486", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_153", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37200", - "standardCode": { - "id": "Code_44487", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24538", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28656", - "extensionAttributes": [], - "code": "C111285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Pacemaker ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_35", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_23", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RHYNOS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Rhythm Not Otherwise Specified ECG Assessment", - "label": "Rhythm Not Otherwise Specified ECG Assessment", - "synonyms": [ - "RHYNOS", - "Rhythm Not Otherwise Specified" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111307", - "properties": [ - { - "id": "BiomedicalConceptProperty_154", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37201", - "standardCode": { - "id": "Code_44488", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_155", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37202", - "standardCode": { - "id": "Code_44489", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_156", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37203", - "standardCode": { - "id": "Code_44490", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_157", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37204", - "standardCode": { - "id": "Code_44491", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_158", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37205", - "standardCode": { - "id": "Code_44492", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24539", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28657", - "extensionAttributes": [], - "code": "C111307", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Rhythm Not Otherwise Specified ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_36", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_24", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/STSTWUW", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ST Segment, T wave, and U wave ECG Assessment", - "label": "ST Segment, T wave, and U wave ECG Assessment", - "synonyms": [ - "STSTWUW", - "ST Segment, T wave, and U wave" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111363", - "properties": [ - { - "id": "BiomedicalConceptProperty_159", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37206", - "standardCode": { - "id": "Code_44493", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_160", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37207", - "standardCode": { - "id": "Code_44494", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_161", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37208", - "standardCode": { - "id": "Code_44495", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_162", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37209", - "standardCode": { - "id": "Code_44496", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_163", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37210", - "standardCode": { - "id": "Code_44497", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24540", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28658", - "extensionAttributes": [], - "code": "C111363", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "ST Segment, T wave, and U wave ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_37", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_25", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SNRARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "label": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "synonyms": [ - "SNRARRY", - "Sinus Node Rhythms and Arrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111312", - "properties": [ - { - "id": "BiomedicalConceptProperty_164", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37211", - "standardCode": { - "id": "Code_44498", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_165", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37212", - "standardCode": { - "id": "Code_44499", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_166", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37213", - "standardCode": { - "id": "Code_44500", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_167", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2848", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_40772", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37214", - "standardCode": { - "id": "Code_44501", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_168", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37215", - "standardCode": { - "id": "Code_44502", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24541", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28659", - "extensionAttributes": [], - "code": "C111312", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_38", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_26", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPRARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Supraventricular Arrhythmia ECG Assessment", - "label": "Supraventricular Arrhythmia ECG Assessment", - "synonyms": [ - "SPRARRY", - "Supraventricular Arrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111320", - "properties": [ - { - "id": "BiomedicalConceptProperty_169", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37216", - "standardCode": { - "id": "Code_44503", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_170", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37217", - "standardCode": { - "id": "Code_44504", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_171", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37218", - "standardCode": { - "id": "Code_44505", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_172", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37219", - "standardCode": { - "id": "Code_44506", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_173", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_2849", - "instanceType": "ResponseCode", - "name": "breaths/min", - "label": "breaths/min", - "isEnabled": true, - "code": { - "id": "Code_40779", - "extensionAttributes": [], - "code": "C49674", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "breaths/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37220", - "standardCode": { - "id": "Code_44507", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24542", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28660", - "extensionAttributes": [], - "code": "C111320", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Arrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_39", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_27", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPRTARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Supraventricular Tachyarrhythmia ECG Assessment", - "label": "Supraventricular Tachyarrhythmia ECG Assessment", - "synonyms": [ - "SPRTARRY", - "Supraventricular Tachyarrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111321", - "properties": [ - { - "id": "BiomedicalConceptProperty_174", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37221", - "standardCode": { - "id": "Code_44508", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_175", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37222", - "standardCode": { - "id": "Code_44509", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_176", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37223", - "standardCode": { - "id": "Code_44510", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_177", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37224", - "standardCode": { - "id": "Code_44511", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_178", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37225", - "standardCode": { - "id": "Code_44512", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24543", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28661", - "extensionAttributes": [], - "code": "C111321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Tachyarrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_40", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_28", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PRAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate PR Interval", - "label": "Aggregate PR Interval", - "synonyms": [ - "PR Interval Aggregate", - "PQ Interval Aggregate", - "PRAG", - "PQAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117773", - "properties": [ - { - "id": "BiomedicalConceptProperty_179", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37226", - "standardCode": { - "id": "Code_44513", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_180", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37227", - "standardCode": { - "id": "Code_44514", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_181", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37228", - "standardCode": { - "id": "Code_44515", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_182", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2853", - "instanceType": "ResponseCode", - "name": "X-RAY", - "label": "X-RAY", - "isEnabled": true, - "code": { - "id": "Code_40968", - "extensionAttributes": [], - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "X-RAY", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37229", - "standardCode": { - "id": "Code_44516", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_183", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37230", - "standardCode": { - "id": "Code_44517", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_184", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37231", - "standardCode": { - "id": "Code_44518", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_185", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37232", - "standardCode": { - "id": "Code_44519", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24544", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28662", - "extensionAttributes": [], - "code": "C117773", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate PR Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_41", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_29", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QRSAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QRS Duration", - "label": "Aggregate QRS Duration", - "synonyms": [ - "QRS Aggregate Duration", - "QRSAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117779", - "properties": [ - { - "id": "BiomedicalConceptProperty_186", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37233", - "standardCode": { - "id": "Code_44520", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_187", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37234", - "standardCode": { - "id": "Code_44521", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_188", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2854", - "instanceType": "ResponseCode", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "isEnabled": true, - "code": { - "id": "Code_40975", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37235", - "standardCode": { - "id": "Code_44522", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_189", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37236", - "standardCode": { - "id": "Code_44523", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_190", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37237", - "standardCode": { - "id": "Code_44524", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_191", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37238", - "standardCode": { - "id": "Code_44525", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_192", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37239", - "standardCode": { - "id": "Code_44526", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24545", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28663", - "extensionAttributes": [], - "code": "C117779", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QRS Duration", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_42", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_30", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QT Interval", - "label": "Aggregate QT Interval", - "synonyms": [ - "QT Interval Aggregate", - "QTAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117783", - "properties": [ - { - "id": "BiomedicalConceptProperty_193", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37240", - "standardCode": { - "id": "Code_44527", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_194", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37241", - "standardCode": { - "id": "Code_44528", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_195", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37242", - "standardCode": { - "id": "Code_44529", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_196", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37243", - "standardCode": { - "id": "Code_44530", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_197", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37244", - "standardCode": { - "id": "Code_44531", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_198", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37245", - "standardCode": { - "id": "Code_44532", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_199", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37246", - "standardCode": { - "id": "Code_44533", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24546", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28664", - "extensionAttributes": [], - "code": "C117783", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QT Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_43", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_31", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCBAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QTCB Interval", - "label": "Aggregate QTCB Interval", - "synonyms": [ - "QTCB Interval Aggregate", - "QTCBAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117784", - "properties": [ - { - "id": "BiomedicalConceptProperty_200", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37247", - "standardCode": { - "id": "Code_44534", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_201", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37248", - "standardCode": { - "id": "Code_44535", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_202", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37249", - "standardCode": { - "id": "Code_44536", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_203", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37250", - "standardCode": { - "id": "Code_44537", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_204", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37251", - "standardCode": { - "id": "Code_44538", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_205", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37252", - "standardCode": { - "id": "Code_44539", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_206", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37253", - "standardCode": { - "id": "Code_44540", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24547", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28665", - "extensionAttributes": [], - "code": "C117784", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCB Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_44", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_32", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCFAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QTCF Interval", - "label": "Aggregate QTCF Interval", - "synonyms": [ - "QTCF Interval Aggregate", - "QTCFAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117786", - "properties": [ - { - "id": "BiomedicalConceptProperty_207", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37254", - "standardCode": { - "id": "Code_44541", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_208", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37255", - "standardCode": { - "id": "Code_44542", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_209", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37256", - "standardCode": { - "id": "Code_44543", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_210", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37257", - "standardCode": { - "id": "Code_44544", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_211", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37258", - "standardCode": { - "id": "Code_44545", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_212", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37259", - "standardCode": { - "id": "Code_44546", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_213", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37260", - "standardCode": { - "id": "Code_44547", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24548", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28666", - "extensionAttributes": [], - "code": "C117786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCF Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_45", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_33", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RRAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate RR Interval", - "label": "Aggregate RR Interval", - "synonyms": [ - "RR Interval Aggregate", - "RRAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117791", - "properties": [ - { - "id": "BiomedicalConceptProperty_214", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37261", - "standardCode": { - "id": "Code_44548", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_215", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37262", - "standardCode": { - "id": "Code_44549", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_216", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37263", - "standardCode": { - "id": "Code_44550", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_217", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2457", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_32362", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37264", - "standardCode": { - "id": "Code_44551", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_218", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37265", - "standardCode": { - "id": "Code_44552", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_219", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37266", - "standardCode": { - "id": "Code_44553", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_220", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_2657", - "instanceType": "ResponseCode", - "name": "breaths/min", - "label": "breaths/min", - "isEnabled": true, - "code": { - "id": "Code_37230", - "extensionAttributes": [], - "code": "C49674", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "breaths/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37267", - "standardCode": { - "id": "Code_44554", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24549", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28667", - "extensionAttributes": [], - "code": "C117791", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Aggregate RR Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_46", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_34", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGHRMN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Mean Heart Rate by Electrocardiogram", - "label": "Mean Heart Rate by Electrocardiogram", - "synonyms": [ - "ECG Mean Heart Rate", - "EKG Mean Heart Rate", - "EGHRMN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C119259", - "properties": [ - { - "id": "BiomedicalConceptProperty_221", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37268", - "standardCode": { - "id": "Code_44555", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_222", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3028", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_42741", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37269", - "standardCode": { - "id": "Code_44556", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_223", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37270", - "standardCode": { - "id": "Code_44557", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_224", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37271", - "standardCode": { - "id": "Code_44558", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_225", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37272", - "standardCode": { - "id": "Code_44559", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_226", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_2855", - "instanceType": "ResponseCode", - "name": "breaths/min", - "label": "breaths/min", - "isEnabled": true, - "code": { - "id": "Code_41016", - "extensionAttributes": [], - "code": "C49674", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "breaths/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37273", - "standardCode": { - "id": "Code_44560", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24550", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28668", - "extensionAttributes": [], - "code": "C119259", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Mean Heart Rate by Electrocardiogram", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_47", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_35", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QRS_AXIS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "QRS Axis", - "label": "QRS Axis", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C118165", - "properties": [ - { - "id": "BiomedicalConceptProperty_227", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37274", - "standardCode": { - "id": "Code_44561", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_228", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2777", - "instanceType": "ResponseCode", - "name": "deg", - "label": "deg", - "isEnabled": true, - "code": { - "id": "Code_38408", - "extensionAttributes": [], - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "deg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37275", - "standardCode": { - "id": "Code_44562", - "extensionAttributes": [], - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Degree Unit of Plane Angle", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_229", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37276", - "standardCode": { - "id": "Code_44563", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_230", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37277", - "standardCode": { - "id": "Code_44564", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_231", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37278", - "standardCode": { - "id": "Code_44565", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_232", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37279", - "standardCode": { - "id": "Code_44566", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24551", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28669", - "extensionAttributes": [], - "code": "C118165", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QRS Axis", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_48", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_36", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCUNSAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "QTc Correction Method Unspecified, Aggregate", - "label": "QTc Correction Method Unspecified, Aggregate", - "synonyms": [ - "QTCUNSAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C174285", - "properties": [ - { - "id": "BiomedicalConceptProperty_233", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37280", - "standardCode": { - "id": "Code_44567", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_234", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37281", - "standardCode": { - "id": "Code_44568", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_235", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37282", - "standardCode": { - "id": "Code_44569", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_236", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37283", - "standardCode": { - "id": "Code_44570", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_237", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37284", - "standardCode": { - "id": "Code_44571", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_238", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37285", - "standardCode": { - "id": "Code_44572", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_239", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37286", - "standardCode": { - "id": "Code_44573", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24552", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28670", - "extensionAttributes": [], - "code": "C174285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QTc Correction Method Unspecified, Aggregate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_49", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_37", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VTARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ventricular Arrhythmia ECG Assessment", - "label": "Ventricular Arrhythmia ECG Assessment", - "synonyms": [ - "VTARRY", - "Ventricular Arrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111330", - "properties": [ - { - "id": "BiomedicalConceptProperty_240", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37287", - "standardCode": { - "id": "Code_44574", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_241", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37288", - "standardCode": { - "id": "Code_44575", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_242", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37289", - "standardCode": { - "id": "Code_44576", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_243", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37290", - "standardCode": { - "id": "Code_44577", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_244", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37291", - "standardCode": { - "id": "Code_44578", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24553", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28671", - "extensionAttributes": [], - "code": "C111330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Arrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_50", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_38", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VTTARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ventricular Tachyarrhythmia ECG Assessment", - "label": "Ventricular Tachyarrhythmia ECG Assessment", - "synonyms": [ - "VTTARRY", - "Ventricular Tachyarrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111331", - "properties": [ - { - "id": "BiomedicalConceptProperty_245", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37292", - "standardCode": { - "id": "Code_44579", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_246", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37293", - "standardCode": { - "id": "Code_44580", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_247", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37294", - "standardCode": { - "id": "Code_44581", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_248", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37295", - "standardCode": { - "id": "Code_44582", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_249", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37296", - "standardCode": { - "id": "Code_44583", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24554", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28672", - "extensionAttributes": [], - "code": "C111331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Tachyarrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_51", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_39", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CTSCANCHEST", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Computed Tomography", - "label": "Computed Tomography", - "synonyms": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "id": "BiomedicalConceptProperty_250", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37297", - "standardCode": { - "id": "Code_44584", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_251", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3029", - "instanceType": "ResponseCode", - "name": "CT SCAN", - "label": "CT SCAN", - "isEnabled": true, - "code": { - "id": "Code_42771", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "CT SCAN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37298", - "standardCode": { - "id": "Code_44585", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_252", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37299", - "standardCode": { - "id": "Code_44586", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_253", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37300", - "standardCode": { - "id": "Code_44587", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_254", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3030", - "instanceType": "ResponseCode", - "name": "CHEST", - "label": "CHEST", - "isEnabled": true, - "code": { - "id": "Code_42775", - "extensionAttributes": [], - "code": "C25389", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "CHEST", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37301", - "standardCode": { - "id": "Code_44588", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_255", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37302", - "standardCode": { - "id": "Code_44589", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_256", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37303", - "standardCode": { - "id": "Code_44590", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_28017", - "extensionAttributes": [], - "standardCode": { - "id": "Code_32135", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_52", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_40", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MRIBRAIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "synonyms": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "id": "BiomedicalConceptProperty_257", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37304", - "standardCode": { - "id": "Code_44591", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_258", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3031", - "instanceType": "ResponseCode", - "name": "MRI", - "label": "MRI", - "isEnabled": true, - "code": { - "id": "Code_43034", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37305", - "standardCode": { - "id": "Code_44592", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_259", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37306", - "standardCode": { - "id": "Code_44593", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_260", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37307", - "standardCode": { - "id": "Code_44594", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_261", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3032", - "instanceType": "ResponseCode", - "name": "BRAIN", - "label": "BRAIN", - "isEnabled": true, - "code": { - "id": "Code_43038", - "extensionAttributes": [], - "code": "C12439", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "BRAIN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37308", - "standardCode": { - "id": "Code_44595", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_262", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37309", - "standardCode": { - "id": "Code_44596", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_263", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37310", - "standardCode": { - "id": "Code_44597", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_15783", - "extensionAttributes": [], - "standardCode": { - "id": "Code_16598", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_54", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "synonyms": [ - "CMYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [ - { - "id": "BiomedicalConceptProperty_264", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37311", - "standardCode": { - "id": "Code_44598", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_265", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37312", - "standardCode": { - "id": "Code_44599", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24555", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28673", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_55", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_41", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMFREE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "synonyms": [ - "Concomitant Medication" - ], - "reference": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ - { - "id": "BiomedicalConceptProperty_266", - "extensionAttributes": [], - "name": "CMTRT", - "label": "CMTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37313", - "standardCode": { - "id": "Code_44600", - "extensionAttributes": [], - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_267", - "extensionAttributes": [], - "name": "CMDECOD", - "label": "CMDECOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37314", - "standardCode": { - "id": "Code_44601", - "extensionAttributes": [], - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_268", - "extensionAttributes": [], - "name": "CMCLAS", - "label": "CMCLAS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37315", - "standardCode": { - "id": "Code_44602", - "extensionAttributes": [], - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_269", - "extensionAttributes": [], - "name": "CMINDC", - "label": "CMINDC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37316", - "standardCode": { - "id": "Code_44603", - "extensionAttributes": [], - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_270", - "extensionAttributes": [], - "name": "CMDOSE", - "label": "CMDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37317", - "standardCode": { - "id": "Code_44604", - "extensionAttributes": [], - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_271", - "extensionAttributes": [], - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37318", - "standardCode": { - "id": "Code_44605", - "extensionAttributes": [], - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_272", - "extensionAttributes": [], - "name": "CMDOSU", - "label": "CMDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37319", - "standardCode": { - "id": "Code_44606", - "extensionAttributes": [], - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_273", - "extensionAttributes": [], - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37320", - "standardCode": { - "id": "Code_44607", - "extensionAttributes": [], - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_274", - "extensionAttributes": [], - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37321", - "standardCode": { - "id": "Code_44608", - "extensionAttributes": [], - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_275", - "extensionAttributes": [], - "name": "CMROUTE", - "label": "CMROUTE", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37322", - "standardCode": { - "id": "Code_44609", - "extensionAttributes": [], - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_276", - "extensionAttributes": [], - "name": "CMSTDTC", - "label": "CMSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37323", - "standardCode": { - "id": "Code_44610", - "extensionAttributes": [], - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_277", - "extensionAttributes": [], - "name": "CMENDTC", - "label": "CMENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37324", - "standardCode": { - "id": "Code_44611", - "extensionAttributes": [], - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_278", - "extensionAttributes": [], - "name": "CMSTRF", - "label": "CMSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37325", - "standardCode": { - "id": "Code_44612", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_279", - "extensionAttributes": [], - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37326", - "standardCode": { - "id": "Code_44613", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_280", - "extensionAttributes": [], - "name": "CMSTTPT", - "label": "CMSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37327", - "standardCode": { - "id": "Code_44614", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_281", - "extensionAttributes": [], - "name": "CMENRF", - "label": "CMENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37328", - "standardCode": { - "id": "Code_44615", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_282", - "extensionAttributes": [], - "name": "CMENRTPT", - "label": "CMENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37329", - "standardCode": { - "id": "Code_44616", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_283", - "extensionAttributes": [], - "name": "CMENTPT", - "label": "CMENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37330", - "standardCode": { - "id": "Code_44617", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24556", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28674", - "extensionAttributes": [], - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_56", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_42", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HGBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hemoglobin Measurement", - "label": "Hemoglobin Measurement", - "synonyms": [ - "Hemoglobin", - "HGB" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64848", - "properties": [ - { - "id": "BiomedicalConceptProperty_284", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37331", - "standardCode": { - "id": "Code_44618", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_285", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37332", - "standardCode": { - "id": "Code_44619", - "extensionAttributes": [], - "code": "C64571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_286", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3033", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43064", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37333", - "standardCode": { - "id": "Code_44620", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_287", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37334", - "standardCode": { - "id": "Code_44621", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_288", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37335", - "standardCode": { - "id": "Code_44622", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24557", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28675", - "extensionAttributes": [], - "code": "C64848", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_57", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_43", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HCTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hematocrit Measurement", - "label": "Hematocrit Measurement", - "synonyms": [ - "Hematocrit", - "Packed Cell Volume", - "PCV", - "Erythrocyte Volume Fraction", - "EVF" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64796", - "properties": [ - { - "id": "BiomedicalConceptProperty_289", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37336", - "standardCode": { - "id": "Code_44623", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_290", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37337", - "standardCode": { - "id": "Code_44624", - "extensionAttributes": [], - "code": "C69174", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume Fraction", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_291", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2783", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_38477", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37338", - "standardCode": { - "id": "Code_44625", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_292", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37339", - "standardCode": { - "id": "Code_44626", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_293", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37340", - "standardCode": { - "id": "Code_44627", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24558", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28676", - "extensionAttributes": [], - "code": "C64796", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hematocrit Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_58", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_44", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "synonyms": [ - "RBC", - "Red Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ - { - "id": "BiomedicalConceptProperty_294", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37341", - "standardCode": { - "id": "Code_44628", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_295", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37342", - "standardCode": { - "id": "Code_44629", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_296", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3034", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43075", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37343", - "standardCode": { - "id": "Code_44630", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_297", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37344", - "standardCode": { - "id": "Code_44631", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_298", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37345", - "standardCode": { - "id": "Code_44632", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24559", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28677", - "extensionAttributes": [], - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_59", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_45", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MCH", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Mean Corpuscular Hemoglobin", - "label": "Erythrocyte Mean Corpuscular Hemoglobin", - "synonyms": [ - "RBC Mean Corpuscular Hemoglobin", - "MCH" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64797", - "properties": [ - { - "id": "BiomedicalConceptProperty_299", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37346", - "standardCode": { - "id": "Code_44633", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_300", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37347", - "standardCode": { - "id": "Code_44634", - "extensionAttributes": [], - "code": "C25709", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Measure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_301", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2785", - "instanceType": "ResponseCode", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "isEnabled": true, - "code": { - "id": "Code_38489", - "extensionAttributes": [], - "code": "C12521", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ERYTHROCYTES", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37348", - "standardCode": { - "id": "Code_44635", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_302", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37349", - "standardCode": { - "id": "Code_44636", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_303", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37350", - "standardCode": { - "id": "Code_44637", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24560", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28678", - "extensionAttributes": [], - "code": "C64797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Hemoglobin", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_60", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_46", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MCV", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Mean Corpuscular Volume", - "label": "Erythrocyte Mean Corpuscular Volume", - "synonyms": [ - "RBC Mean Corpuscular Volume", - "MCV" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64799", - "properties": [ - { - "id": "BiomedicalConceptProperty_304", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37351", - "standardCode": { - "id": "Code_44638", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_305", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3035", - "instanceType": "ResponseCode", - "name": "fL", - "label": "fL", - "isEnabled": true, - "code": { - "id": "Code_43085", - "extensionAttributes": [], - "code": "C64780", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "fL", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37352", - "standardCode": { - "id": "Code_44639", - "extensionAttributes": [], - "code": "C44279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_306", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3036", - "instanceType": "ResponseCode", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "isEnabled": true, - "code": { - "id": "Code_43087", - "extensionAttributes": [], - "code": "C12521", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ERYTHROCYTES", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37353", - "standardCode": { - "id": "Code_44640", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_307", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37354", - "standardCode": { - "id": "Code_44641", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_308", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37355", - "standardCode": { - "id": "Code_44642", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24561", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28679", - "extensionAttributes": [], - "code": "C64799", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Volume", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_61", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_47", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "synonyms": [ - "WBC", - "White Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [ - { - "id": "BiomedicalConceptProperty_309", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37356", - "standardCode": { - "id": "Code_44643", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_310", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37357", - "standardCode": { - "id": "Code_44644", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_311", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2583", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_33937", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37358", - "standardCode": { - "id": "Code_44645", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_312", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37359", - "standardCode": { - "id": "Code_44646", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_313", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37360", - "standardCode": { - "id": "Code_44647", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24562", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28680", - "extensionAttributes": [], - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_62", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_48", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTSGBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Segmented Neutrophil Count", - "label": "Segmented Neutrophil Count", - "synonyms": [ - "Segmented Neutrophils", - "NEUTSG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81997", - "properties": [ - { - "id": "BiomedicalConceptProperty_314", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37361", - "standardCode": { - "id": "Code_44648", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_315", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3037", - "instanceType": "ResponseCode", - "name": "10^9/L", - "label": "10^9/L", - "isEnabled": true, - "code": { - "id": "Code_43097", - "extensionAttributes": [], - "code": "C67255", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^9/L", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37362", - "standardCode": { - "id": "Code_44649", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_316", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3038", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43099", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37363", - "standardCode": { - "id": "Code_44650", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_317", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37364", - "standardCode": { - "id": "Code_44651", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_318", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37365", - "standardCode": { - "id": "Code_44652", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24563", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28681", - "extensionAttributes": [], - "code": "C81997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Segmented Neutrophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_63", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_49", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Neutrophil Band Form Count", - "label": "Neutrophil Band Form Count", - "synonyms": [ - "Neutrophil Bands", - "Bands", - "NEUTB" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64830", - "properties": [ - { - "id": "BiomedicalConceptProperty_319", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37366", - "standardCode": { - "id": "Code_44653", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_320", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2789", - "instanceType": "ResponseCode", - "name": "10^6/L", - "label": "10^6/L", - "isEnabled": true, - "code": { - "id": "Code_38512", - "extensionAttributes": [], - "code": "C67452", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^6/L", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37367", - "standardCode": { - "id": "Code_44654", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_321", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2790", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_38514", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37368", - "standardCode": { - "id": "Code_44655", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_322", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37369", - "standardCode": { - "id": "Code_44656", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_323", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37370", - "standardCode": { - "id": "Code_44657", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24564", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28682", - "extensionAttributes": [], - "code": "C64830", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Neutrophil Band Form Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_64", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_50", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Absolute Neutrophil Count", - "label": "Absolute Neutrophil Count", - "synonyms": [ - "Neutrophils", - "Total Neutrophil Count", - "NEUT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C63321", - "properties": [ - { - "id": "BiomedicalConceptProperty_324", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37371", - "standardCode": { - "id": "Code_44658", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_325", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3039", - "instanceType": "ResponseCode", - "name": "10^9/L", - "label": "10^9/L", - "isEnabled": true, - "code": { - "id": "Code_43109", - "extensionAttributes": [], - "code": "C67255", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^9/L", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37372", - "standardCode": { - "id": "Code_44659", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_326", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3040", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43111", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37373", - "standardCode": { - "id": "Code_44660", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_327", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37374", - "standardCode": { - "id": "Code_44661", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_328", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37375", - "standardCode": { - "id": "Code_44662", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24565", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28683", - "extensionAttributes": [], - "code": "C63321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Neutrophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_65", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_51", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MONOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Monocyte Count", - "label": "Monocyte Count", - "synonyms": [ - "Monocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64823", - "properties": [ - { - "id": "BiomedicalConceptProperty_329", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37376", - "standardCode": { - "id": "Code_44663", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_330", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37377", - "standardCode": { - "id": "Code_44664", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_331", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2791", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_38525", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37378", - "standardCode": { - "id": "Code_44665", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_332", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37379", - "standardCode": { - "id": "Code_44666", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_333", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37380", - "standardCode": { - "id": "Code_44667", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24566", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28684", - "extensionAttributes": [], - "code": "C64823", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Monocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_66", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_52", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EOSBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Eosinophil Count", - "label": "Eosinophil Count", - "synonyms": [ - "Eosinophils" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64550", - "properties": [ - { - "id": "BiomedicalConceptProperty_334", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37381", - "standardCode": { - "id": "Code_44668", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_335", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37382", - "standardCode": { - "id": "Code_44669", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_336", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3041", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43122", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37383", - "standardCode": { - "id": "Code_44670", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_337", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37384", - "standardCode": { - "id": "Code_44671", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_338", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37385", - "standardCode": { - "id": "Code_44672", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24567", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28685", - "extensionAttributes": [], - "code": "C64550", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Eosinophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_67", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_53", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BASOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Absolute Basophil Count", - "label": "Absolute Basophil Count", - "synonyms": [ - "Basophils", - "Total Basophil Count" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64470", - "properties": [ - { - "id": "BiomedicalConceptProperty_339", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37386", - "standardCode": { - "id": "Code_44673", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_340", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37387", - "standardCode": { - "id": "Code_44674", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_341", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2592", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_33976", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37388", - "standardCode": { - "id": "Code_44675", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_342", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37389", - "standardCode": { - "id": "Code_44676", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_343", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37390", - "standardCode": { - "id": "Code_44677", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3354", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3564", - "extensionAttributes": [], - "code": "C64470", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Basophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_68", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_54", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PLATBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Platelet Count", - "label": "Platelet Count", - "synonyms": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ - { - "id": "BiomedicalConceptProperty_344", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37391", - "standardCode": { - "id": "Code_44678", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_345", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37392", - "standardCode": { - "id": "Code_44679", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_346", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2793", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_38542", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37393", - "standardCode": { - "id": "Code_44680", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_347", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37394", - "standardCode": { - "id": "Code_44681", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_348", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37395", - "standardCode": { - "id": "Code_44682", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24568", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28686", - "extensionAttributes": [], - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_69", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_55", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MICROCYBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Microcyte Count", - "label": "Microcyte Count", - "synonyms": [ - "Microcytes", - "MICROCY" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64822", - "properties": [ - { - "id": "BiomedicalConceptProperty_349", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37396", - "standardCode": { - "id": "Code_44683", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_350", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3042", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43137", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37397", - "standardCode": { - "id": "Code_44684", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_351", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37398", - "standardCode": { - "id": "Code_44685", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_352", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37399", - "standardCode": { - "id": "Code_44686", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24569", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28687", - "extensionAttributes": [], - "code": "C64822", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Microcyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_70", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_56", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MACROCYBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Macrocyte Count", - "label": "Macrocyte Count", - "synonyms": [ - "Macrocytes", - "MACROCY" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64821", - "properties": [ - { - "id": "BiomedicalConceptProperty_353", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37400", - "standardCode": { - "id": "Code_44687", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_354", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3043", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43142", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37401", - "standardCode": { - "id": "Code_44688", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_355", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37402", - "standardCode": { - "id": "Code_44689", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_356", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37403", - "standardCode": { - "id": "Code_44690", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24570", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28688", - "extensionAttributes": [], - "code": "C64821", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Macrocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_71", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_57", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ANISOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Anisocyte Measurement", - "label": "Anisocyte Measurement", - "synonyms": [ - "Anisocytes", - "Anisocytosis", - "ANISO" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74797", - "properties": [ - { - "id": "BiomedicalConceptProperty_357", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37404", - "standardCode": { - "id": "Code_44691", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_358", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3044", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43147", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37405", - "standardCode": { - "id": "Code_44692", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_359", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37406", - "standardCode": { - "id": "Code_44693", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_360", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37407", - "standardCode": { - "id": "Code_44694", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24571", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28689", - "extensionAttributes": [], - "code": "C74797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anisocyte Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_72", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_58", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/POIKILOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Poikilocyte Measurement", - "label": "Poikilocyte Measurement", - "synonyms": [ - "POIKILO", - "Poikilocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C79602", - "properties": [ - { - "id": "BiomedicalConceptProperty_361", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37408", - "standardCode": { - "id": "Code_44695", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_362", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2796", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_38561", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37409", - "standardCode": { - "id": "Code_44696", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_363", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37410", - "standardCode": { - "id": "Code_44697", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_364", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37411", - "standardCode": { - "id": "Code_44698", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24572", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28690", - "extensionAttributes": [], - "code": "C79602", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Poikilocyte Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_73", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_59", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/POLYCHRBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Polychromasia", - "label": "Polychromasia", - "synonyms": [ - "POLYCHR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64803", - "properties": [ - { - "id": "BiomedicalConceptProperty_365", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37412", - "standardCode": { - "id": "Code_44699", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_366", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3045", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43156", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37413", - "standardCode": { - "id": "Code_44700", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_367", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37414", - "standardCode": { - "id": "Code_44701", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_368", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37415", - "standardCode": { - "id": "Code_44702", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24573", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28691", - "extensionAttributes": [], - "code": "C64803", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Polychromasia", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_74", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_60", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "synonyms": [ - "ALT", - "SGPT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ - { - "id": "BiomedicalConceptProperty_369", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37416", - "standardCode": { - "id": "Code_44703", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_370", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37417", - "standardCode": { - "id": "Code_44704", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_371", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2797", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_38571", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37418", - "standardCode": { - "id": "Code_44705", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_372", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37419", - "standardCode": { - "id": "Code_44706", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_373", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37420", - "standardCode": { - "id": "Code_44707", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24574", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28692", - "extensionAttributes": [], - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_75", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_61", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "synonyms": [ - "Albumin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ - { - "id": "BiomedicalConceptProperty_374", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37421", - "standardCode": { - "id": "Code_44708", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_375", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37422", - "standardCode": { - "id": "Code_44709", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_376", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2798", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_38577", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37423", - "standardCode": { - "id": "Code_44710", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_377", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37424", - "standardCode": { - "id": "Code_44711", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_378", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37425", - "standardCode": { - "id": "Code_44712", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24575", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28693", - "extensionAttributes": [], - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_76", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_62", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "synonyms": [ - "Alkaline Phosphatase" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [ - { - "id": "BiomedicalConceptProperty_379", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37426", - "standardCode": { - "id": "Code_44713", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_380", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37427", - "standardCode": { - "id": "Code_44714", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_381", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3046", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_43172", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37428", - "standardCode": { - "id": "Code_44715", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_382", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37429", - "standardCode": { - "id": "Code_44716", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_383", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37430", - "standardCode": { - "id": "Code_44717", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24576", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28694", - "extensionAttributes": [], - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_77", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_63", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "synonyms": [ - "AST", - "SGOT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ - { - "id": "BiomedicalConceptProperty_384", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37431", - "standardCode": { - "id": "Code_44718", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_385", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37432", - "standardCode": { - "id": "Code_44719", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_386", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3047", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_43178", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37433", - "standardCode": { - "id": "Code_44720", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_387", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37434", - "standardCode": { - "id": "Code_44721", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_388", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37435", - "standardCode": { - "id": "Code_44722", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24577", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28695", - "extensionAttributes": [], - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_78", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_64", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "synonyms": [ - "Creatinine" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ - { - "id": "BiomedicalConceptProperty_908", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37966", - "standardCode": { - "id": "Code_45253", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_909", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37967", - "standardCode": { - "id": "Code_45254", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_910", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3095", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45256", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37968", - "standardCode": { - "id": "Code_45255", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_911", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37970", - "standardCode": { - "id": "Code_45257", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_912", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37971", - "standardCode": { - "id": "Code_45258", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3355", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3565", - "extensionAttributes": [], - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_79", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_65", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/KBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "synonyms": [ - "Potassium", - "K" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [ - { - "id": "BiomedicalConceptProperty_394", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37441", - "standardCode": { - "id": "Code_44728", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_395", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37442", - "standardCode": { - "id": "Code_44729", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_396", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2800", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_38599", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37443", - "standardCode": { - "id": "Code_44730", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_397", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37444", - "standardCode": { - "id": "Code_44731", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_398", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37445", - "standardCode": { - "id": "Code_44732", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24578", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28696", - "extensionAttributes": [], - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_80", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_66", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "synonyms": [ - "Sodium", - "NA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [ - { - "id": "BiomedicalConceptProperty_399", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37446", - "standardCode": { - "id": "Code_44733", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_400", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37447", - "standardCode": { - "id": "Code_44734", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_401", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3049", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43195", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37448", - "standardCode": { - "id": "Code_44735", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_402", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37449", - "standardCode": { - "id": "Code_44736", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_403", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37450", - "standardCode": { - "id": "Code_44737", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24579", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28697", - "extensionAttributes": [], - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_81", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_67", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "synonyms": [ - "Urea Nitrogen" - ], - "reference": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [ - { - "id": "BiomedicalConceptProperty_404", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37451", - "standardCode": { - "id": "Code_44738", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_405", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37452", - "standardCode": { - "id": "Code_44739", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_406", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2606", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_34055", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37453", - "standardCode": { - "id": "Code_44740", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_407", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37454", - "standardCode": { - "id": "Code_44741", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_408", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37455", - "standardCode": { - "id": "Code_44742", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24580", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28698", - "extensionAttributes": [], - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_82", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_68", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BICARBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Bicarbonate Measurement", - "label": "Bicarbonate Measurement", - "synonyms": [ - "Bicarbonate", - "HCO3" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74667", - "properties": [ - { - "id": "BiomedicalConceptProperty_409", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37456", - "standardCode": { - "id": "Code_44743", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_410", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37457", - "standardCode": { - "id": "Code_44744", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_411", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2607", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_34061", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37458", - "standardCode": { - "id": "Code_44745", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_412", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37459", - "standardCode": { - "id": "Code_44746", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_413", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37460", - "standardCode": { - "id": "Code_44747", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24581", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28699", - "extensionAttributes": [], - "code": "C74667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Bicarbonate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_83", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_69", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CLBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "synonyms": [ - "Chloride", - "CL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [ - { - "id": "BiomedicalConceptProperty_414", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37461", - "standardCode": { - "id": "Code_44748", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_415", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37462", - "standardCode": { - "id": "Code_44749", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_416", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3050", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43211", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37463", - "standardCode": { - "id": "Code_44750", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_417", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37464", - "standardCode": { - "id": "Code_44751", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_418", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37465", - "standardCode": { - "id": "Code_44752", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24582", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28700", - "extensionAttributes": [], - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_84", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_70", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "synonyms": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "id": "BiomedicalConceptProperty_419", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37466", - "standardCode": { - "id": "Code_44753", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_420", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37467", - "standardCode": { - "id": "Code_44754", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_421", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2802", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_38626", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37468", - "standardCode": { - "id": "Code_44755", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_422", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37469", - "standardCode": { - "id": "Code_44756", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_423", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37470", - "standardCode": { - "id": "Code_44757", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24583", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28701", - "extensionAttributes": [], - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_85", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_71", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GGTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Gamma Glutamyl Transpeptidase Measurement", - "label": "Gamma Glutamyl Transpeptidase Measurement", - "synonyms": [ - "Gamma Glutamyl Transferase", - "GGT", - "GGTP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64847", - "properties": [ - { - "id": "BiomedicalConceptProperty_913", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37972", - "standardCode": { - "id": "Code_45259", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_914", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37973", - "standardCode": { - "id": "Code_45260", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_915", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3096", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45262", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37974", - "standardCode": { - "id": "Code_45261", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_916", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37976", - "standardCode": { - "id": "Code_45263", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_917", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37977", - "standardCode": { - "id": "Code_45264", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_37996", - "extensionAttributes": [], - "standardCode": { - "id": "Code_45283", - "extensionAttributes": [], - "code": "C64847", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Gamma Glutamyl Transpeptidase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_86", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_72", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/URATESERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urate Measurement", - "label": "Urate Measurement", - "synonyms": [ - "Urate", - "Uric Acid" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [ - { - "id": "BiomedicalConceptProperty_429", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37476", - "standardCode": { - "id": "Code_44763", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_430", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37477", - "standardCode": { - "id": "Code_44764", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_431", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3051", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_43227", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37478", - "standardCode": { - "id": "Code_44765", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_432", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37479", - "standardCode": { - "id": "Code_44766", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_433", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37480", - "standardCode": { - "id": "Code_44767", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24584", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28702", - "extensionAttributes": [], - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_87", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_73", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHOSSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Phosphate Measurement", - "label": "Phosphate Measurement", - "synonyms": [ - "Phosphorus", - "Phosphate" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64857", - "properties": [ - { - "id": "BiomedicalConceptProperty_918", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37978", - "standardCode": { - "id": "Code_45265", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_919", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37979", - "standardCode": { - "id": "Code_45266", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_920", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3097", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45268", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37980", - "standardCode": { - "id": "Code_45267", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_921", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37982", - "standardCode": { - "id": "Code_45269", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_922", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37983", - "standardCode": { - "id": "Code_45270", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24585", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28703", - "extensionAttributes": [], - "code": "C64857", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Phosphate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_88", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_74", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CABLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "synonyms": [ - "Calcium", - "CA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [ - { - "id": "BiomedicalConceptProperty_923", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37984", - "standardCode": { - "id": "Code_45271", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_924", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37985", - "standardCode": { - "id": "Code_45272", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_925", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3098", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45274", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37986", - "standardCode": { - "id": "Code_45273", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_926", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37988", - "standardCode": { - "id": "Code_45275", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_927", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37989", - "standardCode": { - "id": "Code_45276", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24586", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28704", - "extensionAttributes": [], - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_89", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_75", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "synonyms": [ - "Glucose" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "id": "BiomedicalConceptProperty_444", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37491", - "standardCode": { - "id": "Code_44778", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_445", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37492", - "standardCode": { - "id": "Code_44779", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_446", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2471", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_32605", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37493", - "standardCode": { - "id": "Code_44780", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_447", - "extensionAttributes": [], - "name": "LBMETHOD", - "label": "LBMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37494", - "standardCode": { - "id": "Code_44781", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_448", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37495", - "standardCode": { - "id": "Code_44782", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_449", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37496", - "standardCode": { - "id": "Code_44783", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24587", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28705", - "extensionAttributes": [], - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_90", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_76", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "synonyms": [ - "Protein" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "id": "BiomedicalConceptProperty_450", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37497", - "standardCode": { - "id": "Code_44784", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_451", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37498", - "standardCode": { - "id": "Code_44785", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_452", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3052", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_43249", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37499", - "standardCode": { - "id": "Code_44786", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_453", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37500", - "standardCode": { - "id": "Code_44787", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_454", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_2858", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_41247", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37501", - "standardCode": { - "id": "Code_44788", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24588", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28706", - "extensionAttributes": [], - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_91", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_77", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "synonyms": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [ - { - "id": "BiomedicalConceptProperty_455", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37502", - "standardCode": { - "id": "Code_44789", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_456", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37503", - "standardCode": { - "id": "Code_44790", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_457", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2805", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_38665", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37504", - "standardCode": { - "id": "Code_44791", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_458", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37505", - "standardCode": { - "id": "Code_44792", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_459", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37506", - "standardCode": { - "id": "Code_44793", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24589", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28707", - "extensionAttributes": [], - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_92", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_78", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T3UPSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Triiodothyronine Uptake Measurement", - "label": "Triiodothyronine Uptake Measurement", - "synonyms": [ - "T3UP", - "T3U", - "Triiodothyronine Resin Uptake" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74748", - "properties": [ - { - "id": "BiomedicalConceptProperty_460", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37507", - "standardCode": { - "id": "Code_44794", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_461", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37508", - "standardCode": { - "id": "Code_44795", - "extensionAttributes": [], - "code": "C48570", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_462", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3053", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_43260", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37509", - "standardCode": { - "id": "Code_44796", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_463", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37510", - "standardCode": { - "id": "Code_44797", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_464", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37511", - "standardCode": { - "id": "Code_44798", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24590", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28708", - "extensionAttributes": [], - "code": "C74748", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Uptake Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_93", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_79", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T3SERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Triiodothyronine Measurement", - "label": "Triiodothyronine Measurement", - "synonyms": [ - "T3", - "Total T3" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74747", - "properties": [ - { - "id": "BiomedicalConceptProperty_928", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37990", - "standardCode": { - "id": "Code_45277", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_929", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37991", - "standardCode": { - "id": "Code_45278", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_930", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3099", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45280", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37992", - "standardCode": { - "id": "Code_45279", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_931", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37994", - "standardCode": { - "id": "Code_45281", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_932", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37995", - "standardCode": { - "id": "Code_45282", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24591", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28709", - "extensionAttributes": [], - "code": "C74747", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_94", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_80", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T4FRSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Free Thyroxine Measurement", - "label": "Free Thyroxine Measurement", - "synonyms": [ - "Free T4", - "T4FR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74786", - "properties": [ - { - "id": "BiomedicalConceptProperty_470", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37517", - "standardCode": { - "id": "Code_44804", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_471", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2479", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_32638", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37518", - "standardCode": { - "id": "Code_44805", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_472", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3054", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_43271", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37519", - "standardCode": { - "id": "Code_44806", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_473", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37520", - "standardCode": { - "id": "Code_44807", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_474", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37521", - "standardCode": { - "id": "Code_44808", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24592", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28710", - "extensionAttributes": [], - "code": "C74786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_95", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_81", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T4FRIDXSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Free Thyroxine Index", - "label": "Free Thyroxine Index", - "synonyms": [ - "T4FRIDX" - ], - "reference": "/mdr/bc/biomedicalconcepts/C170598", - "properties": [ - { - "id": "BiomedicalConceptProperty_475", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37522", - "standardCode": { - "id": "Code_44809", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_476", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3055", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_43276", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37523", - "standardCode": { - "id": "Code_44810", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_477", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37524", - "standardCode": { - "id": "Code_44811", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_478", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37525", - "standardCode": { - "id": "Code_44812", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24593", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28711", - "extensionAttributes": [], - "code": "C170598", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Index", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_96", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_82", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TSHBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Thyrotropin Measurement", - "label": "Thyrotropin Measurement", - "synonyms": [ - "TSH", - "Thyrotropin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64813", - "properties": [ - { - "id": "BiomedicalConceptProperty_479", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37526", - "standardCode": { - "id": "Code_44813", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_480", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37527", - "standardCode": { - "id": "Code_44814", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_481", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2481", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_32650", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37528", - "standardCode": { - "id": "Code_44815", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_482", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37529", - "standardCode": { - "id": "Code_44816", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_483", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37530", - "standardCode": { - "id": "Code_44817", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24594", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28712", - "extensionAttributes": [], - "code": "C64813", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Thyrotropin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_97", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_83", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VITB9BLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Folic Acid Measurement", - "label": "Folic Acid Measurement", - "synonyms": [ - "Folate", - "Folic Acid", - "Vitamin B9", - "VITB9" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74676", - "properties": [ - { - "id": "BiomedicalConceptProperty_484", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37531", - "standardCode": { - "id": "Code_44818", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_485", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37532", - "standardCode": { - "id": "Code_44819", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_486", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3056", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43287", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37533", - "standardCode": { - "id": "Code_44820", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_487", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37534", - "standardCode": { - "id": "Code_44821", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_488", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37535", - "standardCode": { - "id": "Code_44822", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3218", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3428", - "extensionAttributes": [], - "code": "C74676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Folic Acid Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_98", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_84", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VITB12BLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Vitamin B12 Measurement", - "label": "Vitamin B12 Measurement", - "synonyms": [ - "Cobalamin", - "Vitamin B12", - "VITB12" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64817", - "properties": [ - { - "id": "BiomedicalConceptProperty_489", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2483", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_32660", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37536", - "standardCode": { - "id": "Code_44823", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_490", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37537", - "standardCode": { - "id": "Code_44824", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_491", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2621", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_34155", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37538", - "standardCode": { - "id": "Code_44825", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_492", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37539", - "standardCode": { - "id": "Code_44826", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_493", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_2484", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_32665", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37540", - "standardCode": { - "id": "Code_44827", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24595", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28713", - "extensionAttributes": [], - "code": "C64817", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Vitamin B12 Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_99", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_85", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TPLAB", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Treponema pallidum Antibody Measurement", - "label": "Treponema pallidum Antibody Measurement", - "synonyms": [ - "TPLAB", - "Treponema pallidum Antibody", - "Syphilis Antibody" - ], - "reference": "/mdr/bc/biomedicalconcepts/C132388", - "properties": [ - { - "id": "BiomedicalConceptProperty_494", - "extensionAttributes": [], - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3057", - "instanceType": "ResponseCode", - "name": "DETECTION", - "label": "DETECTION", - "isEnabled": true, - "code": { - "id": "Code_43296", - "extensionAttributes": [], - "code": "C174330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "DETECTION", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37541", - "standardCode": { - "id": "Code_44828", - "extensionAttributes": [], - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_495", - "extensionAttributes": [], - "name": "MBORRES", - "label": "MBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37542", - "standardCode": { - "id": "Code_44829", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_496", - "extensionAttributes": [], - "name": "MBSPEC", - "label": "MBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3058", - "instanceType": "ResponseCode", - "name": "SERUM", - "label": "SERUM", - "isEnabled": true, - "code": { - "id": "Code_43299", - "extensionAttributes": [], - "code": "C13325", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37543", - "standardCode": { - "id": "Code_44830", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_497", - "extensionAttributes": [], - "name": "MBMETHOD", - "label": "MBMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37544", - "standardCode": { - "id": "Code_44831", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_498", - "extensionAttributes": [], - "name": "MBDTC", - "label": "MBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37545", - "standardCode": { - "id": "Code_44832", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24596", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28714", - "extensionAttributes": [], - "code": "C132388", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum Antibody Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_100", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_86", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TPADNA", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Treponema pallidum DNA Measurement", - "label": "Treponema pallidum DNA Measurement", - "synonyms": [ - "TPADNA", - "Syphilis DNA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C198341", - "properties": [ - { - "id": "BiomedicalConceptProperty_499", - "extensionAttributes": [], - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3059", - "instanceType": "ResponseCode", - "name": "DETECTION", - "label": "DETECTION", - "isEnabled": true, - "code": { - "id": "Code_43303", - "extensionAttributes": [], - "code": "C174330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "DETECTION", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37546", - "standardCode": { - "id": "Code_44833", - "extensionAttributes": [], - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_500", - "extensionAttributes": [], - "name": "MBORRES", - "label": "MBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37547", - "standardCode": { - "id": "Code_44834", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_501", - "extensionAttributes": [], - "name": "MBSPEC", - "label": "MBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37548", - "standardCode": { - "id": "Code_44835", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_502", - "extensionAttributes": [], - "name": "MBMETHOD", - "label": "MBMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3060", - "instanceType": "ResponseCode", - "name": "LINE PROBE ASSAY", - "label": "LINE PROBE ASSAY", - "isEnabled": true, - "code": { - "id": "Code_43307", - "extensionAttributes": [], - "code": "C102656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "LINE PROBE ASSAY", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37549", - "standardCode": { - "id": "Code_44836", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_503", - "extensionAttributes": [], - "name": "MBDTC", - "label": "MBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37550", - "standardCode": { - "id": "Code_44837", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24597", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28715", - "extensionAttributes": [], - "code": "C198341", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum DNA Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_101", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_87", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/COLORURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Color Assessment", - "label": "Color Assessment", - "synonyms": [ - "COLOR", - "Color" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [ - { - "id": "BiomedicalConceptProperty_504", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37551", - "standardCode": { - "id": "Code_44838", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_505", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3061", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_43311", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37552", - "standardCode": { - "id": "Code_44839", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_506", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37553", - "standardCode": { - "id": "Code_44840", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24598", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28716", - "extensionAttributes": [], - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_102", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_88", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Specific Gravity", - "label": "Specific Gravity", - "synonyms": [ - "SPGRAV" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ - { - "id": "BiomedicalConceptProperty_824", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37871", - "standardCode": { - "id": "Code_45158", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_825", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3084", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_45160", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37872", - "standardCode": { - "id": "Code_45159", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_826", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37874", - "standardCode": { - "id": "Code_45161", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_827", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37875", - "standardCode": { - "id": "Code_45162", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3219", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3429", - "extensionAttributes": [], - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_103", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_89", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Protein Measurement", - "label": null, - "synonyms": [ - "Protein" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "id": "BiomedicalConceptProperty_511", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37558", - "standardCode": { - "id": "Code_44845", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_512", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37559", - "standardCode": { - "id": "Code_44846", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_513", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3062", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_43320", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37560", - "standardCode": { - "id": "Code_44847", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_514", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37561", - "standardCode": { - "id": "Code_44848", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_515", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37562", - "standardCode": { - "id": "Code_44849", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24588", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28706", - "extensionAttributes": [], - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_104", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_144", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Glucose Measurement", - "label": null, - "synonyms": [ - "Glucose" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "id": "BiomedicalConceptProperty_828", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37876", - "standardCode": { - "id": "Code_45163", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_829", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37877", - "standardCode": { - "id": "Code_45164", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_830", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3085", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_45166", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37878", - "standardCode": { - "id": "Code_45165", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_831", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37880", - "standardCode": { - "id": "Code_45167", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_832", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37881", - "standardCode": { - "id": "Code_45168", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24587", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28705", - "extensionAttributes": [], - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_105", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_91", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/KETONESURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ketone Measurement", - "label": "Ketone Measurement", - "synonyms": [ - "Ketones" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64854", - "properties": [ - { - "id": "BiomedicalConceptProperty_521", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37568", - "standardCode": { - "id": "Code_44855", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_522", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37569", - "standardCode": { - "id": "Code_44856", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_523", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3063", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_43331", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37570", - "standardCode": { - "id": "Code_44857", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_524", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37571", - "standardCode": { - "id": "Code_44858", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_525", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37572", - "standardCode": { - "id": "Code_44859", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24599", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28717", - "extensionAttributes": [], - "code": "C64854", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Ketone Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_106", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_92", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Bilirubin Measurement", - "label": null, - "synonyms": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "id": "BiomedicalConceptProperty_526", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37573", - "standardCode": { - "id": "Code_44860", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_527", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37574", - "standardCode": { - "id": "Code_44861", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_528", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3064", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_43337", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37575", - "standardCode": { - "id": "Code_44862", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_529", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37576", - "standardCode": { - "id": "Code_44863", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_530", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37577", - "standardCode": { - "id": "Code_44864", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24583", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28701", - "extensionAttributes": [], - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_107", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_93", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/UROBILURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urobilinogen Measurement", - "label": "Urobilinogen Measurement", - "synonyms": [ - "Urobilinogen", - "UROBIL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64816", - "properties": [ - { - "id": "BiomedicalConceptProperty_531", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37578", - "standardCode": { - "id": "Code_44865", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_532", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37579", - "standardCode": { - "id": "Code_44866", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_533", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3065", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_43343", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37580", - "standardCode": { - "id": "Code_44867", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_534", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37581", - "standardCode": { - "id": "Code_44868", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_535", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37582", - "standardCode": { - "id": "Code_44869", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24600", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28718", - "extensionAttributes": [], - "code": "C64816", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urobilinogen Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_108", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_94", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/OCCBLDSTOOL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Occult Blood Measurement", - "label": "Occult Blood Measurement", - "synonyms": [ - "Occult Blood", - "OCCBLD" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74686", - "properties": [ - { - "id": "BiomedicalConceptProperty_536", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37583", - "standardCode": { - "id": "Code_44870", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_537", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3066", - "instanceType": "ResponseCode", - "name": "STOOL", - "label": "STOOL", - "isEnabled": true, - "code": { - "id": "Code_43348", - "extensionAttributes": [], - "code": "C13234", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "STOOL", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37584", - "standardCode": { - "id": "Code_44871", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_538", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37585", - "standardCode": { - "id": "Code_44872", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_539", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37586", - "standardCode": { - "id": "Code_44873", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3356", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3566", - "extensionAttributes": [], - "code": "C74686", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occult Blood Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_109", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_95", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NITRITEURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Nitrite Measurement", - "label": "Nitrite Measurement", - "synonyms": [ - "NITRITE" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64810", - "properties": [ - { - "id": "BiomedicalConceptProperty_833", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37882", - "standardCode": { - "id": "Code_45169", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_834", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37883", - "standardCode": { - "id": "Code_45170", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_835", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3086", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_45172", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37884", - "standardCode": { - "id": "Code_45171", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_836", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37886", - "standardCode": { - "id": "Code_45173", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_837", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37887", - "standardCode": { - "id": "Code_45174", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3357", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3567", - "extensionAttributes": [], - "code": "C64810", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Nitrite Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_110", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_96", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HBA1CBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hemoglobin A1C Measurement", - "label": "Hemoglobin A1C Measurement", - "synonyms": [ - "Hemoglobin A1C", - "HBA1C", - "Glycosylated Hemoglobin A1C" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64849", - "properties": [ - { - "id": "BiomedicalConceptProperty_545", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37592", - "standardCode": { - "id": "Code_44879", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_546", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2819", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_38768", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37593", - "standardCode": { - "id": "Code_44880", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_547", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37594", - "standardCode": { - "id": "Code_44881", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_548", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37595", - "standardCode": { - "id": "Code_44882", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24601", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28719", - "extensionAttributes": [], - "code": "C64849", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin A1C Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_111", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_97", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HBA1CHGBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "label": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "synonyms": [ - "Hemoglobin A1C/Hemoglobin", - "HBA1CHGB" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111207", - "properties": [ - { - "id": "BiomedicalConceptProperty_549", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37596", - "standardCode": { - "id": "Code_44883", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_550", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3067", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_43362", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37597", - "standardCode": { - "id": "Code_44884", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_551", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37598", - "standardCode": { - "id": "Code_44885", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_552", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37599", - "standardCode": { - "id": "Code_44886", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24602", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28720", - "extensionAttributes": [], - "code": "C111207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_112", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_98", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EXPOSCOLL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Exposure as Collected Domain", - "label": "Exposure as Collected Domain", - "synonyms": [ - "EC", - "Exposure as Collected" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117466", - "properties": [ - { - "id": "BiomedicalConceptProperty_553", - "extensionAttributes": [], - "name": "ECTRT", - "label": "ECTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2685", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_37592", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37600", - "standardCode": { - "id": "Code_44887", - "extensionAttributes": [], - "code": "C117473", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Name of Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_554", - "extensionAttributes": [], - "name": "ECREFID", - "label": "ECREFID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37601", - "standardCode": { - "id": "Code_44888", - "extensionAttributes": [], - "code": "C117469", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Reference Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_555", - "extensionAttributes": [], - "name": "ECDOSE", - "label": "ECDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37602", - "standardCode": { - "id": "Code_44889", - "extensionAttributes": [], - "code": "C117479", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_556", - "extensionAttributes": [], - "name": "ECDOSTXT", - "label": "ECDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37603", - "standardCode": { - "id": "Code_44890", - "extensionAttributes": [], - "code": "C117480", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_557", - "extensionAttributes": [], - "name": "ECDOSU", - "label": "ECDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37604", - "standardCode": { - "id": "Code_44891", - "extensionAttributes": [], - "code": "C117481", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Units", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_558", - "extensionAttributes": [], - "name": "ECDOSFRM", - "label": "ECDOSFRM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37605", - "standardCode": { - "id": "Code_44892", - "extensionAttributes": [], - "code": "C117482", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Form", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_559", - "extensionAttributes": [], - "name": "ECDOSFRQ", - "label": "ECDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37606", - "standardCode": { - "id": "Code_44893", - "extensionAttributes": [], - "code": "C117483", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dosing Frequency per Interval", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_560", - "extensionAttributes": [], - "name": "ECDOSRGM", - "label": "ECDOSRGM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37607", - "standardCode": { - "id": "Code_44894", - "extensionAttributes": [], - "code": "C117485", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Intended Dose Regimen", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_561", - "extensionAttributes": [], - "name": "ECROUTE", - "label": "ECROUTE", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37608", - "standardCode": { - "id": "Code_44895", - "extensionAttributes": [], - "code": "C117486", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Route of Administration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_562", - "extensionAttributes": [], - "name": "ECLOC", - "label": "ECLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2687", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_37603", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37609", - "standardCode": { - "id": "Code_44896", - "extensionAttributes": [], - "code": "C117488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Location", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_563", - "extensionAttributes": [], - "name": "ECLAT", - "label": "ECLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37610", - "standardCode": { - "id": "Code_44897", - "extensionAttributes": [], - "code": "C117489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_564", - "extensionAttributes": [], - "name": "ECDIR", - "label": "ECDIR", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37611", - "standardCode": { - "id": "Code_44898", - "extensionAttributes": [], - "code": "C117490", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Directionality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_565", - "extensionAttributes": [], - "name": "ECSTDTC", - "label": "ECSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37612", - "standardCode": { - "id": "Code_44899", - "extensionAttributes": [], - "code": "C117496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Start Date and Time of Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_566", - "extensionAttributes": [], - "name": "ECENDTC", - "label": "ECENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_2688", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_37608", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37613", - "standardCode": { - "id": "Code_44900", - "extensionAttributes": [], - "code": "C117497", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected End Date and Time of Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24603", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28721", - "extensionAttributes": [], - "code": "C117466", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Exposure as Collected Domain", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_113", - "extensionAttributes": [], - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "id": "BiomedicalConceptProperty_567", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37614", - "standardCode": { - "id": "Code_44901", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_568", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37615", - "standardCode": { - "id": "Code_44902", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_569", - "extensionAttributes": [], - "name": "Test Occurrence", - "label": "Test Occurrence", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37616", - "standardCode": { - "id": "Code_44903", - "extensionAttributes": [], - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24604", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28722", - "extensionAttributes": [], - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_114", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_99", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYACCEPTABILITY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Acceptability", - "label": "TTS Acceptability Survey - Patch Acceptability", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT4", - "properties": [ - { - "id": "BiomedicalConceptProperty_570", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [ - { - "id": "ResponseCode_2689", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_37613", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37617", - "standardCode": { - "id": "Code_44904", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_571", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37618", - "standardCode": { - "id": "Code_44905", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_572", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2821", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_38796", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37619", - "standardCode": { - "id": "Code_44906", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24605", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28723", - "extensionAttributes": [], - "code": "NEW_LZZT4", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Acceptability", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_115", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_100", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYAPPEARANCE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Appearance", - "label": "TTS Acceptability Survey - Patch Appearance", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT1", - "properties": [ - { - "id": "BiomedicalConceptProperty_573", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37620", - "standardCode": { - "id": "Code_44907", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_574", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_2690", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_37618", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37621", - "standardCode": { - "id": "Code_44908", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_575", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2822", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_38800", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37622", - "standardCode": { - "id": "Code_44909", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24606", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28724", - "extensionAttributes": [], - "code": "NEW_LZZT1", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Appearance", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_116", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_101", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYDURABILITY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Durability", - "label": "TTS Acceptability Survey - Patch Durability", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT3", - "properties": [ - { - "id": "BiomedicalConceptProperty_576", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37623", - "standardCode": { - "id": "Code_44910", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_577", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37624", - "standardCode": { - "id": "Code_44911", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_578", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3068", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_43391", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37625", - "standardCode": { - "id": "Code_44912", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24607", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28725", - "extensionAttributes": [], - "code": "NEW_LZZT3", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Durability", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_117", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_102", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYSIZE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Size", - "label": "TTS Acceptability Survey - Patch Size", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT2", - "properties": [ - { - "id": "BiomedicalConceptProperty_579", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37626", - "standardCode": { - "id": "Code_44913", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_580", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37627", - "standardCode": { - "id": "Code_44914", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_581", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3069", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_43395", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37628", - "standardCode": { - "id": "Code_44915", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24608", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28726", - "extensionAttributes": [], - "code": "NEW_LZZT2", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Size", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_134", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "synonyms": [ - "AEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "id": "BiomedicalConceptProperty_582", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37629", - "standardCode": { - "id": "Code_44916", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_583", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37630", - "standardCode": { - "id": "Code_44917", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24609", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28727", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_135", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_103", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Solicited Adverse Event", - "label": "Solicited Adverse Event", - "synonyms": [ - "Adverse Event" - ], - "reference": "/mdr/bc/biomedicalconcepts/C179175", - "properties": [ - { - "id": "BiomedicalConceptProperty_584", - "extensionAttributes": [], - "name": "AETERM", - "label": "AETERM", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37631", - "standardCode": { - "id": "Code_44918", - "extensionAttributes": [], - "code": "C78541", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Verbatim Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_585", - "extensionAttributes": [], - "name": "AEDECOD", - "label": "AEDECOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37632", - "standardCode": { - "id": "Code_44919", - "extensionAttributes": [], - "code": "C83344", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_586", - "extensionAttributes": [], - "name": "AELOC", - "label": "AELOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37633", - "standardCode": { - "id": "Code_44920", - "extensionAttributes": [], - "code": "C83205", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Location", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_587", - "extensionAttributes": [], - "name": "AESEV", - "label": "AESEV", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37634", - "standardCode": { - "id": "Code_44921", - "extensionAttributes": [], - "code": "C53253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Severity of Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_588", - "extensionAttributes": [], - "name": "AESER", - "label": "AESER", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [ - { - "id": "ResponseCode_2693", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_37635", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37635", - "standardCode": { - "id": "Code_44922", - "extensionAttributes": [], - "code": "C53252", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Seriousness of Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_589", - "extensionAttributes": [], - "name": "AEACN", - "label": "AEACN", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2872", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41396", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37636", - "standardCode": { - "id": "Code_44923", - "extensionAttributes": [], - "code": "C83013", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Action Taken with Study Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_590", - "extensionAttributes": [], - "name": "AEACNOTH", - "label": "AEACNOTH", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37637", - "standardCode": { - "id": "Code_44924", - "extensionAttributes": [], - "code": "C83109", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Other Actions taken in Response to Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_591", - "extensionAttributes": [], - "name": "AEREL", - "label": "AEREL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37638", - "standardCode": { - "id": "Code_44925", - "extensionAttributes": [], - "code": "C41358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Attribution to Product or Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_592", - "extensionAttributes": [], - "name": "AERELNST", - "label": "AERELNST", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37639", - "standardCode": { - "id": "Code_44926", - "extensionAttributes": [], - "code": "C83210", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Relationship to Non Study Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_593", - "extensionAttributes": [], - "name": "AEPATT", - "label": "AEPATT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37640", - "standardCode": { - "id": "Code_44927", - "extensionAttributes": [], - "code": "C83208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Pattern", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_594", - "extensionAttributes": [], - "name": "AEOUT", - "label": "AEOUT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37641", - "standardCode": { - "id": "Code_44928", - "extensionAttributes": [], - "code": "C49489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Outcome", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_595", - "extensionAttributes": [], - "name": "AESCAN", - "label": "AESCAN", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37642", - "standardCode": { - "id": "Code_44929", - "extensionAttributes": [], - "code": "C83211", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Involves Cancer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_596", - "extensionAttributes": [], - "name": "AESCONG", - "label": "AESCONG", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37643", - "standardCode": { - "id": "Code_44930", - "extensionAttributes": [], - "code": "C83117", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_597", - "extensionAttributes": [], - "name": "AESDISAB", - "label": "AESDISAB", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37644", - "standardCode": { - "id": "Code_44931", - "extensionAttributes": [], - "code": "C113380", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Disabling Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_598", - "extensionAttributes": [], - "name": "AESDTH", - "label": "AESDTH", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37645", - "standardCode": { - "id": "Code_44932", - "extensionAttributes": [], - "code": "C48275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Death Related to Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_599", - "extensionAttributes": [], - "name": "AESHOSP", - "label": "AESHOSP", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37646", - "standardCode": { - "id": "Code_44933", - "extensionAttributes": [], - "code": "C83052", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event associated with Hospitalization", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_600", - "extensionAttributes": [], - "name": "AESLIFE", - "label": "AESLIFE", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37647", - "standardCode": { - "id": "Code_44934", - "extensionAttributes": [], - "code": "C84266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Life Threatening Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_601", - "extensionAttributes": [], - "name": "AESOD", - "label": "AESOD", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37648", - "standardCode": { - "id": "Code_44935", - "extensionAttributes": [], - "code": "C83214", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Occurred with Overdose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_602", - "extensionAttributes": [], - "name": "AESMIE", - "label": "AESMIE", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37649", - "standardCode": { - "id": "Code_44936", - "extensionAttributes": [], - "code": "C83053", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Associated with Serious Medical Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_603", - "extensionAttributes": [], - "name": "AECONTRT", - "label": "AECONTRT", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37650", - "standardCode": { - "id": "Code_44937", - "extensionAttributes": [], - "code": "C83199", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Concomitant Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_604", - "extensionAttributes": [], - "name": "AETOXGR", - "label": "AETOXGR", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2876", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41415", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37651", - "standardCode": { - "id": "Code_44938", - "extensionAttributes": [], - "code": "C78605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Toxicity Grade", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_605", - "extensionAttributes": [], - "name": "AESTDTC", - "label": "AESTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37652", - "standardCode": { - "id": "Code_44939", - "extensionAttributes": [], - "code": "C83215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_606", - "extensionAttributes": [], - "name": "AEENDTC", - "label": "AEENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37653", - "standardCode": { - "id": "Code_44940", - "extensionAttributes": [], - "code": "C83201", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_607", - "extensionAttributes": [], - "name": "AEENRF", - "label": "AEENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37654", - "standardCode": { - "id": "Code_44941", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_608", - "extensionAttributes": [], - "name": "AEENRTPT", - "label": "AEENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37655", - "standardCode": { - "id": "Code_44942", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_609", - "extensionAttributes": [], - "name": "AEENTPT", - "label": "AEENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37656", - "standardCode": { - "id": "Code_44943", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24610", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28728", - "extensionAttributes": [], - "code": "C179175", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Adverse Event", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_136", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_104", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTCOMP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Complete", - "label": "Complete", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C25250", - "properties": [], - "code": { - "id": "AliasCode_24611", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28729", - "extensionAttributes": [], - "code": "C25250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Complete [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_137", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_105", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/FAILCONT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Failure To Meet Continuation Criteria", - "label": "Failure To Meet Continuation Criteria", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C139236", - "properties": [], - "code": { - "id": "AliasCode_24612", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28730", - "extensionAttributes": [], - "code": "C139236", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Failure To Meet Continuation Criteria [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_138", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_106", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DEAD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Dead", - "label": "Dead", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C28554", - "properties": [], - "code": { - "id": "AliasCode_24613", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28731", - "extensionAttributes": [], - "code": "C28554", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Dead [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_139", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_107", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/LACKEFFICACY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Lack of Efficacy", - "label": "Lack of Efficacy", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C48226", - "properties": [], - "code": { - "id": "AliasCode_24614", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28732", - "extensionAttributes": [], - "code": "C48226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lack of Efficacy [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_140", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_108", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/LTFUP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Lost To Follow-Up", - "label": "Lost To Follow-Up", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C48227", - "properties": [], - "code": { - "id": "AliasCode_24615", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28733", - "extensionAttributes": [], - "code": "C48227", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lost To Follow-Up [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_141", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_109", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "code": { - "id": "AliasCode_24616", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28734", - "extensionAttributes": [], - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_142", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_110", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHYDECISION", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Physician Decision", - "label": "Physician Decision", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C48250", - "properties": [], - "code": { - "id": "AliasCode_24617", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28735", - "extensionAttributes": [], - "code": "C48250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Physician Decision [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_143", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_111", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SUBJPREG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Pregnant Subject", - "label": "Pregnant Subject", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C191656", - "properties": [], - "code": { - "id": "AliasCode_24618", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28736", - "extensionAttributes": [], - "code": "C191656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Pregnant Subject [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_144", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_112", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROGDISEASE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Progressive Disease", - "label": "Progressive Disease", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C35571", - "properties": [], - "code": { - "id": "AliasCode_24619", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28737", - "extensionAttributes": [], - "code": "C35571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Progressive Disease [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_145", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_113", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTDEV", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Protocol Deviation", - "label": "Protocol Deviation", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C50996", - "properties": [], - "code": { - "id": "AliasCode_1747", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1937", - "extensionAttributes": [], - "code": "C50996", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Protocol Deviation", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_146", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_114", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SITETRANSFER", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Study Site Transfer", - "label": "Study Site Transfer", - "synonyms": [ - "Site Transfer", - "Study Subject Site Transfer" - ], - "reference": "/mdr/bc/biomedicalconcepts/C186208", - "properties": [ - { - "id": "BiomedicalConceptProperty_610", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3070", - "instanceType": "ResponseCode", - "name": "SITE TRANSFER", - "label": "SITE TRANSFER", - "isEnabled": true, - "code": { - "id": "Code_43425", - "extensionAttributes": [], - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SITE TRANSFER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37657", - "standardCode": { - "id": "Code_44944", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_611", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37658", - "standardCode": { - "id": "Code_44945", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_612", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37659", - "standardCode": { - "id": "Code_44946", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1753", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1943", - "extensionAttributes": [], - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Site Transfer", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_147", - "extensionAttributes": [], - "name": "Study Terminated By Sponsor", - "label": "Study Terminated By Sponsor", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C49632", - "properties": [], - "code": { - "id": "AliasCode_1758", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1948", - "extensionAttributes": [], - "code": "C49632", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Terminated By Sponsor", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_148", - "extensionAttributes": [], - "name": "Subject Removed at Sponsor Request", - "label": "Subject Removed at Sponsor Request", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C161410", - "properties": [], - "code": { - "id": "AliasCode_29205", - "extensionAttributes": [], - "standardCode": { - "id": "Code_33323", - "extensionAttributes": [], - "code": "C161410", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Subject Removed at Sponsor Request [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_149", - "extensionAttributes": [], - "name": "Trial Screen Failure", - "label": "Trial Screen Failure", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C49628", - "properties": [], - "code": { - "id": "AliasCode_1760", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1950", - "extensionAttributes": [], - "code": "C49628", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Screen Failure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_150", - "extensionAttributes": [], - "name": "Trial Site Terminated by Sponsor", - "label": "Trial Site Terminated by Sponsor", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C106576", - "properties": [], - "code": { - "id": "AliasCode_1761", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1951", - "extensionAttributes": [], - "code": "C106576", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Site Terminated by Sponsor", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_151", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_115", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SUBJWITHDRAW", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Withdrawal by Subject", - "label": "Withdrawal by Subject", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C49634", - "properties": [], - "code": { - "id": "AliasCode_1762", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1952", - "extensionAttributes": [], - "code": "C49634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Withdrawal by Subject", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_152", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_116", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSWDRL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Withdrawal of Consent From Protocol-Specified Activity", - "label": "Withdrawal of Consent From Protocol-Specified Activity", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C170610", - "properties": [ - { - "id": "BiomedicalConceptProperty_613", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2825", - "instanceType": "ResponseCode", - "name": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "label": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "isEnabled": true, - "code": { - "id": "Code_39422", - "extensionAttributes": [], - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37660", - "standardCode": { - "id": "Code_44947", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_614", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2879", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41428", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37661", - "standardCode": { - "id": "Code_44948", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_615", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37662", - "standardCode": { - "id": "Code_44949", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_33098", - "extensionAttributes": [], - "standardCode": { - "id": "Code_39422", - "extensionAttributes": [], - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_153", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_117", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "synonyms": [ - "SYSBP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "id": "BiomedicalConceptProperty_616", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [ - { - "id": "ResponseCode_2509", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_32836", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37663", - "standardCode": { - "id": "Code_44950", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_617", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3071", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_43433", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37664", - "standardCode": { - "id": "Code_44951", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_618", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37665", - "standardCode": { - "id": "Code_44952", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_619", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37666", - "standardCode": { - "id": "Code_44953", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_620", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37667", - "standardCode": { - "id": "Code_44954", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_621", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37668", - "standardCode": { - "id": "Code_44955", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1834", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2024", - "extensionAttributes": [], - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_154", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_118", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "synonyms": [ - "DIABP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "id": "BiomedicalConceptProperty_838", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37888", - "standardCode": { - "id": "Code_45175", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_839", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3087", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_45177", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37889", - "standardCode": { - "id": "Code_45176", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_840", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37891", - "standardCode": { - "id": "Code_45178", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_841", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37892", - "standardCode": { - "id": "Code_45179", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_842", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37893", - "standardCode": { - "id": "Code_45180", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_843", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37894", - "standardCode": { - "id": "Code_45181", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_26219", - "extensionAttributes": [], - "standardCode": { - "id": "Code_30337", - "extensionAttributes": [], - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_155", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_119", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Heart Rate", - "label": "Heart Rate", - "synonyms": [ - "HR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "id": "BiomedicalConceptProperty_628", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37675", - "standardCode": { - "id": "Code_44962", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_629", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3072", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_43446", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37676", - "standardCode": { - "id": "Code_44963", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_630", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37677", - "standardCode": { - "id": "Code_44964", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_631", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37678", - "standardCode": { - "id": "Code_44965", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_632", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37679", - "standardCode": { - "id": "Code_44966", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_633", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_2885", - "instanceType": "ResponseCode", - "name": "fL", - "label": "fL", - "isEnabled": true, - "code": { - "id": "Code_41453", - "extensionAttributes": [], - "code": "C64780", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "fL", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37680", - "standardCode": { - "id": "Code_44967", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1833", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2023", - "extensionAttributes": [], - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_156", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_120", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "synonyms": [ - "SYSBP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "id": "BiomedicalConceptProperty_634", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [ - { - "id": "ResponseCode_2886", - "instanceType": "ResponseCode", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "isEnabled": true, - "code": { - "id": "Code_41455", - "extensionAttributes": [], - "code": "C12521", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ERYTHROCYTES", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37681", - "standardCode": { - "id": "Code_44968", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_635", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2827", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_39446", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37682", - "standardCode": { - "id": "Code_44969", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_636", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37683", - "standardCode": { - "id": "Code_44970", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_637", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37684", - "standardCode": { - "id": "Code_44971", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_638", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37685", - "standardCode": { - "id": "Code_44972", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_639", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37686", - "standardCode": { - "id": "Code_44973", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1834", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2024", - "extensionAttributes": [], - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_157", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_121", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "synonyms": [ - "DIABP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "id": "BiomedicalConceptProperty_640", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37687", - "standardCode": { - "id": "Code_44974", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_641", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3073", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_43459", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37688", - "standardCode": { - "id": "Code_44975", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_642", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37689", - "standardCode": { - "id": "Code_44976", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_643", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37690", - "standardCode": { - "id": "Code_44977", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_644", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2888", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41467", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37691", - "standardCode": { - "id": "Code_44978", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_645", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37692", - "standardCode": { - "id": "Code_44979", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_26219", - "extensionAttributes": [], - "standardCode": { - "id": "Code_30337", - "extensionAttributes": [], - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_158", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_122", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Heart Rate", - "label": "Heart Rate", - "synonyms": [ - "HR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "id": "BiomedicalConceptProperty_646", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37693", - "standardCode": { - "id": "Code_44980", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_647", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3074", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_43466", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37694", - "standardCode": { - "id": "Code_44981", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_648", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37695", - "standardCode": { - "id": "Code_44982", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_649", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37696", - "standardCode": { - "id": "Code_44983", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_650", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37697", - "standardCode": { - "id": "Code_44984", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_651", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37698", - "standardCode": { - "id": "Code_44985", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1833", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2023", - "extensionAttributes": [], - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_159", - "extensionAttributes": [], - "name": "Isometric Muscle Strength", - "label": "Isometric Muscle Strength", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C138967", - "properties": [], - "code": { - "id": "AliasCode_2312", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2502", - "extensionAttributes": [], - "code": "C138967", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Isometric Muscle Strength", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_160", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_129", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SMMASS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Skeletal Muscle Mass Measurement", - "label": "Skeletal Muscle Mass Measurement", - "synonyms": [ - "SMMASS", - "Skeletal Muscle Mass" - ], - "reference": "/mdr/bc/biomedicalconcepts/C178017", - "properties": [ - { - "id": "BiomedicalConceptProperty_652", - "extensionAttributes": [], - "name": "MKORRES", - "label": "MKORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37699", - "standardCode": { - "id": "Code_44986", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_653", - "extensionAttributes": [], - "name": "MKORRESU", - "label": "MKORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2890", - "instanceType": "ResponseCode", - "name": "10^9/L", - "label": "10^9/L", - "isEnabled": true, - "code": { - "id": "Code_41478", - "extensionAttributes": [], - "code": "C67255", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^9/L", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37700", - "standardCode": { - "id": "Code_44987", - "extensionAttributes": [], - "code": "C42579", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_654", - "extensionAttributes": [], - "name": "MKLOC", - "label": "MKLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2891", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41480", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37701", - "standardCode": { - "id": "Code_44988", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_655", - "extensionAttributes": [], - "name": "MKLAT", - "label": "MKLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37702", - "standardCode": { - "id": "Code_44989", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_656", - "extensionAttributes": [], - "name": "MKMETHOD", - "label": "MKMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37703", - "standardCode": { - "id": "Code_44990", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_657", - "extensionAttributes": [], - "name": "MKDTC", - "label": "MKDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37704", - "standardCode": { - "id": "Code_44991", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2313", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2503", - "extensionAttributes": [], - "code": "C178017", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Skeletal Muscle Mass Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_161", - "extensionAttributes": [], - "name": "Muscle Endurance Measurement", - "label": "Muscle Endurance Measurement", - "synonyms": [ - "ENDURM", - "Muscle Endurance" - ], - "reference": "/mdr/bc/biomedicalconcepts/C181501", - "properties": [ - { - "id": "BiomedicalConceptProperty_844", - "extensionAttributes": [], - "name": "Observation Result", - "label": "Observation Result", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37895", - "standardCode": { - "id": "Code_45182", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_845", - "extensionAttributes": [], - "name": "Unit of Time", - "label": "Unit of Time", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37896", - "standardCode": { - "id": "Code_45183", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_846", - "extensionAttributes": [], - "name": "Anatomic Site", - "label": "Anatomic Site", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37897", - "standardCode": { - "id": "Code_45184", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_847", - "extensionAttributes": [], - "name": "Laterality", - "label": "Laterality", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37898", - "standardCode": { - "id": "Code_45185", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_848", - "extensionAttributes": [], - "name": "Test Method", - "label": "Test Method", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37899", - "standardCode": { - "id": "Code_45186", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_849", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37900", - "standardCode": { - "id": "Code_45187", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24620", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28738", - "extensionAttributes": [], - "code": "C181501", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Muscle Endurance Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_162", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_139", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGCTMON", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "synonyms": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "reference": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "id": "BiomedicalConceptProperty_850", - "extensionAttributes": [], - "name": "TSPARMCD", - "label": "TSPARMCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3088", - "instanceType": "ResponseCode", - "name": "EGCTMON", - "label": "EGCTMON", - "isEnabled": true, - "code": { - "id": "Code_45189", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "EGCTMON", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37901", - "standardCode": { - "id": "Code_45188", - "extensionAttributes": [], - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_851", - "extensionAttributes": [], - "name": "TSPARM", - "label": "TSPARM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3089", - "instanceType": "ResponseCode", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "isEnabled": true, - "code": { - "id": "Code_45191", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37903", - "standardCode": { - "id": "Code_45190", - "extensionAttributes": [], - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_852", - "extensionAttributes": [], - "name": "TSVAL", - "label": "TSVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37905", - "standardCode": { - "id": "Code_45192", - "extensionAttributes": [], - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_853", - "extensionAttributes": [], - "name": "TSVALCD", - "label": "TSVALCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37906", - "standardCode": { - "id": "Code_45193", - "extensionAttributes": [], - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_854", - "extensionAttributes": [], - "name": "TSVCDREF", - "label": "TSVCDREF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37907", - "standardCode": { - "id": "Code_45194", - "extensionAttributes": [], - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_855", - "extensionAttributes": [], - "name": "TSVCDVER", - "label": "TSVCDVER", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37908", - "standardCode": { - "id": "Code_45195", - "extensionAttributes": [], - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2311", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2501", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_164", - "extensionAttributes": [], - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "id": "BiomedicalConceptProperty_670", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3075", - "instanceType": "ResponseCode", - "name": "EGCTMON", - "label": "EGCTMON", - "isEnabled": true, - "code": { - "id": "Code_43490", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "EGCTMON", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37717", - "standardCode": { - "id": "Code_45004", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_671", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_3076", - "instanceType": "ResponseCode", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "isEnabled": true, - "code": { - "id": "Code_43492", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37718", - "standardCode": { - "id": "Code_45005", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_672", - "extensionAttributes": [], - "name": "Test Occurrence", - "label": "Test Occurrence", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37719", - "standardCode": { - "id": "Code_45006", - "extensionAttributes": [], - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24604", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28722", - "extensionAttributes": [], - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_165", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_141", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MRIBRAIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "synonyms": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "id": "BiomedicalConceptProperty_862", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37917", - "standardCode": { - "id": "Code_45204", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_863", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3092", - "instanceType": "ResponseCode", - "name": "MRI", - "label": "MRI", - "isEnabled": true, - "code": { - "id": "Code_45206", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37918", - "standardCode": { - "id": "Code_45205", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_864", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37920", - "standardCode": { - "id": "Code_45207", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_865", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37921", - "standardCode": { - "id": "Code_45208", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_866", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3093", - "instanceType": "ResponseCode", - "name": "BRAIN", - "label": "BRAIN", - "isEnabled": true, - "code": { - "id": "Code_45210", - "extensionAttributes": [], - "code": "C12439", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "BRAIN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37922", - "standardCode": { - "id": "Code_45209", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_867", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37924", - "standardCode": { - "id": "Code_45211", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_868", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37925", - "standardCode": { - "id": "Code_45212", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_15783", - "extensionAttributes": [], - "standardCode": { - "id": "Code_16598", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_166", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_142", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CTSCAN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Computed Tomography", - "label": "Computed Tomography", - "synonyms": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "id": "BiomedicalConceptProperty_869", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37926", - "standardCode": { - "id": "Code_45213", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_870", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3094", - "instanceType": "ResponseCode", - "name": "CT SCAN", - "label": "CT SCAN", - "isEnabled": true, - "code": { - "id": "Code_45215", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37927", - "standardCode": { - "id": "Code_45214", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_871", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37929", - "standardCode": { - "id": "Code_45216", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_872", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37930", - "standardCode": { - "id": "Code_45217", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_873", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37931", - "standardCode": { - "id": "Code_45218", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_874", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37932", - "standardCode": { - "id": "Code_45219", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_875", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37933", - "standardCode": { - "id": "Code_45220", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_28017", - "extensionAttributes": [], - "standardCode": { - "id": "Code_32135", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_168", - "extensionAttributes": [], - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "synonyms": [ - "Vital Signs", - "VS" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "code": { - "id": "AliasCode_24621", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28739", - "extensionAttributes": [], - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_169", - "extensionAttributes": [], - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "synonyms": [ - "Vital Signs", - "VS" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "code": { - "id": "AliasCode_24621", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28739", - "extensionAttributes": [], - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_170", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_143", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "code": { - "id": "AliasCode_24616", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28734", - "extensionAttributes": [], - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_171", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "synonyms": [ - "AEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "id": "BiomedicalConceptProperty_687", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3078", - "instanceType": "ResponseCode", - "name": "CT SCAN", - "label": "CT SCAN", - "isEnabled": true, - "code": { - "id": "Code_43510", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37734", - "standardCode": { - "id": "Code_45021", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_688", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37735", - "standardCode": { - "id": "Code_45022", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24609", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28727", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_172", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Word Recall Average Score", - "label": "CDISC ADAS-Cog - Word Recall Average Score", - "synonyms": [ - "ADCRL", - "Word Recall", - "CDISC ADAS-Cog - Word Recall Average Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100177", - "properties": [ - { - "id": "BiomedicalConceptProperty_689", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37736", - "standardCode": { - "id": "Code_45023", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_690", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37737", - "standardCode": { - "id": "Code_45024", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_691", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37738", - "standardCode": { - "id": "Code_45025", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_692", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2901", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41528", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37739", - "standardCode": { - "id": "Code_45026", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_693", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2714", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_37767", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37740", - "standardCode": { - "id": "Code_45027", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_694", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37741", - "standardCode": { - "id": "Code_45028", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_695", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37742", - "standardCode": { - "id": "Code_45029", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_696", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37743", - "standardCode": { - "id": "Code_45030", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24622", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28740", - "extensionAttributes": [], - "code": "C100177", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recall Average Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_173", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "label": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "synonyms": [ - "ADCOF", - "Naming Objects and Fingers", - "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100191", - "properties": [ - { - "id": "BiomedicalConceptProperty_697", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37744", - "standardCode": { - "id": "Code_45031", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_698", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37745", - "standardCode": { - "id": "Code_45032", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_699", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2715", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_37774", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37746", - "standardCode": { - "id": "Code_45033", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_700", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37747", - "standardCode": { - "id": "Code_45034", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_701", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2903", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41539", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37748", - "standardCode": { - "id": "Code_45035", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_702", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37749", - "standardCode": { - "id": "Code_45036", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_703", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37750", - "standardCode": { - "id": "Code_45037", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_704", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37751", - "standardCode": { - "id": "Code_45038", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27242", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31360", - "extensionAttributes": [], - "code": "C100191", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_174", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Commands Summary Score", - "label": "CDISC ADAS-Cog - Commands Summary Score", - "synonyms": [ - "ADCCMD", - "Commands", - "CDISC ADAS-Cog - Commands Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100209", - "properties": [ - { - "id": "BiomedicalConceptProperty_705", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37752", - "standardCode": { - "id": "Code_45039", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_706", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37753", - "standardCode": { - "id": "Code_45040", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_707", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37754", - "standardCode": { - "id": "Code_45041", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_708", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37755", - "standardCode": { - "id": "Code_45042", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_709", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2717", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_37786", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37756", - "standardCode": { - "id": "Code_45043", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_710", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2905", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41550", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37757", - "standardCode": { - "id": "Code_45044", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_711", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37758", - "standardCode": { - "id": "Code_45045", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_712", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37759", - "standardCode": { - "id": "Code_45046", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24623", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28741", - "extensionAttributes": [], - "code": "C100209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Commands Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_175", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "label": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "synonyms": [ - "ADCDRL", - "Delayed Word Recall", - "CDISC ADAS-Cog - Delayed Word Recall Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100215", - "properties": [ - { - "id": "BiomedicalConceptProperty_876", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37934", - "standardCode": { - "id": "Code_45221", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_877", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37935", - "standardCode": { - "id": "Code_45222", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_878", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37936", - "standardCode": { - "id": "Code_45223", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_879", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37937", - "standardCode": { - "id": "Code_45224", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_880", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37938", - "standardCode": { - "id": "Code_45225", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_881", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37939", - "standardCode": { - "id": "Code_45226", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_882", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37940", - "standardCode": { - "id": "Code_45227", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_883", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37941", - "standardCode": { - "id": "Code_45228", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27243", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31361", - "extensionAttributes": [], - "code": "C100215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_176", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "label": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "synonyms": [ - "ADCCP", - "Constructional Praxis", - "CDISC ADAS-Cog - Constructional Praxis Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100226", - "properties": [ - { - "id": "BiomedicalConceptProperty_721", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37768", - "standardCode": { - "id": "Code_45055", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_722", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2908", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41565", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37769", - "standardCode": { - "id": "Code_45056", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_723", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_2720", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_37803", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37770", - "standardCode": { - "id": "Code_45057", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_724", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37771", - "standardCode": { - "id": "Code_45058", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_725", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37772", - "standardCode": { - "id": "Code_45059", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_726", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37773", - "standardCode": { - "id": "Code_45060", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_727", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37774", - "standardCode": { - "id": "Code_45061", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_728", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37775", - "standardCode": { - "id": "Code_45062", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27244", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31362", - "extensionAttributes": [], - "code": "C100226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_177", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "label": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "synonyms": [ - "ADCIP", - "Ideational Praxis", - "CDISC ADAS-Cog - Ideational Praxis Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100232", - "properties": [ - { - "id": "BiomedicalConceptProperty_729", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37776", - "standardCode": { - "id": "Code_45063", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_730", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37777", - "standardCode": { - "id": "Code_45064", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_731", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2910", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41576", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37778", - "standardCode": { - "id": "Code_45065", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_732", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37779", - "standardCode": { - "id": "Code_45066", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_733", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_2722", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_37815", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37780", - "standardCode": { - "id": "Code_45067", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_734", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37781", - "standardCode": { - "id": "Code_45068", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_735", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37782", - "standardCode": { - "id": "Code_45069", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_736", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37783", - "standardCode": { - "id": "Code_45070", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24624", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28742", - "extensionAttributes": [], - "code": "C100232", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_178", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Orientation Summary Score", - "label": "CDISC ADAS-Cog - Orientation Summary Score", - "synonyms": [ - "ADCOR", - "Orientation", - "CDISC ADAS-Cog - Orientation Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100238", - "properties": [ - { - "id": "BiomedicalConceptProperty_737", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37784", - "standardCode": { - "id": "Code_45071", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_738", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37785", - "standardCode": { - "id": "Code_45072", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_739", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37786", - "standardCode": { - "id": "Code_45073", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_740", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [ - { - "id": "ResponseCode_2912", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41587", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37787", - "standardCode": { - "id": "Code_45074", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_741", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [ - { - "id": "ResponseCode_2724", - "instanceType": "ResponseCode", - "name": "DETECTION", - "label": "DETECTION", - "isEnabled": true, - "code": { - "id": "Code_37825", - "extensionAttributes": [], - "code": "C174330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "DETECTION", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37788", - "standardCode": { - "id": "Code_45075", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_742", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37789", - "standardCode": { - "id": "Code_45076", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_743", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37790", - "standardCode": { - "id": "Code_45077", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_744", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37791", - "standardCode": { - "id": "Code_45078", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27245", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31363", - "extensionAttributes": [], - "code": "C100238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Orientation Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_179", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Word Recognition Summary Score", - "label": "CDISC ADAS-Cog - Word Recognition Summary Score", - "synonyms": [ - "ADCRG", - "Word Recognition", - "CDISC ADAS-Cog - Word Recognition Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100247", - "properties": [ - { - "id": "BiomedicalConceptProperty_884", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37942", - "standardCode": { - "id": "Code_45229", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_885", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37943", - "standardCode": { - "id": "Code_45230", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_886", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37944", - "standardCode": { - "id": "Code_45231", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_887", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37945", - "standardCode": { - "id": "Code_45232", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_888", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37946", - "standardCode": { - "id": "Code_45233", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_889", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37947", - "standardCode": { - "id": "Code_45234", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_890", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_37948", - "standardCode": { - "id": "Code_45235", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_891", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37949", - "standardCode": { - "id": "Code_45236", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24625", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28743", - "extensionAttributes": [], - "code": "C100247", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recognition Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_180", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Remembering Test Instructions", - "label": "CDISC ADAS-Cog - Remembering Test Instructions", - "synonyms": [ - "ADCRI", - "Remembering Test Instructions", - "CDISC ADAS-Cog - Remembering Test Instructions" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100275", - "properties": [ - { - "id": "BiomedicalConceptProperty_753", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37800", - "standardCode": { - "id": "Code_45087", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_754", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37801", - "standardCode": { - "id": "Code_45088", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_755", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37802", - "standardCode": { - "id": "Code_45089", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_756", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37803", - "standardCode": { - "id": "Code_45090", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_757", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37804", - "standardCode": { - "id": "Code_45091", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_758", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37805", - "standardCode": { - "id": "Code_45092", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_759", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [ - { - "id": "ResponseCode_2916", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_41610", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37806", - "standardCode": { - "id": "Code_45093", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_760", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37807", - "standardCode": { - "id": "Code_45094", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24626", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28744", - "extensionAttributes": [], - "code": "C100275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Remembering Test Instructions", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_181", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Spoken Language Ability", - "label": "CDISC ADAS-Cog - Spoken Language Ability", - "synonyms": [ - "ADCSL", - "Spoken Language Ability", - "CDISC ADAS-Cog - Spoken Language Ability" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100276", - "properties": [ - { - "id": "BiomedicalConceptProperty_761", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37808", - "standardCode": { - "id": "Code_45095", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_762", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37809", - "standardCode": { - "id": "Code_45096", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_763", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37810", - "standardCode": { - "id": "Code_45097", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_764", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37811", - "standardCode": { - "id": "Code_45098", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_765", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37812", - "standardCode": { - "id": "Code_45099", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_766", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37813", - "standardCode": { - "id": "Code_45100", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_767", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37814", - "standardCode": { - "id": "Code_45101", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_768", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37815", - "standardCode": { - "id": "Code_45102", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24627", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28745", - "extensionAttributes": [], - "code": "C100276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Spoken Language Ability", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_182", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "label": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "synonyms": [ - "ADCDIF", - "Word Finding Difficulty in Spont Speech", - "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100277", - "properties": [ - { - "id": "BiomedicalConceptProperty_769", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2732", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_37861", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37816", - "standardCode": { - "id": "Code_45103", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_770", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2347", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_31239", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37817", - "standardCode": { - "id": "Code_45104", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_771", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37818", - "standardCode": { - "id": "Code_45105", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_772", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37819", - "standardCode": { - "id": "Code_45106", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_773", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37820", - "standardCode": { - "id": "Code_45107", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_774", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37821", - "standardCode": { - "id": "Code_45108", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_775", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37822", - "standardCode": { - "id": "Code_45109", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_776", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37823", - "standardCode": { - "id": "Code_45110", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24628", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28746", - "extensionAttributes": [], - "code": "C100277", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_183", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Comprehension", - "label": "CDISC ADAS-Cog - Comprehension", - "synonyms": [ - "ADCCMP", - "Comprehension", - "CDISC ADAS-Cog - Comprehension" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100278", - "properties": [ - { - "id": "BiomedicalConceptProperty_777", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37824", - "standardCode": { - "id": "Code_45111", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_778", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37825", - "standardCode": { - "id": "Code_45112", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_779", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2919", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_41633", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37826", - "standardCode": { - "id": "Code_45113", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_780", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37827", - "standardCode": { - "id": "Code_45114", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_781", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37828", - "standardCode": { - "id": "Code_45115", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_782", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37829", - "standardCode": { - "id": "Code_45116", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_783", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37830", - "standardCode": { - "id": "Code_45117", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_784", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37831", - "standardCode": { - "id": "Code_45118", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24629", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28747", - "extensionAttributes": [], - "code": "C100278", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Comprehension", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_184", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Concentration/Distractibility", - "label": "CDISC ADAS-Cog - Concentration/Distractibility", - "synonyms": [ - "ADCCON", - "Concentration/Distractibility", - "CDISC ADAS-Cog - Concentration/Distractibility" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100279", - "properties": [ - { - "id": "BiomedicalConceptProperty_892", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37950", - "standardCode": { - "id": "Code_45237", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_893", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37951", - "standardCode": { - "id": "Code_45238", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_894", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37952", - "standardCode": { - "id": "Code_45239", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_895", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37953", - "standardCode": { - "id": "Code_45240", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_896", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37954", - "standardCode": { - "id": "Code_45241", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_897", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37955", - "standardCode": { - "id": "Code_45242", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_898", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37956", - "standardCode": { - "id": "Code_45243", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_899", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37957", - "standardCode": { - "id": "Code_45244", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24630", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28748", - "extensionAttributes": [], - "code": "C100279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Concentration/Distractibility", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_185", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "label": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "synonyms": [ - "ADCNC", - "Number Cancellation", - "CDISC ADAS-Cog - Number Cancellation Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100280", - "properties": [ - { - "id": "BiomedicalConceptProperty_900", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37958", - "standardCode": { - "id": "Code_45245", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_901", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37959", - "standardCode": { - "id": "Code_45246", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_902", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37960", - "standardCode": { - "id": "Code_45247", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_903", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37961", - "standardCode": { - "id": "Code_45248", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_904", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37962", - "standardCode": { - "id": "Code_45249", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_905", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37963", - "standardCode": { - "id": "Code_45250", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_906", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37964", - "standardCode": { - "id": "Code_45251", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_907", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37965", - "standardCode": { - "id": "Code_45252", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24631", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28749", - "extensionAttributes": [], - "code": "C100280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_186", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "label": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "synonyms": [ - "ADCMZ01", - "Executive Function Maze: Errors", - "CDISC ADAS-Cog - Executive Function Maze: Errors" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100285", - "properties": [ - { - "id": "BiomedicalConceptProperty_801", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37848", - "standardCode": { - "id": "Code_45135", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_802", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37849", - "standardCode": { - "id": "Code_45136", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_803", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37850", - "standardCode": { - "id": "Code_45137", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_804", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37851", - "standardCode": { - "id": "Code_45138", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_805", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37852", - "standardCode": { - "id": "Code_45139", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_806", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37853", - "standardCode": { - "id": "Code_45140", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_807", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37854", - "standardCode": { - "id": "Code_45141", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_808", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2740", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_37908", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37855", - "standardCode": { - "id": "Code_45142", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24632", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28750", - "extensionAttributes": [], - "code": "C100285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_187", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Executive Function Maze: Time", - "label": "CDISC ADAS-Cog - Executive Function Maze: Time", - "synonyms": [ - "ADCMZ02", - "Executive Function Maze: Time", - "CDISC ADAS-Cog - Executive Function Maze: Time" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100286", - "properties": [ - { - "id": "BiomedicalConceptProperty_809", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [ - { - "id": "ResponseCode_2923", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_41667", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37856", - "standardCode": { - "id": "Code_45143", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_810", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_37857", - "standardCode": { - "id": "Code_45144", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_811", - "extensionAttributes": [], - "name": "Unit of Time", - "label": "Unit of Time", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37858", - "standardCode": { - "id": "Code_45145", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_812", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37859", - "standardCode": { - "id": "Code_45146", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_813", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37860", - "standardCode": { - "id": "Code_45147", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_814", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37861", - "standardCode": { - "id": "Code_45148", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_815", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37862", - "standardCode": { - "id": "Code_45149", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_816", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37863", - "standardCode": { - "id": "Code_45150", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_817", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37864", - "standardCode": { - "id": "Code_45151", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24633", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28751", - "extensionAttributes": [], - "code": "C100286", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_163", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_140", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGCTMON", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "synonyms": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "reference": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "id": "BiomedicalConceptProperty_856", - "extensionAttributes": [], - "name": "TSPARMCD", - "label": "TSPARMCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3090", - "instanceType": "ResponseCode", - "name": "EGCTMON", - "label": "EGCTMON", - "isEnabled": true, - "code": { - "id": "Code_45197", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "EGCTMON", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37909", - "standardCode": { - "id": "Code_45196", - "extensionAttributes": [], - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_857", - "extensionAttributes": [], - "name": "TSPARM", - "label": "TSPARM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3091", - "instanceType": "ResponseCode", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "isEnabled": true, - "code": { - "id": "Code_45199", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37911", - "standardCode": { - "id": "Code_45198", - "extensionAttributes": [], - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_858", - "extensionAttributes": [], - "name": "TSVAL", - "label": "TSVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_37913", - "standardCode": { - "id": "Code_45200", - "extensionAttributes": [], - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_859", - "extensionAttributes": [], - "name": "TSVALCD", - "label": "TSVALCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37914", - "standardCode": { - "id": "Code_45201", - "extensionAttributes": [], - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_860", - "extensionAttributes": [], - "name": "TSVCDREF", - "label": "TSVCDREF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37915", - "standardCode": { - "id": "Code_45202", - "extensionAttributes": [], - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_861", - "extensionAttributes": [], - "name": "TSVCDVER", - "label": "TSVCDVER", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37916", - "standardCode": { - "id": "Code_45203", - "extensionAttributes": [], - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2311", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2501", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - } - ], - "bcSurrogates": [ - { - "id": "BiomedicalConceptSurrogate_9", - "extensionAttributes": [], - "name": "MHIS-NACC / MHIS01", - "label": "Modified Hachinski Ischemic Scale (C112523)", - "description": "Modified Hachinski Ischemic Scale-NACC Version Questionnaire", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112523", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_10", - "extensionAttributes": [], - "name": "MHIS0101", - "label": "Abrupt Onset (C112618)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Abrupt onset (re: cognitive status).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112618", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_11", - "extensionAttributes": [], - "name": "MHIS0102", - "label": "Stepwise Deterioration (C112619)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Stepwise deterioration (re: cognitive status).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112619", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_12", - "extensionAttributes": [], - "name": "MHIS0103", - "label": "Emotional Incontinence (C112620)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Emotional incontinence.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112620", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_13", - "extensionAttributes": [], - "name": "MHIS0104", - "label": "History or Presence of Hypertension (C112621)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - History or presence of hypertension.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112621", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_14", - "extensionAttributes": [], - "name": "MHIS0105", - "label": "History of Stroke (C112622)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - History of stroke.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112622", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_15", - "extensionAttributes": [], - "name": "MHIS0106", - "label": "Focal Neurological Symptoms (C112623)", - "description": "MHIS-NACC - Focal Neurological Symptoms", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112623", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_16", - "extensionAttributes": [], - "name": "MHIS0107", - "label": "Focal Neurological Signs (C112624)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Focal neurological signs.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112624", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_17", - "extensionAttributes": [], - "name": "MHIS0108", - "label": "Somatic Complaints (C112813)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Somatic complaints.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112813", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_18", - "extensionAttributes": [], - "name": "MHIS0109", - "label": "Total Score (C112625)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Sum all circled answers for a total score.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112625", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_19", - "extensionAttributes": [], - "name": "APOE Gene", - "label": "APOE Gene (C84468)", - "description": "This gene is involved in lipid transport and metabolism.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C84468", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_20", - "extensionAttributes": [], - "name": "Mini-Mental Status Exam", - "label": "Mini-Mental Status Exam (C74982)", - "description": "Mini-Mental State Examination (MMSE) (MMSE Copyright 1975, 1998, 2001 by MiniMental, LLC All rights reserved. Published 2001 by Psychological Assessment Resources, Inc. May not be reproduced in whole or in part in any form or by any means without written permission of Psychological Assessment Resources, Inc.).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C74982", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_21", - "extensionAttributes": [], - "name": "MMSE - Question 1", - "label": "MMSE - Question 1 (C100542)", - "description": "The Mini-Mental State Examination (MMSE) Question 1.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100542", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_22", - "extensionAttributes": [], - "name": "MMSE - Question 2", - "label": "MMSE - Question 2 (C100548)", - "description": "The Mini-Mental State Examination (MMSE) Question 2.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100548", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_23", - "extensionAttributes": [], - "name": "MMSE - Question 3", - "label": "MMSE - Question 3 (C100554)", - "description": "The Mini-Mental State Examination (MMSE) Question 3.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100554", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_24", - "extensionAttributes": [], - "name": "MMSE - Question 4", - "label": "MMSE - Question 4 (C100558)", - "description": "The Mini-Mental State Examination (MMSE) Question 4.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100558", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_25", - "extensionAttributes": [], - "name": "MMSE - Question 6", - "label": "MMSE - Question 6 (C100575)", - "description": "The Mini-Mental State Examination (MMSE) Question 6.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100575", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_26", - "extensionAttributes": [], - "name": "MMSE Functional Test Question", - "label": "MMSE Functional Test Question (C100118)", - "description": "A question associated with the MMSE functional test.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100118", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_27", - "extensionAttributes": [], - "name": "ADCS-CGIC", - "label": "ADCS-CGIC Questionnaire Question (C103490)", - "description": "A question associated with the ADCS-CGIC questionnaire.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103490", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_28", - "extensionAttributes": [], - "name": "DAD", - "label": "Disability Assessment for Dementia Questionnaire (C105165)", - "description": "Disability Assessment for Dementia (DAD) (copyright 1994 by L. Gauthier I. Gelinas. All rights reserved.).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C105165", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_29", - "extensionAttributes": [], - "name": "NPI - NPI Total Distress Score", - "label": "NPI - NPI Total Distress Score (C112482)", - "description": "Neuropsychiatric Inventory - Sub-total of distress score.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112482", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_30", - "extensionAttributes": [], - "name": "NPI - Anxiety Severity", - "label": "NPI - Anxiety Severity (C103615)", - "description": "Neuropsychiatric Inventory - Severity of the anxiety.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103615", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_31", - "extensionAttributes": [], - "name": "NPI - Disinhibition Frequency", - "label": "NPI - Disinhibition Frequency (C103623)", - "description": "Neuropsychiatric Inventory - Frequency of the disinhibition.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103623", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_32", - "extensionAttributes": [], - "name": "NPI - Disinhibition Severity", - "label": "NPI - Disinhibition Severity (C103624)", - "description": "Neuropsychiatric Inventory - Severity of the disinhibition.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103624", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_33", - "extensionAttributes": [], - "name": "NPI - Disinhibition Distress", - "label": "NPI - Disinhibition Distress (C103625)", - "description": "Neuropsychiatric Inventory - How emotionally distressing do you find this behavior?", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103625", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_34", - "extensionAttributes": [], - "name": "NPI - Disinhibition FxS Score", - "label": "NPI - Disinhibition FxS Score (C112476)", - "description": "Neuropsychiatric Inventory - Disinhibition: (frequency score x severity score).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112476", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - } - ], - "bcCategories": [], - "eligibilityCriterionItems": [], - "narrativeContentItems": [], - "abbreviations": [], - "administrableProducts": [], - "medicalDevices": [], - "productOrganizationRoles": [], - "dictionaries": [], - "conditions": [], - "notes": [], - "instanceType": "StudyVersion" - } - ], - "documentedBy": [], - "instanceType": "Study" - }, - "usdmVersion": "4.0", - "systemName": "SOA Workbench", - "systemVersion": "1.4.0" -} diff --git a/output/json/H2Q-MC-LZZT-define-20260618T1521.json b/output/json/H2Q-MC-LZZT-define-20260618T1521.json deleted file mode 100644 index dda9aec..0000000 --- a/output/json/H2Q-MC-LZZT-define-20260618T1521.json +++ /dev/null @@ -1,33559 +0,0 @@ -{ - "OID": "MDV.LZZT - Pilot.Version1.Design1", - "name": "MDV LZZT - Pilot", - "description": "Data Definitions for LZZT - Pilot", - "fileOID": "ODM.DEFINE-JSON.LZZT - Pilot.Version1.Design1", - "creationDateTime": "2026-06-18T15:21:31.605476+00:00", - "odmVersion": "1.3.2", - "fileType": "Snapshot", - "originator": "Define-JSON Processor", - "context": "Other", - "defineVersion": "2.1.0", - "studyOID": "ODM.LZZT - Pilot.Version1.Design1", - "studyName": "LZZT - Pilot", - "studyDescription": "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease", - "protocolName": "LZZT - Pilot", - "itemGroups": [ - { - "OID": "IG.DS", - "name": "DS", - "description": "Disposition", - "domain": "DS", - "purpose": "Tabulation", - "structure": "One record per disposition status or protocol milestone per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "DSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.DS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSSEQ", - "mandatory": true, - "name": "DSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSTERM", - "mandatory": true, - "name": "DSTERM", - "description": "Reported Term for the Disposition Event", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_2", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSDECOD", - "mandatory": true, - "name": "DSDECOD", - "description": "Standardized Disposition Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_1", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NCOMPLT" - }, - { - "OID": "IT.DS.DSCAT", - "mandatory": false, - "name": "DSCAT", - "description": "Category for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSCAT" - }, - { - "OID": "IT.DS.DSSCAT", - "mandatory": false, - "name": "DSSCAT", - "description": "Subcategory for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSSCAT" - }, - { - "OID": "IT.DS.DSSTDTC", - "mandatory": false, - "name": "DSSTDTC", - "description": "Start Date/Time of Disposition Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_3", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSSTDY", - "mandatory": false, - "name": "DSSTDY", - "description": "Study Day of Start of Disposition Event", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_1" - }, - { - "OID": "IG.IE", - "name": "IE", - "description": "Inclusion/Exclusion Criteria Not Met", - "domain": "IE", - "purpose": "Tabulation", - "structure": "One record per inclusion/exclusion criterion not met per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "IESEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.IE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IESEQ", - "mandatory": true, - "name": "IESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IETESTCD", - "mandatory": true, - "name": "IETESTCD", - "description": "Inclusion/Exclusion Criterion Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IETEST", - "mandatory": true, - "name": "IETEST", - "description": "Inclusion/Exclusion Criterion", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IECAT", - "mandatory": true, - "name": "IECAT", - "description": "Inclusion/Exclusion Category", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.IECAT" - }, - { - "OID": "IT.IE.IEORRES", - "mandatory": true, - "name": "IEORRES", - "description": "I/E Criterion Original Result", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_5", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.IE.IESTRESC", - "mandatory": true, - "name": "IESTRESC", - "description": "I/E Criterion Result in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.IE.IEDTC", - "mandatory": false, - "name": "IEDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_6", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_2" - }, - { - "OID": "IG.SC", - "name": "SC", - "description": "Subject Characteristics", - "domain": "SC", - "purpose": "Tabulation", - "structure": "One record per characteristic per visit per subject.", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SCSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.SC.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCSEQ", - "mandatory": true, - "name": "SCSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCTESTCD", - "mandatory": true, - "name": "SCTESTCD", - "description": "Subject Characteristic Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.SCTESTCD" - }, - { - "OID": "IT.SC.SCTEST", - "mandatory": true, - "name": "SCTEST", - "description": "Subject Characteristic", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.SCTEST" - }, - { - "OID": "IT.SC.SCORRES", - "mandatory": false, - "name": "SCORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_26", - "dataType": "text", - "length": 100, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SC.SCORRESU", - "mandatory": false, - "name": "SCORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 5, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.SC.SCSTRESC", - "mandatory": false, - "name": "SCSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 100, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCSTRESN", - "mandatory": false, - "name": "SCSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "text", - "length": 100, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCSTRESU", - "mandatory": false, - "name": "SCSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 5, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.SC.SCDTC", - "mandatory": false, - "name": "SCDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_27", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_11" - }, - { - "OID": "IG.MH", - "name": "MH", - "description": "Medical History", - "domain": "MH", - "purpose": "Tabulation", - "structure": "One record per medical history event per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "MHSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.MH.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHSEQ", - "mandatory": true, - "name": "MHSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHTERM", - "mandatory": true, - "name": "MHTERM", - "description": "Reported Term for the Medical History", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_31", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MH.MHDECOD", - "mandatory": false, - "name": "MHDECOD", - "description": "Dictionary-Derived Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_32", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHCAT", - "mandatory": false, - "name": "MHCAT", - "description": "Category for Medical History", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHSCAT", - "mandatory": false, - "name": "MHSCAT", - "description": "Subcategory for Medical History", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHPRESP", - "mandatory": false, - "name": "MHPRESP", - "description": "Medical History Event Pre-Specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.MH.MHOCCUR", - "mandatory": false, - "name": "MHOCCUR", - "description": "Medical History Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.MH.MHSTDTC", - "mandatory": false, - "name": "MHSTDTC", - "description": "Start Date/Time of Medical History Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_33", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MH.MHENDTC", - "mandatory": false, - "name": "MHENDTC", - "description": "End Date/Time of Medical History Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_34", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MH.MHENRF", - "mandatory": false, - "name": "MHENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_35", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.MH.MHENRTPT", - "mandatory": false, - "name": "MHENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_36", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.MH.MHENTPT", - "mandatory": false, - "name": "MHENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_37", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_14" - }, - { - "OID": "IG.SU", - "name": "SU", - "description": "Substance Use", - "domain": "SU", - "purpose": "Tabulation", - "structure": "One record per substance type per reported occurrence per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SUSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.SU.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUSEQ", - "mandatory": true, - "name": "SUSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUTRT", - "mandatory": true, - "name": "SUTRT", - "description": "Reported Name of Substance", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_38", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUCAT", - "mandatory": false, - "name": "SUCAT", - "description": "Category for Substance Use", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUSCAT", - "mandatory": false, - "name": "SUSCAT", - "description": "Subcategory for Substance Use", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUPRESP", - "mandatory": false, - "name": "SUPRESP", - "description": "SU Pre-Specified", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_39", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY_Y" - }, - { - "OID": "IT.SU.SUOCCUR", - "mandatory": false, - "name": "SUOCCUR", - "description": "SU Occurrence", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_40", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.SU.SUDOSE", - "mandatory": false, - "name": "SUDOSE", - "description": "Substance Use Consumption", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_41", - "dataType": "float", - "length": 12, - "displayFormat": "12.4", - "significantDigits": 4, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUDOSTXT", - "mandatory": false, - "name": "SUDOSTXT", - "description": "Substance Use Consumption Text", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_42", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUDOSU", - "mandatory": false, - "name": "SUDOSU", - "description": "Consumption Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_43", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.SU.SUDOSFRQ", - "mandatory": false, - "name": "SUDOSFRQ", - "description": "Use Frequency Per Interval", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_44", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.SU.SUSTDTC", - "mandatory": false, - "name": "SUSTDTC", - "description": "Start Date/Time of Substance Use", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_45", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUENDTC", - "mandatory": false, - "name": "SUENDTC", - "description": "End Date/Time of Substance Use", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_46", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUDUR", - "mandatory": false, - "name": "SUDUR", - "description": "Duration of Substance Use", - "role": "Timing", - "dataType": "durationDatetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUSTRF", - "mandatory": false, - "name": "SUSTRF", - "description": "Start Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_47", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUENRF", - "mandatory": false, - "name": "SUENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_50", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUSTRTPT", - "mandatory": false, - "name": "SUSTRTPT", - "description": "Start Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_48", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUSTTPT", - "mandatory": false, - "name": "SUSTTPT", - "description": "Start Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_49", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUENRTPT", - "mandatory": false, - "name": "SUENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_51", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUENTPT", - "mandatory": false, - "name": "SUENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_52", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_15" - }, - { - "OID": "IG.PR", - "name": "PR", - "description": "Procedures", - "domain": "PR", - "purpose": "Tabulation", - "structure": "One record per recorded procedure per occurrence per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "PRSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.PR.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRSEQ", - "mandatory": true, - "name": "PRSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRTRT", - "mandatory": true, - "name": "PRTRT", - "description": "Reported Name of Procedure", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_84", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.PR.PRDECOD", - "mandatory": false, - "name": "PRDECOD", - "description": "Standardized Procedure Name", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_85", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.PROCEDUR" - }, - { - "OID": "IT.PR.PRCAT", - "mandatory": false, - "name": "PRCAT", - "description": "Category", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRSCAT", - "mandatory": false, - "name": "PRSCAT", - "description": "Subcategory", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRPRESP", - "mandatory": false, - "name": "PRPRESP", - "description": "Pre-specified", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_86", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY_Y" - }, - { - "OID": "IT.PR.PROCCUR", - "mandatory": false, - "name": "PROCCUR", - "description": "Occurrence", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_87", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.PR.PRLOC", - "mandatory": false, - "name": "PRLOC", - "description": "Location of Procedure", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_88", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.PR.PRSTDTC", - "mandatory": false, - "name": "PRSTDTC", - "description": "Start Date/Time of Procedure", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_89", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.PR.PRENDTC", - "mandatory": false, - "name": "PRENDTC", - "description": "End Date/Time of Procedure", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_90", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_18" - }, - { - "OID": "IG.VS", - "name": "VS", - "description": "Vital Signs", - "domain": "VS", - "purpose": "Tabulation", - "structure": "One record per vital sign measurement per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.VS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSEQ", - "mandatory": true, - "name": "VSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSTESTCD", - "mandatory": true, - "name": "VSTESTCD", - "description": "Vital Signs Test Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTESTCD" - }, - { - "OID": "IT.VS.VSTEST", - "mandatory": true, - "name": "VSTEST", - "description": "Vital Signs Test Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTEST" - }, - { - "OID": "IT.VS.VSPOS", - "mandatory": false, - "name": "VSPOS", - "description": "Vital Signs Position of Subject", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.POSITION" - }, - { - "OID": "IT.VS.VSORRES", - "mandatory": false, - "name": "VSORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_94", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSORRESU", - "mandatory": false, - "name": "VSORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_95", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSSTRESC", - "mandatory": false, - "name": "VSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESN", - "mandatory": false, - "name": "VSSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESU", - "mandatory": false, - "name": "VSSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSLOC", - "mandatory": false, - "name": "VSLOC", - "description": "Location of Vital Signs Measurement", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_96", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.VS.VSLAT", - "mandatory": false, - "name": "VSLAT", - "description": "Laterality", - "role": "Result Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.VS.VSLOBXFL", - "mandatory": false, - "name": "VSLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.VS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSDTC", - "mandatory": false, - "name": "VSDTC", - "description": "Date/Time of Measurements", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_97", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_20" - }, - { - "OID": "IG.EG", - "name": "EG", - "description": "ECG Test Results", - "domain": "EG", - "purpose": "Tabulation", - "structure": "One record per ECG observation per replicate per time point or one record per ECG observation per beat per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "EGSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.EG.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.EGSEQ", - "mandatory": true, - "name": "EGSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.EGTESTCD", - "mandatory": true, - "name": "EGTESTCD", - "description": "ECG Test or Examination Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EGTESTCD" - }, - { - "OID": "IT.EG.EGTEST", - "mandatory": true, - "name": "EGTEST", - "description": "ECG Test or Examination Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EGTEST" - }, - { - "OID": "IT.EG.EGCAT", - "mandatory": false, - "name": "EGCAT", - "description": "Category for ECG", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.EGPOS", - "mandatory": false, - "name": "EGPOS", - "description": "ECG Position of Subject", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.POSITION" - }, - { - "OID": "IT.EG.EGORRES", - "mandatory": false, - "name": "EGORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_116", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Vendor" - } - }, - { - "OID": "IT.EG.EGORRESU", - "mandatory": false, - "name": "EGORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Vendor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.EG.EGSTRESC", - "mandatory": false, - "name": "EGSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Derived", - "source": "Vendor" - }, - "codeList": "CL.EGSTRESC" - }, - { - "OID": "IT.EG.EGSTRESN", - "mandatory": false, - "name": "EGSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Vendor" - } - }, - { - "OID": "IT.EG.EGSTRESU", - "mandatory": false, - "name": "EGSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Vendor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.EG.EGMETHOD", - "mandatory": false, - "name": "EGMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_117", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.EGMETHOD" - }, - { - "OID": "IT.EG.EGLOBXFL", - "mandatory": false, - "name": "EGLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.EG.EGEVAL", - "mandatory": false, - "name": "EGEVAL", - "description": "Evaluator", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_118", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.EVAL" - }, - { - "OID": "IT.EG.EGCLSIG", - "mandatory": false, - "name": "EGCLSIG", - "description": "Clinically Significant, Collected", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_119", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.EG.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EG.EGDTC", - "mandatory": false, - "name": "EGDTC", - "description": "Date/Time of ECG", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_120", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_27" - }, - { - "OID": "IG.CM", - "name": "CM", - "description": "Concomitant/Prior Medications", - "domain": "CM", - "purpose": "Tabulation", - "structure": "One record per recorded intervention occurrence or constant-dosing interval per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "CMSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.CM.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSEQ", - "mandatory": true, - "name": "CMSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMTRT", - "mandatory": true, - "name": "CMTRT", - "description": "Reported Name of Drug, Med, or Therapy", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_266", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDECOD", - "mandatory": false, - "name": "CMDECOD", - "description": "Standardized Medication Name", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_267", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCAT", - "mandatory": false, - "name": "CMCAT", - "description": "Category for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSCAT", - "mandatory": false, - "name": "CMSCAT", - "description": "Subcategory for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMPRESP", - "mandatory": false, - "name": "CMPRESP", - "description": "CM Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMOCCUR", - "mandatory": false, - "name": "CMOCCUR", - "description": "CM Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMINDC", - "mandatory": false, - "name": "CMINDC", - "description": "Indication", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_269", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMCLAS", - "mandatory": false, - "name": "CMCLAS", - "description": "Medication Class", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_268", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCLASCD", - "mandatory": false, - "name": "CMCLASCD", - "description": "Medication Class Code", - "role": "Variable Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMDOSE", - "mandatory": false, - "name": "CMDOSE", - "description": "Dose per Administration", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_270", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSTXT", - "mandatory": false, - "name": "CMDOSTXT", - "description": "Dose Description", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_271", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSU", - "mandatory": false, - "name": "CMDOSU", - "description": "Dose Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_272", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.CM.CMDOSFRM", - "mandatory": false, - "name": "CMDOSFRM", - "description": "Dose Form", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_273", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FRM" - }, - { - "OID": "IT.CM.CMDOSFRQ", - "mandatory": false, - "name": "CMDOSFRQ", - "description": "Dosing Frequency per Interval", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_274", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.CM.CMROUTE", - "mandatory": false, - "name": "CMROUTE", - "description": "Route of Administration", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_275", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ROUTE" - }, - { - "OID": "IT.CM.CMSTDTC", - "mandatory": false, - "name": "CMSTDTC", - "description": "Start Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_276", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMENDTC", - "mandatory": false, - "name": "CMENDTC", - "description": "End Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_277", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMSTRF", - "mandatory": false, - "name": "CMSTRF", - "description": "Start Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_278", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENRF", - "mandatory": false, - "name": "CMENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_281", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTRTPT", - "mandatory": false, - "name": "CMSTRTPT", - "description": "Start Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_279", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTTPT", - "mandatory": false, - "name": "CMSTTPT", - "description": "Start Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_280", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMENRTPT", - "mandatory": false, - "name": "CMENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_282", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENTPT", - "mandatory": false, - "name": "CMENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_283", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_55" - }, - { - "OID": "IG.MB", - "name": "MB", - "description": "Microbiology Specimen", - "domain": "MB", - "purpose": "Tabulation", - "structure": "One record per microbiology specimen finding per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "MBSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.MB.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.MBSEQ", - "mandatory": true, - "name": "MBSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.MBTESTCD", - "mandatory": true, - "name": "MBTESTCD", - "description": "Microbiology Test or Finding Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MBTESTCD" - }, - { - "OID": "IT.MB.MBTEST", - "mandatory": true, - "name": "MBTEST", - "description": "Microbiology Test or Finding Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MBTEST" - }, - { - "OID": "IT.MB.MBTSTDTL", - "mandatory": false, - "name": "MBTSTDTL", - "description": "Measurement, Test or Examination Detail", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_494", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MBFTSDTL" - }, - { - "OID": "IT.MB.MBORRES", - "mandatory": false, - "name": "MBORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_495", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Vendor" - } - }, - { - "OID": "IT.MB.MBSTRESC", - "mandatory": false, - "name": "MBSTRESC", - "description": "Result or Finding in Standard Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Derived", - "source": "Vendor" - } - }, - { - "OID": "IT.MB.MBSPEC", - "mandatory": false, - "name": "MBSPEC", - "description": "Specimen Material Type", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_496", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.SPECTYPE" - }, - { - "OID": "IT.MB.MBMETHOD", - "mandatory": false, - "name": "MBMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_497", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.MB.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MB.MBDTC", - "mandatory": false, - "name": "MBDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_498", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_99" - }, - { - "OID": "IG.UR", - "name": "UR", - "description": "Urinary System Findings", - "domain": "UR", - "purpose": "Tabulation", - "structure": "One record per finding per location per per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "URSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.UR.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URSEQ", - "mandatory": true, - "name": "URSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URTESTCD", - "mandatory": true, - "name": "URTESTCD", - "description": "Short Name of Urinary Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTSCD" - }, - { - "OID": "IT.UR.URTEST", - "mandatory": true, - "name": "URTEST", - "description": "Name of Urinary Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTS" - }, - { - "OID": "IT.UR.URORRES", - "mandatory": false, - "name": "URORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URSTRESC", - "mandatory": false, - "name": "URSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URMETHOD", - "mandatory": false, - "name": "URMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.UR.URLOBXFL", - "mandatory": false, - "name": "URLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.UR.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URDTC", - "mandatory": false, - "name": "URDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_101" - }, - { - "OID": "IG.EC", - "name": "EC", - "description": "Exposure as Collected", - "domain": "EC", - "purpose": "Tabulation", - "structure": "One record per protocol-specified study treatment, collected-dosing interval, per subject, per mood", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "ECSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.EC.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.ECSEQ", - "mandatory": true, - "name": "ECSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.ECREFID", - "mandatory": false, - "name": "ECREFID", - "description": "Reference ID", - "role": "Identifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_554", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECTRT", - "mandatory": true, - "name": "ECTRT", - "description": "Name of Treatment", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_553", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECDOSE", - "mandatory": false, - "name": "ECDOSE", - "description": "Dose", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_555", - "dataType": "integer", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECDOSTXT", - "mandatory": false, - "name": "ECDOSTXT", - "description": "Dose Description", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_556", - "dataType": "text", - "length": 100, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECDOSU", - "mandatory": false, - "name": "ECDOSU", - "description": "Dose Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_557", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.EC.ECDOSFRM", - "mandatory": false, - "name": "ECDOSFRM", - "description": "Dose Form", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_558", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FRM" - }, - { - "OID": "IT.EC.ECDOSFRQ", - "mandatory": false, - "name": "ECDOSFRQ", - "description": "Dosing Frequency per Interval", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_559", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.EC.ECDOSRGM", - "mandatory": false, - "name": "ECDOSRGM", - "description": "Intended Dose Regimen", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_560", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECROUTE", - "mandatory": false, - "name": "ECROUTE", - "description": "Route of Administration", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_561", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ROUTE" - }, - { - "OID": "IT.EC.ECLOC", - "mandatory": false, - "name": "ECLOC", - "description": "Location of Dose Administration", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_562", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.EC.ECLAT", - "mandatory": false, - "name": "ECLAT", - "description": "Laterality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_563", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.EC.ECDIR", - "mandatory": false, - "name": "ECDIR", - "description": "Directionality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_564", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DIR" - }, - { - "OID": "IT.EC.ECSTDTC", - "mandatory": false, - "name": "ECSTDTC", - "description": "Start Date/Time of Treatment", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_565", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECENDTC", - "mandatory": false, - "name": "ECENDTC", - "description": "End Date/Time of Treatment", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_566", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_112" - }, - { - "OID": "IG.QS", - "name": "QS", - "description": "Questionnaires", - "domain": "QS", - "purpose": "Tabulation", - "structure": "One record per questionnaire per question per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "QSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.QS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSSEQ", - "mandatory": true, - "name": "QSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSTESTCD", - "mandatory": true, - "name": "QSTESTCD", - "description": "Question Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSTEST", - "mandatory": true, - "name": "QSTEST", - "description": "Question Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSCAT", - "mandatory": true, - "name": "QSCAT", - "description": "Category of Question", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.QSCAT" - }, - { - "OID": "IT.QS.QSORRES", - "mandatory": false, - "name": "QSORRES", - "description": "Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_570", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.QS.QSSTRESC", - "mandatory": false, - "name": "QSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSSTRESN", - "mandatory": false, - "name": "QSSTRESN", - "description": "Numeric Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSLOBXFL", - "mandatory": false, - "name": "QSLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.QS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.QS.QSDTC", - "mandatory": false, - "name": "QSDTC", - "description": "Date/Time of Finding", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_571", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_114" - }, - { - "OID": "IG.AE", - "name": "AE", - "description": "Adverse Events", - "domain": "AE", - "purpose": "Tabulation", - "structure": "One record per adverse event per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "AESEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.AE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESEQ", - "mandatory": true, - "name": "AESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AETERM", - "mandatory": true, - "name": "AETERM", - "description": "Reported Term for the Adverse Event", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_584", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AELLT", - "mandatory": false, - "name": "AELLT", - "description": "Lowest Level Term", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AELLTCD", - "mandatory": false, - "name": "AELLTCD", - "description": "Lowest Level Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEDECOD", - "mandatory": true, - "name": "AEDECOD", - "description": "Dictionary-Derived Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_585", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEPTCD", - "mandatory": false, - "name": "AEPTCD", - "description": "Preferred Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLT", - "mandatory": false, - "name": "AEHLT", - "description": "High Level Term", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLTCD", - "mandatory": false, - "name": "AEHLTCD", - "description": "High Level Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLGT", - "mandatory": false, - "name": "AEHLGT", - "description": "High Level Group Term", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLGTCD", - "mandatory": false, - "name": "AEHLGTCD", - "description": "High Level Group Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AECAT", - "mandatory": false, - "name": "AECAT", - "description": "Category for Adverse Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESCAT", - "mandatory": false, - "name": "AESCAT", - "description": "Subcategory for Adverse Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEPRESP", - "mandatory": false, - "name": "AEPRESP", - "description": "Pre-Specified Adverse Event", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.AE.AEBODSYS", - "mandatory": false, - "name": "AEBODSYS", - "description": "Body System or Organ Class", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEBDSYCD", - "mandatory": false, - "name": "AEBDSYCD", - "description": "Body System or Organ Class Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESOC", - "mandatory": false, - "name": "AESOC", - "description": "Primary System Organ Class", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESOCCD", - "mandatory": false, - "name": "AESOCCD", - "description": "Primary System Organ Class Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AELOC", - "mandatory": false, - "name": "AELOC", - "description": "Location of Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_586", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.AE.AESEV", - "mandatory": false, - "name": "AESEV", - "description": "Severity/Intensity", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_587", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.AESEV" - }, - { - "OID": "IT.AE.AESER", - "mandatory": false, - "name": "AESER", - "description": "Serious Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_588", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AEACN", - "mandatory": false, - "name": "AEACN", - "description": "Action Taken with Study Treatment", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_589", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ACN" - }, - { - "OID": "IT.AE.AEACNOTH", - "mandatory": false, - "name": "AEACNOTH", - "description": "Other Action Taken", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_590", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEREL", - "mandatory": false, - "name": "AEREL", - "description": "Causality", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_591", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AERELNST", - "mandatory": false, - "name": "AERELNST", - "description": "Relationship to Non-Study Treatment", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_592", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEPATT", - "mandatory": false, - "name": "AEPATT", - "description": "Pattern of Adverse Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_593", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEOUT", - "mandatory": false, - "name": "AEOUT", - "description": "Outcome of Adverse Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_594", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.OUT" - }, - { - "OID": "IT.AE.AESCAN", - "mandatory": false, - "name": "AESCAN", - "description": "Involves Cancer", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_595", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESCONG", - "mandatory": false, - "name": "AESCONG", - "description": "Congenital Anomaly or Birth Defect", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_596", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESDISAB", - "mandatory": false, - "name": "AESDISAB", - "description": "Persist or Signif Disability/Incapacity", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_597", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESDTH", - "mandatory": false, - "name": "AESDTH", - "description": "Results in Death", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_598", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESHOSP", - "mandatory": false, - "name": "AESHOSP", - "description": "Requires or Prolongs Hospitalization", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_599", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESLIFE", - "mandatory": false, - "name": "AESLIFE", - "description": "Is Life Threatening", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_600", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESOD", - "mandatory": false, - "name": "AESOD", - "description": "Occurred with Overdose", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_601", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESMIE", - "mandatory": false, - "name": "AESMIE", - "description": "Other Medically Important Serious Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_602", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AECONTRT", - "mandatory": false, - "name": "AECONTRT", - "description": "Concomitant or Additional Trtmnt Given", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_603", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AETOXGR", - "mandatory": false, - "name": "AETOXGR", - "description": "Standard Toxicity Grade", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_604", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AESTDTC", - "mandatory": false, - "name": "AESTDTC", - "description": "Start Date/Time of Adverse Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_605", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEENDTC", - "mandatory": false, - "name": "AEENDTC", - "description": "End Date/Time of Adverse Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_606", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEENRF", - "mandatory": false, - "name": "AEENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_607", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.AE.AEENRTPT", - "mandatory": false, - "name": "AEENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_608", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.AE.AEENTPT", - "mandatory": false, - "name": "AEENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_609", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_135" - }, - { - "OID": "IG.MK", - "name": "MK", - "description": "Musculoskeletal System Findings", - "domain": "MK", - "purpose": "Tabulation", - "structure": "One record per assessment per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "MKSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.MK.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKSEQ", - "mandatory": true, - "name": "MKSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKTESTCD", - "mandatory": true, - "name": "MKTESTCD", - "description": "Short Name of Musculoskeletal Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MUSCTSCD" - }, - { - "OID": "IT.MK.MKTEST", - "mandatory": true, - "name": "MKTEST", - "description": "Name of Musculoskeletal Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MUSCTS" - }, - { - "OID": "IT.MK.MKORRES", - "mandatory": false, - "name": "MKORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_652", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MK.MKORRESU", - "mandatory": false, - "name": "MKORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_653", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.MK.MKSTRESC", - "mandatory": false, - "name": "MKSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKSTRESN", - "mandatory": false, - "name": "MKSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKSTRESU", - "mandatory": false, - "name": "MKSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.MK.MKLOC", - "mandatory": false, - "name": "MKLOC", - "description": "Location Used for the Measurement", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_654", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.MK.MKLAT", - "mandatory": false, - "name": "MKLAT", - "description": "Laterality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_655", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.MK.MKMETHOD", - "mandatory": false, - "name": "MKMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_656", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.MK.MKLOBXFL", - "mandatory": false, - "name": "MKLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.MK.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MK.MKDTC", - "mandatory": false, - "name": "MKDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_657", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_160" - }, - { - "OID": "IG.TS", - "name": "TS", - "description": "Trial Summary", - "domain": "TS", - "purpose": "Tabulation", - "structure": "One record per trial summary parameter value", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "TSPARMCD", - "TSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSSEQ", - "mandatory": true, - "name": "TSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSPARMCD", - "mandatory": true, - "name": "TSPARMCD", - "description": "Trial Summary Parameter Short Name", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_850", - "dataType": "text", - "length": null, - "codeList": "CL.TSPARMCD" - }, - { - "OID": "IT.TS.TSPARM", - "mandatory": true, - "name": "TSPARM", - "description": "Trial Summary Parameter", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_851", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TSPARM" - }, - { - "OID": "IT.TS.TSVAL", - "mandatory": false, - "name": "TSVAL", - "description": "Parameter Value", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_852", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVALCD", - "mandatory": false, - "name": "TSVALCD", - "description": "Parameter Value Code", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_853", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVCDREF", - "mandatory": false, - "name": "TSVCDREF", - "description": "Name of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_854", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DICTNAM" - }, - { - "OID": "IT.TS.TSVCDVER", - "mandatory": false, - "name": "TSVCDVER", - "description": "Version of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_855", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_162", - "slices": [ - { - "OID": "VL.TS.TSPARMCD", - "name": "VL_TS_TSPARMCD", - "type": "ValueList", - "wasDerivedFrom": "IT.TS.TSPARMCD", - "items": [ - { - "OID": "IT.TS.TSPARMCD.COMPTRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.54cd02f1" - ] - }, - { - "OID": "IT.TS.TSPARMCD.CRMDUR", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.f9fa8745" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INDIC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.9cdae039" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INTTYPE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e3ae16cd" - ] - }, - { - "OID": "IT.TS.TSPARMCD.NARMS", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.89c0d243" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJPRIM", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.7a056c75" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.36721696" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSPRI", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d8b84608" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.1d3cd461" - ] - }, - { - "OID": "IT.TS.TSPARMCD.SPONSOR", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.51236927" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TITLE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.43684533" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.1948fed3" - ] - } - ] - } - ] - }, - { - "OID": "IG.FT", - "name": "FT", - "description": "Functional Tests", - "domain": "FT", - "purpose": "Tabulation", - "structure": "One record per Functional Test finding per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "FTSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.FT.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTSEQ", - "mandatory": true, - "name": "FTSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTTESTCD", - "mandatory": true, - "name": "FTTESTCD", - "description": "Short Name of Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTTEST", - "mandatory": true, - "name": "FTTEST", - "description": "Name of Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTCAT", - "mandatory": true, - "name": "FTCAT", - "description": "Category", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.FTCAT" - }, - { - "OID": "IT.FT.FTSCAT", - "mandatory": false, - "name": "FTSCAT", - "description": "Subcategory", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTORRES", - "mandatory": false, - "name": "FTORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 4, - "displayFormat": "5.2", - "significantDigits": 2, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.FT.FTORRESU", - "mandatory": false, - "name": "FTORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.FT.FTSTRESC", - "mandatory": false, - "name": "FTSTRESC", - "description": "Result or Finding in Standard Format", - "role": "Result Qualifier", - "dataType": "float", - "length": 4, - "displayFormat": "5.2", - "significantDigits": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTSTRESN", - "mandatory": false, - "name": "FTSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 4, - "displayFormat": "5.2", - "significantDigits": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTSTRESU", - "mandatory": false, - "name": "FTSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.FT.FTSTAT", - "mandatory": false, - "name": "FTSTAT", - "description": "Completion Status", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ND" - }, - { - "OID": "IT.FT.FTREASND", - "mandatory": false, - "name": "FTREASND", - "description": "Reason Not Done", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.FT.FTLOBXFL", - "mandatory": false, - "name": "FTLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.FT.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.FT.FTDTC", - "mandatory": false, - "name": "FTDTC", - "description": "Date/Time of Test", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_172" - }, - { - "OID": "IG.TA", - "name": "TA", - "description": "Trial Arms", - "domain": "TA", - "purpose": "Tabulation", - "structure": "One record per planned Element per Arm", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ARMCD", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TA.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.ARMCD", - "mandatory": true, - "name": "ARMCD", - "description": "Planned Arm Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARMCD" - }, - { - "OID": "IT.TA.ARM", - "mandatory": true, - "name": "ARM", - "description": "Description of Planned Arm", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARM" - }, - { - "OID": "IT.TA.TAETORD", - "mandatory": true, - "name": "TAETORD", - "description": "Planned Order of Element within Arm", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TA.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TA.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TA.TABRANCH", - "mandatory": false, - "name": "TABRANCH", - "description": "Branch", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.TATRANS", - "mandatory": false, - "name": "TATRANS", - "description": "Transition Rule", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.EPOCH", - "mandatory": true, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - } - ] - }, - { - "OID": "IG.TE", - "name": "TE", - "description": "Trial Elements", - "domain": "TE", - "purpose": "Tabulation", - "structure": "One record per planned Element", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TE.ELEMENT", - "mandatory": true, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TE.TESTRL", - "mandatory": true, - "name": "TESTRL", - "description": "Rule for Start of Element", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ] - }, - { - "OID": "IG.SV", - "name": "SV", - "description": "Subject Visits", - "domain": "SV", - "purpose": "Tabulation", - "structure": "One record per actual or planned visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VISITNUM" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SV.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISITNUM", - "mandatory": true, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Topic", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISIT", - "mandatory": false, - "name": "VISIT", - "description": "Visit Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.SVPRESP", - "mandatory": false, - "name": "SVPRESP", - "description": "Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVOCCUR", - "mandatory": false, - "name": "SVOCCUR", - "description": "Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVCNTMOD", - "mandatory": false, - "name": "SVCNTMOD", - "description": "Contact Mode", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.CNTMODE" - }, - { - "OID": "IT.SV.SVSTDTC", - "mandatory": false, - "name": "SVSTDTC", - "description": "Start Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SV.SVENDTC", - "mandatory": false, - "name": "SVENDTC", - "description": "End Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - }, - { - "OID": "IG.SE", - "name": "SE", - "description": "Subject Elements", - "domain": "SE", - "purpose": "Tabulation", - "structure": "One record per actual Element per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SESTDTC" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.SESEQ", - "mandatory": true, - "name": "SESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.SE.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.SE.EPOCH", - "mandatory": false, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - }, - { - "OID": "IT.SE.SESTDTC", - "mandatory": true, - "name": "SESTDTC", - "description": "Start Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SE.SEENDTC", - "mandatory": false, - "name": "SEENDTC", - "description": "End Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - } - ], - "conditions": [ - { - "OID": "COND.TS.TSPARMCD.cd7838e7", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "COMPTRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.ceb735c9", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "CRMDUR" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.204aa07d", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INDIC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.fd076a8d", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INTTYPE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.770c1610", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "NARMS" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.eb0c9bb2", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJPRIM" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.5ca3cd0c", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.a724d633", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSPRI" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.b313e712", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.2e2517d1", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "SPONSOR" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.52dad99f", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TITLE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.185bd9b1", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - } - ], - "whereClauses": [ - { - "OID": "WC.TS.54cd02f1", - "conditions": [ - "COND.TS.TSPARMCD.cd7838e7" - ] - }, - { - "OID": "WC.TS.f9fa8745", - "conditions": [ - "COND.TS.TSPARMCD.ceb735c9" - ] - }, - { - "OID": "WC.TS.9cdae039", - "conditions": [ - "COND.TS.TSPARMCD.204aa07d" - ] - }, - { - "OID": "WC.TS.e3ae16cd", - "conditions": [ - "COND.TS.TSPARMCD.fd076a8d" - ] - }, - { - "OID": "WC.TS.89c0d243", - "conditions": [ - "COND.TS.TSPARMCD.770c1610" - ] - }, - { - "OID": "WC.TS.7a056c75", - "conditions": [ - "COND.TS.TSPARMCD.eb0c9bb2" - ] - }, - { - "OID": "WC.TS.36721696", - "conditions": [ - "COND.TS.TSPARMCD.5ca3cd0c" - ] - }, - { - "OID": "WC.TS.d8b84608", - "conditions": [ - "COND.TS.TSPARMCD.a724d633" - ] - }, - { - "OID": "WC.TS.1d3cd461", - "conditions": [ - "COND.TS.TSPARMCD.b313e712" - ] - }, - { - "OID": "WC.TS.51236927", - "conditions": [ - "COND.TS.TSPARMCD.2e2517d1" - ] - }, - { - "OID": "WC.TS.43684533", - "conditions": [ - "COND.TS.TSPARMCD.52dad99f" - ] - }, - { - "OID": "WC.TS.1948fed3", - "conditions": [ - "COND.TS.TSPARMCD.185bd9b1" - ] - } - ], - "codeLists": [ - { - "OID": "CL.ARMCD", - "name": "ARM Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Placebo" - }, - { - "codedValue": "Xanomeline Low Dose" - }, - { - "codedValue": "Xanomeline High Dose" - } - ] - }, - { - "OID": "CL.ARM", - "name": "ARM", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Placebo" - }, - { - "codedValue": "Xanomeline Low Dose" - }, - { - "codedValue": "Xanomeline High Dose" - } - ] - }, - { - "OID": "CL.ELEMENT", - "name": "Description of Element", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Screening" - }, - { - "codedValue": "Placebo" - }, - { - "codedValue": "Low" - }, - { - "codedValue": "High - Start" - }, - { - "codedValue": "High - Middle" - }, - { - "codedValue": "High - End" - }, - { - "codedValue": "Follow up" - } - ] - }, - { - "OID": "CL.ETCD", - "name": "Element Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "EL1", - "decode": "Screening" - }, - { - "codedValue": "EL2", - "decode": "Placebo" - }, - { - "codedValue": "EL3", - "decode": "Low" - }, - { - "codedValue": "EL4", - "decode": "High - Start" - }, - { - "codedValue": "EL5", - "decode": "High - Middle" - }, - { - "codedValue": "EL6", - "decode": "High - End" - }, - { - "codedValue": "EL7", - "decode": "Follow up" - } - ] - }, - { - "OID": "CL.EPOCH", - "name": "Epoch", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99079", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "Screening", - "coding": { - "code": "C202487", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Treatment 1", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Treatment 2", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Treatment 3", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Follow-up", - "coding": { - "code": "C202578", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.a30c10b2", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "INFORMED CONSENT OBTAINED", - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED" - } - ] - } - ] - }, - { - "OID": "CL.e1a1b71c", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "RANDOMIZED", - "coding": [ - { - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED" - } - ] - } - ] - }, - { - "OID": "CL.bf247815", - "name": "SCORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "YEARS", - "coding": [ - { - "code": "C29848", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "YEARS" - } - ] - } - ] - }, - { - "OID": "CL.82acb719", - "name": "PRDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "X-RAY", - "coding": [ - { - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "X-RAY" - } - ] - } - ] - }, - { - "OID": "CL.cbd6ad98", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "beats/min", - "coding": [ - { - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min" - } - ] - } - ] - }, - { - "OID": "CL.b63f6642", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "breaths/min", - "coding": [ - { - "code": "C49674", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "breaths/min" - } - ] - } - ] - }, - { - "OID": "CL.04edb9f9", - "name": "EGORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "deg", - "coding": [ - { - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "deg" - } - ] - } - ] - }, - { - "OID": "CL.2e4119e7", - "name": "PRDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "CT SCAN", - "coding": [ - { - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "CT SCAN" - } - ] - } - ] - }, - { - "OID": "CL.3edf8d8c", - "name": "PRLOC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "CHEST", - "coding": [ - { - "code": "C25389", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "CHEST" - } - ] - } - ] - }, - { - "OID": "CL.d03f062b", - "name": "PRDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "MRI", - "coding": [ - { - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI" - } - ] - } - ] - }, - { - "OID": "CL.e2fce626", - "name": "PRLOC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "BRAIN", - "coding": [ - { - "code": "C12439", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "BRAIN" - } - ] - } - ] - }, - { - "OID": "CL.1f6d4af1", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "BLOOD", - "coding": [ - { - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD" - } - ] - } - ] - }, - { - "OID": "CL.8d13b90f", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ERYTHROCYTES", - "coding": [ - { - "code": "C12521", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ERYTHROCYTES" - } - ] - } - ] - }, - { - "OID": "CL.d00a60ac", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "fL", - "coding": [ - { - "code": "C64780", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "fL" - } - ] - } - ] - }, - { - "OID": "CL.d121315c", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "10^9/L", - "coding": [ - { - "code": "C67255", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^9/L" - } - ] - } - ] - }, - { - "OID": "CL.b454d520", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "10^6/L", - "coding": [ - { - "code": "C67452", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^6/L" - } - ] - } - ] - }, - { - "OID": "CL.2148028d", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SERUM OR PLASMA", - "coding": [ - { - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA" - } - ] - } - ] - }, - { - "OID": "CL.b0ec3282", - "name": "MBTSTDTL Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "DETECTION", - "coding": [ - { - "code": "C174330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "DETECTION" - } - ] - } - ] - }, - { - "OID": "CL.64500426", - "name": "MBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SERUM", - "coding": [ - { - "code": "C13325", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM" - } - ] - } - ] - }, - { - "OID": "CL.928af9cb", - "name": "MBMETHOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "LINE PROBE ASSAY", - "coding": [ - { - "code": "C102656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "LINE PROBE ASSAY" - } - ] - } - ] - }, - { - "OID": "CL.64329559", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "URINE", - "coding": [ - { - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE" - } - ] - } - ] - }, - { - "OID": "CL.65d42172", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "STOOL", - "coding": [ - { - "code": "C13234", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "STOOL" - } - ] - } - ] - }, - { - "OID": "CL.d7c5855c", - "name": "QSEVAL Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "CAREGIVER", - "coding": [ - { - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER" - } - ] - } - ] - }, - { - "OID": "CL.fc6fa4d8", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SITE TRANSFER", - "coding": [ - { - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SITE TRANSFER" - } - ] - } - ] - }, - { - "OID": "CL.6e594ef0", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "coding": [ - { - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY" - } - ] - } - ] - }, - { - "OID": "CL.5991b40f", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "mmHg", - "coding": [ - { - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg" - } - ] - } - ] - }, - { - "OID": "CL.b57d3f41", - "name": "TSPARMCD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "EGCTMON", - "coding": [ - { - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "EGCTMON" - } - ] - } - ] - }, - { - "OID": "CL.NCOMPLT", - "name": "Completion/Reason for Non-Completion", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66727", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSCAT", - "name": "Category of Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74558", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSSCAT", - "name": "Subcategory for Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C170443", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.IECAT", - "name": "Category of Inclusion/Exclusion", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66797", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY", - "name": "No Yes Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.AGEU", - "name": "Age Unit", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66781", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.SEX", - "name": "Sex", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66731", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.SCTESTCD", - "name": "Subject Characteristic Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74559", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.SCTEST", - "name": "Subject Characteristic Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C103330", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.UNIT", - "name": "Unit", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71620", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.STENRF", - "name": "Relation to Reference Period", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66728", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY_Y", - "name": "No Yes Response (Subset Y)", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY_NY", - "name": "No Yes Response (Subset NY)", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FREQ", - "name": "Frequency", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71113", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.PROCEDUR", - "name": "Procedure", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C101858", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "CT SCAN", - "decode": "CAT Scan", - "coding": { - "code": "C17204", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "MRI", - "decode": "Magnetic Resonance Imaging", - "coding": { - "code": "C16809", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "X-RAY", - "decode": "Static X-Ray", - "coding": { - "code": "C38101", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.LOC", - "name": "Anatomical Location", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74456", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "BRAIN", - "decode": "Nervous System, Brain", - "coding": { - "code": "C12439", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "CHEST", - "decode": "Chest", - "coding": { - "code": "C25389", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "BLOOD", - "decode": "Peripheral Blood", - "coding": { - "code": "C12434", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.VSTESTCD", - "name": "Vital Signs Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66741", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTEST", - "name": "Vital Signs Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67153", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.POSITION", - "name": "Position", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71148", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSRESU", - "name": "Units for Vital Signs Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66770", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LAT", - "name": "Laterality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99073", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGTESTCD", - "name": "ECG Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71153", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGTEST", - "name": "ECG Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71152", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGSTRESC", - "name": "ECG Result", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71150", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGMETHOD", - "name": "ECG Test Method", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71151", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EVAL", - "name": "Evaluator", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C78735", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "CAREGIVER", - "decode": "Caregiver", - "coding": { - "code": "C17445", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.FRM", - "name": "Dosage Form", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66726", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ROUTE", - "name": "Route of Administration Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66729", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTESTCD", - "name": "Laboratory Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C65047", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTEST", - "name": "Laboratory Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67154", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MBTESTCD", - "name": "Microbiology Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C120527", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MBTEST", - "name": "Microbiology Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C120528", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MBFTSDTL", - "name": "Microbiology Findings Test Details", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C174225", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "DETECTION", - "decode": "", - "coding": { - "code": "C174330", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.SPECTYPE", - "name": "Specimen Type", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C78734", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "SERUM", - "decode": "Sera", - "coding": { - "code": "C13325", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.METHOD", - "name": "Method", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C85492", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "LINE PROBE ASSAY", - "decode": "LiPA", - "coding": { - "code": "C102656", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.URNSTSCD", - "name": "Urinary System Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129942", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.URNSTS", - "name": "Urinary System Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129941", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DIR", - "name": "Directionality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99074", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.QSCAT", - "name": "Category of Questionnaire", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C100129", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.AESEV", - "name": "Severity/Intensity Scale for Adverse Events", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66769", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ACN", - "name": "Action Taken with Study Treatment", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66767", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.OUT", - "name": "Outcome of Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66768", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MUSCTSCD", - "name": "Musculoskeletal System Finding Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C127269", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MUSCTS", - "name": "Musculoskeletal System Finding Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C127270", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TSPARMCD", - "name": "Trial Summary Parameter Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66738", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "EGCTMON", - "decode": "ECG Continuous Monitoring", - "coding": { - "code": "C119561", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.TSPARM", - "name": "Trial Summary Parameter Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67152", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "ECG Continuous Monitoring", - "decode": "ECG Continuous Monitoring", - "coding": { - "code": "C119561", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.DICTNAM", - "name": "Dictionary Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66788", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FTCAT", - "name": "Category of Functional Test", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C115304", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ND", - "name": "Not Done", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66789", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.CNTMODE", - "name": "Mode of Subject Contact", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C171445", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "IN PERSON", - "decode": "In-Person", - "coding": { - "code": "C175574", - "codeSystem": "nci:ExtCodeID" - } - } - ] - } - ], - "methods": [], - "comments": [], - "standards": [ - { - "OID": "STD.SDTMIG", - "name": "SDTMIG", - "type": "IG", - "version": "3.4", - "status": "FINAL" - }, - { - "OID": "STD.SDTMCT", - "name": "CDISC/NCI", - "type": "CT", - "version": "2026-03-27", - "status": "FINAL", - "publishingSet": "SDTM" - } - ], - "annotatedCRF": [], - "concepts": [ - { - "OID": "CONC.BiomedicalConcept_1", - "name": "Informed Consent", - "label": null, - "aliases": [ - "Informed Consent Obtained" - ], - "href": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.a30c10b2" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_2", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_3", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_2", - "name": "Inclusion Criteria", - "label": "Inclusion Criteria", - "aliases": [ - "Inclusion" - ], - "href": "/mdr/bc/biomedicalconcepts/C25532", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_4", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_5", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_6", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Inclusion Criteria" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_3", - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "aliases": [ - "Inclusion Exclusion Criteria Yes No Indicator", - "IEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83063", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_7", - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_8", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_4", - "name": "Exclusion Criteria", - "label": "Exclusion Criteria", - "aliases": [ - "Exclusion" - ], - "href": "/mdr/bc/biomedicalconcepts/C25370", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_9", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ], - "codeList": "CL.a30c10b2" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_10", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_11", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25370", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Exclusion Criteria" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_5", - "name": "Subject is Randomized", - "label": "Subject is Randomized", - "aliases": [ - "Randomized" - ], - "href": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_12", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.e1a1b71c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_13", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_14", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_6", - "name": "Race", - "label": "Race", - "aliases": [ - "Racial Group" - ], - "href": "/mdr/bc/biomedicalconcepts/C17049", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_15", - "name": "RACE", - "label": "RACE", - "mandatory": false, - "coding": [ - { - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Race" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_16", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Race" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_7", - "name": "Ethnic Group", - "label": "Ethnic Group", - "aliases": [ - "Ethnicity", - "Ethnic Origin" - ], - "href": "/mdr/bc/biomedicalconcepts/C16564", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_17", - "name": "ETHNIC", - "label": "ETHNIC", - "mandatory": false, - "coding": [ - { - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ethnic Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_18", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Ethnic Group" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_8", - "name": "Subject Age", - "label": "Subject Age", - "aliases": [ - "Age" - ], - "href": "/mdr/bc/biomedicalconcepts/C69260", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_19", - "name": "AGE", - "label": "AGE", - "mandatory": false, - "coding": [ - { - "code": "C170981", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Numeric Age for Data Tabulation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_20", - "name": "AGEU", - "label": "AGEU", - "mandatory": false, - "coding": [ - { - "code": "C50400", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Age Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_21", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C69260", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Subject Age" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_9", - "name": "Birth Date and Time", - "label": "Birth Date and Time", - "aliases": [ - "BRTHDTC", - "Date/Time of Birth" - ], - "href": "/mdr/bc/biomedicalconcepts/C83217", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_22", - "name": "BRTHDTC", - "label": "BRTHDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_23", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83217", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Birth Date and Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_10", - "name": "Sex", - "label": null, - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C28421", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_24", - "name": "SEX", - "label": "SEX", - "mandatory": false, - "coding": [ - { - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_25", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_11", - "name": "Education Level", - "label": "Education Level", - "aliases": [ - "EDULEVEL", - "Education Level Completed", - "Education" - ], - "href": "/mdr/bc/biomedicalconcepts/C17953", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_26", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_27", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C17953", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Education Level" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_12", - "name": "Number of Years of Education", - "label": "Number of Years of Education", - "aliases": [ - "EDUYRNUM", - "Education" - ], - "href": "/mdr/bc/biomedicalconcepts/C122393", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_28", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.e1a1b71c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_29", - "name": "SCORRESU", - "label": "SCORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.bf247815" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_30", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.e1a1b71c" - } - ], - "coding": [ - { - "code": "C122393", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Number of Years of Education" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_14", - "name": "Solicited Medical History", - "label": "Solicited Medical History", - "aliases": [ - "Medical History", - "Medical History Collection" - ], - "href": "/mdr/bc/biomedicalconcepts/C200145", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_31", - "name": "MHTERM", - "label": "MHTERM", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_32", - "name": "MHDECOD", - "label": "MHDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_33", - "name": "MHSTDTC", - "label": "MHSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83338", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_34", - "name": "MHENDTC", - "label": "MHENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_35", - "name": "MHENRF", - "label": "MHENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_36", - "name": "MHENRTPT", - "label": "MHENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_37", - "name": "MHENTPT", - "label": "MHENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C200145", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Medical History" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_15", - "name": "Alcohol Use History", - "label": "Alcohol Use History", - "aliases": [ - "Alcohol History", - "Alcohol Use" - ], - "href": "/mdr/bc/biomedicalconcepts/C81229", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_38", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_39", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_40", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_41", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_42", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_43", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_44", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_45", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_46", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_47", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_48", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_49", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_50", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_51", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_52", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C81229", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alcohol Use History" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_16", - "name": "Caffeine Use History", - "label": "Caffeine Use History", - "aliases": [ - "Caffeine History", - "Caffeine Use" - ], - "href": "/mdr/bc/biomedicalconcepts/C201990", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_53", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_54", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_55", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_56", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_57", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_58", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_59", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_60", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_61", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_62", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_63", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_64", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_65", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_66", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ], - "codeList": "CL.bf247815" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_67", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C201990", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Caffeine Use History" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_17", - "name": "History of Tobacco Use", - "label": "History of Tobacco Use", - "aliases": [ - "Tobacco Use", - "Tobacco Use History" - ], - "href": "/mdr/bc/biomedicalconcepts/C181760", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_68", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_69", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_70", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_71", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_72", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_73", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_74", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_75", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_76", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_77", - "name": "SUDUR", - "label": "SUDUR", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_78", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_79", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_80", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_81", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_82", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_83", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C181760", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "History of Tobacco Use" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_18", - "name": "X-Ray Imaging", - "label": "X-Ray Imaging", - "aliases": [ - "Conventional X-Ray", - "Medical Imaging", - "X-Ray", - "Static X-Ray" - ], - "href": "/mdr/bc/biomedicalconcepts/C38101", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_84", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_85", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.82acb719" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_86", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_87", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_88", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_89", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_90", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "X-RAY" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_19", - "name": "Subject is Randomized", - "label": null, - "aliases": [ - "Randomized" - ], - "href": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_91", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.e1a1b71c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_92", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_93", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_20", - "name": "Body Temperature", - "label": "Body Temperature", - "aliases": [ - "Temperature" - ], - "href": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_94", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_95", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_96", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_97", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_21", - "name": "Body Weight", - "label": "Body Weight", - "aliases": [ - "WEIGHT" - ], - "href": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_98", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_99", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_100", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_22", - "name": "Body Height", - "label": "Body Height", - "aliases": [ - "HEIGHT" - ], - "href": "/mdr/bc/biomedicalconcepts/C164634", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_101", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_102", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C168688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Height" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_103", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C164634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Height" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_23", - "name": "Pulse Rate", - "label": "Pulse Rate", - "aliases": [ - "Pulse" - ], - "href": "/mdr/bc/biomedicalconcepts/C49676", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_104", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_105", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_106", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_107", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_108", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_109", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_24", - "name": "Respiratory Rate", - "label": "Respiratory Rate", - "aliases": [ - "RESP", - "RESPRATE" - ], - "href": "/mdr/bc/biomedicalconcepts/C49678", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_110", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_111", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.b63f6642" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_112", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49678", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_25", - "name": "Body Mass Index", - "label": "Body Mass Index", - "aliases": [ - "BMI", - "Quetelet Index" - ], - "href": "/mdr/bc/biomedicalconcepts/C16358", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_113", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_114", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Density" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_115", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Mass Index" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_26", - "name": "Blood Pressure", - "label": "Blood Pressure", - "aliases": [ - "BP" - ], - "href": "/mdr/bc/biomedicalconcepts/C54706", - "properties": [], - "coding": [ - { - "code": "C54706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_27", - "name": "Electrocardiogram Analysis", - "label": "Electrocardiogram Analysis", - "aliases": [ - "ECG Analysis", - "EKG Analysis", - "Electrocardiogram Interpretation", - "ECG Interpretation", - "EKG Interpretation" - ], - "href": "/mdr/bc/biomedicalconcepts/C181655", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_116", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C125009", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Interpretation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_117", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_118", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_119", - "name": "EGCLSIG", - "label": "EGCLSIG", - "mandatory": false, - "coding": [ - { - "code": "C93532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinically Significant Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_120", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C181655", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Electrocardiogram Analysis" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_28", - "name": "Atrioventricular Conduction ECG Assessment", - "label": "Atrioventricular Conduction ECG Assessment", - "aliases": [ - "AVCOND", - "Atrioventricular Conduction" - ], - "href": "/mdr/bc/biomedicalconcepts/C111131", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_121", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_122", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_123", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_124", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_125", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111131", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Atrioventricular Conduction ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_29", - "name": "Axis and Voltage ECG Assessment", - "label": "Axis and Voltage ECG Assessment", - "aliases": [ - "AXISVOLT", - "Axis and Voltage" - ], - "href": "/mdr/bc/biomedicalconcepts/C111132", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_126", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_127", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_128", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_129", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_130", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111132", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Axis and Voltage ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_30", - "name": "Chamber Hypertrophy or Enlargement ECG Assessment", - "label": "Chamber Hypertrophy or Enlargement ECG Assessment", - "aliases": [ - "CHYPTENL", - "Chamber Hypertrophy or Enlargement" - ], - "href": "/mdr/bc/biomedicalconcepts/C111155", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_131", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_132", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_133", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_134", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_135", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111155", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Chamber Hypertrophy or Enlargement ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_31", - "name": "ECG Technical Quality", - "label": "ECG Technical Quality", - "aliases": [ - "TECHQUAL" - ], - "href": "/mdr/bc/biomedicalconcepts/C117807", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_136", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C114120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ECG Recording Quality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_137", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_138", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_139", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117807", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "ECG Technical Quality" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_32", - "name": "Intraventricular and Intraatrial Conduction ECG Assessment", - "label": "Intraventricular and Intraatrial Conduction ECG Assessment", - "aliases": [ - "IVTIACD", - "Intraventricular-Intraatrial Conduction" - ], - "href": "/mdr/bc/biomedicalconcepts/C111238", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_140", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_141", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_142", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_143", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_144", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Intraventricular and Intraatrial Conduction ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_33", - "name": "Myocardial Infarction ECG Assessment", - "label": "Myocardial Infarction ECG Assessment", - "aliases": [ - "MI", - "Myocardial Infarction" - ], - "href": "/mdr/bc/biomedicalconcepts/C111280", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_145", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_146", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_147", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_148", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - } - ], - "coding": [ - { - "code": "C111280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Myocardial Infarction ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_34", - "name": "Pacemaker ECG Assessment", - "label": "Pacemaker ECG Assessment", - "aliases": [ - "PACEMAKR", - "Pacemaker" - ], - "href": "/mdr/bc/biomedicalconcepts/C111285", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_149", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_150", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_151", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_152", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_153", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Pacemaker ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_35", - "name": "Rhythm Not Otherwise Specified ECG Assessment", - "label": "Rhythm Not Otherwise Specified ECG Assessment", - "aliases": [ - "RHYNOS", - "Rhythm Not Otherwise Specified" - ], - "href": "/mdr/bc/biomedicalconcepts/C111307", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_154", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_155", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_156", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_157", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_158", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111307", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Rhythm Not Otherwise Specified ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_36", - "name": "ST Segment, T wave, and U wave ECG Assessment", - "label": "ST Segment, T wave, and U wave ECG Assessment", - "aliases": [ - "STSTWUW", - "ST Segment, T wave, and U wave" - ], - "href": "/mdr/bc/biomedicalconcepts/C111363", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_159", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_160", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_161", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_162", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_163", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111363", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "ST Segment, T wave, and U wave ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_37", - "name": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "label": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "aliases": [ - "SNRARRY", - "Sinus Node Rhythms and Arrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111312", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_164", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_165", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_166", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_167", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_168", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111312", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Sinus Node Rhythm and Arrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_38", - "name": "Supraventricular Arrhythmia ECG Assessment", - "label": "Supraventricular Arrhythmia ECG Assessment", - "aliases": [ - "SPRARRY", - "Supraventricular Arrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111320", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_169", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_170", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_171", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_172", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_173", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.b63f6642" - } - ], - "coding": [ - { - "code": "C111320", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Arrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_39", - "name": "Supraventricular Tachyarrhythmia ECG Assessment", - "label": "Supraventricular Tachyarrhythmia ECG Assessment", - "aliases": [ - "SPRTARRY", - "Supraventricular Tachyarrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111321", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_174", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_175", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_176", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_177", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_178", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Tachyarrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_40", - "name": "Aggregate PR Interval", - "label": "Aggregate PR Interval", - "aliases": [ - "PR Interval Aggregate", - "PQ Interval Aggregate", - "PRAG", - "PQAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117773", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_179", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_180", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_181", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_182", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ], - "codeList": "CL.82acb719" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_183", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_184", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_185", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117773", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate PR Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_41", - "name": "Aggregate QRS Duration", - "label": "Aggregate QRS Duration", - "aliases": [ - "QRS Aggregate Duration", - "QRSAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117779", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_186", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_187", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_188", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ], - "codeList": "CL.e1a1b71c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_189", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_190", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_191", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_192", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117779", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QRS Duration" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_42", - "name": "Aggregate QT Interval", - "label": "Aggregate QT Interval", - "aliases": [ - "QT Interval Aggregate", - "QTAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117783", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_193", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_194", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_195", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_196", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_197", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_198", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_199", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117783", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QT Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_43", - "name": "Aggregate QTCB Interval", - "label": "Aggregate QTCB Interval", - "aliases": [ - "QTCB Interval Aggregate", - "QTCBAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117784", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_200", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_201", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_202", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_203", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_204", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_205", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_206", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117784", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCB Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_44", - "name": "Aggregate QTCF Interval", - "label": "Aggregate QTCF Interval", - "aliases": [ - "QTCF Interval Aggregate", - "QTCFAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117786", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_207", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_208", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_209", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_210", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_211", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_212", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_213", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCF Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_45", - "name": "Aggregate RR Interval", - "label": "Aggregate RR Interval", - "aliases": [ - "RR Interval Aggregate", - "RRAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117791", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_214", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_215", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_216", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_217", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_218", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_219", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_220", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ], - "codeList": "CL.b63f6642" - } - ], - "coding": [ - { - "code": "C117791", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Aggregate RR Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_46", - "name": "Mean Heart Rate by Electrocardiogram", - "label": "Mean Heart Rate by Electrocardiogram", - "aliases": [ - "ECG Mean Heart Rate", - "EKG Mean Heart Rate", - "EGHRMN" - ], - "href": "/mdr/bc/biomedicalconcepts/C119259", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_221", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_222", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_223", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_224", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_225", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_226", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.b63f6642" - } - ], - "coding": [ - { - "code": "C119259", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Mean Heart Rate by Electrocardiogram" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_47", - "name": "QRS Axis", - "label": "QRS Axis", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C118165", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Degree Unit of Plane Angle" - } - ], - "codeList": "CL.04edb9f9" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_230", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_231", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_232", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C118165", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QRS Axis" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_48", - "name": "QTc Correction Method Unspecified, Aggregate", - "label": "QTc Correction Method Unspecified, Aggregate", - "aliases": [ - "QTCUNSAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C174285", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_233", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_234", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_235", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_236", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_237", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_238", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C174285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QTc Correction Method Unspecified, Aggregate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_49", - "name": "Ventricular Arrhythmia ECG Assessment", - "label": "Ventricular Arrhythmia ECG Assessment", - "aliases": [ - "VTARRY", - "Ventricular Arrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111330", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Arrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_50", - "name": "Ventricular Tachyarrhythmia ECG Assessment", - "label": "Ventricular Tachyarrhythmia ECG Assessment", - "aliases": [ - "VTTARRY", - "Ventricular Tachyarrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111331", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Tachyarrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_51", - "name": "Computed Tomography", - "label": "Computed Tomography", - "aliases": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "href": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.2e4119e7" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.3edf8d8c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_52", - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "aliases": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "href": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.d03f062b" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.e2fce626" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_54", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "aliases": [ - "CMYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_55", - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "aliases": [ - "Concomitant Medication" - ], - "href": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_56", - "name": "Hemoglobin Measurement", - "label": "Hemoglobin Measurement", - "aliases": [ - "Hemoglobin", - "HGB" - ], - "href": "/mdr/bc/biomedicalconcepts/C64848", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64848", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_57", - "name": "Hematocrit Measurement", - "label": "Hematocrit Measurement", - "aliases": [ - "Hematocrit", - "Packed Cell Volume", - "PCV", - "Erythrocyte Volume Fraction", - "EVF" - ], - "href": "/mdr/bc/biomedicalconcepts/C64796", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C69174", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume Fraction" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64796", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hematocrit Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_58", - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "aliases": [ - "RBC", - "Red Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_59", - "name": "Erythrocyte Mean Corpuscular Hemoglobin", - "label": "Erythrocyte Mean Corpuscular Hemoglobin", - "aliases": [ - "RBC Mean Corpuscular Hemoglobin", - "MCH" - ], - "href": "/mdr/bc/biomedicalconcepts/C64797", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C25709", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Measure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.8d13b90f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_302", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_303", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Hemoglobin" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_60", - "name": "Erythrocyte Mean Corpuscular Volume", - "label": "Erythrocyte Mean Corpuscular Volume", - "aliases": [ - "RBC Mean Corpuscular Volume", - "MCV" - ], - "href": "/mdr/bc/biomedicalconcepts/C64799", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_304", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_305", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" - } - ], - "codeList": "CL.d00a60ac" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_306", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.8d13b90f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_307", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_308", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64799", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Volume" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_61", - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "aliases": [ - "WBC", - "White Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_309", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_310", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_311", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_312", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_313", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_62", - "name": "Segmented Neutrophil Count", - "label": "Segmented Neutrophil Count", - "aliases": [ - "Segmented Neutrophils", - "NEUTSG" - ], - "href": "/mdr/bc/biomedicalconcepts/C81997", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_314", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_315", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.d121315c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_316", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C81997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Segmented Neutrophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_63", - "name": "Neutrophil Band Form Count", - "label": "Neutrophil Band Form Count", - "aliases": [ - "Neutrophil Bands", - "Bands", - "NEUTB" - ], - "href": "/mdr/bc/biomedicalconcepts/C64830", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.b454d520" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64830", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Neutrophil Band Form Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_64", - "name": "Absolute Neutrophil Count", - "label": "Absolute Neutrophil Count", - "aliases": [ - "Neutrophils", - "Total Neutrophil Count", - "NEUT" - ], - "href": "/mdr/bc/biomedicalconcepts/C63321", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.d121315c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C63321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Neutrophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_65", - "name": "Monocyte Count", - "label": "Monocyte Count", - "aliases": [ - "Monocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C64823", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64823", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Monocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_66", - "name": "Eosinophil Count", - "label": "Eosinophil Count", - "aliases": [ - "Eosinophils" - ], - "href": "/mdr/bc/biomedicalconcepts/C64550", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64550", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Eosinophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_67", - "name": "Absolute Basophil Count", - "label": "Absolute Basophil Count", - "aliases": [ - "Basophils", - "Total Basophil Count" - ], - "href": "/mdr/bc/biomedicalconcepts/C64470", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_341", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_342", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_343", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64470", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Basophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_68", - "name": "Platelet Count", - "label": "Platelet Count", - "aliases": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_344", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_345", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_69", - "name": "Microcyte Count", - "label": "Microcyte Count", - "aliases": [ - "Microcytes", - "MICROCY" - ], - "href": "/mdr/bc/biomedicalconcepts/C64822", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64822", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Microcyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_70", - "name": "Macrocyte Count", - "label": "Macrocyte Count", - "aliases": [ - "Macrocytes", - "MACROCY" - ], - "href": "/mdr/bc/biomedicalconcepts/C64821", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_354", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_355", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_356", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64821", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Macrocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_71", - "name": "Anisocyte Measurement", - "label": "Anisocyte Measurement", - "aliases": [ - "Anisocytes", - "Anisocytosis", - "ANISO" - ], - "href": "/mdr/bc/biomedicalconcepts/C74797", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_358", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_359", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_360", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anisocyte Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_72", - "name": "Poikilocyte Measurement", - "label": "Poikilocyte Measurement", - "aliases": [ - "POIKILO", - "Poikilocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C79602", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_361", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C79602", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Poikilocyte Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_73", - "name": "Polychromasia", - "label": "Polychromasia", - "aliases": [ - "POLYCHR" - ], - "href": "/mdr/bc/biomedicalconcepts/C64803", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_365", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_366", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_367", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_368", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64803", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Polychromasia" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_74", - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "aliases": [ - "ALT", - "SGPT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_369", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_370", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_371", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_372", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_373", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_75", - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "aliases": [ - "Albumin" - ], - "href": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_374", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_375", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_376", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_377", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_378", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_76", - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "aliases": [ - "Alkaline Phosphatase" - ], - "href": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_379", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_380", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_381", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_382", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_383", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_77", - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "aliases": [ - "AST", - "SGOT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_384", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_385", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_386", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_387", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_388", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_78", - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "aliases": [ - "Creatinine" - ], - "href": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_908", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_909", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_910", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_911", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_912", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_79", - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "aliases": [ - "Potassium", - "K" - ], - "href": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_394", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_395", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_396", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_397", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_398", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_80", - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "aliases": [ - "Sodium", - "NA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_399", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_400", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_401", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_402", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_403", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_81", - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "aliases": [ - "Urea Nitrogen" - ], - "href": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_404", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_405", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_406", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_407", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_408", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_82", - "name": "Bicarbonate Measurement", - "label": "Bicarbonate Measurement", - "aliases": [ - "Bicarbonate", - "HCO3" - ], - "href": "/mdr/bc/biomedicalconcepts/C74667", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_409", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_410", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_411", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_412", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_413", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Bicarbonate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_83", - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "aliases": [ - "Chloride", - "CL" - ], - "href": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_414", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_415", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_416", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_417", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_418", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_84", - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "aliases": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "href": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_419", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_420", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_421", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_422", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_423", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_85", - "name": "Gamma Glutamyl Transpeptidase Measurement", - "label": "Gamma Glutamyl Transpeptidase Measurement", - "aliases": [ - "Gamma Glutamyl Transferase", - "GGT", - "GGTP" - ], - "href": "/mdr/bc/biomedicalconcepts/C64847", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_913", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_914", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_915", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_916", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_917", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64847", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Gamma Glutamyl Transpeptidase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_86", - "name": "Urate Measurement", - "label": "Urate Measurement", - "aliases": [ - "Urate", - "Uric Acid" - ], - "href": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_429", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_430", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_431", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_432", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_433", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_87", - "name": "Phosphate Measurement", - "label": "Phosphate Measurement", - "aliases": [ - "Phosphorus", - "Phosphate" - ], - "href": "/mdr/bc/biomedicalconcepts/C64857", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_918", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_919", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_920", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_921", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_922", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64857", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Phosphate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_88", - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "aliases": [ - "Calcium", - "CA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_923", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_924", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_925", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_926", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_927", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_89", - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "aliases": [ - "Glucose" - ], - "href": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_444", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_445", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_446", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_447", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_448", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_449", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_90", - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "aliases": [ - "Protein" - ], - "href": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_450", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_451", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_452", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_453", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_454", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.cbd6ad98" - } - ], - "coding": [ - { - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_91", - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "aliases": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_455", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_456", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_457", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_458", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_459", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_92", - "name": "Triiodothyronine Uptake Measurement", - "label": "Triiodothyronine Uptake Measurement", - "aliases": [ - "T3UP", - "T3U", - "Triiodothyronine Resin Uptake" - ], - "href": "/mdr/bc/biomedicalconcepts/C74748", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_460", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_461", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48570", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_462", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_463", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_464", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74748", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Uptake Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_93", - "name": "Triiodothyronine Measurement", - "label": "Triiodothyronine Measurement", - "aliases": [ - "T3", - "Total T3" - ], - "href": "/mdr/bc/biomedicalconcepts/C74747", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_928", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_929", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_930", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_931", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_932", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74747", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_94", - "name": "Free Thyroxine Measurement", - "label": "Free Thyroxine Measurement", - "aliases": [ - "Free T4", - "T4FR" - ], - "href": "/mdr/bc/biomedicalconcepts/C74786", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_470", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_471", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_472", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_473", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_474", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_95", - "name": "Free Thyroxine Index", - "label": "Free Thyroxine Index", - "aliases": [ - "T4FRIDX" - ], - "href": "/mdr/bc/biomedicalconcepts/C170598", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_475", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_476", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_477", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_478", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C170598", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Index" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_96", - "name": "Thyrotropin Measurement", - "label": "Thyrotropin Measurement", - "aliases": [ - "TSH", - "Thyrotropin" - ], - "href": "/mdr/bc/biomedicalconcepts/C64813", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_479", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_480", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_481", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_482", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_483", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64813", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Thyrotropin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_97", - "name": "Folic Acid Measurement", - "label": "Folic Acid Measurement", - "aliases": [ - "Folate", - "Folic Acid", - "Vitamin B9", - "VITB9" - ], - "href": "/mdr/bc/biomedicalconcepts/C74676", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_484", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_485", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_486", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_487", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_488", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Folic Acid Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_98", - "name": "Vitamin B12 Measurement", - "label": "Vitamin B12 Measurement", - "aliases": [ - "Cobalamin", - "Vitamin B12", - "VITB12" - ], - "href": "/mdr/bc/biomedicalconcepts/C64817", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_489", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_490", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_491", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_492", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_493", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.1f6d4af1" - } - ], - "coding": [ - { - "code": "C64817", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Vitamin B12 Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_99", - "name": "Treponema pallidum Antibody Measurement", - "label": "Treponema pallidum Antibody Measurement", - "aliases": [ - "TPLAB", - "Treponema pallidum Antibody", - "Syphilis Antibody" - ], - "href": "/mdr/bc/biomedicalconcepts/C132388", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_494", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.b0ec3282" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_495", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_496", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64500426" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_497", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_498", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C132388", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum Antibody Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_100", - "name": "Treponema pallidum DNA Measurement", - "label": "Treponema pallidum DNA Measurement", - "aliases": [ - "TPADNA", - "Syphilis DNA" - ], - "href": "/mdr/bc/biomedicalconcepts/C198341", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_499", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.b0ec3282" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_500", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_501", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_502", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ], - "codeList": "CL.928af9cb" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_503", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C198341", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum DNA Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_101", - "name": "Color Assessment", - "label": "Color Assessment", - "aliases": [ - "COLOR", - "Color" - ], - "href": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_504", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_505", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_506", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_102", - "name": "Specific Gravity", - "label": "Specific Gravity", - "aliases": [ - "SPGRAV" - ], - "href": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_824", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_825", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_826", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_827", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_103", - "name": "Total Protein Measurement", - "label": null, - "aliases": [ - "Protein" - ], - "href": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_511", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_512", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_513", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_514", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_515", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_104", - "name": "Glucose Measurement", - "label": null, - "aliases": [ - "Glucose" - ], - "href": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_828", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_829", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_830", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_831", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_832", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_105", - "name": "Ketone Measurement", - "label": "Ketone Measurement", - "aliases": [ - "Ketones" - ], - "href": "/mdr/bc/biomedicalconcepts/C64854", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_521", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_522", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_523", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_524", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_525", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64854", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Ketone Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_106", - "name": "Total Bilirubin Measurement", - "label": null, - "aliases": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "href": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_526", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_527", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_528", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_529", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_530", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_107", - "name": "Urobilinogen Measurement", - "label": "Urobilinogen Measurement", - "aliases": [ - "Urobilinogen", - "UROBIL" - ], - "href": "/mdr/bc/biomedicalconcepts/C64816", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_531", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_532", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_533", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_534", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_535", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64816", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urobilinogen Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_108", - "name": "Occult Blood Measurement", - "label": "Occult Blood Measurement", - "aliases": [ - "Occult Blood", - "OCCBLD" - ], - "href": "/mdr/bc/biomedicalconcepts/C74686", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_536", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_537", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.65d42172" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_538", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_539", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74686", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occult Blood Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_109", - "name": "Nitrite Measurement", - "label": "Nitrite Measurement", - "aliases": [ - "NITRITE" - ], - "href": "/mdr/bc/biomedicalconcepts/C64810", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_833", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_834", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_835", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_836", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_837", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64810", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Nitrite Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_110", - "name": "Hemoglobin A1C Measurement", - "label": "Hemoglobin A1C Measurement", - "aliases": [ - "Hemoglobin A1C", - "HBA1C", - "Glycosylated Hemoglobin A1C" - ], - "href": "/mdr/bc/biomedicalconcepts/C64849", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_545", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_546", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_547", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_548", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64849", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin A1C Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_111", - "name": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "label": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "aliases": [ - "Hemoglobin A1C/Hemoglobin", - "HBA1CHGB" - ], - "href": "/mdr/bc/biomedicalconcepts/C111207", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_549", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_550", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_551", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_552", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Hemoglobin A1C to Hemoglobin Ratio Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_112", - "name": "Exposure as Collected Domain", - "label": "Exposure as Collected Domain", - "aliases": [ - "EC", - "Exposure as Collected" - ], - "href": "/mdr/bc/biomedicalconcepts/C117466", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_553", - "name": "ECTRT", - "label": "ECTRT", - "mandatory": true, - "coding": [ - { - "code": "C117473", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Name of Treatment" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_554", - "name": "ECREFID", - "label": "ECREFID", - "mandatory": false, - "coding": [ - { - "code": "C117469", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_555", - "name": "ECDOSE", - "label": "ECDOSE", - "mandatory": false, - "coding": [ - { - "code": "C117479", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_556", - "name": "ECDOSTXT", - "label": "ECDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C117480", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_557", - "name": "ECDOSU", - "label": "ECDOSU", - "mandatory": false, - "coding": [ - { - "code": "C117481", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Units" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_558", - "name": "ECDOSFRM", - "label": "ECDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C117482", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_559", - "name": "ECDOSFRQ", - "label": "ECDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C117483", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dosing Frequency per Interval" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_560", - "name": "ECDOSRGM", - "label": "ECDOSRGM", - "mandatory": false, - "coding": [ - { - "code": "C117485", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Intended Dose Regimen" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_561", - "name": "ECROUTE", - "label": "ECROUTE", - "mandatory": false, - "coding": [ - { - "code": "C117486", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_562", - "name": "ECLOC", - "label": "ECLOC", - "mandatory": false, - "coding": [ - { - "code": "C117488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Location" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_563", - "name": "ECLAT", - "label": "ECLAT", - "mandatory": false, - "coding": [ - { - "code": "C117489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_564", - "name": "ECDIR", - "label": "ECDIR", - "mandatory": false, - "coding": [ - { - "code": "C117490", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_565", - "name": "ECSTDTC", - "label": "ECSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Start Date and Time of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_566", - "name": "ECENDTC", - "label": "ECENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117497", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected End Date and Time of Treatment" - } - ], - "codeList": "CL.1f6d4af1" - } - ], - "coding": [ - { - "code": "C117466", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Exposure as Collected Domain" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_113", - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_567", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_568", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_569", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - } - ], - "coding": [ - { - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_114", - "name": "TTS Acceptability Survey - Patch Acceptability", - "label": "TTS Acceptability Survey - Patch Acceptability", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT4", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_570", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_571", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_572", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.d7c5855c" - } - ], - "coding": [ - { - "code": "NEW_LZZT4", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Acceptability" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_115", - "name": "TTS Acceptability Survey - Patch Appearance", - "label": "TTS Acceptability Survey - Patch Appearance", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT1", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_573", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_574", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_575", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.d7c5855c" - } - ], - "coding": [ - { - "code": "NEW_LZZT1", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Appearance" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_116", - "name": "TTS Acceptability Survey - Patch Durability", - "label": "TTS Acceptability Survey - Patch Durability", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT3", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_576", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_577", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_578", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.d7c5855c" - } - ], - "coding": [ - { - "code": "NEW_LZZT3", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Durability" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_117", - "name": "TTS Acceptability Survey - Patch Size", - "label": "TTS Acceptability Survey - Patch Size", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT2", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_579", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_580", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_581", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.d7c5855c" - } - ], - "coding": [ - { - "code": "NEW_LZZT2", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Size" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_134", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "aliases": [ - "AEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_582", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_583", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_135", - "name": "Solicited Adverse Event", - "label": "Solicited Adverse Event", - "aliases": [ - "Adverse Event" - ], - "href": "/mdr/bc/biomedicalconcepts/C179175", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_584", - "name": "AETERM", - "label": "AETERM", - "mandatory": true, - "coding": [ - { - "code": "C78541", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Verbatim Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_585", - "name": "AEDECOD", - "label": "AEDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83344", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_586", - "name": "AELOC", - "label": "AELOC", - "mandatory": false, - "coding": [ - { - "code": "C83205", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_587", - "name": "AESEV", - "label": "AESEV", - "mandatory": false, - "coding": [ - { - "code": "C53253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Severity of Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_588", - "name": "AESER", - "label": "AESER", - "mandatory": false, - "coding": [ - { - "code": "C53252", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Seriousness of Adverse Event" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_589", - "name": "AEACN", - "label": "AEACN", - "mandatory": false, - "coding": [ - { - "code": "C83013", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Action Taken with Study Treatment" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_590", - "name": "AEACNOTH", - "label": "AEACNOTH", - "mandatory": false, - "coding": [ - { - "code": "C83109", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Other Actions taken in Response to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_591", - "name": "AEREL", - "label": "AEREL", - "mandatory": false, - "coding": [ - { - "code": "C41358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Attribution to Product or Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_592", - "name": "AERELNST", - "label": "AERELNST", - "mandatory": false, - "coding": [ - { - "code": "C83210", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Relationship to Non Study Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_593", - "name": "AEPATT", - "label": "AEPATT", - "mandatory": false, - "coding": [ - { - "code": "C83208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Pattern" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_594", - "name": "AEOUT", - "label": "AEOUT", - "mandatory": false, - "coding": [ - { - "code": "C49489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Outcome" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_595", - "name": "AESCAN", - "label": "AESCAN", - "mandatory": false, - "coding": [ - { - "code": "C83211", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Involves Cancer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_596", - "name": "AESCONG", - "label": "AESCONG", - "mandatory": false, - "coding": [ - { - "code": "C83117", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_597", - "name": "AESDISAB", - "label": "AESDISAB", - "mandatory": false, - "coding": [ - { - "code": "C113380", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Disabling Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_598", - "name": "AESDTH", - "label": "AESDTH", - "mandatory": false, - "coding": [ - { - "code": "C48275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Death Related to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_599", - "name": "AESHOSP", - "label": "AESHOSP", - "mandatory": false, - "coding": [ - { - "code": "C83052", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event associated with Hospitalization" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_600", - "name": "AESLIFE", - "label": "AESLIFE", - "mandatory": false, - "coding": [ - { - "code": "C84266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Life Threatening Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_601", - "name": "AESOD", - "label": "AESOD", - "mandatory": false, - "coding": [ - { - "code": "C83214", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Occurred with Overdose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_602", - "name": "AESMIE", - "label": "AESMIE", - "mandatory": false, - "coding": [ - { - "code": "C83053", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Associated with Serious Medical Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_603", - "name": "AECONTRT", - "label": "AECONTRT", - "mandatory": false, - "coding": [ - { - "code": "C83199", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Concomitant Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_604", - "name": "AETOXGR", - "label": "AETOXGR", - "mandatory": false, - "coding": [ - { - "code": "C78605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Toxicity Grade" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_605", - "name": "AESTDTC", - "label": "AESTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_606", - "name": "AEENDTC", - "label": "AEENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83201", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_607", - "name": "AEENRF", - "label": "AEENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_608", - "name": "AEENRTPT", - "label": "AEENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_609", - "name": "AEENTPT", - "label": "AEENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C179175", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Adverse Event" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_136", - "name": "Complete", - "label": "Complete", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C25250", - "properties": [], - "coding": [ - { - "code": "C25250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Complete [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_137", - "name": "Failure To Meet Continuation Criteria", - "label": "Failure To Meet Continuation Criteria", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C139236", - "properties": [], - "coding": [ - { - "code": "C139236", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Failure To Meet Continuation Criteria [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_138", - "name": "Dead", - "label": "Dead", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C28554", - "properties": [], - "coding": [ - { - "code": "C28554", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Dead [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_139", - "name": "Lack of Efficacy", - "label": "Lack of Efficacy", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C48226", - "properties": [], - "coding": [ - { - "code": "C48226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lack of Efficacy [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_140", - "name": "Lost To Follow-Up", - "label": "Lost To Follow-Up", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C48227", - "properties": [], - "coding": [ - { - "code": "C48227", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lost To Follow-Up [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_141", - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "coding": [ - { - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_142", - "name": "Physician Decision", - "label": "Physician Decision", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C48250", - "properties": [], - "coding": [ - { - "code": "C48250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Physician Decision [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_143", - "name": "Pregnant Subject", - "label": "Pregnant Subject", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C191656", - "properties": [], - "coding": [ - { - "code": "C191656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Pregnant Subject [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_144", - "name": "Progressive Disease", - "label": "Progressive Disease", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C35571", - "properties": [], - "coding": [ - { - "code": "C35571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Progressive Disease [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_145", - "name": "Protocol Deviation", - "label": "Protocol Deviation", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C50996", - "properties": [], - "coding": [ - { - "code": "C50996", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Protocol Deviation" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_146", - "name": "Study Site Transfer", - "label": "Study Site Transfer", - "aliases": [ - "Site Transfer", - "Study Subject Site Transfer" - ], - "href": "/mdr/bc/biomedicalconcepts/C186208", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_610", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.fc6fa4d8" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_611", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_612", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Site Transfer" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_147", - "name": "Study Terminated By Sponsor", - "label": "Study Terminated By Sponsor", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C49632", - "properties": [], - "coding": [ - { - "code": "C49632", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Terminated By Sponsor" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_148", - "name": "Subject Removed at Sponsor Request", - "label": "Subject Removed at Sponsor Request", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C161410", - "properties": [], - "coding": [ - { - "code": "C161410", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Subject Removed at Sponsor Request [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_149", - "name": "Trial Screen Failure", - "label": "Trial Screen Failure", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C49628", - "properties": [], - "coding": [ - { - "code": "C49628", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Screen Failure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_150", - "name": "Trial Site Terminated by Sponsor", - "label": "Trial Site Terminated by Sponsor", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C106576", - "properties": [], - "coding": [ - { - "code": "C106576", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Site Terminated by Sponsor" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_151", - "name": "Withdrawal by Subject", - "label": "Withdrawal by Subject", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C49634", - "properties": [], - "coding": [ - { - "code": "C49634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Withdrawal by Subject" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_152", - "name": "Withdrawal of Consent From Protocol-Specified Activity", - "label": "Withdrawal of Consent From Protocol-Specified Activity", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C170610", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_613", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.6e594ef0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_614", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_615", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_153", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "aliases": [ - "SYSBP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_616", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_617", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_618", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_619", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_620", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_621", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_154", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "aliases": [ - "DIABP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_838", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_839", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_840", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_841", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_842", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_843", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_155", - "name": "Heart Rate", - "label": "Heart Rate", - "aliases": [ - "HR" - ], - "href": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_628", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_629", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_630", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_631", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_632", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_633", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.d00a60ac" - } - ], - "coding": [ - { - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_156", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "aliases": [ - "SYSBP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_634", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.8d13b90f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_635", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_636", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_637", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_638", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_639", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_157", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "aliases": [ - "DIABP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_640", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_641", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_642", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_643", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_644", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_645", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_158", - "name": "Heart Rate", - "label": "Heart Rate", - "aliases": [ - "HR" - ], - "href": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_646", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_647", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_648", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_649", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_650", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_651", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_159", - "name": "Isometric Muscle Strength", - "label": "Isometric Muscle Strength", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C138967", - "properties": [], - "coding": [ - { - "code": "C138967", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Isometric Muscle Strength" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_160", - "name": "Skeletal Muscle Mass Measurement", - "label": "Skeletal Muscle Mass Measurement", - "aliases": [ - "SMMASS", - "Skeletal Muscle Mass" - ], - "href": "/mdr/bc/biomedicalconcepts/C178017", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_652", - "name": "MKORRES", - "label": "MKORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_653", - "name": "MKORRESU", - "label": "MKORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42579", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass" - } - ], - "codeList": "CL.d121315c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_654", - "name": "MKLOC", - "label": "MKLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_655", - "name": "MKLAT", - "label": "MKLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_656", - "name": "MKMETHOD", - "label": "MKMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_657", - "name": "MKDTC", - "label": "MKDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C178017", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Skeletal Muscle Mass Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_161", - "name": "Muscle Endurance Measurement", - "label": "Muscle Endurance Measurement", - "aliases": [ - "ENDURM", - "Muscle Endurance" - ], - "href": "/mdr/bc/biomedicalconcepts/C181501", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_844", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_845", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_846", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_847", - "name": "Laterality", - "label": "Laterality", - "mandatory": true, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_848", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_849", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C181501", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Muscle Endurance Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_162", - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "aliases": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "href": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_850", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_851", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_852", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_853", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_854", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_855", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ], - "coding": [ - { - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_164", - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_670", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_671", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_672", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - } - ], - "coding": [ - { - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_165", - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "aliases": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "href": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_862", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_863", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.d03f062b" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_864", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_865", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_866", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.e2fce626" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_867", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_868", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_166", - "name": "Computed Tomography", - "label": "Computed Tomography", - "aliases": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "href": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_869", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_870", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.2e4119e7" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_871", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_872", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_873", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_874", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_875", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_168", - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "aliases": [ - "Vital Signs", - "VS" - ], - "href": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "coding": [ - { - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_169", - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "aliases": [ - "Vital Signs", - "VS" - ], - "href": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "coding": [ - { - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_170", - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "coding": [ - { - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_171", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "aliases": [ - "AEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_687", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ], - "codeList": "CL.2e4119e7" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_688", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_172", - "name": "CDISC ADAS-Cog - Word Recall Average Score", - "label": "CDISC ADAS-Cog - Word Recall Average Score", - "aliases": [ - "ADCRL", - "Word Recall", - "CDISC ADAS-Cog - Word Recall Average Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100177", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_689", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_690", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_691", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_692", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_693", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_694", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_695", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_696", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100177", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recall Average Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_173", - "name": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "label": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "aliases": [ - "ADCOF", - "Naming Objects and Fingers", - "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100191", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_697", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_698", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_699", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_700", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_701", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_702", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_703", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_704", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100191", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_174", - "name": "CDISC ADAS-Cog - Commands Summary Score", - "label": "CDISC ADAS-Cog - Commands Summary Score", - "aliases": [ - "ADCCMD", - "Commands", - "CDISC ADAS-Cog - Commands Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100209", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_705", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_706", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_707", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_708", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_709", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_710", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_711", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_712", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Commands Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_175", - "name": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "label": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "aliases": [ - "ADCDRL", - "Delayed Word Recall", - "CDISC ADAS-Cog - Delayed Word Recall Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100215", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_876", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_877", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_878", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_879", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_880", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_881", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_882", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_883", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Delayed Word Recall Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_176", - "name": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "label": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "aliases": [ - "ADCCP", - "Constructional Praxis", - "CDISC ADAS-Cog - Constructional Praxis Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100226", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_721", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_722", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_723", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_724", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_725", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_726", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_727", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_728", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - } - ], - "coding": [ - { - "code": "C100226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Constructional Praxis Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_177", - "name": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "label": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "aliases": [ - "ADCIP", - "Ideational Praxis", - "CDISC ADAS-Cog - Ideational Praxis Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100232", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_729", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_730", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_731", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_732", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_733", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_734", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_735", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_736", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - } - ], - "coding": [ - { - "code": "C100232", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Ideational Praxis Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_178", - "name": "CDISC ADAS-Cog - Orientation Summary Score", - "label": "CDISC ADAS-Cog - Orientation Summary Score", - "aliases": [ - "ADCOR", - "Orientation", - "CDISC ADAS-Cog - Orientation Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100238", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_737", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_738", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_739", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_740", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_741", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ], - "codeList": "CL.b0ec3282" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_742", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_743", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_744", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - } - ], - "coding": [ - { - "code": "C100238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Orientation Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_179", - "name": "CDISC ADAS-Cog - Word Recognition Summary Score", - "label": "CDISC ADAS-Cog - Word Recognition Summary Score", - "aliases": [ - "ADCRG", - "Word Recognition", - "CDISC ADAS-Cog - Word Recognition Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100247", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_884", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_885", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_886", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_887", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_888", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_889", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_890", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_891", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - } - ], - "coding": [ - { - "code": "C100247", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recognition Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_180", - "name": "CDISC ADAS-Cog - Remembering Test Instructions", - "label": "CDISC ADAS-Cog - Remembering Test Instructions", - "aliases": [ - "ADCRI", - "Remembering Test Instructions", - "CDISC ADAS-Cog - Remembering Test Instructions" - ], - "href": "/mdr/bc/biomedicalconcepts/C100275", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_753", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_754", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_755", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_756", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_757", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_758", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_759", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_760", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - } - ], - "coding": [ - { - "code": "C100275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Remembering Test Instructions" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_181", - "name": "CDISC ADAS-Cog - Spoken Language Ability", - "label": "CDISC ADAS-Cog - Spoken Language Ability", - "aliases": [ - "ADCSL", - "Spoken Language Ability", - "CDISC ADAS-Cog - Spoken Language Ability" - ], - "href": "/mdr/bc/biomedicalconcepts/C100276", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_761", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_762", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_763", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_764", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_765", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_766", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_767", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_768", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Spoken Language Ability" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_182", - "name": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "label": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "aliases": [ - "ADCDIF", - "Word Finding Difficulty in Spont Speech", - "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" - ], - "href": "/mdr/bc/biomedicalconcepts/C100277", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_769", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_770", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_771", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_772", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_773", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_774", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_775", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_776", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - } - ], - "coding": [ - { - "code": "C100277", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_183", - "name": "CDISC ADAS-Cog - Comprehension", - "label": "CDISC ADAS-Cog - Comprehension", - "aliases": [ - "ADCCMP", - "Comprehension", - "CDISC ADAS-Cog - Comprehension" - ], - "href": "/mdr/bc/biomedicalconcepts/C100278", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_777", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_778", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_779", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_780", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_781", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_782", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_783", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_784", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100278", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Comprehension" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_184", - "name": "CDISC ADAS-Cog - Concentration/Distractibility", - "label": "CDISC ADAS-Cog - Concentration/Distractibility", - "aliases": [ - "ADCCON", - "Concentration/Distractibility", - "CDISC ADAS-Cog - Concentration/Distractibility" - ], - "href": "/mdr/bc/biomedicalconcepts/C100279", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_892", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_893", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_894", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_895", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_896", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_897", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_898", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_899", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - } - ], - "coding": [ - { - "code": "C100279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Concentration/Distractibility" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_185", - "name": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "label": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "aliases": [ - "ADCNC", - "Number Cancellation", - "CDISC ADAS-Cog - Number Cancellation Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100280", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_900", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_901", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_902", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_903", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_904", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_905", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_906", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_907", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Number Cancellation Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_186", - "name": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "label": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "aliases": [ - "ADCMZ01", - "Executive Function Maze: Errors", - "CDISC ADAS-Cog - Executive Function Maze: Errors" - ], - "href": "/mdr/bc/biomedicalconcepts/C100285", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_801", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_802", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_803", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_804", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_805", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_806", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_807", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_808", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ], - "codeList": "CL.64329559" - } - ], - "coding": [ - { - "code": "C100285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Errors" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_187", - "name": "CDISC ADAS-Cog - Executive Function Maze: Time", - "label": "CDISC ADAS-Cog - Executive Function Maze: Time", - "aliases": [ - "ADCMZ02", - "Executive Function Maze: Time", - "CDISC ADAS-Cog - Executive Function Maze: Time" - ], - "href": "/mdr/bc/biomedicalconcepts/C100286", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_809", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_810", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_811", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_812", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_813", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_814", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_815", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_816", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_817", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100286", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_163", - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "aliases": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "href": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_856", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_857", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_858", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_859", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_860", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_861", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ], - "coding": [ - { - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator" - } - ] - } - ], - "conceptProperties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.a30c10b2" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_2", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_3", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_4", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_5", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_6", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_7", - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_8", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_9", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ], - "codeList": "CL.a30c10b2" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_10", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_11", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_12", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.e1a1b71c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_13", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_14", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_15", - "name": "RACE", - "label": "RACE", - "mandatory": false, - "coding": [ - { - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Race" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_16", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_17", - "name": "ETHNIC", - "label": "ETHNIC", - "mandatory": false, - "coding": [ - { - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ethnic Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_18", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_19", - "name": "AGE", - "label": "AGE", - "mandatory": false, - "coding": [ - { - "code": "C170981", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Numeric Age for Data Tabulation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_20", - "name": "AGEU", - "label": "AGEU", - "mandatory": false, - "coding": [ - { - "code": "C50400", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Age Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_21", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_22", - "name": "BRTHDTC", - "label": "BRTHDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_23", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_24", - "name": "SEX", - "label": "SEX", - "mandatory": false, - "coding": [ - { - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_25", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_26", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_27", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_28", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.e1a1b71c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_29", - "name": "SCORRESU", - "label": "SCORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.bf247815" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_30", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.e1a1b71c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_31", - "name": "MHTERM", - "label": "MHTERM", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_32", - "name": "MHDECOD", - "label": "MHDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_33", - "name": "MHSTDTC", - "label": "MHSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83338", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_34", - "name": "MHENDTC", - "label": "MHENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_35", - "name": "MHENRF", - "label": "MHENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_36", - "name": "MHENRTPT", - "label": "MHENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_37", - "name": "MHENTPT", - "label": "MHENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_38", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_39", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_40", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_41", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_42", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_43", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_44", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_45", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_46", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_47", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_48", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_49", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_50", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_51", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_52", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_53", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_54", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_55", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_56", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_57", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_58", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_59", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_60", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_61", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_62", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_63", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_64", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_65", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_66", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ], - "codeList": "CL.bf247815" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_67", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_68", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_69", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_70", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_71", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_72", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_73", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_74", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_75", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_76", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_77", - "name": "SUDUR", - "label": "SUDUR", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_78", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_79", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_80", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_81", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_82", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_83", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_84", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_85", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.82acb719" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_86", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_87", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_88", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_89", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_90", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_91", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.e1a1b71c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_92", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_93", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_94", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_95", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_96", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_97", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_98", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_99", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_100", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_101", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_102", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C168688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Height" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_103", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_104", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_105", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_106", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_107", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_108", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_109", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_110", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_111", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.b63f6642" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_112", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_113", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_114", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Density" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_115", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_116", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C125009", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Interpretation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_117", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_118", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_119", - "name": "EGCLSIG", - "label": "EGCLSIG", - "mandatory": false, - "coding": [ - { - "code": "C93532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinically Significant Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_120", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_121", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_122", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_123", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_124", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_125", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_126", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_127", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_128", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_129", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_130", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_131", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_132", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_133", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_134", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_135", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_136", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C114120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ECG Recording Quality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_137", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_138", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_139", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_140", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_141", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_142", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_143", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_144", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_145", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_146", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_147", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_148", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_149", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_150", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_151", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_152", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_153", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_154", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_155", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_156", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_157", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_158", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_159", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_160", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_161", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_162", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_163", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_164", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_165", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_166", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_167", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_168", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_169", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_170", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_171", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_172", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_173", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.b63f6642" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_174", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_175", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_176", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_177", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_178", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_179", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_180", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_181", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_182", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ], - "codeList": "CL.82acb719" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_183", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_184", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_185", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_186", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_187", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_188", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ], - "codeList": "CL.e1a1b71c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_189", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_190", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_191", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_192", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_193", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_194", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_195", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_196", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_197", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_198", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_199", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_200", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_201", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_202", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_203", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_204", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_205", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_206", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_207", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_208", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_209", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_210", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_211", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_212", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_213", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_214", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_215", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_216", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_217", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_218", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_219", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_220", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ], - "codeList": "CL.b63f6642" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_221", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_222", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_223", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_224", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_225", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_226", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.b63f6642" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Degree Unit of Plane Angle" - } - ], - "codeList": "CL.04edb9f9" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_230", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_231", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_232", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_233", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_234", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_235", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_236", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_237", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_238", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.2e4119e7" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.3edf8d8c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.d03f062b" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.e2fce626" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C69174", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume Fraction" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C25709", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Measure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.8d13b90f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_302", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_303", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_304", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_305", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" - } - ], - "codeList": "CL.d00a60ac" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_306", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.8d13b90f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_307", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_308", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_309", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_310", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_311", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_312", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_313", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_314", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_315", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.d121315c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_316", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.b454d520" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.d121315c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_341", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_342", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_343", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_344", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_345", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_354", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_355", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_356", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_358", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_359", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_360", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_361", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_365", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_366", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_367", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_368", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_369", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_370", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_371", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_372", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_373", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_374", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_375", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_376", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_377", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_378", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_379", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_380", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_381", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_382", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_383", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_384", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_385", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_386", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_387", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_388", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_908", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_909", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_910", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_911", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_912", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_394", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_395", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_396", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_397", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_398", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_399", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_400", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_401", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_402", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_403", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_404", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_405", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_406", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_407", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_408", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_409", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_410", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_411", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_412", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_413", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_414", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_415", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_416", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_417", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_418", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_419", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_420", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_421", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_422", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_423", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_913", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_914", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_915", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_916", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_917", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_429", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_430", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_431", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_432", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_433", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_918", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_919", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_920", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_921", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_922", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_923", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_924", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_925", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_926", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_927", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_444", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_445", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_446", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_447", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_448", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_449", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_450", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_451", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_452", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_453", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_454", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_455", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_456", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_457", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_458", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_459", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_460", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_461", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48570", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_462", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_463", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_464", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_928", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_929", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_930", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_931", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_932", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_470", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_471", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_472", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_473", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_474", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_475", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_476", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_477", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_478", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_479", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_480", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_481", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_482", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_483", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_484", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_485", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_486", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_487", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_488", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_489", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_490", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_491", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_492", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_493", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_494", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.b0ec3282" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_495", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_496", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64500426" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_497", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_498", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_499", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.b0ec3282" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_500", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_501", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_502", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ], - "codeList": "CL.928af9cb" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_503", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_504", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_505", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_506", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_824", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_825", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_826", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_827", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_511", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_512", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_513", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_514", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_515", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_828", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_829", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_830", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_831", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_832", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_521", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_522", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_523", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_524", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_525", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_526", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_527", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_528", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_529", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_530", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_531", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_532", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_533", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_534", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_535", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_536", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_537", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.65d42172" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_538", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_539", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_833", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_834", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_835", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_836", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_837", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_545", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_546", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_547", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_548", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_549", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_550", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_551", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_552", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_553", - "name": "ECTRT", - "label": "ECTRT", - "mandatory": true, - "coding": [ - { - "code": "C117473", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Name of Treatment" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_554", - "name": "ECREFID", - "label": "ECREFID", - "mandatory": false, - "coding": [ - { - "code": "C117469", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_555", - "name": "ECDOSE", - "label": "ECDOSE", - "mandatory": false, - "coding": [ - { - "code": "C117479", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_556", - "name": "ECDOSTXT", - "label": "ECDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C117480", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_557", - "name": "ECDOSU", - "label": "ECDOSU", - "mandatory": false, - "coding": [ - { - "code": "C117481", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Units" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_558", - "name": "ECDOSFRM", - "label": "ECDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C117482", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_559", - "name": "ECDOSFRQ", - "label": "ECDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C117483", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dosing Frequency per Interval" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_560", - "name": "ECDOSRGM", - "label": "ECDOSRGM", - "mandatory": false, - "coding": [ - { - "code": "C117485", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Intended Dose Regimen" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_561", - "name": "ECROUTE", - "label": "ECROUTE", - "mandatory": false, - "coding": [ - { - "code": "C117486", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_562", - "name": "ECLOC", - "label": "ECLOC", - "mandatory": false, - "coding": [ - { - "code": "C117488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Location" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_563", - "name": "ECLAT", - "label": "ECLAT", - "mandatory": false, - "coding": [ - { - "code": "C117489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_564", - "name": "ECDIR", - "label": "ECDIR", - "mandatory": false, - "coding": [ - { - "code": "C117490", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_565", - "name": "ECSTDTC", - "label": "ECSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Start Date and Time of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_566", - "name": "ECENDTC", - "label": "ECENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117497", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected End Date and Time of Treatment" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_567", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_568", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_569", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_570", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_571", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_572", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.d7c5855c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_573", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_574", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_575", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.d7c5855c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_576", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_577", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_578", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.d7c5855c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_579", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_580", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_581", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.d7c5855c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_582", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_583", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_584", - "name": "AETERM", - "label": "AETERM", - "mandatory": true, - "coding": [ - { - "code": "C78541", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Verbatim Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_585", - "name": "AEDECOD", - "label": "AEDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83344", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_586", - "name": "AELOC", - "label": "AELOC", - "mandatory": false, - "coding": [ - { - "code": "C83205", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_587", - "name": "AESEV", - "label": "AESEV", - "mandatory": false, - "coding": [ - { - "code": "C53253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Severity of Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_588", - "name": "AESER", - "label": "AESER", - "mandatory": false, - "coding": [ - { - "code": "C53252", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Seriousness of Adverse Event" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_589", - "name": "AEACN", - "label": "AEACN", - "mandatory": false, - "coding": [ - { - "code": "C83013", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Action Taken with Study Treatment" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_590", - "name": "AEACNOTH", - "label": "AEACNOTH", - "mandatory": false, - "coding": [ - { - "code": "C83109", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Other Actions taken in Response to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_591", - "name": "AEREL", - "label": "AEREL", - "mandatory": false, - "coding": [ - { - "code": "C41358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Attribution to Product or Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_592", - "name": "AERELNST", - "label": "AERELNST", - "mandatory": false, - "coding": [ - { - "code": "C83210", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Relationship to Non Study Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_593", - "name": "AEPATT", - "label": "AEPATT", - "mandatory": false, - "coding": [ - { - "code": "C83208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Pattern" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_594", - "name": "AEOUT", - "label": "AEOUT", - "mandatory": false, - "coding": [ - { - "code": "C49489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Outcome" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_595", - "name": "AESCAN", - "label": "AESCAN", - "mandatory": false, - "coding": [ - { - "code": "C83211", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Involves Cancer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_596", - "name": "AESCONG", - "label": "AESCONG", - "mandatory": false, - "coding": [ - { - "code": "C83117", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_597", - "name": "AESDISAB", - "label": "AESDISAB", - "mandatory": false, - "coding": [ - { - "code": "C113380", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Disabling Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_598", - "name": "AESDTH", - "label": "AESDTH", - "mandatory": false, - "coding": [ - { - "code": "C48275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Death Related to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_599", - "name": "AESHOSP", - "label": "AESHOSP", - "mandatory": false, - "coding": [ - { - "code": "C83052", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event associated with Hospitalization" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_600", - "name": "AESLIFE", - "label": "AESLIFE", - "mandatory": false, - "coding": [ - { - "code": "C84266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Life Threatening Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_601", - "name": "AESOD", - "label": "AESOD", - "mandatory": false, - "coding": [ - { - "code": "C83214", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Occurred with Overdose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_602", - "name": "AESMIE", - "label": "AESMIE", - "mandatory": false, - "coding": [ - { - "code": "C83053", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Associated with Serious Medical Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_603", - "name": "AECONTRT", - "label": "AECONTRT", - "mandatory": false, - "coding": [ - { - "code": "C83199", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Concomitant Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_604", - "name": "AETOXGR", - "label": "AETOXGR", - "mandatory": false, - "coding": [ - { - "code": "C78605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Toxicity Grade" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_605", - "name": "AESTDTC", - "label": "AESTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_606", - "name": "AEENDTC", - "label": "AEENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83201", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_607", - "name": "AEENRF", - "label": "AEENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_608", - "name": "AEENRTPT", - "label": "AEENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_609", - "name": "AEENTPT", - "label": "AEENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_610", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.fc6fa4d8" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_611", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_612", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_613", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.6e594ef0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_614", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_615", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_616", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_617", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_618", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_619", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_620", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_621", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_838", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_839", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_840", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_841", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_842", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_843", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_628", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_629", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_630", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_631", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_632", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_633", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.d00a60ac" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_634", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.8d13b90f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_635", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_636", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_637", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_638", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_639", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_640", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_641", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_642", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_643", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_644", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_645", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_646", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_647", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_648", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_649", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_650", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_651", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_652", - "name": "MKORRES", - "label": "MKORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_653", - "name": "MKORRESU", - "label": "MKORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42579", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass" - } - ], - "codeList": "CL.d121315c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_654", - "name": "MKLOC", - "label": "MKLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_655", - "name": "MKLAT", - "label": "MKLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_656", - "name": "MKMETHOD", - "label": "MKMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_657", - "name": "MKDTC", - "label": "MKDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_844", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_845", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_846", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_847", - "name": "Laterality", - "label": "Laterality", - "mandatory": true, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_848", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_849", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_850", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_851", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_852", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_853", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_854", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_855", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_670", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_671", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_672", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_862", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_863", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.d03f062b" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_864", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_865", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_866", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.e2fce626" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_867", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_868", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_869", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_870", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.2e4119e7" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_871", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_872", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_873", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_874", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_875", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_687", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ], - "codeList": "CL.2e4119e7" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_688", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_689", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_690", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_691", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_692", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_693", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_694", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_695", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_696", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_697", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_698", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_699", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_700", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_701", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_702", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_703", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_704", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_705", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_706", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_707", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_708", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_709", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_710", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_711", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_712", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_876", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_877", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_878", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_879", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_880", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_881", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_882", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_883", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_721", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_722", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_723", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_724", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_725", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_726", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_727", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_728", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_729", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_730", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_731", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_732", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_733", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_734", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_735", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_736", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_737", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_738", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_739", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_740", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_741", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ], - "codeList": "CL.b0ec3282" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_742", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_743", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_744", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_884", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_885", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_886", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_887", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_888", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_889", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_890", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_891", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_753", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_754", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_755", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_756", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_757", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_758", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_759", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_760", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_761", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_762", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_763", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_764", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_765", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_766", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_767", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_768", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_769", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_770", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_771", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_772", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_773", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_774", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_775", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_776", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_777", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_778", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_779", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_780", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_781", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_782", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_783", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_784", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_892", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_893", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_894", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_895", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_896", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_897", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_898", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_899", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_900", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_901", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_902", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_903", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_904", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_905", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_906", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_907", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_801", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_802", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_803", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_804", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_805", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_806", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_807", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_808", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_809", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_810", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_811", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_812", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_813", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_814", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_815", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_816", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_817", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_856", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_857", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.b57d3f41" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_858", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_859", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_860", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_861", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ] -} diff --git a/output/json/NCT01797120-20260618T1511.json b/output/json/NCT01797120-20260618T1511.json deleted file mode 100644 index 3e42eba..0000000 --- a/output/json/NCT01797120-20260618T1511.json +++ /dev/null @@ -1,11441 +0,0 @@ -{ - "study": { - "id": null, - "extensionAttributes": [], - "name": "NCT01797120", - "description": "Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).\r\n\r\nFulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy.\r\n\r\nEverolimus is an orally administered drug that blocks a signaling pathway called \"mTOR\". \"mTOR\" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth.\r\n\r\nThe combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.", - "label": "Phase II - Hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI)", - "versions": [ - { - "id": "StudyVersion_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_44", - "url": "http://www.cdisc.org/usdm/extensions/studyDesignSolution", - "valueExtensionClass": { - "id": "ExtensionClass_1", - "url": "http://www.cdisc.org/usdm/extensions/StudyDesignSolution", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_45", - "url": "tool-name", - "valueString": "SoA Workbench", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_46", - "url": "tool-version", - "valueString": "1.4.0", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_47", - "url": "usdm-creation-date", - "valueString": "20260618T15:11", - "instanceType": "ExtensionAttribute" - } - ], - "instanceType": "ExtensionClass" - }, - "instanceType": "ExtensionAttribute" - } - ], - "versionIdentifier": "1", - "rationale": "", - "studyIdentifiers": [ - { - "id": "StudyIdentifier_1", - "extensionAttributes": [], - "text": "PrE0102", - "scopeId": "Organization_1", - "instanceType": "StudyIdentifier" - } - ], - "referenceIdentifiers": [], - "studyDesigns": [ - { - "id": "InterventionalStudyDesign_1", - "extensionAttributes": [], - "name": "Study of Fulvestrant +/\u200b- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI (PrE0102)", - "label": "Phase II - Hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI)", - "description": "Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).\r\n\r\nFulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy.\r\n\r\nEverolimus is an orally administered drug that blocks a signaling pathway called \"mTOR\". \"mTOR\" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth.\r\n\r\nThe combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.", - "studyType": null, - "studyPhase": null, - "therapeuticAreas": [], - "characteristics": [], - "encounters": [ - { - "id": "Encounter_1", - "extensionAttributes": [], - "name": "PRE-STUDY", - "label": "Pre-Study", - "description": "Occuring before Randomization and Treatment", - "type": { - "id": "Code_485", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "Encounter_2", - "scheduledAtId": "Timing_1", - "environmentalSettings": [ - { - "id": "Code_486", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_487", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_1", - "extensionAttributes": [], - "name": "Start Screening Period", - "label": "Start Screening Period", - "description": "Start of Pre-treatment eligibility window", - "text": "Screening window starts 28 days prior to treatment", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_2", - "extensionAttributes": [], - "name": "End Screening Period", - "label": "End Screening Period", - "description": "End of Screening Window", - "text": "Screening window ends a maximum of 28 days after start", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_2", - "extensionAttributes": [], - "name": "C1D1", - "label": "Cycle 1 Day 1", - "description": "First day of treatment in the first cycle", - "type": { - "id": "Code_488", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_1", - "nextId": "Encounter_3", - "scheduledAtId": null, - "environmentalSettings": [ - { - "id": "Code_489", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_490", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_3", - "extensionAttributes": [], - "name": "Start Study Drug Treatment Period", - "label": "Start Study Drug Treatment Period", - "description": "Fulvestrant + Everolimus; continues until Progressive Disease, unacceptable toxicity, or withdrawal", - "text": "Occurs for at least one cycle and continues until Disease Progression in study drug treatment Arm", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_3", - "extensionAttributes": [], - "name": "C1D15", - "label": "Cycle 1 Day 15", - "description": "Second treament in the first cycle on day 15", - "type": { - "id": "Code_491", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_2", - "nextId": "Encounter_4", - "scheduledAtId": null, - "environmentalSettings": [ - { - "id": "Code_492", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_493", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_4", - "extensionAttributes": [], - "name": "CXD1", - "label": "Next Cycle Day 1", - "description": "Each subsequent Cycle Day 1", - "type": { - "id": "Code_494", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_3", - "nextId": "Encounter_5", - "scheduledAtId": null, - "environmentalSettings": [ - { - "id": "Code_495", - "extensionAttributes": [], - "code": "C18002", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "HOME", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_496", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_5", - "extensionAttributes": [], - "name": "P12W", - "label": "Every 12 Weeks", - "description": "Assessment carried out every 12 weeks", - "type": { - "id": "Code_497", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_4", - "nextId": "Encounter_6", - "scheduledAtId": null, - "environmentalSettings": [ - { - "id": "Code_498", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_499", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_6", - "extensionAttributes": [], - "name": "EOT", - "label": "End of Treatment", - "description": "End of Induction Phase or End of Treatment", - "type": { - "id": "Code_500", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_5", - "nextId": "Encounter_7", - "scheduledAtId": null, - "environmentalSettings": [ - { - "id": "Code_501", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_502", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_4", - "extensionAttributes": [], - "name": "End Study Drug Treatment Period", - "label": "End Study Drug Treatment Period", - "description": "Fulvestrant + Everolimus; continues until PD, unacceptable toxicity, or withdrawal", - "text": "Occurs when Progressive Disease, unacceptable toxicity, or withdrawal in study drug treatment Arm", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_7", - "extensionAttributes": [], - "name": "CPHASE", - "label": "Continuation Phase", - "description": null, - "type": { - "id": "Code_503", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_6", - "nextId": "Encounter_8", - "scheduledAtId": null, - "environmentalSettings": [ - { - "id": "Code_504", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_505", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_8", - "extensionAttributes": [], - "name": "FU", - "label": "Follow-Up", - "description": "Foolow-up off therapy", - "type": { - "id": "Code_506", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_7", - "nextId": null, - "scheduledAtId": null, - "environmentalSettings": [ - { - "id": "Code_507", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_508", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_7", - "extensionAttributes": [], - "name": "Start Follow-up Period", - "label": "Start Follow-up Period", - "description": "Survival and long-term safety data collection", - "text": "Occurs when subject finishes treatment", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_8", - "extensionAttributes": [], - "name": "End Follow-up Period", - "label": "End Follow-up Period", - "description": "Survival and long-term safety data collection", - "text": "Occurs with subject death or End-of-Study", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - } - ], - "activities": [ - { - "id": "Activity_2", - "extensionAttributes": [], - "name": "ELIGIBILITY ASSESSMENT", - "label": "Eligibility Assessment", - "description": "Determine subject meets eligibility requirements", - "previousId": null, - "nextId": "Activity_1", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_2" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_1", - "extensionAttributes": [], - "name": "INFORMED CONSENT", - "label": "Informed Consent", - "description": "Informed Consent collected", - "previousId": "Activity_2", - "nextId": "Activity_19", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_1" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_19", - "extensionAttributes": [], - "name": "RANDOMIZATION", - "label": "Randomization", - "description": "Randomization", - "previousId": "Activity_1", - "nextId": "Activity_3", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_51" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_3", - "extensionAttributes": [], - "name": "MEDICAL HISTORY", - "label": "Medical History", - "description": "Medical History & Assessment of Baseline Signs and Symptoms", - "previousId": "Activity_19", - "nextId": "Activity_5", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_3", - "BiomedicalConcept_4" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_5", - "extensionAttributes": [], - "name": "PHYSICAL EXAM", - "label": "Physical Examination", - "description": "Physical Examination", - "previousId": "Activity_3", - "nextId": "Activity_18", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_6" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_18", - "extensionAttributes": [], - "name": "CONCOMITANT MEDS", - "label": "Concomitant Medications", - "description": "Concomitant Medications", - "previousId": "Activity_5", - "nextId": "Activity_6", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_49", - "BiomedicalConcept_50" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_6", - "extensionAttributes": [], - "name": "VITAL SIGNS", - "label": "Vital Signs", - "description": "Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight", - "previousId": "Activity_18", - "nextId": "Activity_4", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_7", - "BiomedicalConcept_8", - "BiomedicalConcept_9", - "BiomedicalConcept_10", - "BiomedicalConcept_11" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_4", - "extensionAttributes": [], - "name": "ECOG PERFORMANCE STATUS", - "label": "ECOG Performance Status", - "description": "ECOG performance status", - "previousId": "Activity_6", - "nextId": "Activity_17", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_5", - "BiomedicalConcept_60" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_17", - "extensionAttributes": [], - "name": "ADVERSE EVENTS ASSESSMENTS", - "label": "Adverse Event Assessment", - "description": "Adverse Event Assessment", - "previousId": "Activity_4", - "nextId": "Activity_22", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_47", - "BiomedicalConcept_48" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_22", - "extensionAttributes": [], - "name": "IMAGING SCANS", - "label": "Imaging Scans", - "description": "Tumor imaging scans", - "previousId": "Activity_17", - "nextId": "Activity_23", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_73", - "BiomedicalConcept_74", - "BiomedicalConcept_75", - "BiomedicalConcept_76", - "BiomedicalConcept_77" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_23", - "extensionAttributes": [], - "name": "PT/INR", - "label": "PT with INR", - "description": "prothrombin time and international normalized ratio", - "previousId": "Activity_22", - "nextId": "Activity_10", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_52", - "BiomedicalConcept_53", - "BiomedicalConcept_54" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_10", - "extensionAttributes": [], - "name": "URINALYSIS", - "label": "Urinalysis Labs", - "description": "Urinalysis Labs", - "previousId": "Activity_23", - "nextId": "Activity_24", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_26", - "BiomedicalConcept_27", - "BiomedicalConcept_28" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_24", - "extensionAttributes": [], - "name": "CBC", - "label": "CBC with differentials, Platelets", - "description": "CBC with differentials, Platelets", - "previousId": "Activity_10", - "nextId": "Activity_8", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_61", - "BiomedicalConcept_62", - "BiomedicalConcept_63" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_8", - "extensionAttributes": [], - "name": "CHEMISTRY LABS", - "label": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", - "description": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", - "previousId": "Activity_24", - "nextId": "Activity_25", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_18", - "BiomedicalConcept_19", - "BiomedicalConcept_20", - "BiomedicalConcept_21", - "BiomedicalConcept_22", - "BiomedicalConcept_64", - "BiomedicalConcept_65", - "BiomedicalConcept_66", - "BiomedicalConcept_67", - "BiomedicalConcept_68", - "BiomedicalConcept_69", - "BiomedicalConcept_70", - "BiomedicalConcept_71", - "BiomedicalConcept_72" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_1", - "BiomedicalConceptSurrogate_8" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_25", - "extensionAttributes": [], - "name": "GLUCOSE", - "label": "Fasting Glucose", - "description": "Fasting Glucose", - "previousId": "Activity_8", - "nextId": "Activity_26", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_55" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_26", - "extensionAttributes": [], - "name": "LIPID PROFILE", - "label": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", - "description": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", - "previousId": "Activity_25", - "nextId": "Activity_27", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_56", - "BiomedicalConcept_57", - "BiomedicalConcept_58", - "BiomedicalConcept_59" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_27", - "extensionAttributes": [], - "name": "HBV-DNA-1", - "label": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV- RNA-PCR", - "description": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV- RNA-PCR", - "previousId": "Activity_26", - "nextId": "Activity_28", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_2", - "BiomedicalConceptSurrogate_3", - "BiomedicalConceptSurrogate_4", - "BiomedicalConceptSurrogate_5", - "BiomedicalConceptSurrogate_6" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_28", - "extensionAttributes": [], - "name": "HBV-DNA-2", - "label": "HBV DNA", - "description": "HBV DNA", - "previousId": "Activity_27", - "nextId": "Activity_29", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_2" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_29", - "extensionAttributes": [], - "name": "HCV", - "label": "HCV RNA-PCR", - "description": "HCV RNA-PCR", - "previousId": "Activity_28", - "nextId": "Activity_30", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_6" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_30", - "extensionAttributes": [], - "name": "COMPLIANCE", - "label": "Study Drug Compliance (Pill Diary)", - "description": "Study Drug Compliance (Pill Diary)", - "previousId": "Activity_29", - "nextId": "Activity_31", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_19", - "BiomedicalConceptSurrogate_20", - "BiomedicalConceptSurrogate_21", - "BiomedicalConceptSurrogate_22", - "BiomedicalConceptSurrogate_23", - "BiomedicalConceptSurrogate_24" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_31", - "extensionAttributes": [], - "name": "PFTS", - "label": "PFTs with DLCO as medically indicatedn", - "description": "PFTs with DLCO as medically indicatedn", - "previousId": "Activity_30", - "nextId": "Activity_21", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_7" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_21", - "extensionAttributes": [], - "name": "Survival Follow-up", - "label": "Survival Follow-up", - "description": "Survival Follow-up occurs (every 3 months)", - "previousId": "Activity_31", - "nextId": null, - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - } - ], - "arms": [ - { - "id": "StudyArm_1", - "extensionAttributes": [], - "name": "Fulvestrant + Everolimus", - "label": "Fulvestrant + Everolimus", - "description": "Fulvestrant 500mg IM Q28D (loading D1/D15) + Everolimus 10mg PO QD", - "type": { - "id": "Code_4", - "extensionAttributes": [], - "code": "C174266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Experimental Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_5", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - }, - { - "id": "StudyArm_2", - "extensionAttributes": [], - "name": "Fulvestrant + Placebo", - "label": "Fulvestrant + Placebo", - "description": "Fulvestrant 500mg IM Q28D (loading D1/D15) + Placebo PO QD", - "type": { - "id": "Code_6", - "extensionAttributes": [], - "code": "C174267", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Active Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_7", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - } - ], - "studyCells": [ - { - "id": "StudyCell_1", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_2", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_3", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_4" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_4", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_5", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_6", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_4" - ], - "instanceType": "StudyCell" - } - ], - "rationale": "", - "epochs": [ - { - "id": "StudyEpoch_1", - "extensionAttributes": [], - "name": "Pre-Study Phase", - "label": "Pre-Study Phase", - "description": "Eligibility assessment, up to 28 days prior to C1D1", - "type": { - "id": "Code_1", - "extensionAttributes": [], - "code": "C202487", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "SCREENING", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "StudyEpoch_2", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_2", - "extensionAttributes": [], - "name": "Induction Phase", - "label": "Induction Phase", - "description": "From C1D1 until disease progression or discontinuation", - "type": { - "id": "Code_2", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_1", - "nextId": "StudyEpoch_4", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_4", - "extensionAttributes": [], - "name": "Continuation Phase", - "label": "Continuation Phase", - "description": "Continuation Phase (until progression or unacceptable toxicity", - "type": { - "id": "Code_813", - "extensionAttributes": [], - "code": "C123452", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "CONTINUATION TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_2", - "nextId": "StudyEpoch_3", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_3", - "extensionAttributes": [], - "name": "Follow-up Off Therapy", - "label": "Follow-up, off therapy", - "description": "Post-EOT survival and safety follow-up", - "type": { - "id": "Code_3", - "extensionAttributes": [], - "code": "C202578", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "FOLLOW-UP", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_4", - "nextId": null, - "notes": [], - "instanceType": "StudyEpoch" - } - ], - "elements": [ - { - "id": "StudyElement_1", - "extensionAttributes": [], - "name": "Screening Period", - "label": "Screening Period", - "description": "Pre-treatment eligibility window", - "transitionStartRule": { - "id": "TransitionRule_1", - "extensionAttributes": [], - "name": "Start Screening Period", - "label": "Start Screening Period", - "description": "Start of Pre-treatment eligibility window", - "text": "Screening window starts 28 days prior to treatment", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_2", - "extensionAttributes": [], - "name": "End Screening Period", - "label": "End Screening Period", - "description": "End of Screening Window", - "text": "Screening window ends a maximum of 28 days after start", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_2", - "extensionAttributes": [], - "name": "Everolimus Treatment Period", - "label": "Everolimus Treatment Period", - "description": "Fulvestrant + Everolimus; continues until PD, unacceptable toxicity, or withdrawal", - "transitionStartRule": { - "id": "TransitionRule_3", - "extensionAttributes": [], - "name": "Start Study Drug Treatment Period", - "label": "Start Study Drug Treatment Period", - "description": "Fulvestrant + Everolimus; continues until Progressive Disease, unacceptable toxicity, or withdrawal", - "text": "Occurs for at least one cycle and continues until Disease Progression in study drug treatment Arm", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_4", - "extensionAttributes": [], - "name": "End Study Drug Treatment Period", - "label": "End Study Drug Treatment Period", - "description": "Fulvestrant + Everolimus; continues until PD, unacceptable toxicity, or withdrawal", - "text": "Occurs when Progressive Disease, unacceptable toxicity, or withdrawal in study drug treatment Arm", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_3", - "extensionAttributes": [], - "name": "Placebo Treatment Period", - "label": "Placebo Treatment Period", - "description": "Fulvestrant + Placebo; continues until PD, unacceptable toxicity, or withdrawal", - "transitionStartRule": { - "id": "TransitionRule_5", - "extensionAttributes": [], - "name": "Start Placebo Treatment Period", - "label": "Start Placebo Treatment Period", - "description": "Fulvestrant + Placebo; continues until PD, unacceptable toxicity, or withdrawal", - "text": "Occurs for at least one treament cycle with Placebo and continues until Disease Progression in Placebo Arm", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_6", - "extensionAttributes": [], - "name": "End Placebo Treament Period", - "label": "End Placebo Treament Period", - "description": "Fulvestrant + Placebo; continues until PD, unacceptable toxicity, or withdrawal", - "text": "Occurs when Progressive Disease, unacceptable toxicity, or withdrawal in Placebo Arm", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_4", - "extensionAttributes": [], - "name": "Follow-Up Period", - "label": "Follow-Up Period", - "description": "Survival and long-term safety data collection", - "transitionStartRule": { - "id": "TransitionRule_7", - "extensionAttributes": [], - "name": "Start Follow-up Period", - "label": "Start Follow-up Period", - "description": "Survival and long-term safety data collection", - "text": "Occurs when subject finishes treatment", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_8", - "extensionAttributes": [], - "name": "End Follow-up Period", - "label": "End Follow-up Period", - "description": "Survival and long-term safety data collection", - "text": "Occurs with subject death or End-of-Study", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - } - ], - "estimands": [ - { - "id": "Estimand_1", - "extensionAttributes": [], - "name": "Estimand for Progression-Free Survival (PFS)", - "label": "Primary Estimand", - "description": "Comparison of PFS between fulvestrant plus everolimus versus fulvestrant plus placebo in AI-resistant HR+ metastatic breast cancer. Constructed retrospectively per ICH E9(R1); this protocol predates the 2019 addendum.", - "populationSummary": "Post-menopausal women with HR+ (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy; ECOG PS 0-1; no prior mTOR inhibitor; up to one prior systemic chemotherapy for metastatic disease. Randomized 1:1; approximately 120 eligible patients.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_1", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_1", - "extensionAttributes": [], - "name": "Death before documented progression", - "label": "Death before documented progression", - "description": null, - "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", - "strategy": "Composite: death is included as a PFS event (composite endpoint definition per \u00a76.1.6). The time-to-event variable captures whichever occurs first: progression or death.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_2", - "extensionAttributes": [], - "name": "Discontinuation of everolimus due to toxicity", - "label": "Discontinuation of everolimus due to toxicity", - "description": null, - "text": "Patient permanently discontinues everolimus or placebo due to an adverse event but continues on fulvestrant monotherapy.", - "strategy": "Treatment-policy: patient remains on study and continues fulvestrant alone per \u00a75.5. Follow-up for progression and survival continues. PFS events occurring after everolimus discontinuation are included in the primary analysis regardless of treatment status.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_3", - "extensionAttributes": [], - "name": "Withdrawal of consent or loss to follow-up", - "label": "Withdrawal of consent or loss to follow-up", - "description": null, - "text": "Patient withdraws consent or is lost to follow-up before a PFS event is documented.", - "strategy": "Hypothetical (censoring): patient is censored at the date of last tumor assessment. The estimand implicitly assumes non-informative censoring \u2014 that censored patients would have experienced events at the same rate as those who remained in follow-up.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_4", - "extensionAttributes": [], - "name": "Initiation of prohibited anti-cancer therapy before progression", - "label": "Initiation of prohibited anti-cancer therapy before progression", - "description": null, - "text": "Patient receives a prohibited anti-cancer agent before disease progression is documented.", - "strategy": "Treatment-policy: protocol prohibits new anti-cancer agents before progression (\u00a75.3.4). If such a violation occurred, the patient would remain in the analysis with events counted as observed. No censoring at time of prohibited therapy initiation is specified.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_2", - "extensionAttributes": [], - "name": "Estimand for Overall Survival (OS)", - "label": "Secondary Estimand \u2014 OS", - "description": "Comparison of overall survival between treatment arms. Descriptive; no pre-specified alpha or power.", - "populationSummary": "All randomized eligible patients (same as PFS estimand population).", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_2", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_5", - "extensionAttributes": [], - "name": "Discontinuation of study treatment (any reason)", - "label": "Discontinuation of study treatment (any reason)", - "description": null, - "text": "Patient permanently discontinues all study treatment due to disease progression, toxicity, or other reasons.", - "strategy": "Treatment-policy: all patients who discontinue treatment are followed for survival per \u00a75.5. Deaths after treatment cessation are counted as OS events regardless of reason for discontinuation.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_6", - "extensionAttributes": [], - "name": "Initiation of subsequent anti-cancer therapy after progression", - "label": "Initiation of subsequent anti-cancer therapy after progression", - "description": null, - "text": "Patient initiates a new anti-cancer regimen after disease progression on study treatment.", - "strategy": "Treatment-policy: OS reflects real-world outcome including the effect of any subsequent therapies. No censoring or adjustment for post-progression treatment is specified.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_7", - "extensionAttributes": [], - "name": "Withdrawal of consent or loss to follow-up", - "label": "Withdrawal of consent or loss to follow-up", - "description": null, - "text": "Patient withdraws consent or cannot be contacted for survival follow-up.", - "strategy": "Hypothetical (censoring): patient is censored at date of last known alive contact. Non-informative censoring assumed.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_3", - "extensionAttributes": [], - "name": "Estimand for Time to Progression (TTP)", - "label": "Secondary Estimand \u2014 TTP", - "description": "Comparison of time to disease progression, excluding deaths as events. Descriptive.", - "populationSummary": "All randomized eligible patients (same as PFS estimand population).", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_3", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_8", - "extensionAttributes": [], - "name": "Death before documented progression", - "label": "Death before documented progression", - "description": null, - "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", - "strategy": "Hypothetical (censoring): death without prior progression results in censoring at time of death. This reflects the hypothetical question 'what would the time to progression have been if the patient had not died?' \u2014 the key mechanistic distinction from the PFS estimand.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_9", - "extensionAttributes": [], - "name": "Discontinuation of study treatment", - "label": "Discontinuation of study treatment (any reason)", - "description": null, - "text": "Patient permanently discontinues study treatment before disease progression.", - "strategy": "Treatment-policy: follow-up for progression continues after treatment discontinuation per \u00a75.5. TTP events occurring after treatment cessation are included.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_4", - "extensionAttributes": [], - "name": "Estimand for Objective Response Rate (ORR)", - "label": "Secondary Estimand \u2014 ORR", - "description": "Between-arm comparison of the proportion of patients achieving confirmed CR or PR in patients with measurable disease. Descriptive.", - "populationSummary": "Subset of randomized eligible patients with at least one measurable lesion at baseline per RECIST v1.1.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_4", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_10", - "extensionAttributes": [], - "name": "Death or progression before first response assessment", - "label": "Death or progression before first response assessment", - "description": null, - "text": "Patient dies or has documented progression before achieving CR or PR at any post-baseline tumor assessment.", - "strategy": "Composite: patients who die or progress without ever achieving a confirmed CR or PR are counted as non-responders in the ORR denominator.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_11", - "extensionAttributes": [], - "name": "Treatment discontinuation before response assessment", - "label": "Treatment discontinuation before response assessment", - "description": null, - "text": "Patient discontinues all study treatment before a post-baseline tumor assessment confirming CR or PR.", - "strategy": "Treatment-policy: patients who discontinue without a prior confirmed response are counted as non-responders. No censoring at time of treatment discontinuation.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_5", - "extensionAttributes": [], - "name": "Estimand for Clinical Benefit Rate (CBR)", - "label": "Secondary Estimand \u2014 CBR", - "description": "Between-arm comparison of the proportion of patients with CR, PR, or SD maintained for at least 6 months. Descriptive.", - "populationSummary": "All randomized eligible patients including those with measurable and non-measurable disease.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_5", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_12", - "extensionAttributes": [], - "name": "Death or progression before 6-month stable disease threshold", - "label": "Death or progression before 6-month stable disease threshold", - "description": null, - "text": "Patient dies or has documented progression before 6 months of confirmed stable disease, partial response, or complete response.", - "strategy": "Composite: patients who do not achieve and maintain CR, PR, or SD for at least 6 months are counted as not deriving clinical benefit, regardless of cause.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_13", - "extensionAttributes": [], - "name": "Treatment discontinuation before 6-month landmark", - "label": "Treatment discontinuation before 6-month landmark", - "description": null, - "text": "Patient discontinues study treatment before the 6-month landmark required for SD to qualify as clinical benefit.", - "strategy": "Treatment-policy: patients who discontinue and lack tumor assessment confirming \u22656 months of SD are counted as non-responders for CBR.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_6", - "extensionAttributes": [], - "name": "Estimand for Safety and Tolerability", - "label": "Secondary Estimand \u2014 Safety", - "description": "Descriptive characterization of the incidence and severity of adverse events in the safety-evaluable population. No formal hypothesis test.", - "populationSummary": "All patients who received at least one dose of any study treatment. Approximately 65 patients per arm.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_6", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_14", - "extensionAttributes": [], - "name": "Treatment discontinuation", - "label": "Treatment discontinuation", - "description": null, - "text": "Patient permanently discontinues study treatment. AE collection continues for 30 days after last dose of any study drug per \u00a75.5.", - "strategy": "While-on-treatment: TEAEs are collected only during the treatment period and the 30-day post-treatment follow-up window. Adverse events occurring beyond this window are not captured as TEAEs in the primary safety analysis.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_15", - "extensionAttributes": [], - "name": "Dose reduction or interruption of everolimus", - "label": "Dose reduction or interruption of everolimus", - "description": null, - "text": "Patient undergoes dose modification (reduction or temporary interruption) of everolimus or placebo per protocol dose-modification rules.", - "strategy": "Treatment-policy: AEs that prompt dose modification are recorded regardless of the modification. Events are attributed to the randomized treatment arm and included in the safety summary as observed.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - } - ], - "indications": [ - { - "id": "Indication_1", - "extensionAttributes": [], - "name": "Hormone Receptor-Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", - "label": "HR+ AI-Resistant Metastatic Breast Cancer", - "description": "Post-menopausal women with hormone-receptor positive (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy, defined as relapse while receiving adjuvant AI or progressive disease while receiving an AI for metastatic disease.", - "isRareDisease": false, - "codes": [ - { - "id": "Code_7947", - "extensionAttributes": [], - "code": "C9246", - "codeSystem": "http://ncithesaurus.nci.nih.gov", - "codeSystemVersion": "24.04e", - "decode": "Hormone Receptor-Positive Breast Carcinoma", - "instanceType": "Code" - }, - { - "id": "Code_7948", - "extensionAttributes": [], - "code": "C7771", - "codeSystem": "http://ncithesaurus.nci.nih.gov", - "codeSystemVersion": "24.04e", - "decode": "Metastatic Breast Carcinoma", - "instanceType": "Code" - } - ], - "notes": [], - "instanceType": "Indication" - } - ], - "studyInterventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "objectives": [ - { - "id": "Objective_1", - "extensionAttributes": [], - "name": "Primary Objective", - "label": "Primary Objective", - "description": "To assess progression-free survival in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone.", - "text": "", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2355", - "extensionAttributes": [], - "code": "C85826", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C85826", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_1", - "extensionAttributes": [], - "name": "Progression-Free Survival (PFS)", - "label": "Progression-Free Survival (PFS)", - "description": "Time from randomization to documented disease progression or death, whichever occurs first. Subjects who have neither progressed nor died are censored at the date of last tumor assessment. Disease progression assessed per RECIST v1.1.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To demonstrate that the addition of everolimus to fulvestrant improves PFS compared to fulvestrant plus placebo (hypothesized median PFS improvement from 5.4 to 9.2 months; HR \u2248 0.59).", - "level": { - "id": "Code_2356", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_2", - "extensionAttributes": [], - "name": "Secondary Objective", - "label": "Secondary Objective", - "description": "To describe the safety profile, objective response rate, time to progression, and overall survival in this patient population.", - "text": "", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2357", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_2", - "extensionAttributes": [], - "name": "Overall Survival (OS)", - "label": "Overall Survival (OS)", - "description": "Time from randomization until death from any cause. Subjects alive at the time of analysis are censored at the date of last follow-up.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To characterize overall survival in the two treatment arms.", - "level": { - "id": "Code_2358", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_3", - "extensionAttributes": [], - "name": "Time to Progression (TTP)", - "label": "Time to Progression (TTP)", - "description": "Time from randomization until objective disease progression per RECIST v1.1. Unlike PFS, deaths without prior progression are not counted as events (subjects are censored at time of death).", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To estimate and compare median time to disease progression between treatment arms.", - "level": { - "id": "Code_2359", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_4", - "extensionAttributes": [], - "name": "Objective Response Rate (ORR)", - "label": "Objective Response Rate (ORR)", - "description": "Proportion of patients with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1. Assessed in patients with measurable disease at baseline.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To compare the proportion of patients achieving an objective tumor response between treatment arms.", - "level": { - "id": "Code_2360", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_5", - "extensionAttributes": [], - "name": "Clinical Benefit Rate (CBR)", - "label": "Clinical Benefit Rate (CBR)", - "description": "Proportion of patients with stable disease (SD) for \u22656 months, partial response (PR), or complete response (CR) \u2014 i.e., CR + PR + SD \u2265 6 months \u2014 per RECIST v1.1.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To compare the proportion of patients deriving clinical benefit (response or prolonged stable disease) between treatment arms.", - "level": { - "id": "Code_2361", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_6", - "extensionAttributes": [], - "name": "Safety and Tolerability", - "label": "Safety and Tolerability", - "description": "Incidence, severity (CTCAE v4.0 grade), and type of adverse events, including overall toxicity, grade 3\u20134 toxicities, serious adverse events (SAEs), and second primary cancers. Assessed in all patients who received at least one dose of study treatment.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To characterize and compare the safety profile of fulvestrant plus everolimus versus fulvestrant plus placebo.", - "level": { - "id": "Code_2362", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - } - ], - "population": { - "id": "StudyDesignPopulation_1", - "extensionAttributes": [], - "name": "Population_1", - "label": null, - "description": null, - "includesHealthySubjects": false, - "plannedEnrollmentNumber": null, - "plannedCompletionNumber": null, - "plannedSex": [], - "criterionIds": [], - "plannedAge": null, - "notes": [], - "cohorts": [], - "instanceType": "StudyDesignPopulation" - }, - "scheduleTimelines": [ - { - "id": "ScheduleTimeline_1", - "extensionAttributes": [], - "name": "Main Timeline", - "label": "Main Timeline", - "description": "The main timeline for the study", - "mainTimeline": true, - "entryCondition": null, - "entryId": "ScheduledActivityInstance_1", - "exits": [], - "timings": [ - { - "id": "Timing_1", - "extensionAttributes": [], - "name": "SCREENING", - "label": "Screening", - "description": "Timing for screening", - "type": null, - "value": null, - "valueLabel": null, - "relativeToFrom": null, - "relativeFromScheduledInstanceId": null, - "relativeToScheduledInstanceId": null, - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_1", - "extensionAttributes": [], - "name": "SCR", - "label": "Screening", - "description": "Screening", - "defaultConditionId": "ScheduledActivityInstance_2", - "epochId": "StudyEpoch_1", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_1" - }, - { - "id": "ScheduledActivityInstance_2", - "extensionAttributes": [], - "name": "C1D1", - "label": "C1D1", - "description": "Treatment cycle 1 day1", - "defaultConditionId": "ScheduledActivityInstance_3", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_2" - }, - { - "id": "ScheduledActivityInstance_3", - "extensionAttributes": [], - "name": "C1D15", - "label": "C1D15", - "description": "Treatment cycle 1 day 15", - "defaultConditionId": "ScheduledActivityInstance_4", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_3" - }, - { - "id": "ScheduledActivityInstance_6", - "extensionAttributes": [], - "name": "P12W", - "label": "Every 12 Weeks", - "description": "Every 12 weeks assessment", - "defaultConditionId": "ScheduledActivityInstance_7", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_5" - }, - { - "id": "ScheduledActivityInstance_7", - "extensionAttributes": [], - "name": "EOT", - "label": "EOT", - "description": "End of treatment", - "defaultConditionId": "ScheduledActivityInstance_8", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_6" - }, - { - "id": "ScheduledActivityInstance_8", - "extensionAttributes": [], - "name": "FU", - "label": "FU", - "description": "Follow-up", - "defaultConditionId": null, - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_8" - }, - { - "id": "ScheduledActivityInstance_9", - "extensionAttributes": [], - "name": "CxD1", - "label": "Cycle x Day 1", - "description": "Day 1 Each Subsequent Cycle", - "defaultConditionId": "ScheduledActivityInstance_9", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_4" - }, - { - "id": "ScheduledActivityInstance_10", - "extensionAttributes": [], - "name": "RANDOMIZE", - "label": "Randomization", - "description": "Randomization", - "defaultConditionId": "ScheduledActivityInstance_2", - "epochId": "StudyEpoch_1", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_11", - "extensionAttributes": [], - "name": "CPHASE", - "label": "Continuation Phase", - "description": "Occurs until progression or unacceptable toxicity", - "defaultConditionId": "ScheduledActivityInstance_11", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_7" - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - } - ], - "biospecimenRetentions": [], - "documentVersionIds": [], - "eligibilityCriteria": [], - "analysisPopulations": [], - "notes": [], - "subTypes": [], - "model": { - "id": "Code_StudyDesignModel", - "extensionAttributes": [], - "code": "", - "codeSystem": "", - "codeSystemVersion": "", - "decode": "", - "instanceType": "Code" - }, - "intentTypes": [], - "blindingSchema": null, - "instanceType": "InterventionalStudyDesign" - } - ], - "titles": [ - { - "id": "StudyTitle_1", - "extensionAttributes": [], - "text": "Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", - "type": { - "id": "Code_8497", - "extensionAttributes": [], - "code": "C207616", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Official Study Title", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - } - ], - "documentVersionIds": [], - "dateValues": [], - "amendments": [], - "organizations": [ - { - "id": "Organization_1", - "extensionAttributes": [], - "name": "PrECOG, LLC", - "label": "PrECOG", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_7949", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_1", - "extensionAttributes": [], - "text": "PrECOG, LLC, 1818 Market Street, Suite 1100, Philadelphia, PA 19103", - "lines": [ - "1818 Market Street", - "Suite 1100" - ], - "city": "Philadelphia", - "district": null, - "state": "PA", - "postalCode": "19103", - "country": { - "id": "Code_7950", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_2", - "extensionAttributes": [], - "name": "Novartis Pharmaceuticals Corporation", - "label": "Novartis", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_7951", - "extensionAttributes": [], - "code": "C25392", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Manufacturer", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_2", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_7952", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_3", - "extensionAttributes": [], - "name": "clinicaltrials.gov", - "label": "clinicaltrials.gov", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_9956", - "extensionAttributes": [], - "code": "C188863", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Regulatory Agency", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_3", - "extensionAttributes": [], - "text": "National Library of Medicine\n8600 Rockville Pike, Bethesda, MD 20894", - "lines": [ - "National Library of Medicine", - "8600 Rockville Pike" - ], - "city": "Bethesda", - "district": null, - "state": "MD", - "postalCode": "20894", - "country": { - "id": "Code_9957", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_4", - "extensionAttributes": [], - "name": "VendorLab1", - "label": "Vendor1", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_9958", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_4", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_9959", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_5", - "extensionAttributes": [], - "name": "VendorLab2", - "label": "Vendor2", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_9961", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_5", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_9962", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - } - ], - "roles": [ - { - "id": "StudyRole_1", - "extensionAttributes": [], - "name": "Clinical Study Sponsor", - "label": "Clinical Study Sponsor", - "description": "PrECOG, LLC serves as the clinical study sponsor and coordinating group for this investigator-initiated trial.", - "code": { - "id": "Code_8489", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_2", - "extensionAttributes": [], - "name": "Study Chair", - "label": "Study Chair", - "description": null, - "code": { - "id": "Code_9716", - "extensionAttributes": [], - "code": "C19924", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Principal Investigator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_1", - "extensionAttributes": [], - "name": "Noah Kornblum", - "label": null, - "description": null, - "personName": { - "id": "PersonName_1", - "extensionAttributes": [], - "text": null, - "familyName": "Kornblum", - "givenNames": [ - "Noah" - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "MD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Study Chair", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_3", - "extensionAttributes": [], - "name": "Study Co-Chair", - "label": "Study Co-Chair", - "description": null, - "code": { - "id": "Code_9717", - "extensionAttributes": [], - "code": "C25936", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Investigator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_2", - "extensionAttributes": [], - "name": "Joseph A. Sparano", - "label": null, - "description": null, - "personName": { - "id": "PersonName_2", - "extensionAttributes": [], - "text": null, - "familyName": "Sparano", - "givenNames": [ - "Joseph", - "A." - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "MD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Study Co-Chair", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_4", - "extensionAttributes": [], - "name": "Medical Monitor", - "label": "Medical Monitor", - "description": null, - "code": { - "id": "Code_9718", - "extensionAttributes": [], - "code": "C51876", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Sponsor Medical Expert", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_3", - "extensionAttributes": [], - "name": "Katherine M. Smith", - "label": null, - "description": null, - "personName": { - "id": "PersonName_3", - "extensionAttributes": [], - "text": null, - "familyName": "Smith", - "givenNames": [ - "Katherine", - "M." - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "MD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Medical Monitor", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_5", - "extensionAttributes": [], - "name": "Study Statistician", - "label": "Study Statistician", - "description": null, - "code": { - "id": "Code_9719", - "extensionAttributes": [], - "code": "C51877", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Statistician", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_4", - "extensionAttributes": [], - "name": "Judi Manola", - "label": null, - "description": null, - "personName": { - "id": "PersonName_4", - "extensionAttributes": [], - "text": null, - "familyName": "Manola", - "givenNames": [ - "Judi" - ], - "prefixes": [], - "suffixes": [ - "MS" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Study Statistician", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_6", - "extensionAttributes": [], - "name": "Study Contact", - "label": "Study Contact", - "description": null, - "code": { - "id": "Code_9720", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_5", - "extensionAttributes": [], - "name": "Carolyn Andrews", - "label": null, - "description": null, - "personName": { - "id": "PersonName_5", - "extensionAttributes": [], - "text": null, - "familyName": "Andrews", - "givenNames": [ - "Carolyn" - ], - "prefixes": [], - "suffixes": [ - "RN" - ], - "instanceType": "PersonName" - }, - "jobTitle": "PrECOG Study Contact", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_7", - "extensionAttributes": [], - "name": "Investigational Product Manufacturer", - "label": "Investigational Product Manufacturer", - "description": "Novartis Pharmaceuticals Corporation supplies everolimus and matching placebo for the study.", - "code": { - "id": "Code_9714", - "extensionAttributes": [], - "code": "C25392", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Manufacturer", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_2" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_8", - "extensionAttributes": [], - "name": "Pharmacovigilance Group", - "label": "Pharmacovigilance Group", - "description": "Novartis Pharmaceuticals Drug Safety and Epidemiology Department (DS&E). Receives SAE notifications from PrECOG within 24 hours of awareness date.", - "code": { - "id": "Code_9715", - "extensionAttributes": [], - "code": "C215673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Pharmacovigilance Group", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_2" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_9", - "extensionAttributes": [], - "name": "Primary Data Manager", - "label": "Primary Data Manager", - "description": null, - "code": { - "id": "Code_9963", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_6", - "extensionAttributes": [], - "name": "Valerie S", - "label": null, - "description": null, - "personName": { - "id": "PersonName_6", - "extensionAttributes": [], - "text": null, - "familyName": "G", - "givenNames": [ - "Valerie" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Primary Data Manager", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_10", - "extensionAttributes": [], - "name": "Secondary Data Manager", - "label": "Secondary Data Manager", - "description": null, - "code": { - "id": "Code_9964", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_7", - "extensionAttributes": [], - "name": "Patrick G", - "label": null, - "description": null, - "personName": { - "id": "PersonName_7", - "extensionAttributes": [], - "text": null, - "familyName": "G", - "givenNames": [ - "Patrick" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Secondary Data Manager", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_11", - "extensionAttributes": [], - "name": "Data Acquisition Lead", - "label": "Data Acquisition Lead", - "description": null, - "code": { - "id": "Code_9965", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_4" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_8", - "extensionAttributes": [], - "name": "Eva J", - "label": null, - "description": null, - "personName": { - "id": "PersonName_8", - "extensionAttributes": [], - "text": null, - "familyName": "J", - "givenNames": [ - "Eva" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Data Acquisition Lead", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_12", - "extensionAttributes": [], - "name": "Data Acquisition Lead", - "label": "Data Acquisition Lead", - "description": null, - "code": { - "id": "Code_9966", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_5" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_9", - "extensionAttributes": [], - "name": "Melissa T", - "label": null, - "description": null, - "personName": { - "id": "PersonName_9", - "extensionAttributes": [], - "text": null, - "familyName": "T", - "givenNames": [ - "Melissa" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Data Acquisition Lead", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - } - ], - "studyInterventions": [ - { - "id": "StudyIntervention_1", - "extensionAttributes": [], - "name": "Fulvestrant + Everolimus (Arm A)", - "label": "Fulvestrant + Everolimus (Arm A)", - "description": "Fulvestrant 500 mg IM on Day 1 of each 28-day cycle (Day 1 and 15 of Cycle 1 only) plus Everolimus 10 mg orally once daily.", - "role": { - "id": "Code_7943", - "extensionAttributes": [], - "code": "C41161", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Experimental Intervention", - "instanceType": "Code" - }, - "type": { - "id": "Code_7944", - "extensionAttributes": [], - "code": "C54696", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Combination Product", - "instanceType": "Code" - }, - "minimumResponseDuration": null, - "codes": [], - "administrations": [], - "notes": [], - "instanceType": "StudyIntervention" - }, - { - "id": "StudyIntervention_2", - "extensionAttributes": [], - "name": "Fulvestrant + Placebo (Arm B)", - "label": "Fulvestrant + Placebo (Arm B)", - "description": "Fulvestrant 500 mg IM on Day 1 of each 28-day cycle (Day 1 and 15 of Cycle 1 only) plus matching oral placebo once daily.", - "role": { - "id": "Code_7945", - "extensionAttributes": [], - "code": "C68609", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Active Comparator", - "instanceType": "Code" - }, - "type": { - "id": "Code_7946", - "extensionAttributes": [], - "code": "C54696", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Combination Product", - "instanceType": "Code" - }, - "minimumResponseDuration": null, - "codes": [], - "administrations": [], - "notes": [], - "instanceType": "StudyIntervention" - } - ], - "businessTherapeuticAreas": [], - "biomedicalConcepts": [ - { - "id": "BiomedicalConcept_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_1", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Informed Consent", - "label": "Informed Consent", - "synonyms": [ - "Informed Consent Obtained" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "id": "BiomedicalConceptProperty_1", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_927", - "instanceType": "ResponseCode", - "name": "INFORMED CONSENT OBTAINED", - "label": "INFORMED CONSENT OBTAINED", - "isEnabled": true, - "code": { - "id": "Code_9455", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9057", - "standardCode": { - "id": "Code_9721", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_2", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9058", - "standardCode": { - "id": "Code_9722", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_3", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9059", - "standardCode": { - "id": "Code_9723", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1", - "extensionAttributes": [], - "standardCode": { - "id": "Code_8", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_2", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_2", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ELIGMET", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Eligibility Criteria Met By Subject", - "label": "Eligibility Criteria Met By Subject", - "synonyms": [ - "Eligibility Criteria Met" - ], - "reference": "/mdr/bc/biomedicalconcepts/C132447", - "properties": [ - { - "id": "BiomedicalConceptProperty_4", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_928", - "instanceType": "ResponseCode", - "name": "ELIGIBILITY CRITERIA MET", - "label": "ELIGIBILITY CRITERIA MET", - "isEnabled": true, - "code": { - "id": "Code_9459", - "extensionAttributes": [], - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ELIGIBILITY CRITERIA MET", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9060", - "standardCode": { - "id": "Code_9724", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_5", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9061", - "standardCode": { - "id": "Code_9725", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_6", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9062", - "standardCode": { - "id": "Code_9726", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_6", - "extensionAttributes": [], - "standardCode": { - "id": "Code_13", - "extensionAttributes": [], - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Eligibility Criteria Met By Subject", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_3", - "extensionAttributes": [], - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "synonyms": [ - "MHYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C85522", - "properties": [ - { - "id": "BiomedicalConceptProperty_7", - "extensionAttributes": [], - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9063", - "standardCode": { - "id": "Code_9727", - "extensionAttributes": [], - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_8", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9064", - "standardCode": { - "id": "Code_9728", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_11", - "extensionAttributes": [], - "standardCode": { - "id": "Code_18", - "extensionAttributes": [], - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_4", - "extensionAttributes": [], - "name": "Medical History Reported Term [RETIRED]", - "label": "Medical History Reported Term [RETIRED]", - "synonyms": [ - "Medical History", - "MHTERM" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83118", - "properties": [ - { - "id": "BiomedicalConceptProperty_9", - "extensionAttributes": [], - "name": "Medical History Dictionary Derived Term", - "label": "Medical History Dictionary Derived Term", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9065", - "standardCode": { - "id": "Code_9729", - "extensionAttributes": [], - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_10", - "extensionAttributes": [], - "name": "Medical History Occurrence", - "label": "Medical History Occurrence", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9066", - "standardCode": { - "id": "Code_9730", - "extensionAttributes": [], - "code": "C83067", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Occurrence", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_11", - "extensionAttributes": [], - "name": "Medical History Pre-specified", - "label": "Medical History Pre-specified", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9067", - "standardCode": { - "id": "Code_9731", - "extensionAttributes": [], - "code": "C87897", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Pre-specified", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_12", - "extensionAttributes": [], - "name": "Medical History Reported Term", - "label": "Medical History Reported Term", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9068", - "standardCode": { - "id": "Code_9732", - "extensionAttributes": [], - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_13", - "extensionAttributes": [], - "name": "Medical History Category", - "label": "Medical History Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9069", - "standardCode": { - "id": "Code_9733", - "extensionAttributes": [], - "code": "C83018", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_14", - "extensionAttributes": [], - "name": "Medical History Subcategory", - "label": "Medical History Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9070", - "standardCode": { - "id": "Code_9734", - "extensionAttributes": [], - "code": "C83143", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_12", - "extensionAttributes": [], - "standardCode": { - "id": "Code_19", - "extensionAttributes": [], - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_5", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_3", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ECOG101", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECOG - Performance Status", - "label": "ECOG - Performance Status", - "synonyms": [ - "ECOG1-Performance Status", - "ECOG101", - "ECOG - Performance Status" - ], - "reference": "/mdr/bc/biomedicalconcepts/C102408", - "properties": [ - { - "id": "BiomedicalConceptProperty_15", - "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9071", - "standardCode": { - "id": "Code_9735", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_16", - "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9072", - "standardCode": { - "id": "Code_9736", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_13", - "extensionAttributes": [], - "standardCode": { - "id": "Code_20", - "extensionAttributes": [], - "code": "C102408", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG - Performance Status", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_6", - "extensionAttributes": [], - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "code": { - "id": "AliasCode_21", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28", - "extensionAttributes": [], - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_7", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_4", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "synonyms": [ - "SYSBP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "id": "BiomedicalConceptProperty_17", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9073", - "standardCode": { - "id": "Code_9737", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_18", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_929", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_9474", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9074", - "standardCode": { - "id": "Code_9738", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_19", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9075", - "standardCode": { - "id": "Code_9739", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_20", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9076", - "standardCode": { - "id": "Code_9740", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_21", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9077", - "standardCode": { - "id": "Code_9741", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_22", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9078", - "standardCode": { - "id": "Code_9742", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_22", - "extensionAttributes": [], - "standardCode": { - "id": "Code_29", - "extensionAttributes": [], - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_8", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_5", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "synonyms": [ - "DIABP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "id": "BiomedicalConceptProperty_23", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9079", - "standardCode": { - "id": "Code_9743", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_24", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_930", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_9481", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9080", - "standardCode": { - "id": "Code_9744", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_25", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9081", - "standardCode": { - "id": "Code_9745", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_26", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9082", - "standardCode": { - "id": "Code_9746", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_27", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9083", - "standardCode": { - "id": "Code_9747", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_28", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9084", - "standardCode": { - "id": "Code_9748", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_34", - "extensionAttributes": [], - "standardCode": { - "id": "Code_41", - "extensionAttributes": [], - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_9", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_6", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Heart Rate", - "label": "Heart Rate", - "synonyms": [ - "HR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "id": "BiomedicalConceptProperty_29", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_9085", - "standardCode": { - "id": "Code_9749", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_30", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_931", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_9488", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9086", - "standardCode": { - "id": "Code_9750", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_31", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9087", - "standardCode": { - "id": "Code_9751", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_32", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9088", - "standardCode": { - "id": "Code_9752", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_33", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9089", - "standardCode": { - "id": "Code_9753", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_34", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9090", - "standardCode": { - "id": "Code_9754", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_46", - "extensionAttributes": [], - "standardCode": { - "id": "Code_53", - "extensionAttributes": [], - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_10", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_7", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TEMP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Temperature", - "label": "Body Temperature", - "synonyms": [ - "Temperature" - ], - "reference": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ - { - "id": "BiomedicalConceptProperty_35", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9091", - "standardCode": { - "id": "Code_9755", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_36", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9092", - "standardCode": { - "id": "Code_9756", - "extensionAttributes": [], - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_37", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9093", - "standardCode": { - "id": "Code_9757", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_38", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9094", - "standardCode": { - "id": "Code_9758", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5688", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5767", - "extensionAttributes": [], - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Body Temperature", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_11", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_8", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WEIGHT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Weight", - "label": "Body Weight", - "synonyms": [ - "WEIGHT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ - { - "id": "BiomedicalConceptProperty_39", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9095", - "standardCode": { - "id": "Code_9759", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_40", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9096", - "standardCode": { - "id": "Code_9760", - "extensionAttributes": [], - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_41", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9097", - "standardCode": { - "id": "Code_9761", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9354", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10029", - "extensionAttributes": [], - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_18", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_9", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "synonyms": [ - "ALT", - "SGPT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ - { - "id": "BiomedicalConceptProperty_42", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9098", - "standardCode": { - "id": "Code_9762", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_43", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9099", - "standardCode": { - "id": "Code_9763", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_44", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_932", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_9503", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9100", - "standardCode": { - "id": "Code_9764", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_45", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9101", - "standardCode": { - "id": "Code_9765", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_46", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9102", - "standardCode": { - "id": "Code_9766", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9355", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10030", - "extensionAttributes": [], - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_19", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_10", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "synonyms": [ - "AST", - "SGOT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ - { - "id": "BiomedicalConceptProperty_47", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9103", - "standardCode": { - "id": "Code_9767", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_48", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9104", - "standardCode": { - "id": "Code_9768", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_49", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_933", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_9509", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9105", - "standardCode": { - "id": "Code_9769", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_50", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9106", - "standardCode": { - "id": "Code_9770", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_51", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9107", - "standardCode": { - "id": "Code_9771", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_767", - "extensionAttributes": [], - "standardCode": { - "id": "Code_807", - "extensionAttributes": [], - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_20", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_11", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "synonyms": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "id": "BiomedicalConceptProperty_52", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9108", - "standardCode": { - "id": "Code_9772", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_53", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9109", - "standardCode": { - "id": "Code_9773", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_54", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_934", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_9515", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9110", - "standardCode": { - "id": "Code_9774", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_55", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9111", - "standardCode": { - "id": "Code_9775", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_56", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9112", - "standardCode": { - "id": "Code_9776", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_768", - "extensionAttributes": [], - "standardCode": { - "id": "Code_808", - "extensionAttributes": [], - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_21", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_12", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "synonyms": [ - "Creatinine" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ - { - "id": "BiomedicalConceptProperty_57", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9113", - "standardCode": { - "id": "Code_9777", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_58", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9114", - "standardCode": { - "id": "Code_9778", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_59", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_935", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_9521", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9115", - "standardCode": { - "id": "Code_9779", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_60", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9116", - "standardCode": { - "id": "Code_9780", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_61", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9117", - "standardCode": { - "id": "Code_9781", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5689", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5768", - "extensionAttributes": [], - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_22", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_13", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "synonyms": [ - "Albumin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ - { - "id": "BiomedicalConceptProperty_62", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9118", - "standardCode": { - "id": "Code_9782", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_63", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9119", - "standardCode": { - "id": "Code_9783", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_64", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_936", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_9527", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9120", - "standardCode": { - "id": "Code_9784", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_65", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9121", - "standardCode": { - "id": "Code_9785", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_66", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9122", - "standardCode": { - "id": "Code_9786", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5690", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5769", - "extensionAttributes": [], - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_26", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_14", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "pH", - "label": "pH", - "synonyms": [ - "PH", - "potential of Hydrogen" - ], - "reference": "/mdr/bc/biomedicalconcepts/C45997", - "properties": [ - { - "id": "BiomedicalConceptProperty_67", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9123", - "standardCode": { - "id": "Code_9787", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_68", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_937", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_9532", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9124", - "standardCode": { - "id": "Code_9788", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_69", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9125", - "standardCode": { - "id": "Code_9789", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_70", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9126", - "standardCode": { - "id": "Code_9790", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5691", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5770", - "extensionAttributes": [], - "code": "C45997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "pH", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_27", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_15", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/COLORURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Color Assessment", - "label": "Color Assessment", - "synonyms": [ - "COLOR", - "Color" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [ - { - "id": "BiomedicalConceptProperty_71", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9127", - "standardCode": { - "id": "Code_9791", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_72", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_938", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_9537", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9128", - "standardCode": { - "id": "Code_9792", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_73", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9129", - "standardCode": { - "id": "Code_9793", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9356", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10031", - "extensionAttributes": [], - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_28", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_16", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Specific Gravity", - "label": "Specific Gravity", - "synonyms": [ - "SPGRAV" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ - { - "id": "BiomedicalConceptProperty_74", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9130", - "standardCode": { - "id": "Code_9794", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_75", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_939", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_9541", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9131", - "standardCode": { - "id": "Code_9795", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_76", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9132", - "standardCode": { - "id": "Code_9796", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_77", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9133", - "standardCode": { - "id": "Code_9797", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5692", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5771", - "extensionAttributes": [], - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_47", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "synonyms": [ - "AEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "id": "BiomedicalConceptProperty_78", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9134", - "standardCode": { - "id": "Code_9798", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_79", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9135", - "standardCode": { - "id": "Code_9799", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5693", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5772", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_48", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_17", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Adverse Event", - "label": "Adverse Event", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "code": { - "id": "AliasCode_773", - "extensionAttributes": [], - "standardCode": { - "id": "Code_813", - "extensionAttributes": [], - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_49", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "synonyms": [ - "CMYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [ - { - "id": "BiomedicalConceptProperty_80", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9136", - "standardCode": { - "id": "Code_9800", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_81", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9137", - "standardCode": { - "id": "Code_9801", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5694", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5773", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_50", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_18", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMFREE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "synonyms": [ - "Concomitant Medication" - ], - "reference": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ - { - "id": "BiomedicalConceptProperty_82", - "extensionAttributes": [], - "name": "CMTRT", - "label": "CMTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9138", - "standardCode": { - "id": "Code_9802", - "extensionAttributes": [], - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_83", - "extensionAttributes": [], - "name": "CMDECOD", - "label": "CMDECOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9139", - "standardCode": { - "id": "Code_9803", - "extensionAttributes": [], - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_84", - "extensionAttributes": [], - "name": "CMCLAS", - "label": "CMCLAS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9140", - "standardCode": { - "id": "Code_9804", - "extensionAttributes": [], - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_85", - "extensionAttributes": [], - "name": "CMINDC", - "label": "CMINDC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9141", - "standardCode": { - "id": "Code_9805", - "extensionAttributes": [], - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_86", - "extensionAttributes": [], - "name": "CMDOSE", - "label": "CMDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9142", - "standardCode": { - "id": "Code_9806", - "extensionAttributes": [], - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_87", - "extensionAttributes": [], - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9143", - "standardCode": { - "id": "Code_9807", - "extensionAttributes": [], - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_88", - "extensionAttributes": [], - "name": "CMDOSU", - "label": "CMDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9144", - "standardCode": { - "id": "Code_9808", - "extensionAttributes": [], - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_89", - "extensionAttributes": [], - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9145", - "standardCode": { - "id": "Code_9809", - "extensionAttributes": [], - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_90", - "extensionAttributes": [], - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9146", - "standardCode": { - "id": "Code_9810", - "extensionAttributes": [], - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_91", - "extensionAttributes": [], - "name": "CMROUTE", - "label": "CMROUTE", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9147", - "standardCode": { - "id": "Code_9811", - "extensionAttributes": [], - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_92", - "extensionAttributes": [], - "name": "CMSTDTC", - "label": "CMSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9148", - "standardCode": { - "id": "Code_9812", - "extensionAttributes": [], - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_93", - "extensionAttributes": [], - "name": "CMENDTC", - "label": "CMENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9149", - "standardCode": { - "id": "Code_9813", - "extensionAttributes": [], - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_94", - "extensionAttributes": [], - "name": "CMSTRF", - "label": "CMSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9150", - "standardCode": { - "id": "Code_9814", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_95", - "extensionAttributes": [], - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9151", - "standardCode": { - "id": "Code_9815", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_96", - "extensionAttributes": [], - "name": "CMSTTPT", - "label": "CMSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9152", - "standardCode": { - "id": "Code_9816", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_97", - "extensionAttributes": [], - "name": "CMENRF", - "label": "CMENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9153", - "standardCode": { - "id": "Code_9817", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_98", - "extensionAttributes": [], - "name": "CMENRTPT", - "label": "CMENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9154", - "standardCode": { - "id": "Code_9818", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_99", - "extensionAttributes": [], - "name": "CMENTPT", - "label": "CMENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9155", - "standardCode": { - "id": "Code_9819", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_775", - "extensionAttributes": [], - "standardCode": { - "id": "Code_815", - "extensionAttributes": [], - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_51", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_19", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RANDOM", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Randomization", - "label": "Randomization", - "synonyms": [ - "randomization", - "RANDOM", - "Randomized", - "Trial is Randomized", - "randomized" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25196", - "properties": [ - { - "id": "BiomedicalConceptProperty_236", - "extensionAttributes": [], - "name": "TSPARMCD", - "label": "TSPARMCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_947", - "instanceType": "ResponseCode", - "name": "RANDOM", - "label": "RANDOM", - "isEnabled": true, - "code": { - "id": "Code_9968", - "extensionAttributes": [], - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "RANDOM", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9292", - "standardCode": { - "id": "Code_9967", - "extensionAttributes": [], - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_237", - "extensionAttributes": [], - "name": "TSPARM", - "label": "TSPARM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_948", - "instanceType": "ResponseCode", - "name": "Trial is Randomized", - "label": "Trial is Randomized", - "isEnabled": true, - "code": { - "id": "Code_9970", - "extensionAttributes": [], - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial is Randomized", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9294", - "standardCode": { - "id": "Code_9969", - "extensionAttributes": [], - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_238", - "extensionAttributes": [], - "name": "TSVAL", - "label": "TSVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9296", - "standardCode": { - "id": "Code_9971", - "extensionAttributes": [], - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_239", - "extensionAttributes": [], - "name": "TSVALCD", - "label": "TSVALCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9297", - "standardCode": { - "id": "Code_9972", - "extensionAttributes": [], - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_240", - "extensionAttributes": [], - "name": "TSVCDREF", - "label": "TSVCDREF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9298", - "standardCode": { - "id": "Code_9973", - "extensionAttributes": [], - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_241", - "extensionAttributes": [], - "name": "TSVCDVER", - "label": "TSVCDVER", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9299", - "standardCode": { - "id": "Code_9974", - "extensionAttributes": [], - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_8606", - "extensionAttributes": [], - "standardCode": { - "id": "Code_9210", - "extensionAttributes": [], - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "RANDOM", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_52", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_20", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Prothrombin Time", - "label": "Prothrombin Time", - "synonyms": [ - "PT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C62656", - "properties": [ - { - "id": "BiomedicalConceptProperty_106", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9162", - "standardCode": { - "id": "Code_9826", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_107", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_940", - "instanceType": "ResponseCode", - "name": "s", - "label": "s", - "isEnabled": true, - "code": { - "id": "Code_9574", - "extensionAttributes": [], - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9163", - "standardCode": { - "id": "Code_9827", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_108", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_941", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_9576", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9164", - "standardCode": { - "id": "Code_9828", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_109", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [ - { - "id": "ResponseCode_878", - "instanceType": "ResponseCode", - "name": "ELIGIBILITY CRITERIA MET", - "label": "ELIGIBILITY CRITERIA MET", - "isEnabled": true, - "code": { - "id": "Code_9066", - "extensionAttributes": [], - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ELIGIBILITY CRITERIA MET", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9165", - "standardCode": { - "id": "Code_9829", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_110", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9166", - "standardCode": { - "id": "Code_9830", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5695", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5774", - "extensionAttributes": [], - "code": "C62656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Prothrombin Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_53", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_21", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/INRBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "International Normalized Ratio of Prothrombin Time", - "label": "International Normalized Ratio of Prothrombin Time", - "synonyms": [ - "INR", - "Prothrombin Intl. Normalized Ratio" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64805", - "properties": [ - { - "id": "BiomedicalConceptProperty_111", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [ - { - "id": "ResponseCode_796", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_8079", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9167", - "standardCode": { - "id": "Code_9831", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_112", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_694", - "instanceType": "ResponseCode", - "name": "RATIO", - "label": "RATIO", - "isEnabled": true, - "code": { - "id": "Code_6863", - "extensionAttributes": [], - "code": "C44256", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RATIO", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9168", - "standardCode": { - "id": "Code_9832", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_113", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_695", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_6865", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9169", - "standardCode": { - "id": "Code_9833", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_114", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9170", - "standardCode": { - "id": "Code_9834", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5696", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5775", - "extensionAttributes": [], - "code": "C64805", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "International Normalized Ratio of Prothrombin Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_54", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_22", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/APTTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Activated Partial Thromboplastin Time", - "label": "Activated Partial Thromboplastin Time", - "synonyms": [ - "APTT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38462", - "properties": [ - { - "id": "BiomedicalConceptProperty_115", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_9171", - "standardCode": { - "id": "Code_9835", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_116", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_942", - "instanceType": "ResponseCode", - "name": "s", - "label": "s", - "isEnabled": true, - "code": { - "id": "Code_9585", - "extensionAttributes": [], - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9172", - "standardCode": { - "id": "Code_9836", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_117", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_943", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_9587", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9173", - "standardCode": { - "id": "Code_9837", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_118", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9174", - "standardCode": { - "id": "Code_9838", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_776", - "extensionAttributes": [], - "standardCode": { - "id": "Code_816", - "extensionAttributes": [], - "code": "C38462", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Activated Partial Thromboplastin Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_55", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_23", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "synonyms": [ - "Glucose" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "id": "BiomedicalConceptProperty_242", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9300", - "standardCode": { - "id": "Code_9975", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_243", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9301", - "standardCode": { - "id": "Code_9976", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_244", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_949", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_9978", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9302", - "standardCode": { - "id": "Code_9977", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_245", - "extensionAttributes": [], - "name": "LBMETHOD", - "label": "LBMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9304", - "standardCode": { - "id": "Code_9979", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_246", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9305", - "standardCode": { - "id": "Code_9980", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_247", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9306", - "standardCode": { - "id": "Code_9981", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_777", - "extensionAttributes": [], - "standardCode": { - "id": "Code_817", - "extensionAttributes": [], - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_56", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_24", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TRIGSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Triglyceride Measurement", - "label": "Triglyceride Measurement", - "synonyms": [ - "TRIG", - "Triglycerides" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64812", - "properties": [ - { - "id": "BiomedicalConceptProperty_125", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9181", - "standardCode": { - "id": "Code_9845", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_126", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9182", - "standardCode": { - "id": "Code_9846", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_127", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_944", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_9598", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9183", - "standardCode": { - "id": "Code_9847", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_128", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9184", - "standardCode": { - "id": "Code_9848", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_129", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9185", - "standardCode": { - "id": "Code_9849", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_778", - "extensionAttributes": [], - "standardCode": { - "id": "Code_818", - "extensionAttributes": [], - "code": "C64812", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triglyceride Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_57", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_25", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "synonyms": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [ - { - "id": "BiomedicalConceptProperty_248", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9307", - "standardCode": { - "id": "Code_9982", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_249", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9308", - "standardCode": { - "id": "Code_9983", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_250", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_950", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_9985", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9309", - "standardCode": { - "id": "Code_9984", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_251", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9311", - "standardCode": { - "id": "Code_9986", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_252", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9312", - "standardCode": { - "id": "Code_9987", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_534", - "extensionAttributes": [], - "standardCode": { - "id": "Code_574", - "extensionAttributes": [], - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_58", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_26", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HDLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "High Density Lipoprotein Cholesterol Measurement", - "label": "High Density Lipoprotein Cholesterol Measurement", - "synonyms": [ - "HDL", - "HDL Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105587", - "properties": [ - { - "id": "BiomedicalConceptProperty_135", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9191", - "standardCode": { - "id": "Code_9855", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_136", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9192", - "standardCode": { - "id": "Code_9856", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_137", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_868", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_8647", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9193", - "standardCode": { - "id": "Code_9857", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_138", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [ - { - "id": "ResponseCode_884", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_9101", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9194", - "standardCode": { - "id": "Code_9858", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_139", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9195", - "standardCode": { - "id": "Code_9859", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5697", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5776", - "extensionAttributes": [], - "code": "C105587", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "High Density Lipoprotein Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_59", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_27", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/LDLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Low Density Lipoprotein Cholesterol Measurement", - "label": "Low Density Lipoprotein Cholesterol Measurement", - "synonyms": [ - "LDL", - "LDL Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105588", - "properties": [ - { - "id": "BiomedicalConceptProperty_140", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9196", - "standardCode": { - "id": "Code_9860", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_141", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9197", - "standardCode": { - "id": "Code_9861", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_142", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_869", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_8653", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9198", - "standardCode": { - "id": "Code_9862", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_143", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9199", - "standardCode": { - "id": "Code_9863", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_144", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_885", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_9108", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9200", - "standardCode": { - "id": "Code_9864", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_7397", - "extensionAttributes": [], - "standardCode": { - "id": "Code_7476", - "extensionAttributes": [], - "code": "C105588", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Low Density Lipoprotein Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_60", - "extensionAttributes": [], - "name": "ECOG Clinical Classification Question", - "label": "ECOG Clinical Classification Question", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C101874", - "properties": [], - "code": { - "id": "AliasCode_779", - "extensionAttributes": [], - "standardCode": { - "id": "Code_819", - "extensionAttributes": [], - "code": "C101874", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG Clinical Classification Question", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_61", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_28", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "synonyms": [ - "WBC", - "White Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [ - { - "id": "BiomedicalConceptProperty_145", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9201", - "standardCode": { - "id": "Code_9865", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_146", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9202", - "standardCode": { - "id": "Code_9866", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_147", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_870", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_8659", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9203", - "standardCode": { - "id": "Code_9867", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_148", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9204", - "standardCode": { - "id": "Code_9868", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_149", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9205", - "standardCode": { - "id": "Code_9869", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5698", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5777", - "extensionAttributes": [], - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_62", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_29", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "synonyms": [ - "RBC", - "Red Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ - { - "id": "BiomedicalConceptProperty_150", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9206", - "standardCode": { - "id": "Code_9870", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_151", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9207", - "standardCode": { - "id": "Code_9871", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_152", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_871", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_8665", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9208", - "standardCode": { - "id": "Code_9872", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_153", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9209", - "standardCode": { - "id": "Code_9873", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_154", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9210", - "standardCode": { - "id": "Code_9874", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_780", - "extensionAttributes": [], - "standardCode": { - "id": "Code_820", - "extensionAttributes": [], - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_63", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_30", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PLATBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Platelet Count", - "label": "Platelet Count", - "synonyms": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ - { - "id": "BiomedicalConceptProperty_155", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9211", - "standardCode": { - "id": "Code_9875", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_156", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9212", - "standardCode": { - "id": "Code_9876", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_157", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_872", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_8671", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9213", - "standardCode": { - "id": "Code_9877", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_158", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [ - { - "id": "ResponseCode_886", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_9123", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9214", - "standardCode": { - "id": "Code_9878", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_159", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9215", - "standardCode": { - "id": "Code_9879", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5699", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5778", - "extensionAttributes": [], - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_64", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_31", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/KBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "synonyms": [ - "Potassium", - "K" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [ - { - "id": "BiomedicalConceptProperty_253", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9313", - "standardCode": { - "id": "Code_9988", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_254", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9314", - "standardCode": { - "id": "Code_9989", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_255", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_951", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_9991", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9315", - "standardCode": { - "id": "Code_9990", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_256", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9317", - "standardCode": { - "id": "Code_9992", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_257", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9318", - "standardCode": { - "id": "Code_9993", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5700", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5779", - "extensionAttributes": [], - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_65", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_32", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "synonyms": [ - "Sodium", - "NA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [ - { - "id": "BiomedicalConceptProperty_258", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9319", - "standardCode": { - "id": "Code_9994", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_259", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9320", - "standardCode": { - "id": "Code_9995", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_260", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_952", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_9997", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9321", - "standardCode": { - "id": "Code_9996", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_261", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9323", - "standardCode": { - "id": "Code_9998", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_262", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9324", - "standardCode": { - "id": "Code_9999", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5701", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5780", - "extensionAttributes": [], - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_66", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_33", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CLBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "synonyms": [ - "Chloride", - "CL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [ - { - "id": "BiomedicalConceptProperty_170", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9226", - "standardCode": { - "id": "Code_9890", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_171", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_634", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_6447", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9227", - "standardCode": { - "id": "Code_9891", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_172", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_779", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_7665", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9228", - "standardCode": { - "id": "Code_9892", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_173", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [ - { - "id": "ResponseCode_888", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_9140", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9229", - "standardCode": { - "id": "Code_9893", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_174", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9230", - "standardCode": { - "id": "Code_9894", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5702", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5781", - "extensionAttributes": [], - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_67", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_34", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CO2BLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Carbon Dioxide Measurement", - "label": "Carbon Dioxide Measurement", - "synonyms": [ - "Carbon Dioxide", - "CO2" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64545", - "properties": [ - { - "id": "BiomedicalConceptProperty_263", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9325", - "standardCode": { - "id": "Code_10000", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_264", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9326", - "standardCode": { - "id": "Code_10001", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_265", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_953", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10003", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9327", - "standardCode": { - "id": "Code_10002", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_266", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9329", - "standardCode": { - "id": "Code_10004", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_267", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9330", - "standardCode": { - "id": "Code_10005", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5703", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5782", - "extensionAttributes": [], - "code": "C64545", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Carbon Dioxide Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_68", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_35", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CABLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "synonyms": [ - "Calcium", - "CA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [ - { - "id": "BiomedicalConceptProperty_180", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_584", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_5996", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9236", - "standardCode": { - "id": "Code_9900", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_181", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9237", - "standardCode": { - "id": "Code_9901", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_182", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_945", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_9654", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9238", - "standardCode": { - "id": "Code_9902", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_183", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9239", - "standardCode": { - "id": "Code_9903", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_184", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9240", - "standardCode": { - "id": "Code_9904", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5704", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5783", - "extensionAttributes": [], - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_69", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_36", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "synonyms": [ - "Urea Nitrogen" - ], - "reference": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [ - { - "id": "BiomedicalConceptProperty_185", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9241", - "standardCode": { - "id": "Code_9905", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_186", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9242", - "standardCode": { - "id": "Code_9906", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_187", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_946", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_9660", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9243", - "standardCode": { - "id": "Code_9907", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_188", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9244", - "standardCode": { - "id": "Code_9908", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_189", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9245", - "standardCode": { - "id": "Code_9909", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5705", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5784", - "extensionAttributes": [], - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_70", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_37", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "synonyms": [ - "Protein" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "id": "BiomedicalConceptProperty_268", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9331", - "standardCode": { - "id": "Code_10006", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_269", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9332", - "standardCode": { - "id": "Code_10007", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_270", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_954", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10009", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9333", - "standardCode": { - "id": "Code_10008", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_271", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9335", - "standardCode": { - "id": "Code_10010", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_272", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9336", - "standardCode": { - "id": "Code_10011", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5706", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5785", - "extensionAttributes": [], - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_71", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_38", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "synonyms": [ - "Alkaline Phosphatase" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [ - { - "id": "BiomedicalConceptProperty_195", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9251", - "standardCode": { - "id": "Code_9915", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_196", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_893", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_9168", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9252", - "standardCode": { - "id": "Code_9916", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_197", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_874", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_8713", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9253", - "standardCode": { - "id": "Code_9917", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_198", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9254", - "standardCode": { - "id": "Code_9918", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_199", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_894", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_9172", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9255", - "standardCode": { - "id": "Code_9919", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5707", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5786", - "extensionAttributes": [], - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_72", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_39", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/URATESERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urate Measurement", - "label": "Urate Measurement", - "synonyms": [ - "Urate", - "Uric Acid" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [ - { - "id": "BiomedicalConceptProperty_273", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9337", - "standardCode": { - "id": "Code_10012", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_274", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9338", - "standardCode": { - "id": "Code_10013", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_275", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_955", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10015", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9339", - "standardCode": { - "id": "Code_10014", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_276", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9341", - "standardCode": { - "id": "Code_10016", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_277", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9342", - "standardCode": { - "id": "Code_10017", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_717", - "extensionAttributes": [], - "standardCode": { - "id": "Code_757", - "extensionAttributes": [], - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_73", - "extensionAttributes": [], - "name": "Tumor Size Measurement", - "label": "Tumor Size Measurement", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C106303", - "properties": [ - { - "id": "BiomedicalConceptProperty_205", - "extensionAttributes": [], - "name": "Anatomic Site", - "label": "Anatomic Site", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9261", - "standardCode": { - "id": "Code_9925", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_206", - "extensionAttributes": [], - "name": "Observation Result", - "label": "Observation Result", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [ - { - "id": "ResponseCode_637", - "instanceType": "ResponseCode", - "name": "s", - "label": "s", - "isEnabled": true, - "code": { - "id": "Code_6485", - "extensionAttributes": [], - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9262", - "standardCode": { - "id": "Code_9926", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_207", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9263", - "standardCode": { - "id": "Code_9927", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_208", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9264", - "standardCode": { - "id": "Code_9928", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_209", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9265", - "standardCode": { - "id": "Code_9929", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_210", - "extensionAttributes": [], - "name": "Specimen Anatomic Site", - "label": "Specimen Anatomic Site", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9266", - "standardCode": { - "id": "Code_9930", - "extensionAttributes": [], - "code": "C171435", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Specimen Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_211", - "extensionAttributes": [], - "name": "Biospecimen Type", - "label": "Biospecimen Type", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9267", - "standardCode": { - "id": "Code_9931", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_212", - "extensionAttributes": [], - "name": "Unit of Length", - "label": "Unit of Length", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_812", - "instanceType": "ResponseCode", - "name": "s", - "label": "s", - "isEnabled": true, - "code": { - "id": "Code_8196", - "extensionAttributes": [], - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9268", - "standardCode": { - "id": "Code_9932", - "extensionAttributes": [], - "code": "C42578", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Unit of Length", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5708", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5787", - "extensionAttributes": [], - "code": "C106303", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Tumor Size Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_74", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_40", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TUMERGE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Tumor Identification", - "label": "Tumor Identification", - "synonyms": [ - "TUMIDENT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C94523", - "properties": [ - { - "id": "BiomedicalConceptProperty_278", - "extensionAttributes": [], - "name": "TUORRES", - "label": "TUORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_956", - "instanceType": "ResponseCode", - "name": "TARGET", - "label": "TARGET", - "isEnabled": true, - "code": { - "id": "Code_10019", - "extensionAttributes": [], - "code": "C94520", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "TARGET", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9343", - "standardCode": { - "id": "Code_10018", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_279", - "extensionAttributes": [], - "name": "TULOC", - "label": "TULOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9345", - "standardCode": { - "id": "Code_10020", - "extensionAttributes": [], - "code": "C170500", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_280", - "extensionAttributes": [], - "name": "TULAT", - "label": "TULAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9346", - "standardCode": { - "id": "Code_10021", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_281", - "extensionAttributes": [], - "name": "TUDIR", - "label": "TUDIR", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9347", - "standardCode": { - "id": "Code_10022", - "extensionAttributes": [], - "code": "C54215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Directionality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_282", - "extensionAttributes": [], - "name": "TUMETHOD", - "label": "TUMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9348", - "standardCode": { - "id": "Code_10023", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_283", - "extensionAttributes": [], - "name": "TUEVAL", - "label": "TUEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9349", - "standardCode": { - "id": "Code_10024", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_284", - "extensionAttributes": [], - "name": "TUEVALID", - "label": "TUEVALID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9350", - "standardCode": { - "id": "Code_10025", - "extensionAttributes": [], - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_285", - "extensionAttributes": [], - "name": "TUREFID", - "label": "TUREFID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9351", - "standardCode": { - "id": "Code_10026", - "extensionAttributes": [], - "code": "C117442", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_286", - "extensionAttributes": [], - "name": "TULNKID", - "label": "TULNKID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9352", - "standardCode": { - "id": "Code_10027", - "extensionAttributes": [], - "code": "C117436", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_287", - "extensionAttributes": [], - "name": "TUDTC", - "label": "TUDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9353", - "standardCode": { - "id": "Code_10028", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5709", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5788", - "extensionAttributes": [], - "code": "C94523", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identification", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_75", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_41", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NTRGRESP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Response in Non-Target Lesion", - "label": "Response in Non-Target Lesion", - "synonyms": [ - "NTRGRESP", - "Non-Target Response" - ], - "reference": "/mdr/bc/biomedicalconcepts/C94535", - "properties": [ - { - "id": "BiomedicalConceptProperty_223", - "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9279", - "standardCode": { - "id": "Code_9943", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_224", - "extensionAttributes": [], - "name": "RSEVAL", - "label": "RSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9280", - "standardCode": { - "id": "Code_9944", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_225", - "extensionAttributes": [], - "name": "RSEVALID", - "label": "RSEVALID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9281", - "standardCode": { - "id": "Code_9945", - "extensionAttributes": [], - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_226", - "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9282", - "standardCode": { - "id": "Code_9946", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5710", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5789", - "extensionAttributes": [], - "code": "C94535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Non-Target Lesion", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_76", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_42", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TRGRESP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Response in Target Lesion", - "label": "Response in Target Lesion", - "synonyms": [ - "TRGRESP", - "Target Response" - ], - "reference": "/mdr/bc/biomedicalconcepts/C94534", - "properties": [ - { - "id": "BiomedicalConceptProperty_227", - "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9283", - "standardCode": { - "id": "Code_9947", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_228", - "extensionAttributes": [], - "name": "RSEVAL", - "label": "RSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9284", - "standardCode": { - "id": "Code_9948", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_229", - "extensionAttributes": [], - "name": "RSEVALID", - "label": "RSEVALID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9285", - "standardCode": { - "id": "Code_9949", - "extensionAttributes": [], - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_230", - "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9286", - "standardCode": { - "id": "Code_9950", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5711", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5790", - "extensionAttributes": [], - "code": "C94534", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Target Lesion", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_77", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_43", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/OVRLRESP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Overall Response", - "label": "Overall Response", - "synonyms": [ - "OVRLRESP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C96613", - "properties": [ - { - "id": "BiomedicalConceptProperty_231", - "extensionAttributes": [], - "name": "RSLNKGRP", - "label": "RSLNKGRP", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9287", - "standardCode": { - "id": "Code_9951", - "extensionAttributes": [], - "code": "C117394", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Disease Response Link Group", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_232", - "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9288", - "standardCode": { - "id": "Code_9952", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_233", - "extensionAttributes": [], - "name": "RSEVAL", - "label": "RSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9289", - "standardCode": { - "id": "Code_9953", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_234", - "extensionAttributes": [], - "name": "RSEVALID", - "label": "RSEVALID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_897", - "instanceType": "ResponseCode", - "name": "RANDOM", - "label": "RANDOM", - "isEnabled": true, - "code": { - "id": "Code_9210", - "extensionAttributes": [], - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "RANDOM", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9290", - "standardCode": { - "id": "Code_9954", - "extensionAttributes": [], - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_235", - "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [ - { - "id": "ResponseCode_898", - "instanceType": "ResponseCode", - "name": "Trial is Randomized", - "label": "Trial is Randomized", - "isEnabled": true, - "code": { - "id": "Code_9212", - "extensionAttributes": [], - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial is Randomized", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9291", - "standardCode": { - "id": "Code_9955", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_763", - "extensionAttributes": [], - "standardCode": { - "id": "Code_803", - "extensionAttributes": [], - "code": "C96613", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Overall Response", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - } - ], - "bcSurrogates": [ - { - "id": "BiomedicalConceptSurrogate_1", - "extensionAttributes": [], - "name": "Magnesium Measurement", - "label": "Magnesium Measurement (C64840)", - "description": "A quantitative measurement of the amount of magnesium present in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64840", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_2", - "extensionAttributes": [], - "name": "Hepatitis B DNA Measurement", - "label": "Hepatitis B DNA Measurement (C103404)", - "description": "A measurement of the Hepatitis B virus DNA in a biological specimen", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103404", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_3", - "extensionAttributes": [], - "name": "Hepatitis B Surface Antigen", - "label": "Hepatitis B Virus Surface Antigen Measurement (C64850)", - "description": "A measurement of the surface antigen reaction of a biological specimen to the Hepatitis B virus.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64850", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_4", - "extensionAttributes": [], - "name": "HBsAb+", - "label": "Hepatitis B Surface Antibody Positive (C153243)", - "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153243", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_5", - "extensionAttributes": [], - "name": "HBsAb-", - "label": "Hepatitis B Surface Antibody Negative (C153244)", - "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have not been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153244", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_6", - "extensionAttributes": [], - "name": "HCV RNA Positive", - "label": "HCV RNA Positive (C162042)", - "description": "An indication that hepatitis C RNA has been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C162042", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_7", - "extensionAttributes": [], - "name": "PFTs with DLCO", - "label": "Pulmonary function tests (PFTs) that include DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) (C38081)", - "description": "A broad range of tests that are performed to assess how well lungs inhale and exhale air and how efficiently they transfer oxygen into the blood.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38081", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_8", - "extensionAttributes": [], - "name": "Dietary Phosphorus Measurement", - "label": "Dietary Phosphorus Measurement (C184481)", - "description": "A determination of the phosphorus in a nutritional product or meal, or a portion thereof.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C184481", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_19", - "extensionAttributes": [], - "name": "Adherence", - "label": "Adherence (C25729)", - "description": "The act of abiding by a stated treatment plan or protocol.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C25729", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_20", - "extensionAttributes": [], - "name": "Patient Compliance", - "label": "Patient Compliance (C39490)", - "description": "The extent to which a patient conforms to medical advice regarding prescribed regimen, lifestyle, dietary changes, follow-up schedule and other recommendations.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C39490", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_21", - "extensionAttributes": [], - "name": "Compliance Monitoring", - "label": "Compliance Monitoring (C62737)", - "description": "The act of continuously assessing whether an individual is adhering to their treatment plan.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C62737", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_22", - "extensionAttributes": [], - "name": "Non-Compliance With Study Drug", - "label": "Non-Compliance With Study Drug (C49631)", - "description": "An indication that a subject has not agreed with or followed the instructions related to the study medication. (NCI)", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C49631", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_23", - "extensionAttributes": [], - "name": "Non-Compliance with Study Product", - "label": "Non-Compliance with Study Product (C210354)", - "description": "An indication that a subject has not agreed with or followed the instructions related to the study product.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C210354", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_24", - "extensionAttributes": [], - "name": "Trial Compliance", - "label": "Trial Compliance (C142734)", - "description": "Adherence to clinical trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. (ICH)", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C142734", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - } - ], - "bcCategories": [], - "eligibilityCriterionItems": [], - "narrativeContentItems": [], - "abbreviations": [], - "administrableProducts": [], - "medicalDevices": [], - "productOrganizationRoles": [], - "dictionaries": [], - "conditions": [], - "notes": [], - "instanceType": "StudyVersion" - } - ], - "documentedBy": [], - "instanceType": "Study" - }, - "usdmVersion": "4.0", - "systemName": "SOA Workbench", - "systemVersion": "1.4.0" -} diff --git a/output/json/NCT01797120-20260630T1221.json b/output/json/NCT01797120-20260630T1221.json deleted file mode 100644 index 5a617a4..0000000 --- a/output/json/NCT01797120-20260630T1221.json +++ /dev/null @@ -1,7754 +0,0 @@ -{ - "study": { - "id": "Study_60", - "extensionAttributes": [], - "name": "NCT01797120", - "description": "Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).\r\n\r\nFulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy.\r\n\r\nEverolimus is an orally administered drug that blocks a signaling pathway called \"mTOR\". \"mTOR\" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth.\r\n\r\nThe combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.", - "label": "Study of Fulvestrant +/\u200b- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI", - "versions": [ - { - "id": "StudyVersion_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_44", - "url": "http://www.cdisc.org/usdm/extensions/studyDesignSolution", - "valueExtensionClass": { - "id": "ExtensionClass_1", - "url": "http://www.cdisc.org/usdm/extensions/StudyDesignSolution", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_45", - "url": "tool-name", - "valueString": "SoA Workbench", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_46", - "url": "tool-version", - "valueString": "1.5.0", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_47", - "url": "usdm-creation-date", - "valueString": "20260630T12:21", - "instanceType": "ExtensionAttribute" - } - ], - "instanceType": "ExtensionClass" - }, - "instanceType": "ExtensionAttribute" - } - ], - "versionIdentifier": "1", - "rationale": "", - "studyIdentifiers": [ - { - "id": "StudyIdentifier_1", - "extensionAttributes": [], - "text": "PrE0102", - "scopeId": "Organization_1", - "instanceType": "StudyIdentifier" - } - ], - "referenceIdentifiers": [], - "studyDesigns": [ - { - "id": "InterventionalStudyDesign_1", - "extensionAttributes": [], - "name": "PrE0102", - "label": "Study of Fulvestrant +/\u200b- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI", - "description": "Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).\r\n\r\nFulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy.\r\n\r\nEverolimus is an orally administered drug that blocks a signaling pathway called \"mTOR\". \"mTOR\" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth.\r\n\r\nThe combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.", - "studyType": null, - "studyPhase": null, - "therapeuticAreas": [], - "characteristics": [], - "encounters": [ - { - "id": "Encounter_1", - "extensionAttributes": [], - "name": "PRE-STUDY", - "label": "Pre-Study", - "description": "Occuring before Randomization and Treatment", - "type": { - "id": "Code_485", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "Encounter_2", - "scheduledAtId": "Timing_2", - "environmentalSettings": [ - { - "id": "Code_486", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_487", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": { - "id": "TransitionRule_1", - "extensionAttributes": [], - "name": "Screening Exit / Randomization", - "label": "Screening Exit / Randomization", - "description": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", - "text": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_2", - "extensionAttributes": [], - "name": "C1D1", - "label": "Cycle 1 Day 1", - "description": "First day fulvestrant is given with everolimus/placebo; start of Induction Phase. Treatment begins within 7 working days of randomization.", - "type": { - "id": "Code_488", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_1", - "nextId": "Encounter_3", - "scheduledAtId": "Timing_1", - "environmentalSettings": [ - { - "id": "Code_489", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_490", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_2", - "extensionAttributes": [], - "name": "Induction Phase Entry", - "label": "Induction Phase Entry", - "description": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "text": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_3", - "extensionAttributes": [], - "name": "C1D15", - "label": "Cycle 1 Day 15", - "description": "Second fulvestrant dose (Cycle 1 only) plus safety assessments.", - "type": { - "id": "Code_491", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_2", - "nextId": "Encounter_4", - "scheduledAtId": "Timing_3", - "environmentalSettings": [ - { - "id": "Code_492", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_493", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_4", - "extensionAttributes": [], - "name": "C2D1", - "label": "Cycle 2 Day 1", - "description": "Day 1 of Cycle 2 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10038", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_3", - "nextId": "Encounter_5", - "scheduledAtId": "Timing_4", - "environmentalSettings": [ - { - "id": "Code_10039", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10040", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_5", - "extensionAttributes": [], - "name": "C3D1", - "label": "Cycle 3 Day 1", - "description": "Day 1 of Cycle 3 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10041", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_4", - "nextId": "Encounter_6", - "scheduledAtId": "Timing_5", - "environmentalSettings": [ - { - "id": "Code_10042", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10043", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_6", - "extensionAttributes": [], - "name": "C4D1", - "label": "Cycle 4 Day 1", - "description": "Day 1 of Cycle 4 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10044", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_5", - "nextId": "Encounter_7", - "scheduledAtId": "Timing_6", - "environmentalSettings": [ - { - "id": "Code_10045", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10046", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_7", - "extensionAttributes": [], - "name": "C5D1", - "label": "Cycle 5 Day 1", - "description": "Day 1 of Cycle 5 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10047", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_6", - "nextId": "Encounter_8", - "scheduledAtId": "Timing_7", - "environmentalSettings": [ - { - "id": "Code_10048", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10049", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_8", - "extensionAttributes": [], - "name": "C6D1", - "label": "Cycle 6 Day 1", - "description": "Day 1 of Cycle 6 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10050", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_7", - "nextId": "Encounter_9", - "scheduledAtId": "Timing_8", - "environmentalSettings": [ - { - "id": "Code_10051", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10052", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_9", - "extensionAttributes": [], - "name": "C7D1", - "label": "Cycle 7 Day 1", - "description": "Day 1 of Cycle 7 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10053", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_8", - "nextId": "Encounter_10", - "scheduledAtId": "Timing_9", - "environmentalSettings": [ - { - "id": "Code_10054", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10055", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_10", - "extensionAttributes": [], - "name": "C8D1", - "label": "Cycle 8 Day 1", - "description": "Day 1 of Cycle 8 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10056", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_9", - "nextId": "Encounter_11", - "scheduledAtId": "Timing_10", - "environmentalSettings": [ - { - "id": "Code_10057", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10058", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_11", - "extensionAttributes": [], - "name": "C9D1", - "label": "Cycle 9 Day 1", - "description": "Day 1 of Cycle 9 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10059", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_10", - "nextId": "Encounter_12", - "scheduledAtId": "Timing_11", - "environmentalSettings": [ - { - "id": "Code_10060", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10061", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_12", - "extensionAttributes": [], - "name": "C10D1", - "label": "Cycle 10 Day 1", - "description": "Day 1 of Cycle 10 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10062", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_11", - "nextId": "Encounter_13", - "scheduledAtId": "Timing_12", - "environmentalSettings": [ - { - "id": "Code_10063", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10064", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_13", - "extensionAttributes": [], - "name": "C11D1", - "label": "Cycle 11 Day 1", - "description": "Day 1 of Cycle 11 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10065", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_12", - "nextId": "Encounter_14", - "scheduledAtId": "Timing_13", - "environmentalSettings": [ - { - "id": "Code_10069", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10070", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_14", - "extensionAttributes": [], - "name": "C12D1", - "label": "Cycle 12 Day 1", - "description": "Day 1 of Cycle 12 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10066", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_13", - "nextId": "Encounter_15", - "scheduledAtId": "Timing_14", - "environmentalSettings": [ - { - "id": "Code_10067", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10068", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_15", - "extensionAttributes": [], - "name": "EOI_EOT", - "label": "End of Induction / End of Treatment", - "description": "Performed within 30 days of last fulvestrant dose, before moving to the Continuation Phase or directly to Follow-Up.", - "type": { - "id": "Code_10071", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_14", - "nextId": "Encounter_16", - "scheduledAtId": "Timing_15", - "environmentalSettings": [ - { - "id": "Code_10072", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10073", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_3", - "extensionAttributes": [], - "name": "Induction Phase Exit", - "label": "Induction Phase Exit", - "description": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_16", - "extensionAttributes": [], - "name": "CONT_CXD1", - "label": "Continuation Phase Cycle Day 1", - "description": "Day 1 of each 28-day cycle in the Continuation Phase (begins D29 after last Cycle 12 fulvestrant dose); fulvestrant +/- everolimus until progression or unacceptable toxicity. This visit repeats indefinitely - the protocol defines no fixed cycle count for the Continuation Phase, so it cannot be enumerated and is modeled as a single repeating visit.", - "type": { - "id": "Code_10074", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_15", - "nextId": "Encounter_17", - "scheduledAtId": "Timing_16", - "environmentalSettings": [ - { - "id": "Code_10075", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10076", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_4", - "extensionAttributes": [], - "name": "Continuation Phase Entry", - "label": "Continuation Phase Entry", - "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_5", - "extensionAttributes": [], - "name": "Continuation Phase Exit", - "label": "Continuation Phase Exit", - "description": "Documented disease progression or unacceptable toxicity.", - "text": "Documented disease progression or unacceptable toxicity.", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_17", - "extensionAttributes": [], - "name": "FU_OFF_THERAPY", - "label": "Follow-Up Off-Therapy", - "description": "Every 3 months for 3 years from randomization; disease progression, survival and new systemic therapy documented.", - "type": { - "id": "Code_10077", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_16", - "nextId": null, - "scheduledAtId": "Timing_17", - "environmentalSettings": [ - { - "id": "Code_10078", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10079", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_6", - "extensionAttributes": [], - "name": "Follow-Up Off-Therapy Entry", - "label": "Follow-Up Off-Therapy Entry", - "description": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", - "text": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_7", - "extensionAttributes": [], - "name": "Follow-Up Off-Therapy Exit", - "label": "Follow-Up Off-Therapy Exit", - "description": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", - "text": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - } - ], - "activities": [ - { - "id": "Activity_2", - "extensionAttributes": [], - "name": "ELIGIBILITY ASSESSMENT", - "label": "Eligibility Assessment", - "description": "Determine subject meets eligibility requirements", - "previousId": null, - "nextId": "Activity_1", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_2" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_1", - "extensionAttributes": [], - "name": "INFORMED CONSENT", - "label": "Informed Consent", - "description": "Informed Consent collected", - "previousId": "Activity_2", - "nextId": "Activity_19", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_1" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_19", - "extensionAttributes": [], - "name": "RANDOMIZATION", - "label": "Randomization", - "description": "Randomization", - "previousId": "Activity_1", - "nextId": "Activity_3", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_51" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_3", - "extensionAttributes": [], - "name": "MEDICAL HISTORY", - "label": "Medical History", - "description": "Medical History & Assessment of Baseline Signs and Symptoms", - "previousId": "Activity_19", - "nextId": "Activity_5", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_3", - "BiomedicalConcept_4" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_5", - "extensionAttributes": [], - "name": "PHYSICAL EXAM", - "label": "Physical Examination", - "description": "Physical Examination", - "previousId": "Activity_3", - "nextId": "Activity_18", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_6" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_18", - "extensionAttributes": [], - "name": "CONCOMITANT MEDS", - "label": "Concomitant Medications", - "description": "Concomitant Medications", - "previousId": "Activity_5", - "nextId": "Activity_6", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_49", - "BiomedicalConcept_50" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_6", - "extensionAttributes": [], - "name": "VITAL SIGNS", - "label": "Vital Signs", - "description": "Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight", - "previousId": "Activity_18", - "nextId": "Activity_4", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_7", - "BiomedicalConcept_8", - "BiomedicalConcept_9", - "BiomedicalConcept_10", - "BiomedicalConcept_11" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_4", - "extensionAttributes": [], - "name": "ECOG PERFORMANCE STATUS", - "label": "ECOG Performance Status", - "description": "ECOG performance status", - "previousId": "Activity_6", - "nextId": "Activity_17", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_5", - "BiomedicalConcept_60" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_17", - "extensionAttributes": [], - "name": "ADVERSE EVENTS ASSESSMENTS", - "label": "Adverse Event Assessment", - "description": "Adverse Event Assessment", - "previousId": "Activity_4", - "nextId": "Activity_22", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_47", - "BiomedicalConcept_48" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_22", - "extensionAttributes": [], - "name": "IMAGING SCANS", - "label": "Imaging Scans", - "description": "Tumor imaging scans", - "previousId": "Activity_17", - "nextId": "Activity_23", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_73", - "BiomedicalConcept_74", - "BiomedicalConcept_75", - "BiomedicalConcept_76", - "BiomedicalConcept_77" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_23", - "extensionAttributes": [], - "name": "PT/INR", - "label": "PT with INR", - "description": "prothrombin time and international normalized ratio", - "previousId": "Activity_22", - "nextId": "Activity_10", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_52", - "BiomedicalConcept_53", - "BiomedicalConcept_54" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_10", - "extensionAttributes": [], - "name": "URINALYSIS", - "label": "Urinalysis Labs", - "description": "Urinalysis Labs", - "previousId": "Activity_23", - "nextId": "Activity_24", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_26", - "BiomedicalConcept_27", - "BiomedicalConcept_28" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_24", - "extensionAttributes": [], - "name": "CBC", - "label": "CBC with differentials, Platelets", - "description": "CBC with differentials, Platelets", - "previousId": "Activity_10", - "nextId": "Activity_8", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_61", - "BiomedicalConcept_62", - "BiomedicalConcept_63" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_8", - "extensionAttributes": [], - "name": "CHEMISTRY LABS", - "label": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", - "description": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", - "previousId": "Activity_24", - "nextId": "Activity_25", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_18", - "BiomedicalConcept_19", - "BiomedicalConcept_20", - "BiomedicalConcept_21", - "BiomedicalConcept_22", - "BiomedicalConcept_64", - "BiomedicalConcept_65", - "BiomedicalConcept_66", - "BiomedicalConcept_67", - "BiomedicalConcept_68", - "BiomedicalConcept_69", - "BiomedicalConcept_70", - "BiomedicalConcept_71", - "BiomedicalConcept_72" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_1", - "BiomedicalConceptSurrogate_8" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_25", - "extensionAttributes": [], - "name": "GLUCOSE", - "label": "Fasting Glucose", - "description": "Fasting Glucose", - "previousId": "Activity_8", - "nextId": "Activity_26", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_55" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_26", - "extensionAttributes": [], - "name": "LIPID PROFILE", - "label": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", - "description": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", - "previousId": "Activity_25", - "nextId": "Activity_27", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_56", - "BiomedicalConcept_57", - "BiomedicalConcept_58", - "BiomedicalConcept_59" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_27", - "extensionAttributes": [], - "name": "HBV-DNA-1", - "label": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV- RNA-PCR", - "description": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV- RNA-PCR", - "previousId": "Activity_26", - "nextId": "Activity_28", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_2", - "BiomedicalConceptSurrogate_3", - "BiomedicalConceptSurrogate_4", - "BiomedicalConceptSurrogate_5", - "BiomedicalConceptSurrogate_6" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_28", - "extensionAttributes": [], - "name": "HBV-DNA-2", - "label": "HBV DNA", - "description": "HBV DNA", - "previousId": "Activity_27", - "nextId": "Activity_29", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_2" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_29", - "extensionAttributes": [], - "name": "HCV", - "label": "HCV RNA-PCR", - "description": "HCV RNA-PCR", - "previousId": "Activity_28", - "nextId": "Activity_30", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_6" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_30", - "extensionAttributes": [], - "name": "COMPLIANCE", - "label": "Study Drug Compliance (Pill Diary)", - "description": "Study Drug Compliance (Pill Diary)", - "previousId": "Activity_29", - "nextId": "Activity_31", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_19", - "BiomedicalConceptSurrogate_20", - "BiomedicalConceptSurrogate_21", - "BiomedicalConceptSurrogate_22", - "BiomedicalConceptSurrogate_23", - "BiomedicalConceptSurrogate_24" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_31", - "extensionAttributes": [], - "name": "PFTS", - "label": "PFTs with DLCO as medically indicatedn", - "description": "PFTs with DLCO as medically indicatedn", - "previousId": "Activity_30", - "nextId": null, - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_7" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - } - ], - "arms": [ - { - "id": "StudyArm_1", - "extensionAttributes": [], - "name": "ARM A", - "label": "Fulvestrant + Everolimus", - "description": "Fulvestrant 500mg IM Q28D (loading D1/D15) + Everolimus 10mg PO QD", - "type": { - "id": "Code_4", - "extensionAttributes": [], - "code": "C174266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Experimental Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_5", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - }, - { - "id": "StudyArm_2", - "extensionAttributes": [], - "name": "ARM B", - "label": "Fulvestrant + Placebo", - "description": "Fulvestrant 500mg IM Q28D (loading D1/D15) + Placebo PO QD", - "type": { - "id": "Code_6", - "extensionAttributes": [], - "code": "C174268", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Placebo Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_7", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - } - ], - "studyCells": [ - { - "id": "StudyCell_1", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_2", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_7", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_4" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_8", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_6" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_9", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_10", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_11", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_5" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_12", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_6" - ], - "instanceType": "StudyCell" - } - ], - "rationale": "", - "epochs": [ - { - "id": "StudyEpoch_1", - "extensionAttributes": [], - "name": "Pre-Study Phase", - "label": "Pre-Study Phase", - "description": "Eligibility assessment, up to 28 days prior to C1D1", - "type": { - "id": "Code_1", - "extensionAttributes": [], - "code": "C202487", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "SCREENING", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "StudyEpoch_2", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_2", - "extensionAttributes": [], - "name": "Induction Phase", - "label": "Induction Phase", - "description": "From C1D1 until disease progression or discontinuation", - "type": { - "id": "Code_2", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_1", - "nextId": "StudyEpoch_4", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_4", - "extensionAttributes": [], - "name": "Continuation Phase", - "label": "Continuation Phase", - "description": "Continuation Phase (until progression or unacceptable toxicity", - "type": { - "id": "Code_813", - "extensionAttributes": [], - "code": "C123452", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "CONTINUATION TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_2", - "nextId": "StudyEpoch_3", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_3", - "extensionAttributes": [], - "name": "Follow-up Off Therapy", - "label": "Follow-up, off therapy", - "description": "Post-EOT survival and safety follow-up", - "type": { - "id": "Code_3", - "extensionAttributes": [], - "code": "C202578", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "FOLLOW-UP", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_4", - "nextId": null, - "notes": [], - "instanceType": "StudyEpoch" - } - ], - "elements": [ - { - "id": "StudyElement_1", - "extensionAttributes": [], - "name": "SCREENING_ELEMENT", - "label": "Screening", - "description": "Pre-study eligibility and baseline assessment period (within 4 weeks of randomization).", - "transitionStartRule": null, - "transitionEndRule": { - "id": "TransitionRule_1", - "extensionAttributes": [], - "name": "Screening Exit / Randomization", - "label": "Screening Exit / Randomization", - "description": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", - "text": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_2", - "extensionAttributes": [], - "name": "INDUCTION_EVE_FUL", - "label": "Induction: Fulvestrant + Everolimus", - "description": "Induction treatment for Arm A: fulvestrant 500 mg IM (D1 & D15 of Cycle 1, then D1 each cycle) plus everolimus 10 mg PO daily, 28-day cycles, max 12 cycles.", - "transitionStartRule": { - "id": "TransitionRule_2", - "extensionAttributes": [], - "name": "Induction Phase Entry", - "label": "Induction Phase Entry", - "description": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "text": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_3", - "extensionAttributes": [], - "name": "Induction Phase Exit", - "label": "Induction Phase Exit", - "description": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [ - "StudyIntervention_3" - ], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_3", - "extensionAttributes": [], - "name": "INDUCTION_PBO_FUL", - "label": "Induction: Fulvestrant + Placebo", - "description": "Induction treatment for Arm B: fulvestrant 500 mg IM (D1 & D15 of Cycle 1, then D1 each cycle) plus placebo PO daily, 28-day cycles, max 12 cycles.", - "transitionStartRule": { - "id": "TransitionRule_2", - "extensionAttributes": [], - "name": "Induction Phase Entry", - "label": "Induction Phase Entry", - "description": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "text": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_3", - "extensionAttributes": [], - "name": "Induction Phase Exit", - "label": "Induction Phase Exit", - "description": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [ - "StudyIntervention_4" - ], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_4", - "extensionAttributes": [], - "name": "CONTINUATION_EVE_FUL", - "label": "Continuation: Fulvestrant + Everolimus", - "description": "Continuation treatment for patients originally randomized to everolimus: fulvestrant 500 mg IM D1 every 28-day cycle plus everolimus, until progression or unacceptable toxicity.", - "transitionStartRule": { - "id": "TransitionRule_4", - "extensionAttributes": [], - "name": "Continuation Phase Entry", - "label": "Continuation Phase Entry", - "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_5", - "extensionAttributes": [], - "name": "Continuation Phase Exit", - "label": "Continuation Phase Exit", - "description": "Documented disease progression or unacceptable toxicity.", - "text": "Documented disease progression or unacceptable toxicity.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [ - "StudyIntervention_3" - ], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_5", - "extensionAttributes": [], - "name": "CONTINUATION_FUL", - "label": "Continuation: Fulvestrant alone", - "description": "Continuation treatment for patients originally randomized to placebo: fulvestrant 500 mg IM D1 every 28-day cycle alone, until progression or unacceptable toxicity.", - "transitionStartRule": { - "id": "TransitionRule_4", - "extensionAttributes": [], - "name": "Continuation Phase Entry", - "label": "Continuation Phase Entry", - "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_5", - "extensionAttributes": [], - "name": "Continuation Phase Exit", - "label": "Continuation Phase Exit", - "description": "Documented disease progression or unacceptable toxicity.", - "text": "Documented disease progression or unacceptable toxicity.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [ - "StudyIntervention_5" - ], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_6", - "extensionAttributes": [], - "name": "FOLLOW_UP_ELEMENT", - "label": "Follow-Up Off-Therapy", - "description": "Off-therapy follow-up for disease progression and survival, every 3 months for 3 years from randomization.", - "transitionStartRule": { - "id": "TransitionRule_6", - "extensionAttributes": [], - "name": "Follow-Up Off-Therapy Entry", - "label": "Follow-Up Off-Therapy Entry", - "description": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", - "text": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_7", - "extensionAttributes": [], - "name": "Follow-Up Off-Therapy Exit", - "label": "Follow-Up Off-Therapy Exit", - "description": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", - "text": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - } - ], - "estimands": [ - { - "id": "Estimand_1", - "extensionAttributes": [], - "name": "Estimand for Progression-Free Survival (PFS)", - "label": "Primary Estimand", - "description": "Comparison of PFS between fulvestrant plus everolimus versus fulvestrant plus placebo in AI-resistant HR+ metastatic breast cancer. Constructed retrospectively per ICH E9(R1); this protocol predates the 2019 addendum.", - "populationSummary": "Post-menopausal women with HR+ (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy; ECOG PS 0-1; no prior mTOR inhibitor; up to one prior systemic chemotherapy for metastatic disease. Randomized 1:1; approximately 120 eligible patients.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_1", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_1", - "extensionAttributes": [], - "name": "Death before documented progression", - "label": "Death before documented progression", - "description": null, - "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", - "strategy": "Composite: death is included as a PFS event (composite endpoint definition per \u00a76.1.6). The time-to-event variable captures whichever occurs first: progression or death.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_2", - "extensionAttributes": [], - "name": "Discontinuation of everolimus due to toxicity", - "label": "Discontinuation of everolimus due to toxicity", - "description": null, - "text": "Patient permanently discontinues everolimus or placebo due to an adverse event but continues on fulvestrant monotherapy.", - "strategy": "Treatment-policy: patient remains on study and continues fulvestrant alone per \u00a75.5. Follow-up for progression and survival continues. PFS events occurring after everolimus discontinuation are included in the primary analysis regardless of treatment status.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_3", - "extensionAttributes": [], - "name": "Withdrawal of consent or loss to follow-up", - "label": "Withdrawal of consent or loss to follow-up", - "description": null, - "text": "Patient withdraws consent or is lost to follow-up before a PFS event is documented.", - "strategy": "Hypothetical (censoring): patient is censored at the date of last tumor assessment. The estimand implicitly assumes non-informative censoring \u2014 that censored patients would have experienced events at the same rate as those who remained in follow-up.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_4", - "extensionAttributes": [], - "name": "Initiation of prohibited anti-cancer therapy before progression", - "label": "Initiation of prohibited anti-cancer therapy before progression", - "description": null, - "text": "Patient receives a prohibited anti-cancer agent before disease progression is documented.", - "strategy": "Treatment-policy: protocol prohibits new anti-cancer agents before progression (\u00a75.3.4). If such a violation occurred, the patient would remain in the analysis with events counted as observed. No censoring at time of prohibited therapy initiation is specified.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_2", - "extensionAttributes": [], - "name": "Estimand for Overall Survival (OS)", - "label": "Secondary Estimand \u2014 OS", - "description": "Comparison of overall survival between treatment arms. Descriptive; no pre-specified alpha or power.", - "populationSummary": "All randomized eligible patients (same as PFS estimand population).", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_2", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_5", - "extensionAttributes": [], - "name": "Discontinuation of study treatment (any reason)", - "label": "Discontinuation of study treatment (any reason)", - "description": null, - "text": "Patient permanently discontinues all study treatment due to disease progression, toxicity, or other reasons.", - "strategy": "Treatment-policy: all patients who discontinue treatment are followed for survival per \u00a75.5. Deaths after treatment cessation are counted as OS events regardless of reason for discontinuation.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_6", - "extensionAttributes": [], - "name": "Initiation of subsequent anti-cancer therapy after progression", - "label": "Initiation of subsequent anti-cancer therapy after progression", - "description": null, - "text": "Patient initiates a new anti-cancer regimen after disease progression on study treatment.", - "strategy": "Treatment-policy: OS reflects real-world outcome including the effect of any subsequent therapies. No censoring or adjustment for post-progression treatment is specified.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_7", - "extensionAttributes": [], - "name": "Withdrawal of consent or loss to follow-up", - "label": "Withdrawal of consent or loss to follow-up", - "description": null, - "text": "Patient withdraws consent or cannot be contacted for survival follow-up.", - "strategy": "Hypothetical (censoring): patient is censored at date of last known alive contact. Non-informative censoring assumed.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_3", - "extensionAttributes": [], - "name": "Estimand for Time to Progression (TTP)", - "label": "Secondary Estimand \u2014 TTP", - "description": "Comparison of time to disease progression, excluding deaths as events. Descriptive.", - "populationSummary": "All randomized eligible patients (same as PFS estimand population).", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_3", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_8", - "extensionAttributes": [], - "name": "Death before documented progression", - "label": "Death before documented progression", - "description": null, - "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", - "strategy": "Hypothetical (censoring): death without prior progression results in censoring at time of death. This reflects the hypothetical question 'what would the time to progression have been if the patient had not died?' \u2014 the key mechanistic distinction from the PFS estimand.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_9", - "extensionAttributes": [], - "name": "Discontinuation of study treatment", - "label": "Discontinuation of study treatment (any reason)", - "description": null, - "text": "Patient permanently discontinues study treatment before disease progression.", - "strategy": "Treatment-policy: follow-up for progression continues after treatment discontinuation per \u00a75.5. TTP events occurring after treatment cessation are included.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_4", - "extensionAttributes": [], - "name": "Estimand for Objective Response Rate (ORR)", - "label": "Secondary Estimand \u2014 ORR", - "description": "Between-arm comparison of the proportion of patients achieving confirmed CR or PR in patients with measurable disease. Descriptive.", - "populationSummary": "Subset of randomized eligible patients with at least one measurable lesion at baseline per RECIST v1.1.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_4", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_10", - "extensionAttributes": [], - "name": "Death or progression before first response assessment", - "label": "Death or progression before first response assessment", - "description": null, - "text": "Patient dies or has documented progression before achieving CR or PR at any post-baseline tumor assessment.", - "strategy": "Composite: patients who die or progress without ever achieving a confirmed CR or PR are counted as non-responders in the ORR denominator.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_11", - "extensionAttributes": [], - "name": "Treatment discontinuation before response assessment", - "label": "Treatment discontinuation before response assessment", - "description": null, - "text": "Patient discontinues all study treatment before a post-baseline tumor assessment confirming CR or PR.", - "strategy": "Treatment-policy: patients who discontinue without a prior confirmed response are counted as non-responders. No censoring at time of treatment discontinuation.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_5", - "extensionAttributes": [], - "name": "Estimand for Clinical Benefit Rate (CBR)", - "label": "Secondary Estimand \u2014 CBR", - "description": "Between-arm comparison of the proportion of patients with CR, PR, or SD maintained for at least 6 months. Descriptive.", - "populationSummary": "All randomized eligible patients including those with measurable and non-measurable disease.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_5", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_12", - "extensionAttributes": [], - "name": "Death or progression before 6-month stable disease threshold", - "label": "Death or progression before 6-month stable disease threshold", - "description": null, - "text": "Patient dies or has documented progression before 6 months of confirmed stable disease, partial response, or complete response.", - "strategy": "Composite: patients who do not achieve and maintain CR, PR, or SD for at least 6 months are counted as not deriving clinical benefit, regardless of cause.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_13", - "extensionAttributes": [], - "name": "Treatment discontinuation before 6-month landmark", - "label": "Treatment discontinuation before 6-month landmark", - "description": null, - "text": "Patient discontinues study treatment before the 6-month landmark required for SD to qualify as clinical benefit.", - "strategy": "Treatment-policy: patients who discontinue and lack tumor assessment confirming \u22656 months of SD are counted as non-responders for CBR.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_6", - "extensionAttributes": [], - "name": "Estimand for Safety and Tolerability", - "label": "Secondary Estimand \u2014 Safety", - "description": "Descriptive characterization of the incidence and severity of adverse events in the safety-evaluable population. No formal hypothesis test.", - "populationSummary": "All patients who received at least one dose of any study treatment. Approximately 65 patients per arm.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_6", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_14", - "extensionAttributes": [], - "name": "Treatment discontinuation", - "label": "Treatment discontinuation", - "description": null, - "text": "Patient permanently discontinues study treatment. AE collection continues for 30 days after last dose of any study drug per \u00a75.5.", - "strategy": "While-on-treatment: TEAEs are collected only during the treatment period and the 30-day post-treatment follow-up window. Adverse events occurring beyond this window are not captured as TEAEs in the primary safety analysis.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_15", - "extensionAttributes": [], - "name": "Dose reduction or interruption of everolimus", - "label": "Dose reduction or interruption of everolimus", - "description": null, - "text": "Patient undergoes dose modification (reduction or temporary interruption) of everolimus or placebo per protocol dose-modification rules.", - "strategy": "Treatment-policy: AEs that prompt dose modification are recorded regardless of the modification. Events are attributed to the randomized treatment arm and included in the safety summary as observed.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - } - ], - "indications": [ - { - "id": "Indication_1", - "extensionAttributes": [], - "name": "Hormone Receptor-Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", - "label": "HR+ AI-Resistant Metastatic Breast Cancer", - "description": "Post-menopausal women with hormone-receptor positive (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy, defined as relapse while receiving adjuvant AI or progressive disease while receiving an AI for metastatic disease.", - "isRareDisease": false, - "codes": [ - { - "id": "Code_7947", - "extensionAttributes": [], - "code": "C9246", - "codeSystem": "http://ncithesaurus.nci.nih.gov", - "codeSystemVersion": "24.04e", - "decode": "Hormone Receptor-Positive Breast Carcinoma", - "instanceType": "Code" - }, - { - "id": "Code_7948", - "extensionAttributes": [], - "code": "C7771", - "codeSystem": "http://ncithesaurus.nci.nih.gov", - "codeSystemVersion": "24.04e", - "decode": "Metastatic Breast Carcinoma", - "instanceType": "Code" - } - ], - "notes": [], - "instanceType": "Indication" - } - ], - "studyInterventionIds": [ - "StudyIntervention_3", - "StudyIntervention_4", - "StudyIntervention_5" - ], - "objectives": [ - { - "id": "Objective_1", - "extensionAttributes": [], - "name": "Primary Objective", - "label": "Primary Objective", - "description": "To assess progression-free survival in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone.", - "text": "", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2355", - "extensionAttributes": [], - "code": "C85826", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C85826", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_1", - "extensionAttributes": [], - "name": "Progression-Free Survival (PFS)", - "label": "Progression-Free Survival (PFS)", - "description": "Time from randomization to documented disease progression or death, whichever occurs first. Subjects who have neither progressed nor died are censored at the date of last tumor assessment. Disease progression assessed per RECIST v1.1.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To demonstrate that the addition of everolimus to fulvestrant improves PFS compared to fulvestrant plus placebo (hypothesized median PFS improvement from 5.4 to 9.2 months; HR \u2248 0.59).", - "level": { - "id": "Code_2356", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_2", - "extensionAttributes": [], - "name": "Secondary Objective", - "label": "Secondary Objective", - "description": "To describe the safety profile, objective response rate, time to progression, and overall survival in this patient population.", - "text": "", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2357", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_2", - "extensionAttributes": [], - "name": "Overall Survival (OS)", - "label": "Overall Survival (OS)", - "description": "Time from randomization until death from any cause. Subjects alive at the time of analysis are censored at the date of last follow-up.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To characterize overall survival in the two treatment arms.", - "level": { - "id": "Code_2358", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_3", - "extensionAttributes": [], - "name": "Time to Progression (TTP)", - "label": "Time to Progression (TTP)", - "description": "Time from randomization until objective disease progression per RECIST v1.1. Unlike PFS, deaths without prior progression are not counted as events (subjects are censored at time of death).", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To estimate and compare median time to disease progression between treatment arms.", - "level": { - "id": "Code_2359", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_4", - "extensionAttributes": [], - "name": "Objective Response Rate (ORR)", - "label": "Objective Response Rate (ORR)", - "description": "Proportion of patients with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1. Assessed in patients with measurable disease at baseline.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To compare the proportion of patients achieving an objective tumor response between treatment arms.", - "level": { - "id": "Code_2360", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_5", - "extensionAttributes": [], - "name": "Clinical Benefit Rate (CBR)", - "label": "Clinical Benefit Rate (CBR)", - "description": "Proportion of patients with stable disease (SD) for \u22656 months, partial response (PR), or complete response (CR) \u2014 i.e., CR + PR + SD \u2265 6 months \u2014 per RECIST v1.1.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To compare the proportion of patients deriving clinical benefit (response or prolonged stable disease) between treatment arms.", - "level": { - "id": "Code_2361", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_6", - "extensionAttributes": [], - "name": "Safety and Tolerability", - "label": "Safety and Tolerability", - "description": "Incidence, severity (CTCAE v4.0 grade), and type of adverse events, including overall toxicity, grade 3\u20134 toxicities, serious adverse events (SAEs), and second primary cancers. Assessed in all patients who received at least one dose of study treatment.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To characterize and compare the safety profile of fulvestrant plus everolimus versus fulvestrant plus placebo.", - "level": { - "id": "Code_2362", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - } - ], - "population": { - "id": "StudyDesignPopulation_1", - "extensionAttributes": [], - "name": "Population_1", - "label": null, - "description": null, - "includesHealthySubjects": false, - "plannedEnrollmentNumber": null, - "plannedCompletionNumber": null, - "plannedSex": [], - "criterionIds": [], - "plannedAge": null, - "notes": [], - "cohorts": [], - "instanceType": "StudyDesignPopulation" - }, - "scheduleTimelines": [ - { - "id": "ScheduleTimeline_1", - "extensionAttributes": [], - "name": "MAIN_TIMELINE", - "label": "PrE0102 Main Schedule of Activities Timeline", - "description": "Main timeline spanning Screening, Induction (max 12 x 28-day cycles), Continuation and Follow-Up.", - "mainTimeline": true, - "entryCondition": "Patient randomized 1:1 to Arm A (fulvestrant + everolimus) or Arm B (fulvestrant + placebo).", - "entryId": "ScheduledActivityInstance_1", - "exits": [], - "timings": [ - { - "id": "Timing_1", - "extensionAttributes": [], - "name": "C1D1_ANCHOR", - "label": "Cycle 1 Day 1 (anchor)", - "description": "Cycle 1 Day 1 (anchor)", - "type": { - "id": "Code_10080", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "P0D", - "valueLabel": "Day 1", - "relativeToFrom": { - "id": "Code_10081", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_2", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_2", - "extensionAttributes": [], - "name": "SCREEN_WINDOW", - "label": "Within 4 weeks before C1D1", - "description": "Within 4 weeks before C1D1", - "type": { - "id": "Code_10082", - "extensionAttributes": [], - "code": "C201357", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Before", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "Up to 28 days before", - "relativeToFrom": { - "id": "Code_10083", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_1", - "windowLower": "P0D", - "windowUpper": "P28D", - "windowLabel": "<= 4 weeks before C1D1", - "instanceType": "Timing" - }, - { - "id": "Timing_3", - "extensionAttributes": [], - "name": "C1D15_OFFSET", - "label": "14 days after C1D1", - "description": "14 days after C1D1", - "type": { - "id": "Code_10084", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P14D", - "valueLabel": "Day 15", - "relativeToFrom": { - "id": "Code_10085", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_4", - "extensionAttributes": [], - "name": "C2D1_OFFSET", - "label": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", - "description": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", - "type": { - "id": "Code_10086", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10087", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_4", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_5", - "extensionAttributes": [], - "name": "C3D1_OFFSET", - "label": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", - "description": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", - "type": { - "id": "Code_10088", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10089", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_4", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_5", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_6", - "extensionAttributes": [], - "name": "C4D1_OFFSET", - "label": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", - "description": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", - "type": { - "id": "Code_10090", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10091", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_5", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_6", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_7", - "extensionAttributes": [], - "name": "C5D1_OFFSET", - "label": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", - "description": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", - "type": { - "id": "Code_10092", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10093", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_6", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_7", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_8", - "extensionAttributes": [], - "name": "C6D1_OFFSET", - "label": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", - "description": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", - "type": null, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10094", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_7", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_8", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_9", - "extensionAttributes": [], - "name": "C7D1_OFFSET", - "label": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", - "description": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", - "type": null, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10095", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_8", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_9", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_10", - "extensionAttributes": [], - "name": "C8D1_OFFSET", - "label": "Cycle 8 Day 1 (28 days after Cycle 7 Day 1)", - "description": "Cycle 8 Day 1 (28 days after Cycle 7 Day 1)", - "type": { - "id": "Code_10096", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10097", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_9", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_10", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_11", - "extensionAttributes": [], - "name": "C9D1_OFFSET", - "label": "Cycle 9 Day 1 (28 days after Cycle 8 Day 1)", - "description": "Cycle 9 Day 1 (28 days after Cycle 8 Day 1)", - "type": { - "id": "Code_10098", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10099", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_10", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_11", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_12", - "extensionAttributes": [], - "name": "C10D1_OFFSET", - "label": "Cycle 10 Day 1 (28 days after Cycle 9 Day 1)", - "description": "Cycle 10 Day 1 (28 days after Cycle 9 Day 1)", - "type": { - "id": "Code_10100", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10101", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_11", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_12", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_13", - "extensionAttributes": [], - "name": "C11D1_OFFSET", - "label": "Cycle 11 Day 1 (28 days after Cycle 10 Day 1)", - "description": "Cycle 11 Day 1 (28 days after Cycle 10 Day 1)", - "type": { - "id": "Code_10102", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10103", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_12", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_13", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_14", - "extensionAttributes": [], - "name": "C12D1_OFFSET", - "label": "Cycle 12 Day 1 (28 days after Cycle 11 Day 1)", - "description": "Cycle 12 Day 1 (28 days after Cycle 11 Day 1)", - "type": { - "id": "Code_10104", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10105", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_13", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_14", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_15", - "extensionAttributes": [], - "name": "EOI_OFFSET", - "label": "End of Induction", - "description": "End of Induction", - "type": { - "id": "Code_10106", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P30D", - "valueLabel": "within 30 days of last dose", - "relativeToFrom": { - "id": "Code_10107", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_14", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_15", - "windowLower": "P0D", - "windowUpper": "P30D", - "windowLabel": "within 30 days of last fulvestrant dose", - "instanceType": "Timing" - }, - { - "id": "Timing_16", - "extensionAttributes": [], - "name": "CONT_OFFSET", - "label": "Continuation Day 1", - "description": "Continuation Day 1", - "type": { - "id": "Code_10108", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "D29 after last Cycle 12 dose", - "relativeToFrom": { - "id": "Code_10109", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_14", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_16", - "windowLower": "-P7D", - "windowUpper": "P7D", - "windowLabel": "+/- 1 week", - "instanceType": "Timing" - }, - { - "id": "Timing_17", - "extensionAttributes": [], - "name": "FU_OFFSET", - "label": "Every 3 months follow-up", - "description": "Every 3 months follow-up", - "type": { - "id": "Code_10110", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P84D", - "valueLabel": "Every 3 months (12 weeks)", - "relativeToFrom": { - "id": "Code_10111", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_16", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_17", - "windowLower": "-P7D", - "windowUpper": "P7D", - "windowLabel": "+/- 1 week", - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_1", - "extensionAttributes": [], - "name": "SAI_PRESTUDY", - "label": "Pre-Study", - "description": "Pre-Study", - "defaultConditionId": "ScheduledActivityInstance_2", - "epochId": "StudyEpoch_1", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_1" - }, - { - "id": "ScheduledActivityInstance_2", - "extensionAttributes": [], - "name": "SAI_C1D1", - "label": "Cycle 1 Day 1", - "description": "Cycle 1 Day 1", - "defaultConditionId": "ScheduledActivityInstance_3", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_2" - }, - { - "id": "ScheduledActivityInstance_3", - "extensionAttributes": [], - "name": "SAI_C1D15", - "label": "Cycle 1 Day 15", - "description": "Cycle 1 Day 15", - "defaultConditionId": "ScheduledActivityInstance_4", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_3" - }, - { - "id": "ScheduledActivityInstance_4", - "extensionAttributes": [], - "name": "SAI_C2D1", - "label": "Cycle 2 Day 1", - "description": "Cycle 2 Day 1", - "defaultConditionId": "ScheduledActivityInstance_5", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_4" - }, - { - "id": "ScheduledActivityInstance_5", - "extensionAttributes": [], - "name": "SAI_C3D1", - "label": "Cycle 3 Day 1", - "description": "Cycle 3 Day 1", - "defaultConditionId": "ScheduledActivityInstance_6", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_5" - }, - { - "id": "ScheduledActivityInstance_6", - "extensionAttributes": [], - "name": "SAI_C4D1", - "label": "Cycle 4 Day 1", - "description": "Cycle 4 Day 1", - "defaultConditionId": "ScheduledActivityInstance_7", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_6" - }, - { - "id": "ScheduledActivityInstance_7", - "extensionAttributes": [], - "name": "SAI_C5D1", - "label": "Cycle 5 Day 1", - "description": "Cycle 5 Day 1", - "defaultConditionId": "ScheduledActivityInstance_8", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_7" - }, - { - "id": "ScheduledActivityInstance_8", - "extensionAttributes": [], - "name": "SAI_C6D1", - "label": "Cycle 6 Day 1", - "description": "Cycle 6 Day 1", - "defaultConditionId": "ScheduledActivityInstance_9", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_8" - }, - { - "id": "ScheduledActivityInstance_9", - "extensionAttributes": [], - "name": "SAI_C7D1", - "label": "Cycle 7 Day 1", - "description": "Cycle 7 Day 1", - "defaultConditionId": "ScheduledActivityInstance_10", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_9" - }, - { - "id": "ScheduledActivityInstance_10", - "extensionAttributes": [], - "name": "SAI_C8D1", - "label": "Cycle 8 Day 1", - "description": "Cycle 8 Day 1", - "defaultConditionId": "ScheduledActivityInstance_11", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_10" - }, - { - "id": "ScheduledActivityInstance_11", - "extensionAttributes": [], - "name": "SAI_C9D1", - "label": "Cycle 9 Day 1", - "description": "Cycle 9 Day 1", - "defaultConditionId": "ScheduledActivityInstance_12", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_11" - }, - { - "id": "ScheduledActivityInstance_12", - "extensionAttributes": [], - "name": "SAI_C10D1", - "label": "Cycle 10 Day 1", - "description": "Cycle 10 Day 1", - "defaultConditionId": "ScheduledActivityInstance_13", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_12" - }, - { - "id": "ScheduledActivityInstance_13", - "extensionAttributes": [], - "name": "SAI_C11D1", - "label": "Cycle 11 Day 1", - "description": "Cycle 11 Day 1", - "defaultConditionId": "ScheduledActivityInstance_14", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_13" - }, - { - "id": "ScheduledActivityInstance_14", - "extensionAttributes": [], - "name": "SAI_C12D1", - "label": "Cycle 12 Day 1", - "description": "Cycle 12 Day 1", - "defaultConditionId": "ScheduledActivityInstance_15", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_14" - }, - { - "id": "ScheduledActivityInstance_15", - "extensionAttributes": [], - "name": "SAI_EOI", - "label": "End of Induction / End of Treatment", - "description": "End of Induction / End of Treatment", - "defaultConditionId": "ScheduledDecisionInstance_1", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_15" - }, - { - "id": "ScheduledActivityInstance_16", - "extensionAttributes": [], - "name": "SAI_CONT", - "label": "Continuation Phase Cycle Day 1", - "description": "Continuation Phase Cycle Day 1", - "defaultConditionId": "ScheduledDecisionInstance_2", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_16" - }, - { - "id": "ScheduledActivityInstance_17", - "extensionAttributes": [], - "name": "SAI_FU", - "label": "Follow-Up Off-Therapy", - "description": "Follow-Up Off-Therapy", - "defaultConditionId": null, - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_17" - }, - { - "id": "ScheduledDecisionInstance_1", - "extensionAttributes": [], - "name": "SDI_END_INDUCTION", - "label": "Decision: End of Induction (unblinding)", - "description": "Decision: End of Induction (unblinding)", - "defaultConditionId": "ScheduledActivityInstance_17", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [ - { - "id": "Condition_1", - "extensionAttributes": [], - "condition": "No evidence of disease progression after 12 cycles of Induction: patient is unblinded and proceeds to the Continuation Phase.", - "conditionTargetId": "ScheduledActivityInstance_16", - "instanceType": "Condition" - }, - { - "id": "Condition_2", - "extensionAttributes": [], - "condition": "Disease progression or unacceptable toxicity (or other discontinuation per Sections 5.5/5.6): patient moves to Follow-Up Off-Therapy.", - "conditionTargetId": "ScheduledActivityInstance_17", - "instanceType": "Condition" - } - ] - }, - { - "id": "ScheduledDecisionInstance_2", - "extensionAttributes": [], - "name": "SDI_CONTINUATION", - "label": "Decision: Continuation Phase progression check", - "description": "Decision: Continuation Phase progression check", - "defaultConditionId": "ScheduledActivityInstance_16", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [ - { - "id": "Condition_3", - "extensionAttributes": [], - "condition": "No documented progression and no unacceptable toxicity: continue treatment with the next Continuation cycle (this visit repeats; the protocol sets no fixed Continuation cycle count).", - "conditionTargetId": "ScheduledActivityInstance_16", - "instanceType": "Condition" - }, - { - "id": "Condition_4", - "extensionAttributes": [], - "condition": "Documented disease progression or unacceptable toxicity: patient moves to Follow-Up Off-Therapy.", - "conditionTargetId": "ScheduledActivityInstance_17", - "instanceType": "Condition" - } - ] - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - } - ], - "biospecimenRetentions": [], - "documentVersionIds": [], - "eligibilityCriteria": [], - "analysisPopulations": [], - "notes": [], - "subTypes": [], - "model": { - "id": "Code_StudyDesignModel", - "extensionAttributes": [], - "code": "", - "codeSystem": "", - "codeSystemVersion": "", - "decode": "", - "instanceType": "Code" - }, - "intentTypes": [], - "blindingSchema": null, - "instanceType": "InterventionalStudyDesign" - } - ], - "titles": [ - { - "id": "StudyTitle_1", - "extensionAttributes": [], - "text": "Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", - "type": { - "id": "Code_8497", - "extensionAttributes": [], - "code": "C207616", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Official Study Title", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - } - ], - "documentVersionIds": [], - "dateValues": [], - "amendments": [], - "organizations": [ - { - "id": "Organization_1", - "extensionAttributes": [], - "name": "PrECOG, LLC", - "label": "PrECOG", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_7949", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_1", - "extensionAttributes": [], - "text": "PrECOG, LLC, 1818 Market Street, Suite 1100, Philadelphia, PA 19103", - "lines": [ - "1818 Market Street", - "Suite 1100" - ], - "city": "Philadelphia", - "district": null, - "state": "PA", - "postalCode": "19103", - "country": { - "id": "Code_7950", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_2", - "extensionAttributes": [], - "name": "Novartis Pharmaceuticals Corporation", - "label": "Novartis", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_7951", - "extensionAttributes": [], - "code": "C25392", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Manufacturer", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_2", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_7952", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_3", - "extensionAttributes": [], - "name": "clinicaltrials.gov", - "label": "clinicaltrials.gov", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_9956", - "extensionAttributes": [], - "code": "C188863", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Regulatory Agency", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_3", - "extensionAttributes": [], - "text": "National Library of Medicine\n8600 Rockville Pike, Bethesda, MD 20894", - "lines": [ - "National Library of Medicine", - "8600 Rockville Pike" - ], - "city": "Bethesda", - "district": null, - "state": "MD", - "postalCode": "20894", - "country": { - "id": "Code_9957", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_4", - "extensionAttributes": [], - "name": "VendorLab1", - "label": "Vendor1", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_9958", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_4", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_9959", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_5", - "extensionAttributes": [], - "name": "VendorLab2", - "label": "Vendor2", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_9961", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_5", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_9962", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - } - ], - "roles": [ - { - "id": "StudyRole_1", - "extensionAttributes": [], - "name": "Clinical Study Sponsor", - "label": "Clinical Study Sponsor", - "description": "PrECOG, LLC serves as the clinical study sponsor and coordinating group for this investigator-initiated trial.", - "code": { - "id": "Code_8489", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_2", - "extensionAttributes": [], - "name": "Study Chair", - "label": "Study Chair", - "description": null, - "code": { - "id": "Code_9716", - "extensionAttributes": [], - "code": "C19924", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Principal Investigator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_1", - "extensionAttributes": [], - "name": "Noah Kornblum", - "label": null, - "description": null, - "personName": { - "id": "PersonName_1", - "extensionAttributes": [], - "text": null, - "familyName": "Kornblum", - "givenNames": [ - "Noah" - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "MD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Study Chair", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_3", - "extensionAttributes": [], - "name": "Study Co-Chair", - "label": "Study Co-Chair", - "description": null, - "code": { - "id": "Code_9717", - "extensionAttributes": [], - "code": "C25936", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Investigator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_2", - "extensionAttributes": [], - "name": "Joseph A. Sparano", - "label": null, - "description": null, - "personName": { - "id": "PersonName_2", - "extensionAttributes": [], - "text": null, - "familyName": "Sparano", - "givenNames": [ - "Joseph", - "A." - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "MD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Study Co-Chair", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_4", - "extensionAttributes": [], - "name": "Medical Monitor", - "label": "Medical Monitor", - "description": null, - "code": { - "id": "Code_9718", - "extensionAttributes": [], - "code": "C51876", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Sponsor Medical Expert", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_3", - "extensionAttributes": [], - "name": "Katherine M. Smith", - "label": null, - "description": null, - "personName": { - "id": "PersonName_3", - "extensionAttributes": [], - "text": null, - "familyName": "Smith", - "givenNames": [ - "Katherine", - "M." - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "MD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Medical Monitor", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_5", - "extensionAttributes": [], - "name": "Study Statistician", - "label": "Study Statistician", - "description": null, - "code": { - "id": "Code_9719", - "extensionAttributes": [], - "code": "C51877", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Statistician", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_4", - "extensionAttributes": [], - "name": "Judi Manola", - "label": null, - "description": null, - "personName": { - "id": "PersonName_4", - "extensionAttributes": [], - "text": null, - "familyName": "Manola", - "givenNames": [ - "Judi" - ], - "prefixes": [], - "suffixes": [ - "MS" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Study Statistician", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_6", - "extensionAttributes": [], - "name": "Study Contact", - "label": "Study Contact", - "description": null, - "code": { - "id": "Code_9720", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_5", - "extensionAttributes": [], - "name": "Carolyn Andrews", - "label": null, - "description": null, - "personName": { - "id": "PersonName_5", - "extensionAttributes": [], - "text": null, - "familyName": "Andrews", - "givenNames": [ - "Carolyn" - ], - "prefixes": [], - "suffixes": [ - "RN" - ], - "instanceType": "PersonName" - }, - "jobTitle": "PrECOG Study Contact", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_7", - "extensionAttributes": [], - "name": "Investigational Product Manufacturer", - "label": "Investigational Product Manufacturer", - "description": "Novartis Pharmaceuticals Corporation supplies everolimus and matching placebo for the study.", - "code": { - "id": "Code_9714", - "extensionAttributes": [], - "code": "C25392", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Manufacturer", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_2" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_8", - "extensionAttributes": [], - "name": "Pharmacovigilance Group", - "label": "Pharmacovigilance Group", - "description": "Novartis Pharmaceuticals Drug Safety and Epidemiology Department (DS&E). Receives SAE notifications from PrECOG within 24 hours of awareness date.", - "code": { - "id": "Code_9715", - "extensionAttributes": [], - "code": "C215673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Pharmacovigilance Group", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_2" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_9", - "extensionAttributes": [], - "name": "Primary Data Manager", - "label": "Primary Data Manager", - "description": null, - "code": { - "id": "Code_9963", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_6", - "extensionAttributes": [], - "name": "Valerie S", - "label": null, - "description": null, - "personName": { - "id": "PersonName_6", - "extensionAttributes": [], - "text": null, - "familyName": "G", - "givenNames": [ - "Valerie" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Primary Data Manager", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_10", - "extensionAttributes": [], - "name": "Secondary Data Manager", - "label": "Secondary Data Manager", - "description": null, - "code": { - "id": "Code_9964", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_7", - "extensionAttributes": [], - "name": "Patrick G", - "label": null, - "description": null, - "personName": { - "id": "PersonName_7", - "extensionAttributes": [], - "text": null, - "familyName": "G", - "givenNames": [ - "Patrick" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Secondary Data Manager", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_11", - "extensionAttributes": [], - "name": "Data Acquisition Lead", - "label": "Data Acquisition Lead", - "description": null, - "code": { - "id": "Code_9965", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_4" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_8", - "extensionAttributes": [], - "name": "Eva J", - "label": null, - "description": null, - "personName": { - "id": "PersonName_8", - "extensionAttributes": [], - "text": null, - "familyName": "J", - "givenNames": [ - "Eva" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Data Acquisition Lead", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_12", - "extensionAttributes": [], - "name": "Data Acquisition Lead", - "label": "Data Acquisition Lead", - "description": null, - "code": { - "id": "Code_9966", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_5" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_9", - "extensionAttributes": [], - "name": "Melissa T", - "label": null, - "description": null, - "personName": { - "id": "PersonName_9", - "extensionAttributes": [], - "text": null, - "familyName": "T", - "givenNames": [ - "Melissa" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Data Acquisition Lead", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - } - ], - "studyInterventions": [ - { - "id": "StudyIntervention_3", - "extensionAttributes": [], - "name": "Fulvestrant + Everolimus (Arm A)", - "label": "Fulvestrant + Everolimus", - "description": "Fulvestrant 500 mg IM on Day 1 of each 28-day cycle (Day 1 and 15 of Cycle 1 only) plus Everolimus 10 mg orally once daily.", - "role": { - "id": "Code_10033", - "extensionAttributes": [], - "code": "C41161", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Experimental Intervention", - "instanceType": "Code" - }, - "type": { - "id": "Code_10034", - "extensionAttributes": [], - "code": "C54696", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Combination Product", - "instanceType": "Code" - }, - "minimumResponseDuration": null, - "codes": [], - "administrations": [], - "notes": [], - "instanceType": "StudyIntervention" - }, - { - "id": "StudyIntervention_4", - "extensionAttributes": [], - "name": "Fulvestrant + Placebo (Arm B)", - "label": "Fulvestrant + Placebo", - "description": "Fulvestrant 500 mg IM on Day 1 of each 28-day cycle (Day 1 and 15 of Cycle 1 only) plus matching oral placebo once daily.", - "role": { - "id": "Code_10036", - "extensionAttributes": [], - "code": "C68609", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Active Comparator", - "instanceType": "Code" - }, - "type": { - "id": "Code_10037", - "extensionAttributes": [], - "code": "C54696", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Combination Product", - "instanceType": "Code" - }, - "minimumResponseDuration": null, - "codes": [], - "administrations": [], - "notes": [], - "instanceType": "StudyIntervention" - }, - { - "id": "StudyIntervention_5", - "extensionAttributes": [], - "name": "Fulvestrant", - "label": "Fulvestrant", - "description": "Fulvestrant administered on its own in Continuation Phase minus the placebo. Indicates subject PFS while on Fulvestrant + Placebo treatment arm (ARM B).", - "role": { - "id": "Code_10112", - "extensionAttributes": [], - "code": "C41161", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Experimental Intervention", - "instanceType": "Code" - }, - "type": { - "id": "Code_10113", - "extensionAttributes": [], - "code": "C1909", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Pharmacologic Substance", - "instanceType": "Code" - }, - "minimumResponseDuration": null, - "codes": [], - "administrations": [], - "notes": [], - "instanceType": "StudyIntervention" - } - ], - "businessTherapeuticAreas": [], - "biomedicalConcepts": [ - { - "id": "BiomedicalConcept_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_1", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Informed Consent", - "label": "Informed Consent", - "synonyms": [ - "Informed Consent Obtained" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [], - "code": { - "id": "AliasCode_1", - "extensionAttributes": [], - "standardCode": { - "id": "Code_8", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_2", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_2", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ELIGMET", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Eligibility Criteria Met By Subject", - "label": "Eligibility Criteria Met By Subject", - "synonyms": [ - "Eligibility Criteria Met" - ], - "reference": "/mdr/bc/biomedicalconcepts/C132447", - "properties": [], - "code": { - "id": "AliasCode_6", - "extensionAttributes": [], - "standardCode": { - "id": "Code_13", - "extensionAttributes": [], - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Eligibility Criteria Met By Subject", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_3", - "extensionAttributes": [], - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "synonyms": [ - "MHYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C85522", - "properties": [], - "code": { - "id": "AliasCode_11", - "extensionAttributes": [], - "standardCode": { - "id": "Code_18", - "extensionAttributes": [], - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_4", - "extensionAttributes": [], - "name": "Medical History Reported Term [RETIRED]", - "label": "Medical History Reported Term [RETIRED]", - "synonyms": [ - "Medical History", - "MHTERM" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83118", - "properties": [], - "code": { - "id": "AliasCode_12", - "extensionAttributes": [], - "standardCode": { - "id": "Code_19", - "extensionAttributes": [], - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_5", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_3", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ECOG101", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECOG - Performance Status", - "label": "ECOG - Performance Status", - "synonyms": [ - "ECOG1-Performance Status", - "ECOG101", - "ECOG - Performance Status" - ], - "reference": "/mdr/bc/biomedicalconcepts/C102408", - "properties": [], - "code": { - "id": "AliasCode_13", - "extensionAttributes": [], - "standardCode": { - "id": "Code_20", - "extensionAttributes": [], - "code": "C102408", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG - Performance Status", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_6", - "extensionAttributes": [], - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "code": { - "id": "AliasCode_21", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28", - "extensionAttributes": [], - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_7", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_4", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "synonyms": [ - "SYSBP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [], - "code": { - "id": "AliasCode_22", - "extensionAttributes": [], - "standardCode": { - "id": "Code_29", - "extensionAttributes": [], - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_8", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_5", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "synonyms": [ - "DIABP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [], - "code": { - "id": "AliasCode_34", - "extensionAttributes": [], - "standardCode": { - "id": "Code_41", - "extensionAttributes": [], - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_9", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_6", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Heart Rate", - "label": "Heart Rate", - "synonyms": [ - "HR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [], - "code": { - "id": "AliasCode_46", - "extensionAttributes": [], - "standardCode": { - "id": "Code_53", - "extensionAttributes": [], - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_10", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_7", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TEMP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Temperature", - "label": "Body Temperature", - "synonyms": [ - "Temperature" - ], - "reference": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [], - "code": { - "id": "AliasCode_5688", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5767", - "extensionAttributes": [], - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Body Temperature", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_11", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_8", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WEIGHT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Weight", - "label": "Body Weight", - "synonyms": [ - "WEIGHT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [], - "code": { - "id": "AliasCode_9354", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10029", - "extensionAttributes": [], - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_18", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_9", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "synonyms": [ - "ALT", - "SGPT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [], - "code": { - "id": "AliasCode_9355", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10030", - "extensionAttributes": [], - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_19", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_10", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "synonyms": [ - "AST", - "SGOT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [], - "code": { - "id": "AliasCode_767", - "extensionAttributes": [], - "standardCode": { - "id": "Code_807", - "extensionAttributes": [], - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_20", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_11", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "synonyms": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [], - "code": { - "id": "AliasCode_768", - "extensionAttributes": [], - "standardCode": { - "id": "Code_808", - "extensionAttributes": [], - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_21", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_12", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "synonyms": [ - "Creatinine" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [], - "code": { - "id": "AliasCode_5689", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5768", - "extensionAttributes": [], - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_22", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_13", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "synonyms": [ - "Albumin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [], - "code": { - "id": "AliasCode_5690", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5769", - "extensionAttributes": [], - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_26", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_14", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "pH", - "label": "pH", - "synonyms": [ - "PH", - "potential of Hydrogen" - ], - "reference": "/mdr/bc/biomedicalconcepts/C45997", - "properties": [], - "code": { - "id": "AliasCode_5691", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5770", - "extensionAttributes": [], - "code": "C45997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "pH", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_27", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_15", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/COLORURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Color Assessment", - "label": "Color Assessment", - "synonyms": [ - "COLOR", - "Color" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [], - "code": { - "id": "AliasCode_9356", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10031", - "extensionAttributes": [], - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_28", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_16", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Specific Gravity", - "label": "Specific Gravity", - "synonyms": [ - "SPGRAV" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [], - "code": { - "id": "AliasCode_5692", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5771", - "extensionAttributes": [], - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_47", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "synonyms": [ - "AEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [], - "code": { - "id": "AliasCode_5693", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5772", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_48", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_17", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Adverse Event", - "label": "Adverse Event", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "code": { - "id": "AliasCode_773", - "extensionAttributes": [], - "standardCode": { - "id": "Code_813", - "extensionAttributes": [], - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_49", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "synonyms": [ - "CMYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [], - "code": { - "id": "AliasCode_5694", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5773", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_50", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_18", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMFREE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "synonyms": [ - "Concomitant Medication" - ], - "reference": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [], - "code": { - "id": "AliasCode_775", - "extensionAttributes": [], - "standardCode": { - "id": "Code_815", - "extensionAttributes": [], - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_51", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_19", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RANDOM", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Randomization", - "label": "Randomization", - "synonyms": [ - "randomization", - "RANDOM", - "Randomized", - "Trial is Randomized", - "randomized" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25196", - "properties": [], - "code": { - "id": "AliasCode_9357", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10032", - "extensionAttributes": [], - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Randomization", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_52", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_20", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Prothrombin Time", - "label": "Prothrombin Time", - "synonyms": [ - "PT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C62656", - "properties": [], - "code": { - "id": "AliasCode_5695", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5774", - "extensionAttributes": [], - "code": "C62656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Prothrombin Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_53", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_21", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/INRBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "International Normalized Ratio of Prothrombin Time", - "label": "International Normalized Ratio of Prothrombin Time", - "synonyms": [ - "INR", - "Prothrombin Intl. Normalized Ratio" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64805", - "properties": [], - "code": { - "id": "AliasCode_5696", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5775", - "extensionAttributes": [], - "code": "C64805", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "International Normalized Ratio of Prothrombin Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_54", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_22", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/APTTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Activated Partial Thromboplastin Time", - "label": "Activated Partial Thromboplastin Time", - "synonyms": [ - "APTT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38462", - "properties": [], - "code": { - "id": "AliasCode_776", - "extensionAttributes": [], - "standardCode": { - "id": "Code_816", - "extensionAttributes": [], - "code": "C38462", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Activated Partial Thromboplastin Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_55", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_23", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "synonyms": [ - "Glucose" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [], - "code": { - "id": "AliasCode_777", - "extensionAttributes": [], - "standardCode": { - "id": "Code_817", - "extensionAttributes": [], - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_56", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_24", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TRIGSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Triglyceride Measurement", - "label": "Triglyceride Measurement", - "synonyms": [ - "TRIG", - "Triglycerides" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64812", - "properties": [], - "code": { - "id": "AliasCode_778", - "extensionAttributes": [], - "standardCode": { - "id": "Code_818", - "extensionAttributes": [], - "code": "C64812", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triglyceride Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_57", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_25", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "synonyms": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [], - "code": { - "id": "AliasCode_534", - "extensionAttributes": [], - "standardCode": { - "id": "Code_574", - "extensionAttributes": [], - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_58", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_26", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HDLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "High Density Lipoprotein Cholesterol Measurement", - "label": "High Density Lipoprotein Cholesterol Measurement", - "synonyms": [ - "HDL", - "HDL Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105587", - "properties": [], - "code": { - "id": "AliasCode_5697", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5776", - "extensionAttributes": [], - "code": "C105587", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "High Density Lipoprotein Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_59", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_27", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/LDLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Low Density Lipoprotein Cholesterol Measurement", - "label": "Low Density Lipoprotein Cholesterol Measurement", - "synonyms": [ - "LDL", - "LDL Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105588", - "properties": [], - "code": { - "id": "AliasCode_7397", - "extensionAttributes": [], - "standardCode": { - "id": "Code_7476", - "extensionAttributes": [], - "code": "C105588", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Low Density Lipoprotein Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_60", - "extensionAttributes": [], - "name": "ECOG Clinical Classification Question", - "label": "ECOG Clinical Classification Question", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C101874", - "properties": [], - "code": { - "id": "AliasCode_779", - "extensionAttributes": [], - "standardCode": { - "id": "Code_819", - "extensionAttributes": [], - "code": "C101874", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG Clinical Classification Question", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_61", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_28", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "synonyms": [ - "WBC", - "White Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [], - "code": { - "id": "AliasCode_5698", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5777", - "extensionAttributes": [], - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_62", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_29", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "synonyms": [ - "RBC", - "Red Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [], - "code": { - "id": "AliasCode_780", - "extensionAttributes": [], - "standardCode": { - "id": "Code_820", - "extensionAttributes": [], - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_63", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_30", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PLATBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Platelet Count", - "label": "Platelet Count", - "synonyms": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [], - "code": { - "id": "AliasCode_5699", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5778", - "extensionAttributes": [], - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_64", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_31", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/KBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "synonyms": [ - "Potassium", - "K" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [], - "code": { - "id": "AliasCode_5700", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5779", - "extensionAttributes": [], - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_65", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_32", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "synonyms": [ - "Sodium", - "NA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [], - "code": { - "id": "AliasCode_5701", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5780", - "extensionAttributes": [], - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_66", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_33", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CLBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "synonyms": [ - "Chloride", - "CL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [], - "code": { - "id": "AliasCode_5702", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5781", - "extensionAttributes": [], - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_67", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_34", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CO2BLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Carbon Dioxide Measurement", - "label": "Carbon Dioxide Measurement", - "synonyms": [ - "Carbon Dioxide", - "CO2" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64545", - "properties": [], - "code": { - "id": "AliasCode_5703", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5782", - "extensionAttributes": [], - "code": "C64545", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Carbon Dioxide Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_68", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_35", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CABLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "synonyms": [ - "Calcium", - "CA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [], - "code": { - "id": "AliasCode_5704", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5783", - "extensionAttributes": [], - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_69", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_36", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "synonyms": [ - "Urea Nitrogen" - ], - "reference": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [], - "code": { - "id": "AliasCode_5705", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5784", - "extensionAttributes": [], - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_70", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_37", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "synonyms": [ - "Protein" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [], - "code": { - "id": "AliasCode_5706", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5785", - "extensionAttributes": [], - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_71", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_38", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "synonyms": [ - "Alkaline Phosphatase" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [], - "code": { - "id": "AliasCode_5707", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5786", - "extensionAttributes": [], - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_72", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_39", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/URATESERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urate Measurement", - "label": "Urate Measurement", - "synonyms": [ - "Urate", - "Uric Acid" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [], - "code": { - "id": "AliasCode_717", - "extensionAttributes": [], - "standardCode": { - "id": "Code_757", - "extensionAttributes": [], - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_73", - "extensionAttributes": [], - "name": "Tumor Size Measurement", - "label": "Tumor Size Measurement", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C106303", - "properties": [], - "code": { - "id": "AliasCode_5708", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5787", - "extensionAttributes": [], - "code": "C106303", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Tumor Size Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_74", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_40", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TUMERGE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Tumor Identification", - "label": "Tumor Identification", - "synonyms": [ - "TUMIDENT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C94523", - "properties": [], - "code": { - "id": "AliasCode_5709", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5788", - "extensionAttributes": [], - "code": "C94523", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identification", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_75", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_41", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NTRGRESP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Response in Non-Target Lesion", - "label": "Response in Non-Target Lesion", - "synonyms": [ - "NTRGRESP", - "Non-Target Response" - ], - "reference": "/mdr/bc/biomedicalconcepts/C94535", - "properties": [], - "code": { - "id": "AliasCode_5710", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5789", - "extensionAttributes": [], - "code": "C94535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Non-Target Lesion", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_76", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_42", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TRGRESP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Response in Target Lesion", - "label": "Response in Target Lesion", - "synonyms": [ - "TRGRESP", - "Target Response" - ], - "reference": "/mdr/bc/biomedicalconcepts/C94534", - "properties": [], - "code": { - "id": "AliasCode_5711", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5790", - "extensionAttributes": [], - "code": "C94534", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Target Lesion", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_77", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_43", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/OVRLRESP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Overall Response", - "label": "Overall Response", - "synonyms": [ - "OVRLRESP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C96613", - "properties": [], - "code": { - "id": "AliasCode_763", - "extensionAttributes": [], - "standardCode": { - "id": "Code_803", - "extensionAttributes": [], - "code": "C96613", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Overall Response", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - } - ], - "bcSurrogates": [ - { - "id": "BiomedicalConceptSurrogate_1", - "extensionAttributes": [], - "name": "Magnesium Measurement", - "label": "Magnesium Measurement (C64840)", - "description": "A quantitative measurement of the amount of magnesium present in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64840", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_2", - "extensionAttributes": [], - "name": "Hepatitis B DNA Measurement", - "label": "Hepatitis B DNA Measurement (C103404)", - "description": "A measurement of the Hepatitis B virus DNA in a biological specimen", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103404", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_3", - "extensionAttributes": [], - "name": "Hepatitis B Surface Antigen", - "label": "Hepatitis B Virus Surface Antigen Measurement (C64850)", - "description": "A measurement of the surface antigen reaction of a biological specimen to the Hepatitis B virus.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64850", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_4", - "extensionAttributes": [], - "name": "HBsAb+", - "label": "Hepatitis B Surface Antibody Positive (C153243)", - "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153243", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_5", - "extensionAttributes": [], - "name": "HBsAb-", - "label": "Hepatitis B Surface Antibody Negative (C153244)", - "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have not been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153244", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_6", - "extensionAttributes": [], - "name": "HCV RNA Positive", - "label": "HCV RNA Positive (C162042)", - "description": "An indication that hepatitis C RNA has been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C162042", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_7", - "extensionAttributes": [], - "name": "PFTs with DLCO", - "label": "Pulmonary function tests (PFTs) that include DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) (C38081)", - "description": "A broad range of tests that are performed to assess how well lungs inhale and exhale air and how efficiently they transfer oxygen into the blood.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38081", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_8", - "extensionAttributes": [], - "name": "Dietary Phosphorus Measurement", - "label": "Dietary Phosphorus Measurement (C184481)", - "description": "A determination of the phosphorus in a nutritional product or meal, or a portion thereof.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C184481", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_19", - "extensionAttributes": [], - "name": "Adherence", - "label": "Adherence (C25729)", - "description": "The act of abiding by a stated treatment plan or protocol.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C25729", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_20", - "extensionAttributes": [], - "name": "Patient Compliance", - "label": "Patient Compliance (C39490)", - "description": "The extent to which a patient conforms to medical advice regarding prescribed regimen, lifestyle, dietary changes, follow-up schedule and other recommendations.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C39490", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_21", - "extensionAttributes": [], - "name": "Compliance Monitoring", - "label": "Compliance Monitoring (C62737)", - "description": "The act of continuously assessing whether an individual is adhering to their treatment plan.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C62737", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_22", - "extensionAttributes": [], - "name": "Non-Compliance With Study Drug", - "label": "Non-Compliance With Study Drug (C49631)", - "description": "An indication that a subject has not agreed with or followed the instructions related to the study medication. (NCI)", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C49631", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_23", - "extensionAttributes": [], - "name": "Non-Compliance with Study Product", - "label": "Non-Compliance with Study Product (C210354)", - "description": "An indication that a subject has not agreed with or followed the instructions related to the study product.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C210354", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_24", - "extensionAttributes": [], - "name": "Trial Compliance", - "label": "Trial Compliance (C142734)", - "description": "Adherence to clinical trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. (ICH)", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C142734", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - } - ], - "bcCategories": [], - "eligibilityCriterionItems": [], - "narrativeContentItems": [ - { - "id": "NarrativeContentItem_1", - "extensionAttributes": [], - "name": "NCI_1", - "text": "

See section 1 Introduction.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_2", - "extensionAttributes": [], - "name": "NCI_1_1", - "text": "
\n

Endocrine therapy represents the foundation of treatment for hormone-receptor\npositive metastatic and locally advanced breast cancer. Multiple compounds in\nvarying classes exist, and those most widely used include the selective estrogen\nreceptor modulators (SERMs), aromatase inhibitors (AIs), and the selective estrogen\nreceptor down-regulators (SERDs). Although the utility of these drugs is well\nestablished, as many as 50% of women with hormone-receptor positive breast cancer\nwill fail to respond to endocrine treatment (de novo resistance). Moreover, those who\ndo respond will inevitably develop acquired resistance.1 Resistance to endocrine\ntherapy remains a serious clinical challenge.\nBasic scientific research into the mechanisms surrounding endocrine therapy\nresistance has been particularly intense in recent years. Advances in this area of\ninvestigation are driving the development of novel treatments and therapeutic\nstrategies. For example, various signal transduction pathways, when activated, have\nbeen demonstrated to allow breast cancer cells to escape the effect of endocrine\ntherapy. The Protein Kinase B (Akt/PKB), a downstream target in the PI3 kinase\nsignaling pathway appears to play a vital role in drug resistance.2 Several studies\nidentify a close association between aberrant Akt signaling and tamoxifen resistance.3\nHigh levels of Akt activity confer resistance to the aromatase inhibitor letrozole and\nthe selective estrogen receptor down-regulator fulvestrant.4 This Akt-induced\nresistance does not appear to be secondary to failure of these agents to inhibit the\nestrogen receptor α activity, but instead may lead to altered cell cycle and apoptotic\nresponse.5 Clinically, Akt/PKB activation in breast cancer appears to predict an\ninferior outcome among patients treated with endocrine therapy.6\nmTOR, mammalian target of rapamycin, is a cytoplasmic protein kinase that acts as a\ncentral regulator of many biological processes involved in cellular proliferation,\nangiogenesis and metabolism. mTOR is a key protein involved in control and\nregulation of the cell’s translational machinery through multiple mechanisms including\nby directly activating or inhibiting ribosomal activity.7 mTOR is a key intracellular point\nof convergence for a number of cellular signaling pathways, including Akt/PKB.8\nmTOR lies downstream to Akt/PKB, and targeted inhibition of this protein has\nemerged as an important therapeutic strategy in clinical oncology. Inhibition of mTOR\nactivity has been shown to restore tamoxifen response in breast cancer cells with\naberrant Akt activity.9\nEverolimus is an orally bioavailable inhibitor of the mTOR pathway. Combination\ntreatment with everolimus and either letrozole or fulvestrant has been shown to\nreverse Akt-mediated endocrine therapy resistance and restore responsiveness to\nanti-estrogens in preclinical studies.5 These observations formed the rationale leading\nto the Phase I clinical trial evaluating the combination of everolimus and letrozole in\nwomen previously treated with letrozole ≥ 4 months without objective response (e.g.,\nstable or progressive disease). Eighteen postmenopausal female patients with\nadvanced HR+ breast cancer were treated with letrozole 2.5 mg/day and everolimus\nat 5 mg/day (cohort 1) or 10 mg/day (cohort 2).10 Overall the combination was well\ntolerated and toxicities were manageable and consistent with that expected for

\n

everolimus monotherapy. The results suggest antitumor activity for this combination\nwithout Pharmacokinetic (PK) interactions.\nThis study will examine the efficacy and tolerability of the combination of fulvestrant\nand everolimus for the treatment of postmenopausal metastatic breast cancer\nresistant to an aromatase inhibitor.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_3", - "extensionAttributes": [], - "name": "NCI_1_2", - "text": "
\n

Breast cancer is the most commonly diagnosed malignancy in women worldwide. In\nthe United States, an estimated 230,480 new cases of invasive breast cancer were\ndiagnosed in 2011, with 39,520 breast cancer deaths.11 Despite the recent advances\nin breast cancer therapy, 40-80% of women with node-positive disease and up to\n30% of women with node-negative disease at diagnosis will relapse. When distant\nmetastases occur, the prognosis remains poor with a median survival of 18 to 36\nmonths from time of recurrence. Among the 60-70% of women with hormone-receptor\npositive breast cancer, 40-60% of them will benefit from endocrine therapy. Endocrine\ntherapy has shown to yield similar survival rates in hormone-sensitive disease as\ncompared to chemotherapy; although response rates are lower and responses\ndevelop more slowly. Endocrine therapy is considerably less toxic than\nchemotherapy, and is therefore the preferred treatment option for patients with\nhormone-receptor (HR)-positive disease.12,13 Chemotherapy is generally indicated in\nHR-negative disease, in cases unresponsive to endocrine therapy, or when extensive\nmetastases require rapid tumor response.14

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_4", - "extensionAttributes": [], - "name": "NCI_1_3", - "text": "
\n

Several endocrine therapies are available for the treatment of metastatic breast\ncancer in postmenopausal women, including selective estrogen-receptor modulators\n(SERMs), aromatase inhibitors (AIs), progestins, androgens, and most recently the\nselective estrogen receptor downregulators (SERDs- e.g., fulvestrant). Tamoxifen\nwas generally regarded as a standard option in HR-positive disease for adjuvant\ntherapy, and for first-line therapy of metastatic disease in postmenopausal women.\nWithin the past decade, however, the AIs (letrozole, anastrozole, exemestane) have\nsupplanted tamoxifen as the preferred choice for adjuvant therapy and metastatic\ndisease in postmenopausal women.15,16 There is therefore a need to develop more\neffective endocrine therapies for patients with AI-resistant disease, and to enhance\nthe effectiveness of existing endocrine therapies that have demonstrated efficacy in\nAI-resistant disease.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_5", - "extensionAttributes": [], - "name": "NCI_1_3_1", - "text": "
\n

Fulvestrant (Faslodex®, AstraZeneca Pharmaceuticals LP, Wilmington, DE) has\nseveral unique characteristics. It is the first drug which acts as a pure estrogen\nreceptor (ER) antagonist without known agonist effects. It competitively binds to the\nERs with an approximately 100 times greater affinity than that of tamoxifen.\nFulvestrant promotes the degradation of ERs and subsequently prevents ERmediated gene transcription. Two studies that led to the approval of fulvestrant were\nperformed in postmenopausal women with HR-positive metastatic breast cancer who\nhad progressive disease after tamoxifen therapy. These trials compared fulvestrant

\n

(250 mg IM injection monthly) with anastrozole (1 mg PO daily) (Table 1-0).17,18 The\nprimary endpoint for both studies was time to disease progression (TTP), which was\nsimilar between the two treatment arms (5.4 versus 3.4 months in the North American\ntrial, and 5.5 versus 5.1 months in the European trial). Secondary endpoints were\nalso comparable. The response rate for fulvestrant was 17-20% (versus 15.7-17.5%\nfor anastrozole), Clinical Benefit Rate (CBR) was 42-45% (versus 36-45% for\nanastrozole), median duration of response was 15-19 months (versus 11-15 months\nfor anastrozole), and median time to disease progression (TTP) was 5.5 months\n(versus 3.4-5.1 months for anastrozole). Further subgroups analyses confirm the\nclinical activity of fulvestrant in both visceral and non-visceral metastatic disease as\ncompared with anastrozole.19 These trials led to the approval of Faslodex®\n(fulvestrant) Injection for “…the treatment of hormone-receptor positive metastatic\nbreast cancer in postmenopausal women with disease progression following\nantiestrogen therapy”.\nTable 1-0\nPhase III Studies Comparing Fulvestrant and Anastrozole after TamoxifenFailure in Postmenopausal Women with HR-Positive Metastatic Breast Cancer\nNorth American Trial

\n

European Trial

\n

Treatment Group:

\n

Fulvestrant

\n

Anastrozole

\n

Fulvestrant

\n

Anastrozole

\n

No. of Patients:

\n

Overall RR (%):

\n

17.5

\n

17.5

\n

20.7

\n

15.7

\n

CR (%):

\n

4.9

\n

3.6

\n

4.5

\n

1.7

\n

PR (%):

\n

12.6

\n

13.9

\n

16.2

\n

14.0

\n

42.2

\n

36.1

\n

44.6

\n

45.0

\n

24.8

\n

18.6

\n

23.9

\n

29.3

\n

Median TTP (months):

\n

5.4

\n

3.4

\n

5.5

\n

5.1

\n

Median Duration of Response\n(months):

\n

19.0

\n

10.8

\n

15.0

\n

14.5

\n

Withdrawal Rate (%):

\n

2.5

\n

2.6

\n

3.2

\n

1.3

\n

Clinical Benefit Rate (%):\nSD for more than 24 weeks (%):

\n

Fulvestrant has also been compared with tamoxifen as first line therapy in a Phase III\ntrial that included 587 postmenopausal women with HR-positive metastatic breast\ncancer, but proved to be no more effective than tamoxifen in this setting.20 When\ncomparing fulvestrant with tamoxifen, the objective response rate (34% versus 32%)\nand clinical benefit rate (57% versus 62%) were similar.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_6", - "extensionAttributes": [], - "name": "NCI_1_3_2", - "text": "
\n

Several trials have evaluated the role of fulvestrant in AI-resistant disease, as\nsummarized in Table 1-1.

\n

Table 1-1\nPhase II or III Trial of Fulvestrant in AI-Resistant Disease\nReference\nIngle, 2006

\n

Treatment

\n

No.

\n

RR

\n

CBR

\n

Median TTP

\n

Fulvestrant

\n

14%

\n

25%

\n

3.0 mo.

\n

Fulvestrant

\n

5%

\n

37%

\n

3.5 mo.

\n

Fulvestrant

\n

7%

\n

23%

\n

3.7 mo.

\n

Exemestane

\n

7%

\n

19%

\n

3.7 mo.

\n

Perey, 2007

\n

Chia, 2008

\n

The Clinical Benefit Rate (CBR) for patients with AI-resistant disease is approximately\n20-30%, and median TTP is approximately 3.5 months. In the EFECT trial reported by\nChia et al, patients who had progressive disease after treatment with a non-steroidal\nAI (anastrozole, letrozole) were randomized to fulvestrant or the steroidal aromatase\ninhibitor exemestane. In contrast to most other trials that utilized a single 250 mg\nmonthly dose based upon the original pharmacokinetic studies,23 patients in the\nEFECT trial received a 500 mg loading dose on day 1, then 250 mg on day 15 and 28\n(then every 4 weeks thereafter) based upon recent evidence that this dose/schedule\nmay more rapidly achieve therapeutic blood levels. There was no significant\ndifference in CBR between the two treatment arms. Nevertheless, the EFECT trial\nconfirmed the effectiveness of fulvestrant previously reported in other smaller trials of\nfulvestrant in AI-resistant disease.\nPrevious trials had demonstrated that a dose of 125 mg was less effective than the\n250 mg monthly dose.16,20 Based upon evidence that dosing schedules higher than\nthe 250 mg monthly dose may produce greater clinical benefit, several trials\nevaluated alternative dosing schedules (similar to that used in the EFECT trial),\nincluding FINDER I (NCT00305448), FINDER II (NCT00313170), and CONFIRM\n(NCT00099437).

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_7", - "extensionAttributes": [], - "name": "NCI_1_3_3", - "text": "
\n

Fulvestrant has demonstrated activity when used as first, second, or third line\nendocrine therapy, making it an attractive therapy for combination with other agents.\nIn addition, it is commonly reserved for use following disease progression on AI\ntherapy. The loading dose schedule employed in the EFECT trial will be used in this\nstudy taking advantage of the known dose-response effect observed for fulvestrant,\nthe more rapid achievement of therapeutic blood levels, the extensive efficacy and\nsafety experience with this schedule, and because it appears to be emerging as the\npreferred schedule for fulvestrant based upon the results of ongoing and recently\ncompleted clinical trials.\nThe recently reported CONFIRM trial compared fulvestrant dosing of 250 mg every\n28 days (the previously FDA-approved dose) with 500 mg on days 1, 14, 28 and\nevery 28 days thereafter (the current FDA-approved dose).24 The study demonstrated\nthat the higher dose was more effective. Median time to progression (TTP) was 6.5\nmonths with the higher dose compared with 5.5 months with the lower dose (HR 0.8,\np=0.006). The CBR was 45%, with the high dose as compared to 39.6% with the low\ndose arm (odds ratio 1.28, p= 0.10). In the subgroup of patients who had

\n

relapsed/progressed on an aromatase inhibitor (the population targeted in this study),\nmedian TTP was 5.4 months with the high-dose arm, and 4.1 months on the standard\narm (with CBRs of 36% and 32% respectively). We will therefore use the high-dose\nregimen as utilized in the CONFIRM trial.24

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_8", - "extensionAttributes": [], - "name": "NCI_1_4", - "text": "
\n

Everolimus (RAD001) is a novel oral derivative of rapamycin that is an m-TOR\ninhibitor.\nEverolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation. Everolimus is approved in Europe and other global\nmarkets (trade name: Certican®) for cardiac and renal transplantation, and in the\nUnited States (trade name: Zortress®) for the prevention of organ rejection of kidney\ntransplantation.\nEverolimus was developed in oncology as Afinitor® and was approved for advanced\nrenal cell carcinoma (RCC) in 2009. In 2010, Afinitor® received United States (US)\napproval for patients with subependymal giant cell astrocytoma (SEGA) associated\nwith tuberous sclerosis (TS). Everolimus is also available as Votubia® in the\nEuropean Union (EU) for patients with SEGA associated with TS. Afinitor® was\napproved for “progressive pancreatic neuroendocrine tumor (PNET) in patients with\nunresectable, locally advanced, or metastatic disease” in 2011 in various countries,\nincluding the US and Europe.\nIn 2012 Afinitor® received approval for the treatment of postmenopausal women with\nadvanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+\nBC) in combination with exemestane, after failure of treatment with letrozole or\nanastrozole. Furthermore in 2012, Afinitor® received approval for the treatment of\npatients with Tuberous Sclerosis Complex (TSC) who have renal angiomyolipoma not\nrequiring immediate surgery.\nEverolimus is being investigated as an anticancer agent based on its potential to act:\n•

\n

Directly on the tumor cells by inhibiting tumor cell growth and proliferation.

\n

•

\n

Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via\npotent inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced\nproliferation of endothelial cells). The role of angiogenesis in the maintenance of\nsolid tumor growth is well established, and the mTOR pathway has been\nimplicated in the regulation of tumor production of proangiogenic factors as well\nas modulation of VEGFR signaling in endothelial cells.

\n

At weekly and daily schedules and at various doses explored, everolimus is generally\nwell tolerated. The most frequent adverse events (rash, mucositis, fatigue and\nheadache) associated with everolimus therapy are manageable. Non-infectious\npneumonitis has been reported with mTOR inhibitors but is commonly low-grade and\nreversible.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_9", - "extensionAttributes": [], - "name": "NCI_1_4_1", - "text": "
\n

At cellular and molecular levels, everolimus acts as a signal transduction inhibitor.\nEverolimus selectively inhibits mTOR (mammalian target of rapamycin), specifically

\n

targeting the mTOR-raptor signal transduction complex. mTOR is a key and highly\nconserved serine-threonine kinase which is present in all cells and is a central\nregulator of protein synthesis and ultimately cell growth, cell proliferation,\nangiogenesis and cell survival. mTOR is the only currently known target of\neverolimus.25\nmTOR is downstream of PI3K/AKT pathway, a pathway known to be dysregulated in\na wide spectrum of human cancers (e.g. through loss/mutation of the PTEN negative\nregulator; through PI3K mutation/amplification; through AKT/PKB overexpression/\noveractivation; through modulation of TSC1/TSC2 tumor suppressors). In addition,\nactivation of the PI3K/AKT/mTOR pathway is associated with worsening prognosis\nthrough increased aggressiveness, resistance to treatment and progression.\nThe main known functions of mTOR include the following:7,25\n•\n•\n•

\n

•\n•

\n

mTOR functions as a sensor of mitogens, growth factors and energy, and nutrient\nlevels, facilitating cell-cycle progression from G1 to S phase in appropriate growth\nconditions.\nThe PI3K-mTOR pathway itself is frequently activated in many human cancers,\nand oncogenic transformation may sensitize tumor cells to mTOR inhibitors.\nThrough inactivating eukaryotic initiation factor 4E binding proteins (4E-BP1) and\nactivating the 40S ribosomal S6 kinases (e.g., p70S6K1), mTOR regulates protein\ntranslation, including the HIF-1 proteins. Inhibition of mTOR is expected to lead to\ndecreased expression of HIF-1.\nThe activation of mTOR pathway is involved in the production of pro-angiogenic\nfactors (i.e., VEGF) and inhibition of endothelial cell growth and proliferation.\nThe regulation of mTOR signaling is complex and involves positive regulators,\nsuch as AKT that phosphorylate and inactivate negative regulators such as the\nTuberous Sclerosis Complex (TSC1/TSC2).

\n

mTOR is represented by two structurally and functionally distinct multiprotein\nsignaling complexes, mTORC1 (mTOR complex 1, rapamycin sensitive) and\nmTORC2 (mTOR complex 2, rapamycin insensitive).26\nmTORC1 is mainly activated via the PI3 kinase pathway through AKT (also known as\nPKB, protein kinase B) and the tuberous sclerosis complex (TSC1/TSC2).7 Activated\nAKT phosphorylates TSC2, which leads to the dissociation of TSC1/TSC2 complex,\nthus inhibiting the ability of TSC2 to act as a GTPase activating protein. This allows\nRheb, a small G-protein, to remain in a GTP bound state and to activate mTORC1.\nAKT can also activate mTORC1 by PRAS40 phosphorylation, thereby relieving the\nPRAS40-mediated inhibition of mTORC1.27,28\nmTORC2 (mTOR complex 2) is activated through a currently unknown mechanism,\npossibly by receptor tyrosine kinase (RTK) signaling.27 It has been suggested that\nmTORC2 phosphorylates and activates a different pool of AKT that is not upstream of\nmTORC1. PHLPP phosphatase plays a role of a negative regulator. mTORC2 is\nrapamycin insensitive and is required for the organization of the actin cytoskeleton.26\nmTORC1-mediated signaling is subject to modulation by the macrocyclic lactone\nrapamycin and its derivatives, such as everolimus. Once these agents bind to the 12\nkDa cytosolic FK506-binding protein immunophilin FKBP12, the resulting rapamycinFKBP12 complexes bind to a specific site near the catalytic domain of mTORC1 and

\n

inhibit phosphorylation of mTOR substrates. As a consequence, downstream\nsignaling events involved in regulation of the G1 to S-phase transition are inhibited.\nThis mechanism is thought to be responsible for the immunosuppressive effects of\nrapamycin as well as its putative antineoplastic activity.29 As many cancers are\ncharacterized by dysregulation of G1 transit (for example, overexpression of cyclin or\ncyclin-dependent kinases), inhibition of mTOR becomes an intriguing target for\ninducing cytostasis.7\n1.4.1.1

\n

Preclinical Studies

\n

Everolimus acts as an inhibitor of cytokine and growth-factor-dependent proliferation\nof cells. The only currently known target of everolimus is mTOR, a key regulatory\nprotein affecting cell growth.25 Everolimus exerts its activity through high affinity\ninteraction with an intracellular receptor protein, the immunophilin FKBP12. The\nFKBP12/everolimus complex subsequently interacts with the mTOR protein kinase,\ninhibiting downstream signaling events involved in regulation of the G1 to S-phase\ntransition.\nThe main known functions of mTOR include:\n•

\n

Function as a sensor of mitogens, growth factors, energy and nutrient levels,\nfacilitating cell-cycle progression from G1 - S phase in appropriate growth\nconditions.

\n

•

\n

Regulation of protein synthesis important for tumor cell proliferation and\nangiogenesis through inactivating eukaryotic initiation factor 4E binding proteins\nand activating the 40S ribosomal S6 kinases (e.g. p70S6K1). For example,\nactivation of the mTOR pathway leads to a) increased production of proangiogenic factors (e.g. VEGF) in tumors b) tumor, endothelial and smooth\nmuscle cell growth and proliferation.

\n

The PI3K-mTOR pathway itself is frequently activated in many human cancers, and\noncogenic transformation may sensitize tumor cells to mTOR inhibitors. The\nregulation of mTOR signaling is complex and involves positive regulators such as\nAKT that phosphorylate and inactivate negative regulators such as the Tuberous\nSclerosis Complex (TSC1/TSC2). In summary, mTOR has pleiotropic functions;\nhence, the activities of everolimus may vary depending upon cell type.\nThe mTOR inhibitory activities presumably contribute to the anti-proliferative activity\nof everolimus against tumor cell lines. However, everolimus may also exert an\nantitumor effect through the inhibition of angiogenesis. Indeed, both rapamycin and\neverolimus potently inhibit proliferation of endothelial cells and have antiangiogenic\nactivity in vivo.30,31 Exactly which molecular determinants predict responsiveness of\ntumor cells to everolimus is still unclear. Currently, the activation status of the\nPI3K/AKT/mTOR/p70 S6K pathway may be indicative of responsiveness to\nrapamycins. For example, pre-clinically, loss of PTEN or constitutive/hyper-activation\nof AKT has been suggested to sensitize tumors to the effects of inhibition of\nmTOR.25,31 Also, clinically, it has been suggested that high p70S6K activation in\nbaseline Glioblastoma Multiforme (GBM) tumor samples may predict a patient\npopulation more likely to derive benefit from mTOR inhibition.32

\n

Everolimus is a highly specific inhibitor of mTOR, which is afforded by high-affinity\nbinding to the protein FKBP-12 (IC50 of 5.3 nM) similar to that of rapamycin. Similar\npotency of rapamycin and everolimus was also demonstrated at forming the mTOR/\nFKBP-12 tertiary complex in vitro. Specificity was demonstrated by a lack of inhibitory\nactivity against 10 other protein kinases at concentrations up to 10 μM.\nThe anti-proliferative effects of everolimus were investigated in a mixed panel of 48\ndifferent tumor cell lines (including breast, colon, epidermoid, glioblastoma, lung,\nmelanoma, prostate and renal). The majority of tumor cell lines were highly sensitive\nto the anti-proliferative effects of everolimus while a few others appeared intrinsically\ninsensitive, or ‘resistant’ (IC50 range 0.2 to 4125 nM).33 The median IC50 value of the\n48 cell lines was 0.5 nM. Similar findings have been observed for rapamycin.34\nEverolimus was also shown to have activity in human pancreatic neuroendocrine\ncells, where induction of apoptosis was reported,35 as well as in acute myeloid\nleukemia cells,36 mantle cell lymphoma cells37, adult T-cell leukemia cells38, diffuse\nlarge B cell lymphoma cells,39 pancreatic tumor cells,40 ovarian cancer cells,31,41 and\nhepatocellular carcinoma cells.42\nEverolimus was also evaluated in a clonogenic assay using cells derived from 81\npatient derived tumor xenografts never cultured in vitro (11 human tumor types with 3\nto 24 tumors each: bladder, colon, gastric, Non-Small Cell Lung Cancer (NSCLC),\nSmall Cell Lung Cancer (SCLC), breast, ovary, pancreatic, renal, melanoma, and\npleuramesothelioma). Everolimus inhibited colony formation in a concentrationdependent manner (mean IC50: 175 nM). In addition, normal hematopoetic stem cells\nwere found to be relatively insensitive to everolimus, with an IC50 about 15 fold higher\nthan the tumor lines.\nEverolimus was effective and well tolerated against subcutaneous (s.c.) tumors\nestablished from a variety of tumor cell lines of diverse histotypes (NSCLC,\npancreatic, colon, melanoma, epidermoid), including a PgP170-overexpressing, multidrug resistant tumor line. Typically, the antitumor activity of everolimus was that of\nreduction of tumor growth rates rather than producing regressions or stable disease\nalthough, in the case of A549 and NCI-H596 lung and ARJ42 pancreatic tumors,\nregressions could be obtained. These effects occurred within the dose range of 2.5 to\n10 mg/kg, P.O., once per day. The change in tumor volume of the treated mice\ndivided by the change in tumor volume of control mice (T/C) typically ranged from\napproximately 15 to 50% at optimal doses. A marked loss of antitumor activity\noccurred when tumor-bearing mice were treated with everolimus once per week, but\nimproved moderately with twice per week dosing. Antitumor activity of everolimus has\nalso been demonstrated in mouse models of ovarian,31 breast,43,44 and\ngastrointestinal stromal tumors.45

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_10", - "extensionAttributes": [], - "name": "NCI_1_4_2", - "text": "
\n

In safety pharmacology studies, everolimus was devoid of relevant effects on vital\norgan functions including the cardiovascular, respiratory and nervous systems.\nEverolimus had no effects on QT interval. Furthermore, everolimus showed no\nantigenic potential. Although everolimus passes the blood-brain barrier, there was no\nindication of relevant changes in the behavior of rodents, even after single oral doses\nup to 2000 mg/kg or after repeated administration at up to 40 mg/kg/day.

\n

The preclinical safety profile of everolimus was assessed in mice, rats, minipigs,\nmonkeys, and rabbits. The major target organs were male and female reproductive\nsystems (testicular tubular degeneration, reduced sperm content in epididymides and\nuterine atrophy) in several species; lungs (increased alveolar macrophages) in rats\nand mice; and eyes (lenticular anterior suture line opacities) in rats only. Minor kidney\nchanges were seen in the rat (exacerbation of age-related lipofuscin in tubular\nepithelium, increases in hydronephrosis) and mouse (exacerbation of background\nlesions). There was no indication of kidney toxicity in monkeys or minipigs.\nGenotoxicity studies covering relevant genotoxicity endpoints showed no evidence of\nclastogenic or mutagenic activity. Administration of everolimus for up to 2 years did\nnot indicate any oncogenic potential in mice and rats up to the highest doses,\ncorresponding respectively to 4.2 and 0.2 times the estimated clinical exposure. In\nreproduction studies, everolimus was toxic to the conceptus in rats and rabbits, and\nwas considered potentially teratogenic in rats. It is therefore recommended that\nwomen of childbearing potential should use effective contraceptive measures during\nthe entire treatment period and for 8 weeks thereafter.\nMore pre-clinical information is provided in the Investigator’s Brochure.

\n

1.4.3\n1.4.3.1

\n

Clinical Experience

\n

Everolimus Pharmacokinetics

\n

Everolimus is rapidly absorbed with a median tmax of 1-2 hours. The steady-state\nAUC0-τ is dose-proportional over the dose range between 5 to 70 mg in the weekly\nregimen and 5 and 10 mg in the daily regimen. Steady-state was achieved within two\nweeks with the daily dosing regimen. Cmax is dose-proportional between 5 and 10 mg\nfor both the weekly and daily regimens. At doses of 20 mg/week and higher, the\nincrease in Cmax is less than dose proportional. In healthy subjects, high fat meals\nreduced systemic exposure to everolimus 10 mg (as measured by Area Under the\nConcentration Time-Curve (AUC)) by 22% and the peak plasma concentration Cmax\nby 54%. Light fat meals reduced AUC by 32% and Cmax by 42%. Food, however, had\nno apparent effect on the post absorption phase concentration-time profile.\nThe blood-to-plasma ratio of everolimus, which is concentration-dependent over the\nrange of 5 to 5,000 ng/mL, is 17% to 73%. The amount of everolimus confined to the\nplasma is approximately 20% at blood concentrations observed in cancer patients\ngiven everolimus 10 mg/day. Plasma protein binding is approximately 74% both in\nhealthy subjects and in patients with moderate hepatic impairment.\nEverolimus is a substrate of CYP3A4 and a substrate and moderate inhibitor of PgP.\nFollowing oral administration, everolimus is the main circulating component in human\nblood and is considered to contribute the majority of the overall pharmacologic\nactivity. No specific excretion studies have been undertaken in cancer patients;\nhowever, data available from the transplantation setting found the drug to be mainly\neliminated through the feces. There was a significant correlation between AUC0-τ and\npre-dose trough concentration at steady-state on the daily regimen. The mean\nelimination half-life of everolimus is approximately 30 hours.\nAppendix C lists examples of clinically relevant CYP3A4 inhibitors and inducers.

\n

Please refer to Section 5.3.5 for more information on the concomitant use of CYP3A4\ninhibitors/inducers and other medications.\nMore information on everolimus pharmacokinetics is provided in the Investigator’s\nBrochure.\n1.4.3.2

\n

Everolimus Pharmacodynamic Studies

\n

Pharmacokinetic/pharmacodynamic modeling based on inhibition of the biomarker\np70S6 kinase 1 [S6K1] in peripheral blood mononuclear cells [PBMC]) suggests that\n5-10 mg daily should be an adequate dose to produce a high-degree of sustained\ntarget inhibition ([Study C2101]/[Study 2102]).46 Molecular changes in tumor were\nevaluated through serial biopsy before and during treatment. Biopsy on treatment\ntook place in week 4 (pharmacokinetic steady-state). All patients underwent a 24hour post-dose biopsy. Patients following the weekly regimen had a further biopsy on\nDay 4 or 5 of the same week. Molecular activity was measured by\nimmunohistochemistry. In the absence of a reliable technique for measuring mTOR\nphosphorylation, the phosphorylation status of downstream markers S6 and eIF4G,\nfor which reliable antibodies exist, was selected as reflecting the immediate\npharmacodynamic effect of everolimus. Also measured were changes in the\nphosphorylation status of upstream AKT and the proliferation index Ki67. Fifty-five\npatients were treated and the results revealed a dose and schedule dependent\ninhibition of the mTOR pathway with a near complete inhibition of pS6 and pelF-4G at\nthe 10 mg/day and 50 mg/wk schedules. In addition, pAKT was upregulated in 50% of\nthe treated tumors. In the daily schedule, there was a correlation between everolimus\nplasma trough concentrations and inhibition of peIF4G and p4E-BP1. There was\ngood concordance of mTOR pathway inhibition between skin and tumor. [Study\nC2107].47\nMore information on everolimus pharmacodynamics is provided in the Investigator’s\nBrochure (IB).\n1.4.3.3

\n

Clinical Experience with Everolimus

\n

Everolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation and was approved in Europe in 2003 under the trade\nname Certican®, for the prevention of organ rejection in patients with renal and\ncardiac transplantation. It is also approved in the United States (trade name:\nZortress®) for the prevention of organ rejection of kidney transplantation. Additional\nnon-oncologic indications currently being explored are wet age-related macular\ndegeneration (AMD) and autosomal dominant polycystic kidney disease (ADPKD).\nClinical experience of everolimus in the transplant indication is summarized in a\nseparate Investigator’s Brochure.\nIn oncology, everolimus has been in clinical development since 2002 for patients with\nvarious hematologic and non-hematologic malignancies as a single agent or in\ncombination with antitumor agents. Please note that safety pharmacology and\ntoxicology studies as well as some human pharmacology studies which have been\nconducted in support of the transplant indication, are described in the oncology IB\ndue to the relevance of these data for the oncology indication. Malignancies that are\ncurrently being evaluated in Novartis sponsored studies include the following:

\n

metastatic renal cell carcinoma (mRCC), breast cancer, gastroenteropancreatic\nneuroendocrine tumors (GEP-NET), mantle cell lymphoma and diffuse large B cell\nlymphoma (DLBCL), hepatocellular cancer (HCC), gastric cancer, and lung cancer. In\naddition, treatment of patients with Tuberous Sclerosis Complex (TSC) associated\nsubependymal giant cell astrocytoma (SEGA) and Angiomyolypoma is also being\nevaluated. Colorectal cancer (CRC) is no longer being evaluated.\nEverolimus 2.5 mg, 5 mg and 10 mg tablets were approved under the trade name\nAfinitor® for patients with advanced renal cell carcinoma in the US, EU and several\nother countries and is undergoing registration in other regions worldwide. Recent\napproval was granted in the US for the treatment of patients with subependymal giant\ncell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require\ntherapeutic intervention but are not candidates for curative surgical resection.\nPhase I dose escalating studies, exploratory Phase I/II studies with everolimus as\nsingle agent or in combination with other anti-cancer agents, Phase II/III studies of\neverolimus in indications, and Phase III double-blind studies are contributing to the\nextensive database.\nApproximately 18,730 cancer patients have been treated with everolimus as of 30Sep-2011:\n•\n•\n•\n•

\n

9,528 patients in Novartis-sponsored clinical trials\n2,559 patients in the individual patient supply program\n6,638 in investigator-sponsored studies.\nIn addition, healthy volunteer subjects have participated in the clinical\npharmacology studies as described in Section 1.4.3.1.

\n

As of 30-Sep-2011, there are a total of 11 Phase III trials ongoing in the indications\nmRCC (1), advanced NET (2), breast cancer (3), TSC (2), DLBCL (1), gastric cancer\n(1) and HCC (1).\nRecent approvals of everolimus (Afinitor®) were based upon a Phase III, international,\nmulticenter randomized, double-blind, placebo-controlled study [C2240] in patients\nwith metastatic renal cell carcinoma (mRCC) whose disease had progressed despite\nprior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine\nkinase inhibitor) therapy. Progression-free survival (PFS) assessed via a blinded,\nindependent central review, was the primary endpoint. Secondary endpoints included\nsafety and objective tumor response.\nIn the pivotal, Phase III study [C2240], which included patients with advanced renal\ncell carcinoma, the most common adverse reactions (incidence ≥ 10%) were\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, pneumonitis, cough, peripheral edema, infections, dry skin, epistaxis,\npruritus, and dyspnea. The most common grade 3-4 adverse reactions (incidence ≥\n2%) were infections, stomatitis, fatigue, and pneumonitis. Non-infectious pneumonitis\nis a class effect of rapamycin derivatives, including everolimus and some of these\ncases have been severe and on rare occasions, fatal outcomes have been observed.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral

\n

infections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.\nThe most common laboratory abnormalities (incidence ≥ 50%) were anemia,\nhypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and\nincreased creatinine. The most common grade 3/4 laboratory abnormalities\n(incidence ≥ 3%) were lymphopenia, hyperglycemia, anemia, hypophosphatemia, and\nhypercholesterolemia. Deaths due to acute respiratory failure (0.7%), infection\n(0.7%), and acute renal failure (0.4%) were observed on the everolimus arm. The\nrates of treatment-emergent adverse reactions resulting in permanent discontinuation\nwere 7% and 0% for the everolimus and placebo treatment groups, respectively.\nSafety data from study [C2240] are described in detail in Section 1.4.3.3.\nOverall, safety data available from completed, controlled and uncontrolled studies are\nconsistent with the aforementioned findings of the Phase III trial. Everolimus is\ngenerally well tolerated at weekly and daily dose schedules. The safety profile is\ncharacterized by manageable adverse events (AEs). These AEs are generally\nreversible and non-cumulative.\nFurther detailed information regarding everolimus clinical development, safety and\nefficacy is provided in the Investigator’s Brochure.\n1.4.3.4

\n

Clinical Experience with Everolimus in Metastatic Breast Cancer\nResistant to Non-Steroidal Aromatase Inhibitors

\n

Based on data indicating that resistance to endocrine therapy in breast cancer is\nassociated with activation of the mammalian target of rapamycin (mTOR) intracellular\nsignaling pathway, a Phase 3, randomized trial (BOLERO2) compared the steroidal\naromatase inhibitor exemestane (25 mg PO daily) plus either everolimus (10 mg PO\ndaily) or a placebo (randomly assigned in a 2:1 ratio) in 724 patients with HR-positive\nadvanced breast cancer who had recurrence or progression while receiving previous\ntherapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat\nadvanced disease (or both). The primary end point was progression-free survival.\nSecondary end points included survival, response rate, and safety. A preplanned\ninterim analysis was performed by an independent data and safety monitoring\ncommittee after 359 progression-free survival events were observed. Baseline\ncharacteristics were well balanced between the two study groups. The median age\nwas 62 years, 56% had visceral involvement, and 84% had hormone-sensitive\ndisease. Previous therapy included letrozole or anastrozole (100%), tamoxifen (48%),\nfulvestrant (16%), and chemotherapy (68%). The most common grade 3 or 4 adverse\nevents were stomatitis (8% in the everolimus-plus-exemestane group vs. 1% in the\nplacebo-plus-exemestane group), anemia (6% vs. <1%), dyspnea (4% vs. 1%),\nhyperglycemia (4% vs. <1%), fatigue (4% vs. 1%), and pneumonitis (3% vs. 0%). At\nthe interim analysis, median progression-free survival was 6.9 months with\neverolimus plus exemestane and 2.8 months with placebo plus exemestane,\naccording to assessments by local investigators (hazard ratio for progression or\ndeath, 0.43; 95% confidence interval [CI], 0.35 to 0.54; P<0.001). Median\nprogression-free survival was 10.6 months and 4.1 months, respectively, according to\ncentral assessment (hazard ratio, 0.36; 95% CI, 0.27 to 0.47; P<0.001). The study\nmet its pre-specified endpoint, which led to FDA approval of everolimus in

\n

combination with exemestane for this indication in the U.S. on July 20, 2012.48\nOverall survival results were immature at the time of the interim analysis, with a total\nof 83 deaths: 10.7% of patients in the combination-therapy group and 13.0% of those\nin the exemestane-alone group died. Patients and investigators continue to be\nunaware of study assignments and will remain so until survival results are mature for\nanalysis.49

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_11", - "extensionAttributes": [], - "name": "NCI_1_4_3", - "text": "

See section 1.4.3 Clinical Experience.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_12", - "extensionAttributes": [], - "name": "NCI_1_5", - "text": "
\n

We hypothesize more complete blockade of the ER-signaling pathway may be\nachieved with selective estrogen receptor downregulator fulvestrant (given at a high\ndose) than may be achieved with the steroidal AI exemestane, and that this will result\nin either comparable or greater effectiveness for the fulvestrant-everolimus\ncombination than the exemestane-everolimus combination. This is supported by\npreclinical data demonstrating that fulvestrant is particularly effective when combined\nwith agents targeting the PI3K-AKT-m-TOR pathway in tumors that have undergone\nlong-term estrogen deprivation, as is the case for patients who have acquired\nresistance to AI therapy.50\nWe therefore propose to study the efficacy of fulvestrant in combination with\neverolimus for the treatment of post-menopausal HR-positive metastatic breast\ncancer in women who have progressed after treatment with an aromatase inhibitor.\nThe combination of a novel class of agents (mTOR inhibitors) and an established\nstandard treatment for metastatic HR-positive breast cancer may potentially increase\nthe clinical benefit by targeting multiple different biological pathways.\nThis is a randomized, double-blind, placebo controlled Phase II study. It is expected\nthat 130 patients will be accrued at 25 centers within the US. Patients will be\nrandomized (1:1) to receive everolimus or placebo after consideration of stratification\nfactors of performance status (0 vs.1), measurable disease (with or without nonmeasurable) vs. non-measurable disease, and prior chemotherapy for metastatic\ndisease vs. no prior chemotherapy.\nInduction Phase:\nTreatment during the Induction Phase includes:\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus everolimus 10 mg (two- 5 mg tablets) PO daily\nOR\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus placebo two tablets PO daily\nPatients will be evaluated for disease response every 12 weeks (every 3 treatment\ncycles), +/- 1 week, and treated until disease progression, unacceptable toxicity or for\na total of up to 12 cycles.

\n

Continuation Phase:\nPatients with no evidence of progressive disease who remain on study after\ncompleting Cycle 12 will be unblinded and proceed to the Continuation Phase.\nPatients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule. Patients will continue to\nbe evaluated for disease response every 12 weeks (every 3 treatment cycles), +/- 1\nweek, and may continue treatment until disease progression or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to ≤ grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).

\n

Objectives

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_13", - "extensionAttributes": [], - "name": "NCI_2", - "text": "

See section 2 Objectives.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_14", - "extensionAttributes": [], - "name": "NCI_2_1", - "text": "
\n

To assess progression-free survival in post-menopausal patients with hormonereceptor positive metastatic breast cancer that is resistant to aromatase inhibitor\ntherapy treated with fulvestrant and everolimus compared to fulvestrant alone.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_15", - "extensionAttributes": [], - "name": "NCI_2_2", - "text": "
\n

To describe the safety profile, objective response rate, time to progression and\noverall survival in this patient population.

\n

Selection of Patients

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_16", - "extensionAttributes": [], - "name": "NCI_3", - "text": "

See section 3 Selection of Patients.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_17", - "extensionAttributes": [], - "name": "NCI_3_1", - "text": "
\n

Each of the criteria in the following section must be met in order for a patient to be\nconsidered eligible for this study.\nPrECOG will not grant any exceptions or waivers to protocol eligibility criteria.\nIn calculating pre-treatment days of tests and measurements, the day a test or\nmeasurement is done is considered Day 0. Therefore, if a test is done on a\nMonday, the Monday four weeks later would be considered Day 28.\nNote: All questions regarding eligibility should be directed to the PrECOG Study\nContact in study materials. Questions will be further discussed with the medical leads\nfor the trial as deemed appropriate (e.g., medical monitor, study chair).\nInvestigator sites may use the eligibility checklist (see Appendix A: Eligibility\nChecklist) which will be provided as a separate study document, as documentation\nthat eligibility criteria were verified. If used, it should be reviewed, signed, and dated\nprior to patient randomization by the treating physician, and all required elements of\nsource documentation must be found in the patient record (e.g. scans, consent,\npathology).\nInclusion Criteria:\n1. Must be willing to sign a protocol-specific informed consent.\n2. Patients must be 18 years of age or older.\n3. Patients must have an ECOG Performance Status 0 or 1 (see Appendix B:\nECOG Performance Status Scale).\n4. Patients must have histologically or cytologically confirmed adenocarcinoma\nof the breast.\n5. Patients must have stage IV disease or inoperable locally advanced disease.\n6. Patients must have ER and/or PR-positive disease as determined by their\nlocal pathology or reference laboratory by ASCO-CAP criteria.51 Tumors must\nbe HER-2/neu negative or equivocal by standard ICH/FISH or ICH/CISH\nmethodologies by ASCO-CAP criteria.52\n7. Patients must be Aromatase Inhibitor (AI) resistant, defined as:\n•\n•

\n

relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or,\nprogressive disease while receiving an aromatase inhibitor for metastatic\ndisease.

\n

Note: Patients may have received an endocrine agent (e.g., Tamoxifen)\nbetween the time of progression on an AI and registration.

\n

8. Patients who have received one prior cycle (dose on day 1 and day 15) of\nfulvestrant within 28 days of randomization are eligible so long as they meet\nother eligibility criteria.\n•

\n

patients previously treated with two or more prior cycles of fulvestrant are\nnot eligible.

\n

9. Patients must be female and postmenopausal, defined as:\n•\n•\n•\n•

\n

•

\n

a history of at least 12 months without spontaneous menstrual bleeding or,\nprior bilateral salpingo-oophorectomy, with or without hysterectomy or,\nage ≥ 55 years with a prior hysterectomy with or without oophorectomy or,\nage <55 years with a prior hysterectomy without oophorectomy or\nunknown status, with a documented FSH level in postmenopausal range\nwithin 4 weeks of randomization or,\nreceiving a gonadotropin releasing hormone analog (GnRH) to suppress\novarian function (e.g., goserelin 3.6 mg q 4 weeks).

\n

10. Patients may have received up to one prior systemic chemotherapy regimen\nfor metastatic disease.\n11. Adequate organ function, as evidenced by ALL the following obtained within 4\nweeks of randomization*:\n•\n•\n•\n•\n•\n•\n•

\n

•

\n

total white blood cell count (leukocytes, WBC) ≥ 3.0 x 109/L, absolute\nneutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L\nhemoglobin ≥ 9 g/dL\nserum bilirubin ≤ 1.5 x ULN\nAST or ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases)\nserum creatinine ≤ 1.5 x ULN\nserum albumin ≥ 3 g/dL\nfasting serum cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND fasting\ntriglycerides ≤ 2.5 x ULN. Note: In case one or both of these thresholds\nare exceeded, the patient can only be included after initiation of\nappropriate lipid lowering medication.\nPT with INR ≤ 1.5 (Anticoagulation is allowed if target INR ≤ 1.5 on a\nstable dose of warfarin or on a stable dose of LMW heparin for >2 weeks\nat time of randomization.)

\n

*Please see study table in Section 7.0 for labs that may need to be repeated\nwithin ≤ 7 days of Cycle 1 Day 1 (C1D1).\n12. Patients may have measurable disease, non-measurable disease (e.g., bone\nonly metastases), or both per RECIST Version 1.1 Criteria. Measurable\nlesions are defined as those that can be accurately measured in at least one\ndimension (longest diameter to be recorded) as ≥ 20 mm by chest x-ray, as ≥\n10 mm with CT scan, or ≥ 10 mm with calipers by clinical exam. All tumor\nmeasurements must be recorded in millimeters (or decimal fractions of\ncentimeters). Note: Tumor lesions that are situated in a previously irradiated\narea are not considered measurable.

\n

13. Patients with basal cell or squamous cell carcinoma of the skin or carcinoma\nin situ of the cervix within the past five years must have been treated with\ncurative intent. Patients with a history of prior malignancy are eligible provided\nthey were treated with curative intent and have been free of disease for >3\nyears.\nExclusion Criteria:\n1. Patients who have had any major surgery or significant traumatic injury within\n4 weeks of randomization, or have not recovered from the side effects of any\nmajor surgery (defined as requiring general anesthesia) or patients that may\nrequire major surgery during the course of the study are not eligible.\n(Placement of vascular access device will not be considered major surgery.)\n2. Patients may not be receiving any other investigational agents or have\nreceived any investigational agent within 4 weeks of randomization.\n3. Patients must not be receiving any concomitant anticancer treatment or have\nreceived anticancer treatment within 4 weeks of randomization (including\nchemotherapy, radiation therapy, antibody based therapy, etc.), with the\nfollowing exceptions:\n•

\n

Bisphosphonates, Zometa or Xgeva for bone metastases

\n

•

\n

Hormonal therapy (e.g., AI, Tamoxifen)

\n

•

\n

a GnRH analog is permitted if the patient had progressive disease on a\nGnRH analog plus a SERM or an AI; the GnRH analog may continue but\nthe SERM or AI must be discontinued.

\n

4. Patients must not have received prior treatment with an mTOR inhibitor\n(sirolimus, temsirolimus, everolimus).\n5. Patients must not be receiving chronic, systemic treatment with corticosteroids\nor another immunosuppressive agent greater than or equal to 5 mg\nprednisone or its equivalent daily. Topical or inhaled corticosteroids are\nallowed.\n6. Patients must not receive immunization with attenuated live vaccines within\none week of randomization or during the study period. Close contact with\nthose who have received attenuated live vaccines should be avoided during\ntreatment with everolimus. Examples of live vaccines include intranasal\ninfluenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\n7. Patients must not have current or a prior history of brain metastases or\nleptomeningeal disease. Patients must not have rapidly progressive, lifethreatening metastases. This includes patients with extensive hepatic\ninvolvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\n8. Patients must not have a known hypersensitivity/history of allergic reactions\nattributed to compounds of similar chemical or biologic composition to\neverolimus (or other rapamycins such as sirolimus, temsirolimus) or\nfulvestrant.

\n

9. Since everolimus may cause bone marrow suppression, patients with\ncongenital or acquired immune deficiency at increased risk of infection are not\neligible. This includes patients being treated with chronic immunosuppressive\nagents (including greater than or equal to 5 mg prednisone or its equivalent\ndaily), and patients with known HIV seropositivity.\n10. Patients must not have any impairment of gastrointestinal function or\ngastrointestinal disease that may significantly alter the absorption of\neverolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea,\nmalabsorption syndrome or small bowel resection).\n11. Patients must not have an active, bleeding diathesis.\n12. Patients must not have a history of any condition or uncontrolled intercurrent\nillness including, but not limited to, ongoing or active infection or psychiatric\nillness/social situations that in the opinion of the local investigator might\ninterfere with or limit the patient’s ability to comply with the protocol or pose\nadditional or unacceptable risk to the patient.\n13. Patients must not have any severe and/or uncontrolled medical conditions or\nother conditions that could affect their participation in the study such as:\n•

\n

Symptomatic congestive heart failure of New York Heart Association Class\nIII or IV (see Appendix D)

\n

•

\n

Unstable angina pectoris, myocardial infarction within 6 months of\nrandomization, serious uncontrolled cardiac arrhythmia or any other\nclinically significant cardiac disease

\n

•

\n

History of symptomatic pulmonary disease or non-malignant pulmonary\ndisease (e.g. COPD) requiring treatment. Such patients would be eligible if\nPFTs performed within 8 weeks of treatment noted a DLCO greater than\n50%.

\n

•

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN\n(Note: Optimal glycemic control should be achieved before starting trial\ntherapy.)

\n

•

\n

Active (acute or chronic) or uncontrolled severe infections

\n

•

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh\nClass C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors\nmust be done at screening for all patients. HBV DNA and HCV RNA PCR\ntesting are required at screening for all patients with a positive medical history\nbased on risk factors and/or confirmation of prior HBV/HCV infection. (see\nSection 7.1.1 for additional details).

\n

Randomization Procedures

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_18", - "extensionAttributes": [], - "name": "NCI_4", - "text": "

See section 4 Randomization Procedures.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_19", - "extensionAttributes": [], - "name": "NCI_4_1", - "text": "
\n

This study will be conducted in accordance with the ethical principles that have their\norigin in the current Declaration of Helsinki and will be consistent with applicable US\nregulatory requirements and International Conference on Harmonization Good\nClinical Practice (ICH GCP).\nThe study will be conducted in compliance with the protocol. The protocol and any\namendments and the patient informed consent will receive Institutional Review Board\n(IRB) approval prior to initiation of the study.\nFreely given written informed consent must be obtained from every patient or their\nlegally acceptable representative prior to clinical trial participation, including informed\nconsent for any screening procedures conducted to establish patient eligibility for the\ntrial.\nStudy personnel involved in conducting this trial will be qualified by education,\ntraining, and experience to perform their respective task(s). This trial will not use the\nservices of investigators or study personnel where sanctions have been invoked or\nwhere there has been scientific misconduct or fraud (e.g., loss of medical licensure,\ndebarment). Investigators are responsible for the conduct of the study at their study\nsite.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_20", - "extensionAttributes": [], - "name": "NCI_4_2", - "text": "
\n

Before a site may enter patients, protocol-specific regulatory and other documents\nmust be submitted to PrECOG as noted in study materials. Detailed information\nregarding document submission and control is provided to each site in separate study\nmaterials.\nOnce all required documents are received, reviewed and approved by PrECOG or\ntheir representative, a Study Reference Manual (SRM) will be forwarded to the site.\nAny changes to site regulatory documents must be submitted by the investigator to\nthe responsible party in a timely manner. Initial study drug shipment will not occur\nuntil the regulatory packet is complete. No patients will begin protocol therapy without\nformal randomization as per the process below.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_21", - "extensionAttributes": [], - "name": "NCI_4_3", - "text": "
\n

Patients must meet all of the eligibility requirements listed in Section 3 prior to\nrandomization. Treatment must begin ≤ 7 working days from randomization.\nAn eligibility checklist has been appended as an example to the protocol and a usable\nversion is available in separate study materials provided to the site. A confirmation of\neligibility assessment by the investigator/site will be performed during the\nrandomization process.\nInformation regarding stratification factors (performance status, measurable disease\nand prior chemotherapy) must be available at the time of randomization.

\n

Once it is determined that a patient meets all eligibility requirements, the patient will\nbe randomized to the study by site personnel using an electronic interactive web\nregistration (IWR) system. Full information regarding registration and randomization\nprocedures and guidelines can be found in the SRM provided to your site. All\ncorrespondence regarding patient randomization must be kept in the study records.

\n

Treatment Plan

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_22", - "extensionAttributes": [], - "name": "NCI_5", - "text": "

See section 5 Treatment Plan.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_23", - "extensionAttributes": [], - "name": "NCI_5_1", - "text": "
\n

Note: 1 cycle = 28 days.\nPatients must begin treatment within 7 working days of randomization.\nDisease evaluations will occur after every 12 weeks, +/- 1 week (which corresponds\nto every 3 treatment cycles) and patients will be treated until disease progression,\nunacceptable toxicity or for a total duration of 12 cycles (Induction Phase). Patients\nwith no evidence of progressive disease who remain on study after completing 12\ncycles will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule. Disease evaluations will continue to\noccur after every 12 weeks (every 3 treatment cycles), +/- 1 week, and patients may\ncontinue treatment until disease progression is documented or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to ≤ grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).\nSee Sections 8.1 and 8.2 for information on study drug procurement, storage,\npreparation, handling and destruction information.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_24", - "extensionAttributes": [], - "name": "NCI_5_2", - "text": "

See section 5.2 Dosing and Administration.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_25", - "extensionAttributes": [], - "name": "NCI_5_2_1", - "text": "
\n

Induction Phase:\nCycle 1 (28 day cycle)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections each dose)\non day 1 and 15.\nNote: Cycle 1 is the only time fulvestrant is given on day 15. If patient\npreviously received one cycle of fulvestrant (day 1 and day 15) prior to study\nentry as permitted in Inclusion Criteria #8, patient should receive fulvestrant 500\nmg on day 1 only.\nCycle 2, and thereafter (28 day cycles)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections) on day 1 of\nall subsequent cycles for a maximum of 12 cycles.\nContinuation Phase:\nPatients with no evidence of disease progression after completing 12 cycles are\nunblinded and continue fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until progression of disease or unacceptable toxicity.

\n

Fulvestrant will be obtained from commercial pharmacy stock.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_26", - "extensionAttributes": [], - "name": "NCI_5_2_2", - "text": "
\n

•

\n

The study drug everolimus/placebo will be self-administered (by the patients\nthemselves). The local investigator will instruct the patient to take the study drug\nexactly as specified in the protocol. Everolimus/placebo should be administered\norally once daily, preferably in the morning, at the same time every day with or\nwithout food. Everolimus/placebo tablets should be swallowed whole with a glass\nof water. The tablets must not be chewed or crushed. In cases where tablets\ncannot be swallowed, the tablets should be disintegrated in water just prior to\nbeing taken. Approximately 30 mL (2 tablespoons) of water should be put into a\nglass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should\nthen be drunk. If the patient vomits after taking the study drug, they should not\ntake another tablet that day. If the patient forgets to take the medication and\nremembers by 10 PM, they may take the dose. Otherwise, skip that dose and\nbegin as usual the next day.

\n

•

\n

Everolimus/placebo will be administered orally as once daily dose of 10 mg (two5 mg tablets) continuously from study day 1 until progression of disease or\nunacceptable toxicity for 12 cycles. See Section 5.5 regarding duration of therapy\n(including guidelines for treatment beyond Cycle 12).

\n

•

\n

If vomiting occurs, no attempt should be made to replace the vomited dose.

\n

•

\n

All dosages prescribed and dispensed to the patient and all dose changes during\nthe study must be recorded.

\n

•

\n

PrECOG, or their designee, will be responsible for blinding, drug randomization,\nand management of the electronic interactive web registration (IWR) system. Both\ntablets will be blinded and identified by kit number only. The IWR system will\nassign the proper kit to the patient based on the patient randomization. Conditions\nfor study drug will be described on the medication label.

\n

•

\n

Both everolimus and placebo will be provided by Novartis. Everolimus is\nformulated as tablets for oral administration of 5 mg strength. Both placebo and\neverolimus tablets are blister-packed under aluminum foil in units of 10 tablets per\nblister card, which should be opened only at the time of administration as drug is\nboth hygroscopic and light-sensitive.

\n

•

\n

Dose modifications should be made prior to dose calculation at the beginning of\neach cycle and reasons recorded in source documents and on appropriate case\nreport forms.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_27", - "extensionAttributes": [], - "name": "NCI_5_3", - "text": "

See section 5.3 Dose Modifications and Toxicity Management.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_28", - "extensionAttributes": [], - "name": "NCI_5_3_1", - "text": "
\n

Placebo

\n

CTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE)\nVersion 4.0 will be utilized for AE reporting. All appropriate treatment areas should\nhave access to a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0\ncan be downloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0. (see Appendix E).\nDose modifications for all drugs will be made using the general guidelines below.\n•

\n

All dose reductions are permanent. Fulvestrant will not be dose reduced.

\n

•

\n

Regardless of the reason for holding any study drug treatment, the maximum\nallowable length of treatment interruption is ≤ 3 weeks. If the delivery of any study\ndrug due to toxicity is delayed for more than 3 weeks, that drug should be\npermanently discontinued.

\n

•

\n

No more than 2 dose reductions for everolimus/placebo will be allowed. Further\nneed for dose reduction will result in discontinuation of that drug.

\n

•

\n

If dose is delayed due to toxicity, labs/toxicity should be reevaluated at least\nweekly until recovery to treatment levels, or as indicated in the dose modification\ntables.

\n

•

\n

Patients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression.

\n

•

\n

In unusual circumstances where fulvestrant must be discontinued prior to disease\nprogression due to intolerable fulvestrant-associated toxicity, the Medical Monitor\nshould be contacted.

\n

Table 5-0\nEverolimus or Placebo Dose Level Modification Guidelines\nEverolimus/Placebo

\n

Fulvestrant

\n

Starting dose

\n

10 mg daily\n(two- 5 mg tablets)

\n

500 mg

\n

Dose Level -1

\n

5 mg daily

\n

No reduction

\n

Dose Level -2

\n

5 mg every other day

\n

No reduction

\n

Table 5-1\nNon-Hematological Criteria for Dose-Modification in Case of Suspected\nEverolimus or Placebo Related Adverse Events and Re-Initiation of Everolimus\nor Placebo Treatment\nAdverse Event

\n

Action

\n

Non Hematological\nReactivation of HBV or HCV flare

\n

Please refer to Table 5-4 and Table 5-5.

\n

Non-Infectious Pneumonitis

\n

Please refer to Table 5-6.

\n

AST or ALT elevation

\n

Maintain current dose level.

\n

Grade 1 (>ULN - 3.0x ULN)\nGrade 2 (>3.0 - 5.0x ULN)\nAST or ALT elevation\nGrade 3 (>5.0 - 20.0 ULN)*

\n

Interrupt everolimus administration until resolution to ≤ grade 1\n(or ≤ grade 2 if baseline values were within the range of grade\n2). If resolution occurs ≤ 7 days, everolimus should be re-started\nat the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to ≤ grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.

\n

AST or ALT elevation\nGrade 4 (>20x ULN)*

\n

Intolerable Grade 2 mucositis\n(see Section 5.3.2.5)

\n

Interrupt everolimus administration until resolution to ≤ grade 1\n(or ≤ grade 2 if baseline values were within the range of grade\n2). If resolution occurs ≤ 7 days, everolimus should be re-started\nat one dose level lower. If resolution takes >7 days, discontinue\neverolimus.\nInterrupt everolimus administration until resolution to ≤ grade 1\nor baseline grade/value.\nIf resolution occurs within ≤ 7 days, everolimus should be restarted at the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to ≤ grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.\nPatients will be withdrawn from the study if they fail to recover to\n≤ grade 1 or baseline grade/value within 21 days.

\n

Grade 3 AE, except:\nhyperglycemia or\nhypertriglyceridemia or\nhypercholesterolemia\n(see Section 5.3.2.7)

\n

Interrupt everolimus administration until resolution to ≤ grade 1\nor baseline grade/value.\nReintroduce everolimus at one dose level lower, if available.\nPatients will be withdrawn from the study if they fail to recover to\n≤ grade 1 or baseline grade/value within 21 days.

\n

Any other Grade 4

\n

Hold everolimus until recovery to grade ≤ 1 or baseline value.\nReintroduce everolimus at one dose level lower, if available.

\n

Grade 3 or 4 clinical liver failure\n(asterixis or encephalopathy/\ncoma)

\n

Discontinue everolimus.

\n

Recurrence of intolerable Grade 2\nmucositis or Grade 3 event after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

Recurrence of Grade 4 after\ndose reduction

\n

Discontinue everolimus.

\n

Any non-hematologic toxicity\nrequiring\ninterruption\nof\neverolimus for >21 days

\n

Discontinue everolimus.

\n

* Should HCV flare be confirmed, the guidelines for flare must take precedence (Table 5-5).

\n

Table 5-2\nHematological Criteria for Dose-Modification in Case of Suspected Everolimus\nor Placebo Related Adverse Events and Re-Initiation of Everolimus or Placebo\nAdverse Event

\n

Action

\n

Hematological\nGrade 2 thrombocytopenia

\n

No action.

\n

(platelets <75, ≥ 50 x 10 /L)\nGrade 3 thrombocytopenia

\n

Interrupt everolimus until resolution to grade ≤1

\n

(platelets <50, ≥ 25 x 10 /L)

\n

If resolution occurs ≤ 7 days, reintroduce everolimus at the\ndose level prior to interruption.

\n

If resolution occurs >7 days, or event occurs within 28 days,\nreintroduce everolimus at one dose level lower, if available.\nGrade 4 thrombocytopenia

\n

(platelets <25 x 10 /L)\nGrade 3 neutropenia or anemia

\n

(neutrophil <1, ≥ 0.5 x 10 /L)

\n

Interrupt everolimus until recovery to grade ≤ 1. Then\nreintroduce everolimus at one dose level lower, if available.\nInterrupt everolimus until resolution to grade ≤1 or baseline\nvalue\nIf AE resolution occurs ≤ 7 days, reintroduce everolimus at\nthe same dose level.\nIf AE resolution occurs >7 days, or event occurs within 28\ndays, reintroduce everolimus at one dose level lower, if\navailable.

\n

Grade 4 neutropenia or anemia

\n

Interrupt everolimus until recovery to grade ≤ 1 or baseline\nvalue. Reintroduce everolimus at one dose level lower, if\navailable.*

\n

Febrile neutropenia

\n

Interrupt everolimus until resolution to grade ≤ 1 (or baseline\nvalue) and no fever. Reintroduce everolimus at one dose\nlevel lower, if available.*

\n

Recurrence of Grade 3 toxicity after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

*Recurrence of Grade 4 toxicity\n(including febrile neutropenia) after\ndose reduction

\n

Discontinue everolimus.

\n

*Any hematologic toxicity requiring\neverolimus interruption for >21\ndays

\n

Discontinue everolimus.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_29", - "extensionAttributes": [], - "name": "NCI_5_3_2", - "text": "
\n

The data described below reflect exposure to everolimus (n= 274) and placebo\n(n= 137) in a randomized Phase III study for the treatment of metastatic renal cell\ncarcinoma. In total, 165 patients were exposed to everolimus 10 mg/day for ≥ 4\nmonths. The median age of patients was 61 years (range 27 to 85). The most\ncommon adverse reactions (incidence ≥ 10%) were stomatitis, rash, fatigue, asthenia,\ndiarrhea, anorexia, nausea, mucosal inflammation, vomiting, cough, peripheral\nedema, infections, dry skin, epistaxis, pruritus, and dyspnea. The most common\ngrade 3-4 adverse reactions (incidence ≥ 2%) were infections, stomatitis, fatigue, and\npneumonitis.\nThe median duration of blinded study treatment was 141 days (range 19 to 451) for\npatients receiving everolimus and 60 days (range 21 to 295) for those receiving\nplacebo. The rates of treatment-emergent adverse reactions resulting in permanent\ndiscontinuation were 7% and 0% for the everolimus and placebo treatment groups,\nrespectively. Most treatment-emergent adverse reactions were grade 1 or 2 in\nseverity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 39%\nversus 7% of patients receiving everolimus and placebo, respectively. Deaths due to\nacute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were\nobserved on the everolimus arm.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral\ninfections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.

\n

Physicians and patients should be aware of the increased risk of infection with\neverolimus. Treat pre-existing infections prior to starting treatment with everolimus.\nWhile taking everolimus, be vigilant for symptoms and signs of infection; if a diagnosis\nof infection is made, institute appropriate treatment promptly and consider interruption\nor discontinuation of everolimus. If a diagnosis of invasive systemic fungal infection is\nmade, discontinue everolimus and treat with appropriate antifungal therapy.\nReactivation of Hepatitis B (HBV) has been observed in patients with cancer\nreceiving chemotherapy.53 Sporadic cases of Hepatitis B reactivation have also been\nseen in this setting with everolimus. Use of antivirals during anti-cancer therapy has\nbeen shown to reduce the risk of Hepatitis B virus reactivation and associated\nmorbidity and mortality.54 A detailed assessment of Hepatitis B/C medical history and\nrisk factors must be done for all patients at screening, with testing performed prior to\nthe first dose of everolimus.\nHypersensitivity reactions manifested by symptoms including, but not limited to,\nanaphylaxis, dyspnea, flushing, chest pain or angioedema (e.g. swelling of the\nairways or tongue, with or without respiratory impairment) have been observed with\neverolimus.\nElevations of serum creatinine, usually mild, have been reported in clinical trials.\nMonitoring of renal function, including measurement of blood urea nitrogen (BUN) or\nserum creatinine, is recommended prior to the start of everolimus therapy and\nperiodically thereafter.\nDecreased hemoglobin, lymphocytes, platelets and neutrophils have been reported in\nclinical trials. Monitoring of complete blood count is recommended prior to the start of\neverolimus therapy and periodically thereafter.\nThe use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus.\nHypophosphatemia, hypomagnesaemia, hyponatremia and hypocalcaemia have\nbeen reported as serious adverse reactions. Electrolytes should be monitored in\npatients treated with everolimus.\nTable 5-1 and Table 5-2 provide general recommendations for the management of\npatients, with suspected drug toxicities while on treatment with everolimus as singleagent therapy.\nMore detailed information regarding everolimus reported suspected toxicities and\nindividual cases are provided in the Investigator’s Brochure.\n5.3.2.1

\n

Management of Hepatitis Reactivation/Flare

\n

In cancer patients with hepatitis B, whether carriers or in chronic state, use of\nantivirals during anticancer therapy has been shown to reduce the risk of hepatitis B\nvirus (HBV) reactivation and associated HBV morbidity and mortality.54

\n

5.3.2.2

\n

Monitoring and\nReactivation

\n

Prophylactic

\n

Treatment

\n

for

\n

Hepatitis

\n

B

\n

Table 5-3 provides details of monitoring and prophylactic therapy according to the\nbaseline results of viral load and serologic markers testing.\nTable 5-3\nAction to be Taken for Positive Baseline Hepatitis B Results

\n

Test

\n

Result

\n

Result

\n

Result

\n

Result

\n

Result

\n

HBV-DNA

\n

+

\n

+ or -

\n

-

\n

-

\n

-

\n

HBsAg

\n

+ or -

\n

+

\n

-

\n

-

\n

-

\n

HBsAb

\n

+ or -

\n

+ or -

\n

+

\n

+ or -

\n

-

\n

and no prior HBV\nvaccination\nHBcAb

\n

+ or -

\n

Recommendation

\n

+ or -

\n

+ or -

\n

or + with prior\nHBV vaccination\n+

\n

No prophylaxis

\n

Prophylaxis treatment should be\nstarted 1-2 weeks prior to first dose of\nstudy drug

\n

Monitor HBV-DNA approximately\nevery 3-4 weeks

\n

No specific\naction

\n

Monitor HBV-DNA approximately\nevery 4-8 weeks

\n

Antiviral prophylaxis therapy should continue for at least 4 weeks after last dose of\nstudy drug.\nFor hepatitis B reactivation, definition and management guidelines see Table 5-4\nGuidelines for Management of Hepatitis B.

\n

Table 5-4\nGuidelines for Management of Hepatitis B\nHBV Reactivation (with or without clinical signs and symptoms)*\nFor patients with baseline\nresults:\nPositive HBV-DNA

\n

≤ baseline HBV-DNA levels

\n

Positive HBsAg\n-------------------------------------Reactivation is defined as:\nIncrease of 1 log in HBVDNA relative to baseline\nHBV-DNA value OR new\nappearance of measurable\nHBV-DNA\nFor patients with baseline\nresults:\nHBV-DNA

\n

AND\nInterrupt study drug administration until resolution:

\n

OR

\n

Negative\nHBsAg

\n

Treat: Start a second antiviral

\n

and

\n

If resolution occurs within ≤ 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Both antiviral\ntherapies should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue both antiviral therapies at least 4 weeks after last\ndose of study drug.\nTreat: Start first antiviral medication\nAND\nInterrupt study drug administration until resolution:\n≤ baseline HBV-DNA levels

\n

AND\nPositive HBsAb (with no\nprior history of vaccination\nagainst HBV), OR positive\nHBcAb\n------------------------------------Reactivation is defined as:\nNew\nappearance\nmeasurable HBV-DNA

\n

of

\n

If resolution occurs within ≤ 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Antiviral\ntherapy should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue antiviral therapy at least 4 weeks after last dose of\nstudy drug.

\n

* All reactivations of hepatitis B are to be recorded as grade 3 (CTEP CTCAE Version\n4.0 Metabolic Laboratory/Other: Viral Reactivation), unless considered life threatening\nby the investigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Reactivation).

\n

5.3.2.3

\n

Monitoring for Hepatitis C Flare

\n

The following two categories of patients should be monitored every 4-8 weeks for\nHCV reactivation:\n•

\n

Patients with detectable HCV RNA-PCR test at baseline.

\n

•

\n

Patients known to have a history of HCV infection, despite a negative viral load\ntest at baseline (including those that were treated and are considered ‘cured’).

\n

For definition of hepatitis C flare and the management guidelines, see Table 5-5\nGuidelines for Management of Hepatitis C.\nTable 5-5\nGuidelines for Management of Hepatitis C\nHCV Flare*\nFor patients with baseline results:

\n

Discontinue study drug.

\n

Detectable HCV-RNA:\nHCV Flare is defined as:\n˃2 log10 IU/mL increase in HCV-RNA\nAND\nALT elevation ˃5x ULN or 3x baseline level,\nwhichever is higher\nDiscontinue study drug.

\n

For patients with baseline results:\nKnowledge of past hepatitis C infection\nwith no detectable HCV-RNA:\nHCV Flare is defined as:\nNew appearance of detectable HCV-RNA\nAND\nALT elevation ˃5x ULN or 3x baseline level,\nwhichever is higher

\n

* All flares of hepatitis C are to be recorded as grade 3 (CTEP CTCAE Version 4.0.\nMetabolic Laboratory/Other: Viral Flare), unless considered life threatening by the\ninvestigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Flare).

\n

5.3.2.4

\n

Management of Skin Toxicity

\n

For patients with grade 1 toxicity, no specific supportive care is usually needed or\nindicated. Rash must be reported as an AE. Patients with grade 2 or higher toxicity\nmay be treated with the following suggested supportive measures at the discretion of\nthe investigator: oral minocycline, topical tetracycline, topical clindamycin, topical\nsilver sulfadiazine, diphenhydramine, oral prednisolone (short course), topical\ncorticosteroids, or pimecrolimus.

\n

5.3.2.5

\n

Management of Stomatitis/Oral Mucositis/Mouth Ulcers

\n

Patients with a clinical history of stomatitis/mucositis/mouth ulcers and those with\ngastrointestinal morbidity associated with mouth/dental infections, irritation of\nesophageal mucosa e.g. gastroesophageal reflux disease (GERD) and pre-existing\nstomatitis/mucositis must be monitored even more closely. Patients should be\ninstructed to report the first onset of buccal mucosa irritation/reddening to their study\nphysician immediately.\nSuggested prophylactic treatment for prevention of stomatitis/mucositis:\na) Use 15 mL baking soda/salt mouth rinse QID (swish and spit). Mix 1/3 teaspoon\nbaking soda and 1/3 teaspoon of salt in 1 quart of water (refrigeration is not\nneeded); do not eat or drink anything for 10 minutes after rinsing.\nb) Use 10 mL prescribed “miracle mouth wash’’ QID (swish and spit). For 16-ounce\nrecipe: 320 mL Benadryl solution, 2 g tetracycline powder, 80 mg hydrocortisone,\nand 40 mL nystatin suspension, quantity sufficient with water. Wait 10-15 minutes\nafter the baking soda/salt rinse before using “miracle mouthwash’’.55\nStomatitis/oral mucositis/mouth ulcers due to everolimus should be treated using local\nsupportive care. Please note that investigators in earlier trials have described the oral\ntoxicities associated with everolimus as mouth ulcers, rather than mucositis or\nstomatitis. If your examination reveals mouth ulcers rather than a more general\ninflammation of the mouth, please classify the adverse event as such. Please follow\nthe paradigm below for treatment of stomatitis/oral mucositis/mouth ulcers:\n1. For mild toxicity (Grade 1), use conservative measures as noted above, baking\nsoda/salt mouth rinse and “miracle mouth wash”.\n2. For more severe toxicity (Grade 2 in which case patients have pain but are able to\nmaintain adequate oral alimentation, or Grade 3 in which case patients cannot\nmaintain adequate oral alimentation), the suggested treatments are:\nIn addition to baking soda/salt mouth rinse and “miracle mouth wash”\nabove, topical analgesic mouth treatments (e.g., local anesthetics such as\nbenzocaine, butyl aminobenzoate, tetracaine hydrochloride, menthol, or phenol)\nwith or without topical corticosteroids, such as triamcinolone oral paste 0.1%\n(Kenalog in Orabase®) or Periogard® oral rinse.\n3. Agents containing hydrogen peroxide, iodine, and thyme derivatives may tend to\nworsen mouth ulcers. It is preferable to avoid these agents. Alcohol–containing\nrinses and tooth paste with sodium lauryl sulfate should also be avoided. Avoid\nacidic, spicy, hard, or crunchy foods, and consume foods that are tepid rather\nthan hot.55\n4. Antifungal agents must be avoided unless a fungal infection is diagnosed. In\nparticular, systemic imidazole antifungal agents (ketoconazole, fluconazole,\nitraconazole, etc.) should be avoided in all patients due to their strong inhibition of\neverolimus metabolism, thereby leading to higher everolimus exposures.\nTherefore, topical antifungal agents are preferred if an infection is diagnosed.\nSimilarly, antiviral agents such as acyclovir should be avoided unless a viral\ninfection is diagnosed.\nNote: Stomatitis/oral mucositis should be appropriately graded using the functional\ngrading given on the CTEP CTCAE Version 4.0.

\n

5.3.2.6

\n

Management of Diarrhea

\n

Appearance of grade 1-2 diarrhea attributed to study drug toxicity may be treated with\nsupportive care such as loperamide, initiated at the earliest onset (for example 4 mg\norally followed by 2 mg orally every 2 hours until resolution of diarrhea).\n5.3.2.7

\n

Management of Hyperlipidemia and Hyperglycemia

\n

Treatment of hyperlipidemia should take into account the pre-treatment status and\ndietary habits. Grade 2 or higher hypercholesterolemia (>300 mg/dL or 7.75 mmol/L)\nor grade 2 hypertriglyceridemia or higher (>2.5x upper normal limit) should be treated\nwith a 3-hydroxy-3-methyl-glutaryl (HMG)-CoA reductase inhibitor (e.g. atorvastatin,\npravastatin, fluvastatin) or appropriate triglyceride-lowering medication, in addition to\ndiet.\nNote: Concomitant therapy with fibrates and an HMG-CoA reductase inhibitor is\nassociated with an increased risk of a rare but serious skeletal muscle toxicity\nmanifested by rhabdomyolysis, markedly elevated creatine phosphokinase (CPK)\nlevels and myoglobinuria, acute renal failure and sometimes death. The risk versus\nbenefit of using this therapy should be determined for individual patients based on\ntheir risk of cardiovascular complications of hyperlipidemia.\nHyperglycemia has been reported in clinical trials. Monitoring of fasting serum\nglucose is recommended prior to the start of everolimus therapy and periodically\nthereafter. Optimal glycemic control should be achieved before starting trial therapy.\n5.3.2.8

\n

Management of Non-Infectious Pneumonitis

\n

Non-infectious pneumonitis is a class effect of rapamycin derivatives. Cases of noninfectious pneumonitis (including interstitial lung disease) have also been described in\npatients taking everolimus. Some of these have been severe and on rare occasions,\na fatal outcome was observed.\nA diagnosis of non-infectious pneumonitis should be considered in patients\npresenting with non-specific respiratory signs and symptoms such as hypoxia, pleural\neffusion, cough or dyspnea, and in whom infectious, neoplastic and other nonmedicinal causes have been excluded by means of appropriate investigations.\nPatients should be advised to report promptly any new or worsening respiratory\nsymptoms.\nPatients who develop radiological changes suggestive of non-infectious pneumonitis\nand have few or no symptoms may continue everolimus therapy without dose\nalteration. If symptoms are moderate (Grade 2), consideration should be given to\ninterruption of therapy until symptoms improve. The use of corticosteroids may be\nindicated. Everolimus may be reintroduced at a reduced dose until recovery to Grade\n1 or better.\nFor cases where symptoms of non-infectious pneumonitis are severe (Grade 3),\neverolimus therapy should be discontinued and the use of corticosteroids may be\nindicated until clinical symptoms resolve. Therapy with everolimus may be re-initiated\nat a reduced dose depending on the individual clinical circumstances.

\n

For non-infectious pneumonitis definition and management guidelines, see Table 5-6\nManagement of Non-Infectious Pneumonitis.\nTable 5-6\nManagement of Non-Infectious Pneumonitis\nWorst Grade\nPneumonitis

\n

Management of\nPneumonitis

\n

Required Investigations

\n

therapy

\n

Everolimus Dose\nAdjustment

\n

Grade 1

\n

CT scans with lung windows.

\n

No specific\nrequired

\n

is

\n

No dose adjustment required.\nInitiate appropriate monitoring.

\n

Grade 2

\n

CT scan with lung windows.\nConsider pulmonary function\ntesting includes: spirometry,\nDLCO, and room air O2\nsaturation at rest. Consider a\nbronchoscopy\nwith\nbiopsy\nand/or BAL. Monitoring at each\nvisit until return to ≤ grade 1.\nReturn to initial monitoring\nfrequency if no recurrence.

\n

Symptomatic only.\nConsider\ncorticosteroids\nand/or other supportive\ntherapy if symptoms are\ntroublesome.

\n

Rule out infection and consider\ninterruption of everolimus until\nsymptoms improve to Grade ≤\n1.\nRe-initiate everolimus at one\ndose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within ≤ 21\ndays.

\n

Grade 3

\n

CT scan with lung windows and\npulmonary\nfunction\ntesting\nincludes: spirometry, DLCO,\nand room air O2 saturation at\nrest. Monitoring at each visit\nuntil return to ≤ grade 1. Return\nto initial monitoring frequency if\nno recurrence. Bronchoscopy\nwith biopsy and/or BAL is\nrecommended.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule out infection and interrupt\neverolimus until symptoms\nimprove to Grade ≤ 1.\nConsider re-initiating everolimus at one dose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within ≤ 21\ndays.

\n

Grade 4

\n

CT scan with lung windows and\nrequired pulmonary function\ntesting, if possible, includes:\nspirometry, DLCO, and room air\nO2 saturation at rest. Monitoring\nat each visit until return to ≤\ngrade 1. Return to initial\nmonitoring frequency if no\nrecurrence. Bronchoscopy with\nbiopsy\nand/or\nBAL\nis\nrecommended if possible.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule\nout\ninfection\ndiscontinue everolimus.

\n

All interruptions or changes to study drug administration must be recorded.\nIt will be documented whether or not each patient completed the clinical study. If for\nany patient either study treatment or observations were discontinued the reason will\nbe recorded.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_30", - "extensionAttributes": [], - "name": "NCI_5_3_3", - "text": "
\n

Patients will be instructed not to take any additional medications (including over-thecounter products) during the course of the study without prior consultation with the\nlocal investigator. At each visit, the investigator will ask the patient about any new\nmedications he/she is or has taken after the start of the study drug.

\n

and

\n

Concomitant medications/significant non-drug therapies taken ≤ 28 days prior\nto start and after start of study drug, including physical therapy and blood\ntransfusions, should be reviewed.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_31", - "extensionAttributes": [], - "name": "NCI_5_3_4", - "text": "
\n

The following restrictions apply during the entire duration of the study:\n•

\n

No other investigational therapy should be given to patients.

\n

•

\n

No anticancer agents other than the study medication should be given to patients,\nwith the following exceptions:\no\no

\n

Bisphosphonates, Zometa, or Xgeva for bone metastases\na GnRH analog is permitted if the patient had progressive disease on a GnRH\nanalog plus a SERM or an AI; the GnRH analog may continue but the SERM\nor AI must be discontinued.

\n

•

\n

If any other anticancer agents are required for a patient then the patient must first\nbe withdrawn from the study.

\n

•

\n

Concurrent radiation therapy is prohibited, however palliative radiotherapy may be\nconsidered on a case by case basis after discussion with the Study Chair.

\n

•

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or\nanother immunosuppressive agent greater than or equal to 5 mg prednisone or its\nequivalent daily. Topical or inhaled corticosteroids are allowed.

\n

•

\n

The use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus. Examples of live\nvaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG,\nyellow fever, varicella and TY21a typhoid vaccines.

\n

•

\n

It is highly recommended that patients with positive HBV-DNA or HBsAg are\ntreated prophylactically with an antiviral for 1-2 weeks prior to receiving study drug\n(see Table 5-3).

\n

•

\n

The antiviral treatment should continue throughout the entire study period and for\nat least 4 weeks after the last dose of study drug.

\n

•

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA according to study visit schedule.

\n

•

\n

Oral contraceptives in preclinical and clinical data have shown everolimus to have\nCYP3A4 inhibitory activity rather than induction activity, induction of metabolism\nof contraceptive hormones by everolimus is unlikely. Consequently, administration\nof everolimus should not reduce the efficacy of oral contraceptives.

\n

•

\n

Grapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.

\n

5.3.5\n5.3.5.1

\n

Administration of Everolimus and CYP3A4 Inhibitors/\nInducers

\n

Inhibitors of CYP3A4 and/or PgP

\n

Everolimus is metabolized by CYP3A4 in the liver and to some extent in the intestinal\nwall.\nTherefore, the following are recommended:\nCo-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole,\nritonavir) or P-glycoprotein (PgP) should be avoided.\nCo-administration with moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole)\nor PgP inhibitors should be used with caution. If a patient requires co-administration\nof moderate CYP3A4 inhibitors or PgP inhibitors, reduce the dose of everolimus to 5\nmg every other day. Additional dose reductions to every other day may be required to\nmanage toxicities. If the inhibitor is discontinued, the everolimus dose should be\nreturned to the dose used prior to initiation of the moderate CYP3A4/PgP inhibitor\nafter a washout period of 2-3 days.\nGrapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.\nRefer to Appendix C Table 15-0 for list of medications known to induce/inhibit\nCYP3A4 and Table 15-1 for a list of medications known to inhibit PgP.\n5.3.5.2

\n

Inducers of CYP3A4 and/or PgP

\n

Avoid the use of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin,\nrifabutin, phenobarbital, St. John’s Wort). If a patient requires co-administration of\nstrong CYP3A4 inducers, an increase in the dose of everolimus up to twice the\ncurrently used daily dose should be considered, 5 mg increments. Enzyme induction\nusually occurs within 7-10 days; therefore everolimus dose should be increased by\none increment 7 days after the start of the inducer therapy. If no safety concerns are\nseen within the next 7 days, the dose can be increased again one additional\nincrement up to a maximum of twice the daily dose used prior to initiation of the\nstrong CYP3A4 inducer. The choice to adjust the dose of everolimus in a patient\nrequiring co-administration of strong CYP3A4 inducers will be done at the discretion\nof the treating investigator.\nThis dose adjustment of everolimus is intended to achieve similar AUC to the range\nobserved without inducers. However, there are no clinical data with this dose\nadjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is\ndiscontinued the everolimus dose should be returned to the dose used prior to\ninitiation of the strong CYP3A4/PgP inducer. Refer to Appendix C Table 15-0 for list\nof medications known to induce CYP3A4 and Table 15-1 for a list of medications\nknown to induce PgP.\nOral anticoagulants such as warfarin are CYP2C9 substrates and, as such, no\ninteraction with everolimus is expected. However, drug-drug interaction studies\nbetween macrolide antibiotics and warfarin have produced mixed outcomes and the\ndisparity in these findings has led to the conclusion that multiple factors may alter the

\n

clearance of warfarin. The co-administration of everolimus and oral anticoagulants is\npossible but should be subject to verification of coagulation (INR) once steady state is\nreached (after one week’s treatment).\nA comprehensive list of cytochrome P450 isoenzymes and CYP3A4 inhibitors,\ninducers, and substrates can be found at:\nhttp://medicine.iupui.edu/clinpharm/ddis/table.aspx. This\nrevised and should be checked frequently for updates.

\n

5.4

\n

website

\n

is

\n

continually

\n

Supportive Care

\n

All supportive measures consistent with optimal patient care will be given throughout\nthe study.\nThe clinical tolerance of the patient, the overall tumor response, and the medical\njudgment of the investigator will determine if it is in the patient’s best interest to\ncontinue or discontinue treatment. If treatment is discontinued due to any toxicity, the\npatient must be followed to monitor duration of toxicity, response and time to\nprogression or survival and initiation of any new systemic therapy.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_32", - "extensionAttributes": [], - "name": "NCI_5_3_5", - "text": "

See section 5.3.5 Administration of Everolimus and CYP3A4 Inhibitors/Inducers.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_33", - "extensionAttributes": [], - "name": "NCI_5_4", - "text": "

See section 5.4 Supportive Care.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_34", - "extensionAttributes": [], - "name": "NCI_5_5", - "text": "
\n

CR, PR, or SD patients will continue therapy per their induction arm randomized\nassignments until evidence of progressive disease, unacceptable toxicity occurs, or\nfor a total of 12 cycles (Induction Phase). Patients with no evidence of progressive\ndisease who remain on study after completing 12 cycles will be unblinded and\nproceed to the Continuation Phase. Patients in the Continuation Phase should\ncontinue to receive fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until disease progression or unacceptable toxicity.\nProtocol therapy will be discontinued for progressive disease at any time. Patients are\nfree to halt therapy at their request. Treatment may be discontinued if intercurrent comorbidities occur, which, in the opinion of the treating physician, would preclude safe\nadministration of study drugs.\nPatients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression. In unusual circumstances where fulvestrant must be discontinued prior\nto disease progression due to intolerable fulvestrant-associated toxicity, the medical\nmonitor should be contacted. All patients who have discontinued protocol therapy will\nbe followed for survival and for progression if protocol therapy was discontinued\nbecause of toxicity or for other reasons. All surviving patients who have discontinued\ninduction protocol therapy (fulvestrant and everolimus/placebo) for any reason will be\nfollowed for 30 days for study drug related (fulvestrant and/or everolimus/placebo)\ntoxicities to ≤ grade 1 (or if >grade 1, event must be permanent and stable).

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_35", - "extensionAttributes": [], - "name": "NCI_5_6", - "text": "
\n

Patients MUST be discontinued from study therapy AND be withdrawn from the study\nfor the following reasons:\n•

\n

Withdrawal of the patient’s consent (patient’s decision to withdraw for any reason)

\n

•

\n

Termination of the study by PrECOG

\n

•

\n

Any clinical adverse event, laboratory abnormality or intercurrent illness which, in\nthe opinion of the investigator, indicates that continued participation in the study is\nnot in the best interest of the subject

\n

•

\n

Inability to comply with protocol

\n

•

\n

Discretion of the investigator

\n

•

\n

Disease progression (patient will continued to be followed for survival)

\n

All subjects who discontinue treatment should comply with protocol specified followup procedures as outlined in Section 7.1.5.\nIf a subject is withdrawn before completing the study, the reason for withdrawal must\nbe entered on the appropriate case report form.

\n

Measurement of Effect

\n

6.1

\n

Antitumor Effect- Solid Tumors

\n

For the purposes of this study, patients should be re-evaluated for response every 12\nweeks, +/- 1 week. All baseline evaluations should be performed as closely as\npossible to the beginning of treatment and never more than four weeks before\nrandomization.\nResponse and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors\n(RECIST) guideline (Version 1.1).56 Changes in the largest diameter (unidimensional\nmeasurement) of the tumor lesions and the shortest diameter in the case of malignant\nlymph nodes are used in the RECIST criteria.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_36", - "extensionAttributes": [], - "name": "NCI_6", - "text": "

See section 6 Measurement of Effect.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_37", - "extensionAttributes": [], - "name": "NCI_6_1", - "text": "

See section 6.1 Antitumor Effect - Solid Tumors.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_38", - "extensionAttributes": [], - "name": "NCI_6_1_1", - "text": "
\n

Evaluable for toxicity: All patients will be evaluable for toxicity from the time of their\nfirst treatment with fulvestrant and everolimus/placebo. All patients will be followed for\n30 days for toxicity after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until recovery from all toxicity (to ≤ grade 1) attributed to study\ntherapy, whichever is longer (or if >grade 1, event must be permanent and stable).\nEvaluable for objective response: Only those patients who have measurable disease\npresent at baseline, have received at least one cycle of therapy, and have had their\ndisease re-evaluated will be considered evaluable for response. These patients will\nhave their response classified according to the definitions stated below. (Note:\nPatients who exhibit objective disease progression prior to the end of Cycle 1 will also\nbe considered evaluable.)\nEvaluable non-target disease response: Patients who have lesions present at\nbaseline that are evaluable but do not meet the definitions of measurable disease,\nhave received at least one cycle of therapy, and have had their disease re-evaluated\nwill be considered evaluable for non-target disease. The response assessment is\nbased on the presence, absence, or unequivocal progression of the lesions.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_39", - "extensionAttributes": [], - "name": "NCI_6_1_2", - "text": "
\n

Measurable lesions: are defined as those that can be accurately measured in at least\none dimension (longest diameter in the plane of measurement) is to be recorded with\na minimum size of:\n•

\n

≥ 20 mm by chest x-ray (if clearly defined and surrounded by aerated lung)

\n

•

\n

≥ 10 mm with CT scan (irrespective of scanner type) and MRI (no less than\ndouble the slice thickness and a minimum of 10 mm)

\n

•

\n

≥ 10 mm with calipers by clinical exam when superficial

\n

All tumor measurements must be recorded in millimeters (or decimal fractions of\ncentimeters).

\n

Note: Tumor lesions that are situated in a previously irradiated area, or in an area\nsubjected to other loco-regional therapy, are usually not considered measurable\nunless there has been demonstrated progression in the lesion.\nMalignant lymph nodes: to be considered pathologically enlarged and measurable, a\nlymph node must be ≥ 15 mm in short axis (perpendicular to longest diameter) when\nassessed by CT scan (CT scan slice thickness recommended to be no greater than 5\nmm). At baseline and in follow-up, only the short axis will be measured and followed.\nNon-measurable lesions: all other lesions (or sites of disease), including small lesions\n(longest diameter <10 mm or pathological lymph nodes with ≥ 10 to <15 mm short\naxis), are considered non-measurable disease. Leptomeningeal disease, ascites,\npleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast\ndisease, and abdominal masses/organomegaly (not followed by CT or MRI), are\nconsidered as non-measurable.\nNote: Cystic lesions that meet the criteria for radiographically defined simple cysts\nshould not be considered as malignant lesions (neither measurable nor nonmeasurable) since they are, by definition, simple cysts.\n‘Cystic lesions’ thought to represent cystic metastases can be considered as\nmeasurable lesions, if they meet the definition of measurability described above.\nHowever, if non-cystic lesions are present in the same patient, these are preferred for\nselection as target lesions.\nLytic bone lesions, with an identifiable soft tissue component, evaluated by CT or\nMRI, can be considered as measurable lesions if the soft tissue component otherwise\nmeets the definition of measurability noted above. Blastic bone lesions are nonmeasurable.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_40", - "extensionAttributes": [], - "name": "NCI_6_1_3", - "text": "
\n

All measurements should be taken and recorded in metric notation using a ruler or\ncalipers. All baseline evaluations should be performed as closely as possible to the\nbeginning of treatment and never more than 4 weeks before randomization.\nThe same method of assessment and the same technique should be used to\ncharacterize each identified and reported lesion at baseline and during follow-up.\nImaging-based evaluation is preferred to evaluation by clinical examination unless the\nlesion(s) being followed cannot be imaged but are assessable by clinical exam.\nClinical lesions: Clinical lesions will only be considered measurable when they are\nsuperficial (e.g., skin nodules and palpable lymph nodes) and ≥ 10 mm diameter as\nassessed using calipers (e.g., skin nodules). In the case of skin lesions,\ndocumentation by color photography, including a ruler to estimate the size of the\nlesion, is recommended.\nChest x-ray: Lesions on chest x-ray are acceptable as measurable lesions when they\nare clearly defined and surrounded by aerated lung. However, CT is preferable.

\n

Conventional CT and MRI: This guideline has defined measurability of lesions on CT\nscan based on the assumption that CT slice thickness is 5 mm or less. If CT scans\nhave slice thickness greater than 5 mm, the minimum size for a measurable lesion\nshould be twice the slice thickness. MRI is also acceptable in certain situations (e.g.\nfor body scans).\nUse of MRI remains a complex issue. MRI has excellent contrast, spatial, and\ntemporal resolution; however, there are many image acquisition variables involved in\nMRI, which greatly impact image quality, lesion conspicuity, and measurement.\nFurthermore, the availability of MRI is variable globally. As with CT, if an MRI is\nperformed, the technical specifications of the scanning sequences used should be\noptimized for the evaluation of the type and site of disease. Furthermore, as with CT,\nthe modality used at follow-up should be the same as was used at baseline and the\nlesions should be measured/assessed on the same pulse sequence. It is beyond the\nscope of the RECIST guidelines to prescribe specific MRI pulse sequence\nparameters for all scanners, body parts, and diseases. Ideally, the same type of\nscanner should be used and the image acquisition protocol should be followed as\nclosely as possible to prior scans. Body scans should be performed with breath-hold\nscanning techniques, if possible.\nPET-CT: At present, the low dose or attenuation correction CT portion of a combined\nPET-CT is not always of optimal diagnostic CT quality for use with RECIST\nmeasurements. However, if the site can document that the CT performed as part of a\nPET-CT is of identical diagnostic quality to a diagnostic CT (with IV and oral contrast),\nthen the CT portion of the PET-CT can be used for RECIST measurements and can\nbe used interchangeably with conventional CT in accurately measuring cancer\nlesions over time. Note, however, that the PET portion of the CT introduces additional\ndata which may bias an investigator if it is not routinely or serially performed.\nUltrasound: Ultrasound is not useful in assessment of lesion size and should not be\nused as a method of measurement. Ultrasound examinations cannot be reproduced\nin their entirety for independent review at a later date and, because they are operator\ndependent, it cannot be guaranteed that the same technique and measurements will\nbe taken from one assessment to the next. If new lesions are identified by ultrasound\nin the course of the study, confirmation by CT or MRI is advised. If there is concern\nabout radiation exposure at CT, MRI may be used instead of CT in selected\ninstances.\nEndoscopy, Laparoscopy: The utilization of these techniques for objective tumor\nevaluation is not advised. However, such techniques may be useful to confirm\ncomplete pathological response when biopsies are obtained or to determine relapse\nin trials where recurrence following complete response (CR) or surgical resection is\nan endpoint.\nTumor markers: Tumor markers alone cannot be used to assess response. If markers\nare initially above the upper normal limit, they must normalize for a patient to be\nconsidered in complete clinical response. Specific guidelines for both CA-125\nresponse (in recurrent ovarian cancer) and PSA response (in recurrent prostate\ncancer) have been published.57-59 In addition, the Gynecologic Cancer Intergroup has\ndeveloped CA-125 progression criteria which are to be integrated with objective\ntumor assessment for use in first-line trials in ovarian cancer.60

\n

Cytology, Histology: These techniques can be used to differentiate between partial\nresponses (PR) and complete responses (CR) in rare cases (e.g., residual lesions in\ntumor types, such as germ cell tumors, where known residual benign tumors can\nremain).\nThe cytological confirmation of the neoplastic origin of any effusion that appears or\nworsens during treatment when the measurable tumor has met criteria for response\nor stable disease is mandatory to differentiate between response or stable disease\n(an effusion may be a side effect of the treatment) and progressive disease.\nFDG-PET: While FDG-PET response assessments need additional study, it is\nsometimes reasonable to incorporate the use of FDG-PET scanning to complement\nCT scanning in assessment of progression (particularly possible 'new' disease). New\nlesions on the basis of FDG-PET imaging can be identified according to the following\nalgorithm:\n•\n•

\n

•

\n

Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of\nPD based on a new lesion.\nNo FDG-PET at baseline and a positive FDG-PET at follow-up:\no If the positive FDG-PET at follow-up corresponds to a new site of disease\nconfirmed by CT, this is PD.\no If the positive FDG-PET at follow-up is not confirmed as a new site of disease\non CT, additional follow-up CT scans are needed to determine if there is truly\nprogression occurring at that site (if so, the date of PD will be the date of the\ninitial abnormal FDG-PET scan).\no If the positive FDG-PET at follow-up corresponds to a pre-existing site of\ndisease on CT that is not progressing on the basis of the anatomic images,\nthis is not PD.\nFDG-PET may be used to upgrade a response to a CR in a manner similar to a\nbiopsy in cases where a residual radiographic abnormality is thought to represent\nfibrosis or scarring. The use of FDG-PET in this circumstance should be\nprospectively described in the protocol and supported by disease-specific medical\nliterature for the indication. However, it must be acknowledged that both\napproaches may lead to false positive CR due to limitations of FDG-PET and\nbiopsy resolution/sensitivity.

\n

Note: A ‘positive’ FDG-PET scan lesion means one which is FDG avid with an uptake\ngreater than twice that of the surrounding tissue on the attenuation corrected image.

\n

6.1.4\n6.1.4.1

\n

Response Criteria

\n

Evaluation of Target Lesions

\n

All measurable lesions up to a maximum of 2 lesions per organ and five lesions in\ntotal, representative of all involved organs, should be identified as target lesions and\nrecorded and measured at baseline. Target lesions should be selected on the basis\nof their size (those with the longest diameters), be representative of all involved\norgans, but in addition should be those that lend themselves to reproducible repeated\nmeasurements. It may be the case that, on occasion, the largest lesion does not lend\nitself to reproducible measurement in which circumstance the next largest lesion\nwhich can be measured reproducibly should be selected.

\n

The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions)\nfor all target lesions will be calculated and reported as the baseline sum diameters. If\nlymph nodes are to be included in the sum, then only the short axis is added into the\nsum. The baseline sum of the diameters will be used as reference to further\ncharacterize any objective tumor regression in the measurable dimension of the\ndisease.\nComplete Response (CR): Disappearance of all target lesions. Any pathological\nlymph nodes (whether target or non-target) must have reduction in short axis to <10\nmm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target\nlesions, taking as reference the baseline sum diameters.\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of\ntarget lesions, taking as reference the smallest sum on study (this includes the\nbaseline sum if that is the smallest on study). In addition to the relative increase of\n20%, the sum must also demonstrate an absolute increase of at least 5 mm over the\nnadir. (Note: the appearance of one or more new lesions is also considered\nprogression).\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient\nincrease to qualify for PD, taking as reference the smallest sum diameters while on\nstudy. (Note: a change of 20% or more that does not increase the sum of the\ndiameters by 5 mm or more is coded as stable disease).\n6.1.4.2

\n

Evaluation of Non-Target Lesions

\n

All other lesions or sites of disease including any measurable lesions over and above\nthe 5 target lesions should be identified as non-target lesions and should also be\nrecorded at baseline. Measurements of these lesions are not required, but the\npresence or absence of unequivocal progression of each should be noted throughout\nfollow-up.\nComplete Response (CR): Disappearance of all non-target lesions and normalization\nof tumor marker level. All lymph nodes must be non-pathological in size (<10 mm\nshort axis).\nNote: If tumor markers are initially above the upper normal limit, they must normalize\nfor a patient to be considered in complete clinical response.\nNon-CR/Non-PD: Persistence of one or more non-target\nmaintenance of tumor marker level above the normal limits.

\n

lesion(s)

\n

and/or

\n

Progressive Disease (PD): Appearance of one or more new lesions and/or\nunequivocal progression of existing non-target lesions. Unequivocal progression\nshould not normally trump target lesion status. It must be representative of overall\ndisease status change, not a single lesion increase.\nWhen the patient also has measurable disease, there must be an overall level of\nsubstantial worsening in non-target disease such that, even in the presence of SD or\nPR in target disease, the overall tumor burden has increased sufficiently to merit\ndiscontinuation of therapy. A modest “increase” in the size of one or more non-target\nlesions is usually not sufficient to qualify for unequivocal progression status. The

\n

designation of overall progression solely on the basis of change in non-target disease\nin the face of SD or PR of target disease will therefore be extremely rare.\nWhen the patient only has non-measurable disease, the increase in overall disease\nburden should be comparable in magnitude to the increase that would be required to\ndeclare PD for measurable disease: i.e., an increase in tumor burden from “trace” to\n“large”, an increase in nodal disease from “localized” to “widespread”, or an increase\nsufficient to require a change in therapy.\nAlthough a clear progression of “non-target” lesions only is exceptional, the opinion of\nthe treating physician should prevail in such circumstances, and the progression\nstatus should be confirmed at a later time by the review panel (or Principal\nInvestigator).\n6.1.4.3

\n

Evaluation of New Lesions

\n

The appearance of new lesions constitutes Progressive Disease (PD).\n6.1.4.4

\n

Evaluation of Patient’s Best Overall Response

\n

The best overall response is the best response recorded from the start of the\ntreatment until disease progression/recurrence (taking as reference for progressive\ndisease the smallest measurements recorded since the treatment started). The\npatient's best response assignment will depend on the achievement of both\nmeasurement and confirmation criteria.

\n

Table 6-0\nPatients with Measurable Disease (e.g., Target Disease)\nTarget\nLesions

\n

Non-Target\nLesions

\n

New\nLesions

\n

Overall\nResponse

\n

Best Overall Response when\nConfirmation is Required*

\n

CR

\n

CR

\n

No

\n

CR

\n

Confirmation not required

\n

CR

\n

Non-CR/NonPD

\n

No

\n

PR

\n

CR

\n

Not Evaluated

\n

No

\n

PR

\n

PR

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

PR

\n

SD

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

SD

\n

PD

\n

Any

\n

Yes or No

\n

PD

\n

Any

\n

PD**

\n

Yes or No

\n

PD

\n

Any

\n

Any

\n

Yes

\n

PD

\n

Confirmation not required

\n

Confirmation not required

\n

No prior SD, PR or CR

\n

*See RECIST 1.1 manuscript for further details on what is evidence of a new lesion.\n**In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as\ndisease progression.\nNote:

\n

Patients with a global deterioration of health status requiring discontinuation of treatment\nwithout objective evidence of disease progression at that time should be reported as\n“symptomatic deterioration”. Every effort should be made to document the objective\nprogression even after discontinuation of treatment.

\n

Table 6-1\nPatients with Non-Measurable Disease (e.g., Non-Target Disease)\nNon-Target Lesions

\n

New Lesions

\n

Overall Response

\n

CR

\n

No

\n

CR

\n

Non-CR/Non-PD

\n

No

\n

Non-CR/Non-PD*

\n

Not all evaluated

\n

No

\n

Not Evaluated

\n

Unequivocal PD

\n

Yes or No

\n

PD

\n

Any

\n

Yes

\n

PD

\n

*‘Non-CR/Non-PD’ is preferred over ‘stable disease’ for non-target disease since SD is increasingly\nused as an endpoint for assessment of efficacy in some trials so to assign this category when no\nlesions can be measured is not advised.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_41", - "extensionAttributes": [], - "name": "NCI_6_1_4", - "text": "

See section 6.1.4 Response Criteria.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_42", - "extensionAttributes": [], - "name": "NCI_6_1_5", - "text": "
\n

Duration of overall response: The duration of overall response is measured from the\ntime measurement criteria are met for CR or PR (whichever is first recorded) until the\nfirst date that recurrent or progressive disease is objectively documented (taking as\nreference for PD the smallest measurements recorded since the treatment started).\nThe duration of overall CR is measured from the time measurement criteria are first\nmet for CR until the first date that progressive disease is objectively documented.\nDuration of stable disease: Stable disease is measured from the start of the treatment\nuntil the criteria for progression are met, taking as reference the smallest\nmeasurements recorded since the treatment started, including the baseline\nmeasurements.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_43", - "extensionAttributes": [], - "name": "NCI_6_1_6", - "text": "
\n

PFS is defined as the duration of time from time of randomization to time of\nprogression or death, whichever occurs first. A subject who has neither progressed\nnor died will be censored on the date of last tumor assessment.

\n

Study Parameters

\n

TREATMENT MUST BEGIN ≤ 7 WORKING DAYS FROM RANDOMIZATION\nInduction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable

\n

Phase\n(until

\n

toxicity)

\n

Section 5.6^

\n

X

\n

Informed Consent

\n

X

\n

Medical History & Assessment of Baseline\nSigns and Symptoms

\n

X

\n

Physical Exam

\n

X

\n

a

\n

X

\n

a

\n

Vital Signs (Blood Pressure, Heart Rate,\nTemperature) and Weight\nECOG Performance Status

\n

Follow-Up Off\no\nTherapy\n(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a

\n

Eligibility Assessment

\n

Concomitant Meds (see Appendix C)

\n

£

\n

a

\n

X

\n

a

\n

X\n(includes Ht)\na

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

c

\n

X

\n

j

\n

X

\n

X

\n

i

\n

X

\n

X

\n

b

\n

Adverse Events Assessments

\n

X

\n

X

\n

a,i

\n

i

\n

Imaging Scans

\n

X

\n

X

\n

PT with INR

\n

X

\n

Urinalysis

\n

X

\n

CBC with differentials, Platelets

\n

X

\n

a

\n

X

\n

b

\n

X

\n

d

\n

X

\n

Serum Creatinine, Electrolytes (K, Na, Cl,\nCO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT),\nAlkaline Phosphatase, Total Bilirubin,\nMagnesium, Uric Acid.

\n

X

\n

a

\n

X

\n

b

\n

X

\n

X

\n

Fasting Glucose

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

Fasting serum Lipid Profile (triglycerides,\ntotal cholesterol, HDL and LDL)

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

X

\n

j

\n

i

\n

a\na

\n

c,d

\n

X

\n

d

\n

X

\n

k

\n

c

\n

X

\n

X

\n

X

\n

e

\n

X

\n

e

\n

X

\n

k

\n

k\nk

\n

j

\n

X

\n

i,m,o

\n

X

\n

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation\nPhase\n(until

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable\ntoxicity)

\n

Section 5.6^

\n

HBV-DNA, HbsAg, HBsAb, HBcAb, HCVRNA-PCR

\n

(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a,f\nf,g

\n

X

\n

f,h

\n

X

\n

X

\n

HCV RNA-PCR

\n

X

\n

PFTs with DLCO as medically indicated

\n

Follow-Up Off\no\nTherapy

\n

X

\n

HBV DNA\nStudy Drug Compliance (Pill Diary)

\n

£

\n

X

\n

f,g

\n

X

\n

f,h

\n

X

\n

X

\n

k\nk

\n

X

\n

l

\n

X

\n

n

\n

a: ≤ 4 weeks of randomization; if assessments required ≤ 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).\nb: ≤ 7 days prior to the start of C1D1.\nc: +/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends,\nbad weather or other unforeseen circumstances will be permitted.\nd: In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of\nhematologic recovery.\ne: +/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of\ntreatment.\nf: All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a\npositive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or\nHBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment\nshould continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.\ng: Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior\nto D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions.\nh: Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered ‘cured’) should have HCV RNAPCR testing performed on ≤ 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be\ndiscontinued if HCV flare is confirmed according to the guidance in Table 5-5.\ni: Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week\n(every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be\nrepeated once disease progression is documented.\nj: Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until ≤ grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last\ndose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.

\n

k: CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone.\nPatients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per\nlabeling guidelines.\nl: Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase.\nm: All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed\nduring the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented\nprogression.\nn: PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study).\no: Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented.\n* Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15\nof the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo.\n^ End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant.\n£ Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination\nwith everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to\nholidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_44", - "extensionAttributes": [], - "name": "NCI_7", - "text": "

See section 7 Study Parameters.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_45", - "extensionAttributes": [], - "name": "NCI_7_1", - "text": "
\n

Written informed consent must be obtained prior to any study required procedures that\nwould not have been performed as part of normal patient care at the site.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_46", - "extensionAttributes": [], - "name": "NCI_7_1_1", - "text": "
\n

Prior to randomization, patients will complete the informed consent process and have all\nrequired protocol assessments completed in order to assess eligibility requirements. All\nprocedures and an assessment of eligibility should be documented in the patient record.\nWithin ≤ 4 weeks of randomization to protocol therapy:\n•

\n

Medical history

\n

•

\n

Assessment of baseline signs and symptoms

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate and temperature, height and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Imaging scans for complete disease assessment. Care should be taken to continue\nto use the same evaluation method during the study as used for initial evaluation.\nSee Section 6 for additional details.

\n

•

\n

PT with INR

\n

•

\n

Urinalysis

\n

•

\n

CBC with differential and platelets

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

A detailed assessment of hepatitis B/C medical history and risk factors must be done for\nall patients. Patients with positive hepatitis B and/or hepatitis C test results must begin a\ncourse of antivirals within 1-2 weeks prior to the first dose of everolimus (as outlined in\nSection 5.3.2.2 and 5.3.2.3).\nTesting for hepatitis B viral load and serologic markers: HBV-DNA, HBsAg, HBsAb,\nHBcAb and HCV RNA-PCR are required at screening for all patients in the following risk\ncategories:\no All patients who have lived in Asia, Africa, Central and South America, Eastern\nEurope, Spain, Portugal, and Greece.\n[http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseasesrelated-to-travel/hepatitis-b.htm]

\n

o Patients with any of the following risk factors:\n• known or suspected past hepatitis B infection\n• blood transfusion(s) prior to 1990\n• current or prior IV drug users\n• current or prior dialysis\n• household contact with hepatitis B infected patient(s)\n• current or prior high-risk sexual activity\n• body piercing or tattoos\n• mother known to have hepatitis B\n• history suggestive of hepatitis B infection, e.g., dark urine, jaundice, right\nupper quadrant pain.\no Additional patients at the discretion of the investigator

\n

Testing for hepatitis C should be performed using quantitative RNA-PCR at screening for\nall patients in the following risk categories:\no\no\no\no\no\no\no\no

\n

known or suspected past hepatitis C infection (including patients with past\ninterferon ‘curative’ treatment)\nblood transfusions prior to 1990\ncurrent or prior IV drug users\ncurrent or prior dialysis\nhousehold contact of hepatitis C infected patient(s)\ncurrent or prior high-risk sexual activity\nbody piercing or tattoos\nAt the discretion of the investigator, additional patients may also be tested for\nhepatitis C.

\n

Final determination of eligibility and randomization to therapy should be done only after\nall assessments are completed.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_47", - "extensionAttributes": [], - "name": "NCI_7_1_2", - "text": "
\n

Day 1 of each cycle is defined as the day in which fulvestrant is given, including the first\nfulvestrant dose, third fulvestrant dose, and every dose thereafter (the second fulvestrant\ndoses is given on day 15 of the first cycle only). Note: If patient previously received one\ncycle of fulvestrant (day 1 and day 15) prior to study entry as permitted in Inclusion\nCriteria #8, patient should receive fulvestrant 500 mg on day 1 only.\nPatients will be assessed continually for toxicity and study continuation. Protocol therapy\ndoses should be calculated and modified as per Section 5. Assessment of disease for\nresponse should be performed as per Section 6.\nOne cycle in the Induction Phase is equal to 28 days. Patients are treated for a\nmaximum of 12 cycles in the Induction Phase.\n7.1.2.1

\n

Within 7 Days of Cycle 1 Day 1

\n

Note: The following assessments do not have to be repeated if the pre-study\nassessments were performed within ≤ 7 days of Cycle 1 Day 1.

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). AE assessment should begin after the first dose of study\nmedication has been administered.

\n

•

\n

CBC with differential and platelets

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

•

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered ‘cured’) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

7.1.2.2

\n

Cycle 1 Day 15

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature, and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). (see Section 5.3 for dose modification guidelines)

\n

•

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differentia and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.3

\n

Cycle 2 (and each subsequent cycle) Day 1

\n

•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously, see Section 5.3 for dose modification guidelines).

\n

•

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differential and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose (Cycle 2 Day 1, then every 12 weeks during treatment, and more\nfrequently as clinically indicated)

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) (Cycle 2\nDay 1, then every 12 weeks during treatment, and more frequently as clinically\nindicated)

\n

•

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered ‘cured’) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

•

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.4

\n

Every 12 Weeks

\n

•

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the Induction\nPhase. Scans should be repeated at the assigned intervals regardless of cycle or\ntreatment delays.

\n

•

\n

Fasting Glucose and Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL\nand LDL) to be done every 12 weeks during Induction Phase (and more frequently\nas clinically indicated)

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_48", - "extensionAttributes": [], - "name": "NCI_7_1_3", - "text": "
\n

End of Induction Phase <OR> End of Treatment

\n

All patients will have the following assessments completed whether they are moving into\nthe Continuation Phase or no longer will be receiving treatment and are moving into\nFollow-Up Off-Therapy due to reasons noted in Sections 5.5 or 5.6. The assessments\nshould be completed within 30 days of last dose of fulvestrant and before moving from\nthe Induction Phase into the Continuation Phase or before moving directly into the\nFollow-Up Phase. (Note: Day 1 of the Continuation Phase should start on D29 of cycle\n12 if the assessments below are completed in order to maintain the 28 day fulvestrant\ndosing schedule).\n•

\n

Physical examination

\n

•

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

•

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

•

\n

Assessment of ECOG performance status

\n

•

\n

Adverse event assessment. All patients will be followed for toxicity assessment for\n30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo)\nor until resolution to ≤ grade 1 attributed to study therapy (or if >grade 1, event must\nbe permanent and stable). Serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus/placebo are not reported unless the event may be\nrelated to everolimus/placebo.

\n

•

\n

Tumor evaluation if due per every 12 weeks +/- 1 week (every 3 months) evaluation\nschedule.

\n

•

\n

CBC with differential and platelets

\n

•

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

•

\n

Fasting Glucose

\n

•

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

•

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

Patients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule until disease progression or\nunacceptable toxicity.\nPatients that are moving from the Induction Phase into Follow-Up Off Therapy should\nnot receive further investigational therapies for at least 30 days after the last dose of\nstudy drug, if possible, in order to eliminate overlapping toxicity.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_49", - "extensionAttributes": [], - "name": "NCI_7_1_4", - "text": "
\n

Patients with no evidence of disease progression after 12 cycles of treatment (Induction\nPhase) will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally randomized\nto placebo) or in combination with everolimus (if originally randomized to everolimus) at\nthe same dose and schedule until disease progression is documented or unacceptable\ntoxicity. Once progression is documented, patients will move into Follow-Up Off Therapy.\nOne cycle in the Continuation Phase is equal to 28 days. Day 1 of the Continuation\nPhase should start 28 days (D29) after the last dose of fulvestrant was given during\nCycle 12 in the Induction Phase.\nAll adverse events that are related to fulvestrant and/or everolimus will be followed for 30\ndays after the last dose of study therapy (fulvestrant and/or everolimus) until ≤ grade 1\nor if the grade is >1, the event must be permanent and stable.\n•

\n

CBC and chemistry may be used to monitor any ongoing toxicities, but are not\nrequired for patients that receive fulvestrant alone.

\n

•

\n

Patients who continue fulvestrant in combination with everolimus should periodically\nhave CBC, chemistries, fasting glucose, fasting serum lipids, HBV DNA, and HCV\nRNA-PCR per labeling guidelines.

\n

•

\n

Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the\nContinuation Phase.

\n

After the Continuation Phase, serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus are not reported unless the event may be related to\neverolimus.\n7.1.4.1\n•

\n

Every 12 Weeks

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the\nContinuation Phase until disease progression is documented.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_50", - "extensionAttributes": [], - "name": "NCI_7_1_5", - "text": "
\n

All patients, including those who discontinue protocol therapy, will be followed for 3\nyears from the time of randomization. Patients that did not progress during the Induction\nor Continuation Phase will continue to have imaging scans completed every 3 months\nuntil documented progression. Patients will then be followed for survival. Initiation of any\nnew systemic therapy will also be documented. Patients that have adverse events\nrelated to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last\ndose of study therapy (fulvestrant and/or everolimus/placebo) until ≤ grade 1 or if the\ngrade is >1, the event must be permanent and stable. Serious adverse events >30 days\nafter last dose of fulvestrant and/or everolimus/placebo are not reported unless the event\nmay be related to everolimus/placebo.

\n

Drug Formulation and Procurement

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_51", - "extensionAttributes": [], - "name": "NCI_8", - "text": "

See section 8 Drug Formulation and Procurement.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_52", - "extensionAttributes": [], - "name": "NCI_8_1", - "text": "

See section 8.1 Everolimus.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_53", - "extensionAttributes": [], - "name": "NCI_8_1_1", - "text": "
\n

Full instructions for investigator sites and investigational pharmacies will be available in\nseparate protocol-specific documents. The supply of everolimus or placebo will be\nshipped directly to the local investigator. Drug ordering procedures will be provided in\nsupplemental study materials.\n8.1.1.1

\n

How Supplied

\n

Everolimus and an identically appearing placebo will be provided by Novartis.\nEverolimus is formulated as tablets for oral administration of 5 mg strength. Tablets are\nblister-packed under aluminum foil in units of 10 tablets per blister card, which should be\nopened only at the time of administration as drug is both hygroscopic and light-sensitive.\nEach tablet contains as inactive ingredients: butylhyroxytoluene/butylated\nhydroxytoluene (BHT), magnesium stearate, lactose monohydrate, hypromellose,\ncrospovidone and lactose anhydrous.\nMedication labels will comply with US legal requirements and be printed in English. They\nwill supply no information about the patient. The storage conditions for study drug will be\ndescribed on the medication label.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_54", - "extensionAttributes": [], - "name": "NCI_8_1_2", - "text": "
\n

Everolimus should be stored at room temperature between 20°C to 25°C (68°F to 77°F).\nAll investigational products must be kept in a secure place under appropriate storage\nconditions. A description of the appropriate storage and shipment conditions is specified\non the investigational product label and investigator brochure. The stored study drug\nsupplies must be accessible to authorized staff only. The storage area must also have\nadequate control of temperature in order to maintain stability and potency of study drug\nsupplies. The tablets should be stored in the original pack until use. For further\ninformation, investigators should refer to the current Investigators Brochure (IB).

\n

8.1.3\n8.1.3.1

\n

Handling, Dispensing and Administration

\n

Handling

\n

No special precautions are necessary when handling intact tablets. Avoid contact with\nskin and eyes. Wash hands after use. The risk to health in normal handling of tablets is\nvery low. Exposure to dust from crushed tablets may cause adverse health effects.\n8.1.3.2

\n

Dispensing

\n

Drug should be dispensed in original packaging. If other packaging is required by\ninstitutional policy, this procedure will need to be approved by PrECOG, or their\ndesignee, prior to proceeding. The PrECOG Site Contact should be contacted for further

\n

instruction. Investigational product records should be kept as per Section 8.1.5 and\ninstitutional policies.\n8.1.3.3

\n

Administration

\n

Patients should be instructed to take their assigned, once-a-day oral dose of\neverolimus/placebo at the same time each morning.\n•

\n

Everolimus/placebo dose may be taken with or without food.

\n

•

\n

Patients should be instructed to swallow the capsules whole and not chew them.

\n

•

\n

Vomited doses should not be replaced.

\n

•

\n

If the patient forgets to take the medication and remembers by 10 PM, they may take\nthe dose. Otherwise, skip that dose and begin as usual the next day.

\n

In cases where tablets cannot be swallowed, the tablets should be disintegrated in water\njust prior to being taken. Approximately 30 mL (2 tablespoons) of water should be put\ninto a glass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should then be\ndrunk.\nPatients should be given instructions on correct dosing based on study requirements\nand toxicity management (dose modifications). All changes to recommended dosing\nregimen/schedule should be documented in the patient record. Documentation of patient\ninstructions for dosing changes should also be in source records.\nPatients should be instructed to record the reason for any missed doses and report to\nthe investigator at the next visit. If a dose is vomited, that dose should not be replaced,\n(and recorded as a vomited dose).\nCompliance with therapy will be assessed at the beginning of each cycle. Patients will be\ngiven a diary (see Appendix F for an Example Patient Pill Diary) for recording of doses of\nstudy drug as provided by each study site. A copy of the patient diary will be provided to\nsites in study materials.\n8.1.3.4

\n

Special Instructions for Unblinding

\n

Patients on study therapy and all site study staff will remain blinded as to the assignment\nof everolimus or placebo. Patients who have not had progressive disease and remain on\nstudy after 12 cycles are unblinded and continue fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule in the Continuation Phase. If an emergency\nsituation arises and the patient must be unblinded during the Induction Phase (Cycles 112), the Medical Monitor for the study must be consulted.\nEmergency Unblinding for Patients during the Induction Phase (within Cycles 1-12):\nUnblinding is a serious action that should be restricted in order to limit potential study\nbias. The breaking of the blinding code in all cases will render the patient off-protocol.\nThe Medical Monitor for the study must be involved in the decision to unblind and must\ngrant approval for unblinding any individual. Requests for unblinding will only be\nconsidered in the event of an emergency or severe adverse reaction where identification

\n

of the medication is considered important for the welfare of the patient, and the rationale\nfor unblinding is applicable to the situation. All patients should be provided emergency\nmedical care by the treating physician and appropriate therapies for the medical\nemergency should be initiated prior to the request for unblinding.\nFor example, a Serious Adverse Event (SAE) possibly, probably or definitely related to\nthe study drug occurs during the trial and the treatment of the SAE would be influenced\nby whether he/she received everolimus or placebo. Unblinding is typically not necessary\nif the medical management of the patient would not be materially altered by knowledge\nof the treatment assignment. In the event that accidental unblinding occurs, the Principal\nInvestigator should report the occurrence promptly to the Medical Monitor and document\nthe incident in the patient records. All unblinding will be recorded as a protocol deviation.\nIf a participant is in a life-threatening situation in which knowledge of the treatment is\ncrucial to care AND the Medical Monitor cannot be reached immediately, the PM should\nbe contacted to facilitate the unblinding process. A report including the unblinding details\nwill be generated after the patient has been unblinded and will be sent to the site for\ndocumentation (refer to Study Reference Manual for Unblinding Process). Report\ninformation will include but is not limited to:\n•\n•\n•\n•\n•

\n

ID number of the participant whose treatment assignment was unblinded\nDate of unblinding and reconciliation of study drug in site and patient records\nReason for unblinding, including initial SAE report\nPerson responsible for unblinding\nList of persons who are unblinded (e.g. study staff)

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_55", - "extensionAttributes": [], - "name": "NCI_8_1_3", - "text": "

See section 8.1.3 Handling, Dispensing and Administration.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_56", - "extensionAttributes": [], - "name": "NCI_8_1_4", - "text": "
\n

The most common adverse reactions (incidence ≥ 10%) reported for everolimus include\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, cough, peripheral edema, infections, dry skin, epistaxis, pruritus, and dyspnea.\nThe most commonly reported grade 3-4 adverse reactions (incidence ≥ 2%) reported for\neverolimus include infections, stomatitis, fatigue, and pneumonitis.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_57", - "extensionAttributes": [], - "name": "NCI_8_1_5", - "text": "
\n

Investigational product dispensing record/inventory logs and copies of signed packing\nlists must be maintained at the investigational site for everolimus. It is the responsibility\nof the Investigator to ensure that a current record of investigational product disposition is\nmaintained at each study site where investigational product is stored and/or dispensed.\nRecords must comply with applicable regulations and guidelines, and should include:\n•

\n

Amount received and placed in storage area.

\n

•

\n

Amount currently in storage area.

\n

•

\n

Label ID number or batch number.

\n

•

\n

Dates and initials of person responsible for each investigational product inventory\nentry/movement.

\n

•

\n

Amount dispensed to and returned by each patient, including unique patient\nidentifiers.

\n

•

\n

Amount transferred to another area for dispensing or storage.

\n

•

\n

Non-study disposition (e.g., wasted, broken).

\n

•

\n

Amount returned to manufacturer, if applicable

\n

•

\n

Amount destroyed at study site, if applicable

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_58", - "extensionAttributes": [], - "name": "NCI_8_1_6", - "text": "
\n

Investigational product should be maintained at the site for accountability purposes.\nSites will be referred to the study pharmacy manual for instructions regarding the return\nor destruction of everolimus study drug supply (site’s drug destruction policy must be\nreviewed and approved by PrECOG before any study drug can be destroyed at a site).\nPatients will be instructed to return all blister packs (empty or partially used) to the study\ncenter.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_59", - "extensionAttributes": [], - "name": "NCI_8_2", - "text": "
\n

8.2.1

\n

Packaging and Labeling

\n

Fulvestrant is commercially available and approved and is indicated for the treatment of\nHR-positive metastatic breast cancer in postmenopausal women whose disease has\nreturned or progressed following antiestrogen therapy.\nInvestigators should review the approved Package Insert (PI) (http://www.faslodex.com/\nfaslodex-prescribing-info/index.aspx) for full information on storage, handling,\npreparation and stability.\nFulvestrant is supplied as:\nOne clear neutral glass (Type 1) barrel containing 250 mg/5 mL (50 mg/mL) Injection for\nintramuscular injection and fitted with a tamper-evident closure. NDC 0310-0720-50.\n(Note: Patients will be receiving 500 mg doses IM therefore 2 injections of 250 mg will\nbe required for one dose.)\nThe syringes are presented in a tray with polystyrene plunger rod and safety needles\n(SafetyGlide™) for connection to the barrel.\nEach injection contains as inactive ingredients: Alcohol, USP, Benzyl Alcohol, NF, and\nBenzyl Benzoate, USP as co-solvents, and Castor Oil, USP as a co-solvent and release\nrate modifier.

\n

8.2.2\n8.2.2.1

\n

Handling and Dispensing

\n

Storage Requirements/Stability

\n

Refrigerate 2°-8°C (36°-46°F). To protect from light, store in the original carton until time\nof use.\n8.2.2.2

\n

Preparation and Administration

\n

Fulvestrant should be disposed of or destroyed as per written institutional policies and\nper recommendations in the current approved Package Insert. To help avoid infectious\ndiseases due to accidental needle sticks, contaminated needles should not be recapped\nor removed, unless there is no alternative or that such action is required by a specific\nmedical procedure.\nWARNING: - Do not autoclave safety needle before use. Hands must remain\nbehind the needle at all times during use and disposal.\nDirections:\n(Source: Faslodex® Package Insert 1621903 Rev 12/11)\n• Remove the glass syringe barrel from tray and check that it is not damaged\n• Remove perforated patient record label from syringe\n• Peel open the safety needle outer packaging.\n• Break the seal of the white plastic cover on the syringe luer connector to remove the\ncover with the attached rubber tip cap (Figure 1).\n• Twist to lock the needle to the luer container.\n• Remove the needle sheath. Pull shield straight off needle to avoid damaging needle\npoint.\n• Remove excess gas from the syringe.\n• Administer intramuscularly slowly in the buttock. Administer injection following\npackage instruction. For user convenience, the needle ‘bevel up’ position is\norientated to the lever arm (Figure 3).\n• Immediately activate needle protection device upon withdrawal from patient by\npushing lever arm completely forward until the tip is fully covered (Figure 2).\n• Visually confirm that the lever arm has fully advanced and the needle tip is covered.\nIf unable to activate, discard immediately into an approved sharps collector.\nActivation of the protective mechanism may cause minimal splatter of fluid that may\nremain on the needle after injection. For greatest safety, use a one-handed\ntechnique and activate away from self and others.\n• If the 250 mg/5 mL formulation is used, repeat the above steps for the second\nsyringe. After single use, discard in an approved sharps collector in accordance with\napplicable regulations and institutional policy.\n• Review the official package insert for more information regarding the use of the\nSafetyGlide Needle.

\n

8.2.3

\n

Side Effects

\n

The most commonly reported adverse experiences in the Faslodex® treatment groups,\nregardless of the investigator’s assessment of causality, were gastrointestinal symptoms\n(including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back\npain, vasodilatation (hot flushes), and pharyngitis.\nInjection site reactions with mild transient pain and inflammation were seen with\nFaslodex® and occurred in 7% of patients (1% of treatments) given the single 5 mL\ninjection (predominately European Trial) and in 27% of patients (4.6% of treatments)\ngiven the 2 x 2.5 mL injections (North American Trial).\nOther adverse events reported as drug-related and seen infrequently (<1%) include\nthromboembolic phenomena, myalgia, vertigo, leukopenia and hypersensitivity reactions\nincluding angioedema and urticaria. Vaginal bleeding has been reported infrequently\n(<1%), mainly in patients during the first 6 weeks after changing from existing hormonal\ntherapy to treatment with Faslodex® If bleeding persists, further evaluation should be\nconsidered.

\n

Statistical Considerations

\n

The efficacy endpoints will be assessed among all eligible patients who receive protocol\ntherapy. Safety endpoints will be assessed among all treated patients, regardless of\neligibility.

\n

9.1

\n

Primary Efficacy Endpoint

\n

The primary efficacy endpoint is progression-free survival (PFS). PFS is defined as the\ntime from randomization to documented disease progression or death. Based on results\nfrom the CONFIRM trial, median PFS among patients with AI-resistant disease on\nfulvestrant alone is 5.4 months. AI resistant disease is defined as: patients who have\neither relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or have progressive disease while receiving an\naromatase inhibitor for metastatic disease. (Patients previously treated with two or more\nprior cycles of fulvestrant are not eligible. Patients who have received one prior cycle\n(day 1 and day 15) of fulvestrant within 28 days of randomization are eligible so long as\nthey meet other eligibility criteria). Randomization will be 1:1, stratified for balancing\npurposes using ECOG performance status (0 vs. 1), presence of measurable disease\n(yes vs. no), and prior chemotherapy (yes vs. no).\nWe hypothesize that the addition of everolimus to fulvestrant will result in an\nimprovement in median PFS to 9.2 months. A one-sided stratified logrank test with a\ntype I error rate of 10% will be used to evaluate whether the addition of everolimus\nshows promising improvement in PFS relative to fulvestrant alone. To have 90% power\nto detect the hypothesized improvement, enrollment of approximately 120 eligible\npatients (60 per arm) and full information of 98 events (deaths or progressions) are\nrequired. Allowing up to 10 patients to be ineligible or to not start study treatment,\napproximately 130 patients will need to be enrolled. With accrual of approximately 130\npatients in 12 months, the required 98 events are expected to occur approximately 12\nmonths after accrual is completed. Other endpoints that will be evaluated include clinical\nbenefit rate (proportion stable or responding for at least 6 months), objective response\nrate (CR+PR), time to progression (TTP; defined as the time from randomization until\nprogression of the disease), and overall survival (OS; defined as the time from\nrandomization until death or censored at the date of last follow-up).\nPFS will be evaluated using the stratified log-rank test described above, as will TTP and\nOS. Kaplan-Meier plots will be used to graphically portray these time-to-event endpoints.\nClinical benefit rate and objective response rates will be compared between arms using\nFisher’s exact tests. 90% exact binomial confidence intervals on the rates will be\nprovided.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_60", - "extensionAttributes": [], - "name": "NCI_9", - "text": "

See section 9 Statistical Considerations.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_61", - "extensionAttributes": [], - "name": "NCI_9_1", - "text": "

See section 9.1 Primary Endpoint Analysis.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_62", - "extensionAttributes": [], - "name": "NCI_9_2", - "text": "
\n

A descriptive comparison of overall toxicity and of grade 3-4 toxicity in the combination\narm and the fulvestrant arm will be provided. Assuming 65 patients are treated on each\narm, the exact binomial 90% confidence interval on the rate of severe toxicities will be no\nwider than 22% (+/- 11%). The probabilities of observing a rare toxicity (true rate of 5%)\nwill be 96% on each arm.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_63", - "extensionAttributes": [], - "name": "NCI_9_3", - "text": "
\n

Other endpoints that will be evaluated include overall survival, time to progression, and\nobjective response rate. Overall survival will be characterized using Kaplan-Meier plots\nand other descriptive metrics. The objective response rate will be provided for each arm,\nwith 90% exact binomial confidence intervals. Median time to progression will be\nestimated for each arm.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_64", - "extensionAttributes": [], - "name": "NCI_10", - "text": "
\n

10 Adverse Event Reporting

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_65", - "extensionAttributes": [], - "name": "NCI_10_1", - "text": "
\n

10.1 Collection of Safety Information\nAdverse Event (AE) is defined as any new untoward medical occurrence or worsening\nof a pre-existing medical condition in a patient administered a medicinal product in a\nclinical investigation and which does not necessarily have a causal relationship with this\ntreatment. An AE can therefore be any unfavorable and unintended sign (including an\nabnormal laboratory finding, for example), symptom, or disease temporally associated\nwith the use of a product (investigational or marketed), whether or not considered related\nto the product (investigational or marketed). Abnormal laboratory values or test results\nconstitute adverse events only if they induce clinical signs and symptoms, are\nconsidered clinically significant, or require therapy.\nFollowing written consent to participate in the study, all serious AEs should be collected\non a patient. The collection of non-serious AE information should begin at initiation of\ntherapy.\nAll identified AEs must be recorded and described on the appropriate page of the Case\nReport Form (CRF). If known, the diagnosis of the underlying illness or disorder should\nbe recorded, rather than individual symptoms. The following information should be\ndocumented for all AEs: date of onset and resolution, severity of the event; the\ninvestigator’s opinion of the relationship to investigational product (see definitions\nbelow); treatment required for the AE; cause of the event (if known); and information\nregarding resolution/outcome.\nSeverity\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0 (see Appendix E).\nAttribution\nThe following categories and definitions of causal relationship or attribution to study drug\nshould be used to assess Adverse Events:\n•

\n

Definite: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to withdrawal of study drug (dechallenge) and recurs with\nrechallenge, if clinically feasible.

\n

•

\n

Probable: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to dechallenge. Rechallenge is not required.

\n

•

\n

Possible: There is a reasonable causal relationship between the study drug and the\nevent. Dechallenge information is lacking or unclear.

\n

•

\n

Unlikely: There is doubtful causal relationship between the study drug and the event.

\n

•

\n

Unrelated: There is clearly not a causal relationship between the study drug and the\nevent or there is a causal relationship between another drug, concurrent disease, or\ncircumstances and the event.

\n

Categories ‘Definite’, ‘probable’ and ‘possible’ are considered study drug related.\nCategories ‘not likely’ and ‘not related’ are considered not study drug-related.\nThe development of a new cancer should be regarded as an AE. New cancers are those\nthat are not the primary reason for administration of study treatment and have been\nidentified after inclusion of the patient into the clinical study.\nAEs related to fulvestrant and/or everolimus/placebo will be followed for 30 days\nafter the last dose of study therapy (fulvestrant and/or everolimus/placebo) until ≤\ngrade 1 or stabilization, and reported as SAEs if they become serious. Serious\nadverse events >30 days after last dose of fulvestrant and/or everolimus/placebo\nare not reported unless the event may be related to everolimus/placebo.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_66", - "extensionAttributes": [], - "name": "NCI_10_2", - "text": "
\n

10.2 Handling of Serious Adverse Events (SAEs)

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_67", - "extensionAttributes": [], - "name": "NCI_10_2_1", - "text": "
\n

10.2.1 SAE Definitions\nA serious AE is any untoward medical occurrence occurring after informed consent is\ngranted or that at any dose:\n•

\n

results in death,

\n

•

\n

is life-threatening (defined as an event in which the study patient was at risk of death\nat the time of the event; it does not refer to an event which hypothetically might have\ncaused death if it were more severe),

\n

•

\n

requires inpatient hospitalization or causes prolongation of existing hospitalization,

\n

•

\n

results in persistent or significant disability/incapacity,

\n

•

\n

is a congenital anomaly/birth defect,

\n

•

\n

is an important medical event (defined as a medical event(s) that may not be\nimmediately life-threatening or result in death or hospitalization but, based upon\nappropriate medical and scientific judgment, may jeopardize the patient or may\nrequire intervention (e.g., medical, surgical) to prevent one of the other serious\noutcomes listed in the definition above.)\nExamples of such events include, but are not limited to, intensive treatment in an\nemergency room or at home for allergic bronchospasm; blood dyscrasias or\nconvulsions that do not result in hospitalization.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_68", - "extensionAttributes": [], - "name": "NCI_10_2_2", - "text": "
\n

10.2.2 SAE Reporting Requirements\nAll serious adverse events require expeditious handling and reporting to comply with\nregulatory requirements. The Principal Investigator has the obligation to report all\nserious adverse events to PrECOG, or their designee. A study specific SAE form to be\nutilized for SAE reporting will be provided with supplemental study materials.

\n

All serious adverse events that occur either during the study period (Induction and/or\nContinuation) or within 30 days of discontinuation of dosing regardless of event\nrelationship to the study medications (fulvestrant and/or everolimus/placebo) should be\nreported to PrECOG, or their designee within 24 hours of the investigator’s knowledge of\nthe event or, when the event occurs on a weekend or national holiday, at the latest on\nthe following working day. All deaths during treatment or within 30 days following\ncompletion of active protocol therapy must be reported. Serious adverse events that\noccur >30 days from last dose of fulvestrant and/or everolimus/placebo and are judged\nrelated to the everolimus/placebo (definitely, probably or possibly) must be reported to\nPrECOG, or their designee using the 24 hour timeline noted above. If only limited\ninformation is initially available, follow-up reports are required. Serious adverse events\nthat occur >30 days from last dose of fulvestrant and are judged to be related to\nfulvestrant will follow normal reporting mechanisms for commercial drugs.\nSAE Hotline Phone Number:\n610-354-0404 during normal business hours (8:30 AM – 5 PM EST)\n484-574-2367 after normal business hours (after 5 PM EST)\nSAE Fax Number:\n888-801-8795\nPrECOG will notify Novartis Pharmaceuticals Drug Safety and Epidemiology Department\n(DS&E) of all SAE’s within 24 hours of the Awareness Date. Relevant follow-up\ninformation will be provided to Novartis DS&E as soon as it becomes available.\nIn addition, Investigators should also report event(s) to their IRB as required.\nCollection of complete information concerning SAEs is extremely important. Full\ndescriptions of each event will be followed. Thus, follow-up information which becomes\navailable as the SAE evolves, as well as supporting documentation (e.g., hospital\ndischarge summaries and autopsy reports), should be collected subsequently, if not\navailable at the time of the initial report, and immediately sent using the same procedure\nas the initial SAE report. The original and all follow-up SAEs form must be kept on file at\nthe study site.\nFor Comparator Drugs/Secondary Suspects (Concomitant Medications), all serious\nadverse experiences will be forwarded to the product manufacturer by PrECOG (or their\ndesignee), if applicable.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_69", - "extensionAttributes": [], - "name": "NCI_10_3", - "text": "
\n

10.3 Reporting of Second Primary Cancers\nNew cancers are those that are not the primary reason for administration of study\ntreatment and have been identified after inclusion of the patient into the clinical study.\nAll cases of new primary cancers that occur during or after protocol treatment must be\nreported to PrECOG within 30 days of diagnosis, regardless of relationship to protocol\ntreatment. Secondary primary malignancies should also be reported as a SAE. This form\nis not for use for reporting recurrence or development of metastatic disease. A copy of\nthe pathology report, if applicable, should be sent, if available.\nNote: Once data regarding survival and remission status are no longer required by the\nprotocol, no follow-up data should be submitted, including the PrECOG Second Primary\nForm.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_70", - "extensionAttributes": [], - "name": "NCI_11", - "text": "
\n

11 Administrative

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_71", - "extensionAttributes": [], - "name": "NCI_11_1", - "text": "
\n

11.1 Protocol Compliance\nThe study shall be conducted as described in this protocol. All revisions to the protocol\nmust be discussed with, and be prepared by PrECOG and/or representatives. The\nInvestigator should not implement any deviation or change to the protocol or consent\nwithout prior review and documented approval from PrECOG and/or representatives and\nthe IRB of an amendment, except where necessary to eliminate an immediate hazard(s)\nto study patients.\nIf a deviation or change to the approved protocol is implemented to eliminate an\nimmediate hazard(s) prior to obtaining IRB approval, notification will be submitted to the\nIRB for review and approval as soon as possible afterward. Documentation of approval\nsigned by the chairperson or designee of the IRB(s) should be in the study records. If\nPrECOG and/or representatives provides an amendment that substantially alters the\nstudy design or increases the potential risk to the patient; the consent form must be\nrevised and submitted to the IRB(s) for review and approval; the revised form must be\nused to obtain consent from patients currently enrolled in the study if they are affected\nby the amendment; and the new form must be used to obtain consent from new patients\nprior to study entry. Information as to who investigators should send correspondence will\nbe provided in additional study documents.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_72", - "extensionAttributes": [], - "name": "NCI_11_2", - "text": "
\n

11.2 Institutional Review Board\nBefore study initiation, the Investigator must have written and dated approval from their\nrespective IRB for the protocol, consent form, patient recruitment materials/process and\nany other written information to be provided to patients. The Investigator should also\nprovide the IRB with a copy of the Investigator Brochure or product labeling, and any\nupdates.\nThe Investigator should provide the IRB with reports, updates, and other information\n(e.g., Safety Updates, amendments, and administrative letters) according to regulatory\nrequirements, IRB or study site procedures.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_73", - "extensionAttributes": [], - "name": "NCI_11_3", - "text": "
\n

11.3 Informed Consent Procedures\nInvestigators must ensure that patients who volunteer for clinical trials or their legally\nacceptable representative are clearly and fully informed about the purpose, potential\nrisks and other information.\nA protocol specific informed consent form (ICF) template will be provided to sites.\nPreparation of the site-specific consent form is the responsibility of the site Investigator\nand must include all applicable regulatory and IRB requirements, and must adhere to\nGood Clinical Practice (GCP) and to the ethical principles that have their origin in the\nDeclaration of Helsinki. All changes to the ICF template will be approved by PrECOG\nand/or their representatives prior to implementation.\nIn accordance with the Health Information Portability and Accountability Act (HIPAA), the\nconsent process will also include written authorization by patients to release medical\ninformation to allow PrECOG and/or its agents, regulatory authorities, and the IRB of

\n

record at the study site for access to patient records and medical information relevant to\nthe study, including the medical history. This will be documented in the informed consent\nform or other approved form obtained at the time of informed consent per institutional\npolicies. This form should also be submitted to PrECOG and/or its agents for review\nprior to its implementation.\nThe Investigator must provide the patient or legally acceptable representative with a\ncopy of the consent form and written information about the study in the language in\nwhich the patient is most proficient. The language must be non-technical and easily\nunderstood. The Investigator should allow time necessary for patient or patient's legally\nacceptable representative to inquire about the details of the study, then informed\nconsent must be signed and personally dated by the patient or the patient's legally\nacceptable representative and by the person who conducted the informed consent\ndiscussion. The patient or legally acceptable representative should receive a copy of the\nsigned informed consent and any other written information provided to study patients\nprior to patient's participation in the trial. The investigator is responsible for assuring\nadequate documentation of this process and for storage and maintenance of the original\nsigned consent form for each patient/subject.\nThe informed consent and any other information provided to patients or the patient's\nlegally acceptable representative, should be revised whenever important new\ninformation becomes available that is relevant to the patient's consent, and should\nreceive IRB approval prior to use. The Investigator, or a person designated by the\nInvestigator should inform the patient or the patient's legally acceptable representative of\nall pertinent aspects of the study and of any new information relevant to the patient's\nwillingness to continue participation in the study. This communication should be\ndocumented in the patient record. During a patient's participation in the trial, any updates\nto the consent form and any updates to the written information will be provided to the\npatient.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_74", - "extensionAttributes": [], - "name": "NCI_11_4", - "text": "
\n

11.4 Safety Communication\nInvestigators will be notified of all AEs that are serious, unexpected, and definitely,\nprobably, or possibly related to the investigational product. Upon receiving such notices,\nthe Investigator must review and retain the notice with the Investigator Brochure and\nsubmit a copy of this information to the Institutional Review Board (IRB) according to\nlocal regulations. The Investigator and IRB will determine if the informed consent\nrequires revision. The Investigator should also comply with the IRB procedures for\nreporting any other safety information. All revisions should be submitted to PrECOG\nand/or agents for review.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_75", - "extensionAttributes": [], - "name": "NCI_11_5", - "text": "
\n

11.5 Monitoring\nRepresentatives and agents of PrECOG and, as applicable to the study, the\nmanufacturer of Investigational Product must be allowed to visit all study site locations\nperiodically to assess the data, quality and study integrity. The purpose of this visit is to\nreview study records and directly compare them with source documents and discuss the\nconduct of the study with the Investigator, and verify that the facilities remain acceptable.\nThe study may be evaluated by other auditors and government inspectors who must be\nallowed access to electronic Case Report Forms (eCRFs), source documents and other

\n

study files. The investigator must notify PrECOG of any scheduled visits by regulatory\nauthorities, and submit copies of all reports. Information as to who investigators should\nnotify of an audit or where to address questions will be provided in additional study\nmaterials. Monitoring of drug accountability will also occur.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_76", - "extensionAttributes": [], - "name": "NCI_11_6", - "text": "
\n

11.6 Study Records\nAn Investigator is required to maintain adequate regulatory files with corresponding\ncommunication and approvals, accurate histories, observations and other data on each\nindividual treated. Full details of required regulatory documents will be provided in\nadditional study materials. Data reported on the eCRF must be consistent with the\nsource documents as part of the patient record.\nThe confidentiality of records that could identify patients must be protected, respecting\nthe privacy and confidentiality rules in accordance with the applicable regulatory\nrequirement(s).\nA study specific signature record will be maintained to document signatures and initials\nof all persons at a study site who are authorized to make entries and/or corrections on\neCRFs as well as document other study-specific roles.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_77", - "extensionAttributes": [], - "name": "NCI_11_7", - "text": "
\n

11.7 Electronic Case Report Form (eCRF) Information\nAdditional information regarding eCRF instructions, timelines for data entry/submission\nand query completion can be found in supplemental materials provided to the site. Sites\nwill be expected to complete eCRFs as per the schedule provided and submit all\nrelevant data as per the specified timelines. All items recorded on eCRFs must be found\nin source documents.\nThe completed eCRF must be promptly reviewed, electronically signed, and dated by a\nqualified physician who is an Investigator or Sub-Investigator.\nInstructions for management of patients who do not receive any protocol therapy:\nIf a patient is randomized and does not receive any assigned protocol treatment,\nbaseline, Serious Adverse Event and follow-up data will still be entered and must be\nsubmitted according to the eCRF instructions. Document the reason for not starting\nprotocol treatment on the appropriate electronic off-treatment form.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_78", - "extensionAttributes": [], - "name": "NCI_11_8", - "text": "
\n

11.8 Records Retention\nFDA Regulations (21CFR 312.62) require clinical investigators to retain all trial-related\ndocumentation, including source documents for the periods described below for studies\nperformed under a US IND:\n•\n•\n•

\n

two years after the FDA approves the marketing application, or\ntwo years after the FDA disapproves the application for the indication being studied,\nor\ntwo years after the FDA is notified by the sponsor of the discontinuation of trials and\nthat an application will not be submitted.

\n

The Investigator must retain investigational product disposition records, copies of eCRFs\n(or electronic files), and source documents for the maximum period required by

\n

applicable regulations and guidelines, or Institution procedures, whichever is longer but\nnot less than 5 years from the completion of the study. The Investigator must contact\nPrECOG and/or representatives prior to destroying any records associated with the\nstudy.\nInformation as to who investigators should contact for questions will be provided in\nadditional study documents. PrECOG and/or representatives will notify the Investigator\nwhen the trial records for this study are no longer needed.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_79", - "extensionAttributes": [], - "name": "NCI_12", - "text": "
\n

12 Glossary of Terms and List of Abbreviations\nTerm

\n

Definition

\n

4E-BP1

\n

4E-Binding Protein

\n

Ab\nADPKD

\n

Antibodies\nAutosomal Dominant Polycystic Kidney Disease

\n

ADR

\n

Adverse Drug Reaction

\n

AE(s)

\n

Adverse Events(s)

\n

Akt/PKB

\n

Protein Kinase B

\n

AI

\n

Aromatase Inhibitor

\n

Alk Phos

\n

Alkaline Phosphatase

\n

ALT/SGPT\nAMD

\n

Alanine Aminotransferase/Glutamic Pyruvic Transaminase/Serum GlutamicPyruvic Transaminase\nAge-Related Macular Degeneration

\n

ANC

\n

Absolute Neutrophil Count

\n

ASCO-CAP

\n

American Society of Clinical Oncology-College of American Pathologist

\n

AST/SGOT

\n

Aspartate\nAminotransferase/Glutamic\nGlutamic-Oxaloacetic Transaminase

\n

AUC\n°C

\n

Area Under the Concentration-Time Curve\ndegrees Celsius

\n

Ca

\n

Calcium

\n

CBC

\n

Complete Blood Count

\n

CBR

\n

Clinical Benefit Rate

\n

CI

\n

Confidence Interval

\n

CISH

\n

Chromogenic In Situ Hybridization

\n

Cl

\n

Chloride

\n

cm\nCmax

\n

centimeter\nMaximum plasma concentration

\n

CO2

\n

Carbon Dioxide

\n

CoA

\n

Coenzyme A

\n

COPD

\n

Chronic Obstructive Pulmonary Disease

\n

CPK

\n

Creatine Phosphokinase

\n

CR

\n

Complete Response

\n

CRC

\n

Colorectal Cancer

\n

Creat

\n

Creatinine

\n

CRF

\n

Case Report Form

\n

CRO

\n

Contract Research Organization

\n

CT

\n

Computer Tomography

\n

CTC

\n

Common Toxicity Criteria

\n

Oxaloacetic

\n

Transaminase/Serum

\n

Term

\n

Definition

\n

CTCAE

\n

The CTEP Common Terminology Criteria for Adverse Events (CTCAE)

\n

CTEP

\n

Cancer Therapy Evaluation Program

\n

CYP3A4

\n

CytochromeP450 3A4 Isoenzyme

\n

DLBCL

\n

Diffuse Large B Cell Lymphoma

\n

DLCO

\n

Diffusing Capacity of the Lung for Carbon Monoxide

\n

DLT

\n

Dose Limiting Toxicity

\n

DNA

\n

Deoxyribonucleic Acid

\n

DS&E

\n

Drug Safety and Epidemiology

\n

eCRF\ne.g.\nER

\n

Electronic Case Report Form\nexempli gratia (for example)\nEstrogen Receptor

\n

FSH\nEU\nFDA

\n

Follicle Stimulating Hormone\nEuropean Union\nFood and Drug Administration\nFluorine-18-2-fluoro-Deoxy-D-Glucose Positron Emission Tomography

\n

FDG-PET\nFISH\nFKBP-12\nFSH

\n

Fluorescence In Situ Hybridization\nFK506-Binding Protein 12\nFollicle Stimulating Hormone

\n

GBM

\n

Glioblastoma Multiforme

\n

GCP

\n

Good Clinical Practice

\n

GEP-NET

\n

Gastroenteropancreatic Neuroendocrine Tumor

\n

GERD

\n

Gastroesophageal Reflux Disease

\n

GF

\n

Growth Factor

\n

GI

\n

Gastrointestinal

\n

GnRH

\n

Gonadotropin-Releasing Hormone

\n

HBV

\n

Hepatitis B Virus

\n

HBcAb

\n

Hepatitis B core Antibodies

\n

HBsAb

\n

Hpatitis B surface Antibodies

\n

HbsAg

\n

Hepatitis B surface Antigen

\n

HCC

\n

Hepatocellular Cancer

\n

HCV

\n

Hepatitis C Virus

\n

HER-2

\n

Human Epidermal Growth Factor Receptor 2

\n

HIF-1

\n

Hypoxia-Inducible Factor-1

\n

HIPAA

\n

Health Information Portability and Accountability Act

\n

HIV

\n

Human Immunodeficiency Virus

\n

HMG

\n

3-hydroxy-3-methyl-glutaryl

\n

HR

\n

Hormone-Receptor

\n

HUVECS

\n

Human Umbilical Endothelial Cells

\n

IB

\n

Investigator Brochure (also called Investigator Drug Brochure, IDB)

\n

Term

\n

Definition

\n

ICF

\n

Informed Consent Form

\n

ICH

\n

International Conference on Harmonization

\n

IND\nINN

\n

Investigational New Drug\nInternational Non-Proprietary Name

\n

INR

\n

International Normal Ratio

\n

IRB\nIU

\n

Institutional Review Board\nInternational Unit

\n

IV

\n

Intravenous

\n

IWR

\n

Interactive Web Randomization

\n

K

\n

Potassium

\n

kg

\n

Kilogram

\n

L

\n

Liter

\n

LDH

\n

Lactate Dehydrogenase

\n

LDL

\n

Low-Density Lypoproteins

\n

LFTs

\n

Liver Function Tests

\n

LLN

\n

Lower Limit Normal

\n

LMW\nLog10

\n

Low Molecular Weight\nDecadic logarithm (common logarithm)

\n

M

\n

Meter

\n

mg\nMg

\n

Milligram\nMagnesium

\n

min

\n

minute

\n

mL

\n

Milliliter

\n

mRCC

\n

Metastatic Renal Cell Carcinoma

\n

MRI

\n

Magnetic Resonance Imaging

\n

mTOR

\n

mammalian Target of Rapamycin

\n

N\nNa

\n

Number of patients or observations\nSodium

\n

N/A

\n

Not Applicable

\n

NCI

\n

National Cancer Institute

\n

NSCLC

\n

Non-Small Cell Lung Cancer

\n

Ng

\n

Nanogram

\n

µM\nNm

\n

Nanometer

\n

nM

\n

Nanomolar

\n

OS

\n

Overall Survival

\n

PD

\n

Progressive Disease\nPhosphoinositide 3-kinase

\n

P13K

\n

Micromolar

\n

Term

\n

Definition

\n

PI

\n

Package Insert

\n

PBMC

\n

Peripheral Blood Mononuclear Cells

\n

PCR\nPET

\n

Polymerase Chain Reaction\nProton Emission Tomography

\n

PFS\nPgP

\n

Progression Free Survival\nP-glycoprotein

\n

PK

\n

Pharmacokinetic

\n

Plt

\n

Platelet

\n

PNET

\n

Pancreatic Neuroendocrine Tumor

\n

PO\nPR

\n

Per Oral (by mouth route of administration)\nPartial Response

\n

PR-positive

\n

Progesterone Receptor

\n

PSA

\n

Prostate-Specific Antigen

\n

PTEN

\n

Phosphatase and Tensin Homolog Deleted on Chromosome 10

\n

PT/PTT

\n

Prothrombin Time/Partial Thromboplastin Time

\n

QC\nQD

\n

Quality Control\nOnce Daily\nthe interval between the beginning of the Q-wave and the end of the T-wave on\nan electrocardiogram

\n

QT\nQTc

\n

corrected Q to T wave interval on electrocardiogram

\n

RCC\nRECIST\nRNA

\n

Renal Cell Carcinoma\nResponse Evaluation Criterion Solid Tumors\nRibonucleic Acid\nResponse Rate

\n

RR\nRTK\nS6K1\nSAE\nSC\nSCLC\nSD\nSEGA\nSERD

\n

Receptor Tyrosine Kinase\nS6 Kinase 1\nSerious Adverse Event\nSubcutaneous\nSmall Cell Lung Cancer\nStable Disease\nSubependymal Giant Cell Astrocytoma\nSelective Estrogen Receptor Down-Regulators

\n

SERM

\n

Selective Estrogen Receptor Modulator

\n

T Bili\nTKI

\n

Total Bilirubin\nTyrosine Kinase Inhibitor

\n

TS

\n

Tuberous Sclerosis

\n

TSC

\n

Tuberous Sclerosis Complex

\n

TTP

\n

Time to Progression

\n

Term

\n

Definition

\n

TUNNEL

\n

Terminal Deoxynucleotidyl Transferase (TdT)-Mediated dUTP-Biotin Nick End\nLabeling

\n

µg

\n

microgram

\n

ULN

\n

Upper Limit Normal

\n

US

\n

United States

\n

USP\nVEGF

\n

United States Pharmacopeia\nVascular Endothelial Growth Factor

\n

WBC

\n

White Blood Cell Count

\n

WHO

\n

World Health Organization

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_80", - "extensionAttributes": [], - "name": "NCI_13", - "text": "
\n

13 Appendix A: Eligibility Checklist\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

INCLUSION CRITERIA\nMust be willing to sign a protocol-specific informed consent.\nConsent Date: _____/_____/_____

\n

Consent in patient record

\n

Age > 18 and female.\nBirth Date: _____/_____/_____

\n

Documentation in patient record

\n

ECOG Performance Status 0 or 1.\nPS

\n

(must document in patient record)

\n

Patient must have histologically or cytologically confirmed adenocarcinoma of the breast.\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Must have stage IV disease or inoperable locally advanced disease.\nDocumentation in patient record (via imaging scans as per RECIST Section 6.0)\nPatients must have ER and/or PR-positive disease as determined by their local pathology or

\n

reference laboratory by ASCO-CAP criteria. Tumors must be HER-2/neu negative or equivocal

\n

by standard ICH/FISH or ICH/CISH methodologies by ASCO-CAP criteria.\nER+

\n

PR+

\n

ER+ and PR+

\n

Tumor is HER-2/neu negative by standard ICH/FISH or ICH/CISH methodologies\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Patients must have had relapse while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane), OR progressive disease while receiving an aromatase\ninhibitor for metastatic disease. Note: Patients may have received an endocrine agent (e.g.,\nTamoxifen) between the time of progression on an AI and registration.\nDocumentation in patient record\nPatients previously treated with two or more prior cycles of fulvestrant are not eligible. Patients\nwho have received one prior cycle (dose on day 1 and day 15) of fulvestrant within 28 days of\nrandomization are eligible as long as they meet other eligibility criteria.\nDocumentation in patient record\nPatients must be post menopausal. (see Section 3.1)\nDocumentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patient may have received up to one prior systemic chemotherapy regimen for metastatic\ndisease.\nno prior systemic chemotherapy\none prior systemic chemotherapy regimen\ndocumentation in patient record\nAdequate end organ function, as evidenced by the following obtained within 4 weeks of\nrandomization: all must be present (see Section 7.0 for labs that may need to be repeated within\n≤ 7 days of Cycle 1, Day 1)

\n

Total White Blood Cell Count (leucocytes, WBC) ≥ 3.0 x 10 /L, absolute neutrophil count

\n

(ANC) ≥ 1.5 x 10 /L and platelet count ≥ 100 x 10 /L\n(Total WBC value:_________unit__________)\n(ANC value:_________unit__________)\n(Platelet Count value:_________unit__________)\nHemoglobin ≥ 9 g/dL\n(value:_________unit___________)\nSerum Bilirubin ≤ 1.5 x ULN\n(value:_________unit___________ULN_______)\nAST or ALT ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases)\n(AST value:_________unit___________ULN_______)\n(ALT value:_________unit___________ULN_______)\nSerum Creatinine ≤ 1.5 x ULN (value:_________unit___________ULN_______)\nSerum Albumin ≥ 3 g/dL\n(value:_________unit__________)\nFasting Serum Cholesterol ≤ 300 mg/dL OR ≤ 7.75 mmol/L AND Fasting Triglycerides ≤ 2.5 x\nULN Note: In case one or both of these thresholds are exceeded, the patient can only be\nincluded after initiation of appropriate lipid lowering medication.\n(Fasting Serum Cholesterol value:_________unit__________)\n(Fasting Triglycerides value:_________unit___________ULN_______)\nPT with INR ≤ 1.5. (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin\nor on a stable dose of low molecular weight heparin for >2 weeks at time of randomization.\n(INR value:_________unit___________)\n(PT value:_________unit___________)\nDocumentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients may have measurable disease, non-measurable disease (e.g., bone only metastases),\nor both. Response and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST)\nguideline (Version 1.1) [Eur J Ca 45:228-247, 2009]. Measurable lesions are defined as those\nthat can be accurately measured in at least one dimension (longest diameter to be recorded) as\n≥ 20 mm by chest x-ray, as ≥ 10 mm with CT scan, or ≥ 10 mm with calipers by clinical exam. All\ntumor measurements must be recorded in millimeters (or decimal fractions of centimeters).\nMeasurable disease only\nNon-measurable disease only\nBoth measurable and non-measurable disease\nDocumentation in patient record\nNote: Tumor lesions in a previously irradiated field are not considered measurable.\nPatients with basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\nwithin the past five years must have been treated with curative intent. Patients with a history of\nprior malignancy are eligible provided they were treated with curative intent and have been free\nof disease for >3 years.\nN/A

\n

Date of treatment: _____/_____/_____

\n

Documentation in patient record

\n

EXCLUSION CRITERIA\nPatients who have had any major surgery or significant traumatic injury within 4 weeks of\nrandomization, or have not recovered from the side effects of any major surgery (defined as\nrequiring general anesthesia) or patients that may require major surgery during the course of the\nstudy are not eligible. (Placement of vascular access device will not be considered major\nsurgery.)\nDate of surgery: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients may not be receiving any other investigational agents or have received any\ninvestigational agent within 4 weeks of randomization.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients must not be receiving any concomitant anticancer treatment or have received anticancer\ntreatment within 4 weeks of randomization (including chemotherapy, radiation therapy, antibody\nbased therapy, e.g.), with the following exceptions:\n• Bisphosphonates, Zometa or Xgeva for bone metastases\n• Hormonal therapy (e.g., AI, Tamoxifen)\n• a GnRH analog is permitted if the patient had progressive disease on a GnRH analog\nplus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be\ndiscontinued.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus,\neverolimus).\nN/A

\n

Documentation in patient record

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or another\nimmunosuppressive agent greater than or equal to 5 mg prednisone or its equivalent daily.\nTopical or inhaled corticosteroids are allowed.\nN/A

\n

Documentation in patient record

\n

Patients must not receive immunization with attenuated live vaccines within one week of\nrandomization or during the study period. Close contact with those who have received attenuated\nlive vaccines should be avoided during treatment with everolimus. Examples of live vaccines\ninclude intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\nN/A

\n

Documentation in patient record

\n

Patients must not have current or a prior history of brain metastases or leptomeningeal disease.\nPatients must not have rapidly progressive, life-threatening metastases. This includes patients\nwith extensive hepatic involvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\nN/A

\n

Documentation in patient record

\n

Patients must not have a known hypersensitivity/history of allergic reactions attributed to\ncompounds of similar chemical or biologic composition to everolimus (or other rapamycins such\nas sirolimus, temsirolimus) or fulvestrant.\nN/A

\n

Documentation in patient record

\n

Since everolimus may cause bone marrow suppression, patients with congenital or acquired\nimmune deficiency at increased risk of infection are not eligible. This includes patients being\ntreated with chronic immunosuppressive agents (including greater than or equal to 5 mg\nprednisone or its equivalent daily), and patients with known HIV seropositivity.\nN/A

\n

Documentation in patient record

\n

Patients must not have any impairment of gastrointestinal function or gastrointestinal disease\nthat may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled\nnausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).\nN/A

\n

Documentation in patient record

\n

Patients must not have an active, bleeding diathesis.\nN/A

\n

Documentation in patient record

\n

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have a history of any condition or uncontrolled intercurrent illness including,\nbut not limited to, ongoing or active infection or psychiatric illness/social situations that in the\nopinion of the investigator might intefere with or limit the patient’s ability to comply with the\nprotocol or pose additional or unacceptable risk to the patient.\nN/A

\n

Documentation in patient record

\n

Patients must not have any severe and/or uncontrolled medical conditions or other conditions\nthat could affect their participation in the study such as:\n•

\n

Symptomatic congestive heart failure of New York Heart Association Class III or IV (see\nAppendix D)

\n

•

\n

Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious\nuncontrolled cardiac arrhythmia or any other clinically significant cardiac disease

\n

•

\n

History of symptomatic pulmonary disease or non-malignant pulmonary disease (e.g.\nCOPD) requiring treatment. Such patients would be eligible if PFTs performed within 8\nweeks of treatment noted a DLCO greater than 50%.

\n

•

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal\nglycemic control should be achieved before starting trial therapy.)

\n

•

\n

Active (acute or chronic) or uncontrolled severe infections

\n

•

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at\nscreening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all\npatients with a positive medical history based on risk factors and/or confirmation of prior\nHBV/HCV infection.\nN/A

\n

Documentation in patient record

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_81", - "extensionAttributes": [], - "name": "NCI_14", - "text": "
\n

14 Appendix B: ECOG Performance Status Scale\nGrade ECOG

\n

Fully active, able to carry on all pre-disease performance without restriction

\n

Restricted in physically strenuous activity but ambulatory and able to carry out\nwork of a light or sedentary nature, e.g., light house work, office work

\n

Ambulatory and capable of all self-care but unable to carry out any work\nactivities. Up and about more than 50% of waking hours

\n

Capable of only limited self-care, confined to bed or chair more than 50% of\nwaking hours

\n

Completely disabled. Cannot carry on any self-care. Totally confined to bed or\nchair

\n

Dead

\n

Source: Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_82", - "extensionAttributes": [], - "name": "NCI_15", - "text": "
\n

15 Appendix C: Medications that can Inhibit/Induce CYP3A4\nand PgP\nSee Section 5.3.5.1 for guidelines on use of inhibitors and Section 5.3.5.2 for guidelines\non use of inducers. Table 15-0 shows clinically relevant drug interactions for inhibitors\nand inducers of isoenzyme CYP3A. Table 15-1 shows clinically relevant drug\ninteractions for substrates, inducers, and inhibitors of PgP and PgP/CYP3A.\nTable 15-0\nClinically Relevant Drug Interactions: Inhibitors and Inducers of Isoenzyme\nCYP3A\nINHIBITORS\nStrong Inhibitors:\nclarithromycin, conivaptan, elvitegravir, indinavir, itraconazole, ketoconazole, lopinavir,\nmibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin,\ntipranavir, troleandamycin, voriconazole\n(Krishna et al, 2009)\nModerate Inhibitors:\naprepitant, amprenavir, atazanavir, casopitant, cimetidine, ciprofloxacin, darunavir, diltiazem,\ndronedarone, erythromycin, fluconazole, fosamprenavir, grapefruit juice (citrus parasidi fruit\njuice), imatinib, tofisopam, verapamil\nINDUCERS\namprenavir, aprepitant, armodafinil (R-modafinil), avasimibe, bosentan, carbamazepine,\ndexamethasone, efavirenz, etravirine, glucocorticoids, modafinil, nafcillin, nevirapine,\noxcarbazepine, phenobarbital, phenytoin, pioglitazone, prednisone, rifabutin, rifampin,\nritonavir, rufinamide, St. John’s wort, talviraline, tipranavir, topiramate, troglitazone

\n

Table 15-1\nClinically Relevant Drug Interactions: Substrates, Inducers, and Inhibitors of PgP\nand PgP/CYP3A\nSUBSTRATES\nColchicines, digoxin, fexofenadine, indinavir, paclitaxel, topotecan, vincristine\nINDUCERS\nRifampin, St. John’s wort\nPgP INHIBITORS and PgP/CYP3A DUAL INHIBITORS\nAmiodarone, captopril, carvedilol, clarithromycin, conivaptan, diltiazem, dronedarone,\nelacridar, erythromycin, felodipine, fexofenadine, ginkgo (ginkgo biloba), indinavir,\nitraconazole, lopinavir, mibefradil, milk thistle (silybum marianum), nifedipine, nitrendipine,\nquercetin, quinidine, ranolazine, ritonavir, saquinavir, Schisandra chinensis, St John’s wort\n(hypericum perforatum), talinolol, telmisartan, tipranavir, valspodar, verapamil\nReference: Internal Clinical Pharmacology Drug-drug interaction (DDI) memo, updated\nOct. 2, 2011, which summarizes DDI data from three sources including the FDA’s\n“Guidance for Industry, Drug Interaction Studies”, the University of Washington’s Drug\nInteraction Database, and Indiana University School of Medicine's Drug Interaction\nTable.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_83", - "extensionAttributes": [], - "name": "NCI_16", - "text": "
\n

16 Appendix D: New York Heart Association (NYHA) Cardiac\nClassification of Functional Capacity and Objective\nAssessment\nIn 1928 the New York Heart Association published a classification of patients with cardiac\ndisease based on clinical severity and prognosis. This classification has been updated in seven\nsubsequent editions of Nomenclature and Criteria for Diagnosis of Diseases of the Heart and\nGreat Vessels (Little, Brown & Co.). The ninth edition, revised by the Criteria Committee of the\nAmerican Heart Association, New York City Affiliate, was released March 4, 1994*. The new\nclassifications are summarized below.\nThe NYHA classification system relates symptoms to everyday activities and the patient’s quality\nof life.

\n

Class

\n

Symptoms

\n

Class I

\n

Patients with cardiac disease but without resulting limitation of physical\nactivity. Ordinary physical activity does not cause undue fatigue,\npalpitation, dyspnea (shortness of breath), or anginal pain.

\n

Class II

\n

Patients with cardiac disease resulting in slight limitation of physical\nactivity. Comfortable at rest, but ordinary physical activity results in\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class III

\n

Patients with cardiac disease resulting in marked limitation of physical\nactivity. Comfortable at rest, but less than ordinary activity causes\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class IV

\n

Patients with cardiac disease resulting in inability to carry out any\nphysical activity without discomfort. Symptoms of heart failure or anginal\nsyndrome may be present even at rest. If any physical activity is\nundertaken, discomfort increases.

\n

Objective Assessment\nI:

\n

No objective evidence of cardiovascular disease

\n

II:

\n

Objective evidence of minimal cardiovascular disease

\n

III:

\n

Objective evidence of moderately severe cardiovascular disease

\n

IV:

\n

Objective evidence of severe cardiovascular disease

\n

Accessed October 2009* http://www.americanheart.org/presenter.jhtml?identifier=1712\nThe Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of\nDiseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_84", - "extensionAttributes": [], - "name": "NCI_17", - "text": "
\n

17 Appendix E: CTEP Common Terminology Criteria for\nAdverse Events (CTCAE) Version 4.0\nCommon Terminology Criteria for Adverse Events (CTCAE)\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. All appropriate treatment areas should have access\nto a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_85", - "extensionAttributes": [], - "name": "NCI_18", - "text": "
\n

18 Appendix F: Patient Pill Diary\nCopies of this form will be made available to study staff in study materials. This form is\nappended as an example only, and may be modified during the study.

\n

Site Instructions:\n1. If this or a similar diary is used this may be considered source documentation, if the\ndiary has been reviewed and signed by a member of the study staff. Patient\ncompliance with protocol therapy can be assessed using a pill record or by other\ndocumentation in the patient record.\n2. Patients should be instructed to begin Day 1 with the beginning of each cycle, with\neach cycle being 28 days.\n3. If a dose modification occurs, patients should be given instructions for dosing, and\nthe form can be modified as appropriate. Any dose changes should be recorded in\nthe patient chart with appropriate rationale as per protocol.\n4. A new form can be used at any time during a cycle; as long as the patient is made\naware of changes (e.g. study staff fills in dates and mark lines/dates not to be used).\n5. It is the responsibility of the investigator to appropriately dispense and monitor study\nmedications and to comply with the protocol.

\n

Patient Name: _____________________________

\n

Patient Study ID (filled in by Site Staff):\n______________________

\n

Patient Instructions:\n1. Complete each form as instructed by your physician or study nurse.\n2. You will take 2 pill(s) each day. You should take the pill(s) the same time each day, and in the\nmorning, if possible. If you forget to take a pill and remember by 10 PM, you may take the dose.\nOtherwise just skip that dose and begin as usual the next day. Please mark dates of any missed\npills on your record.\n3. .Each dose should be swallowed whole with a glass of water and may be taken with or without food.\nThe tablets must not be chewed or crushed. In cases where tablets cannot be swallowed, the tablets\nshould be disintegrated in water just prior to being taken. Approximately 30 mL (2 tablespoons) of\nwater should be put into a glass. The tablets should then be added and the contents stirred gently\n(for a maximum of 7 minutes) until the tablets are disintegrated. The contents should then be drunk.\nIf you vomit after taking the study drug, you should NOT take another tablet that day. If you forget to\ntake the medication and remembers by 10 PM, you may take the dose. Otherwise, skip that dose\nand begin as usual the next day.\n4. If you have any side effects or comments, please note in the comment section or on the back of the\npage. For questions or if you have any side effects that should be immediately reported to your\nstudy doctor, please call _______________________________at: (_____) _____ - _________.\n5. Please bring your pill(s) and this form to your study doctor when you go for each appointment. If\nyour dose changes, the study nurse or doctor will let you know. You should note this on the form.\nDate

\n

Day

\n

# Pills

\n

Comments

\n

Date

\n

Day

\n

Patient Signature: _________________________________

\n

# Pills

\n

Comments

\n

Date: ___________________

\n

Physician Office to complete this section:\nStudy Personnel Signature: __________________________

\n

Date: ____________________

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_86", - "extensionAttributes": [], - "name": "NCI_19", - "text": "
\n

19 References\n1.\nMoy B, Goss PE. Estrogen receptor pathway: resistance to endocrine therapy\nand new therapeutic approaches. Clin Cancer Res 2006;12:4790-3.\n2.\nNicholson KM, Anderson NG. The protein kinase B/Akt signalling pathway in\nhuman malignancy. Cell Signal 2002;14:381-95.\n3.\nDeGraffenried LA, Friedrichs WE, Fulcher L, et al. Eicosapentaenoic acid\nrestores tamoxifen sensitivity in breast cancer cells with high Akt activity. Ann Oncol\n2003;14:1051-6.\n4.\nTokunaga E, Kataoka A, Kimura Y, et al. The association between Akt\nactivation and resistance to hormone therapy in metastatic breast cancer. Eur J Cancer\n2006;42:629-35.\n5.\nBeeram M, Tan QT, Tekmal RR, Russell D, Middleton A, DeGraffenried LA.\nAkt-induced endocrine therapy resistance is reversed by inhibition of mTOR signaling.\nAnn Oncol 2007;18:1323-8.\n6.\nPerez-Tenorio G, Stal O. Activation of AKT/PKB in breast cancer predicts a\nworse outcome among endocrine treated patients. Br J Cancer 2002;86:540-5.\n7.\nBjornsti MA, Houghton PJ. The TOR pathway: A target for cancer therapy. Nat\nRev Cancer 2004;4:335-38.\n8.\nShaw RJ, Cantley LC. Ras, PI(3)K and mTOR signalling controls tumour cell\ngrowth. Nature 2006;441:424-30.\n9.\ndeGraffenried LA, Friedrichs WE, Russell DH, et al. Inhibition of mTOR activity\nrestores tamoxifen response in breast cancer cells with aberrant Akt Activity. Clin\nCancer Res 2004;10:8059-67.\n10.\nAwada A, Cardoso F, Fontaine C, et al. The oral mTOR inhibitor RAD001\n(everolimus) in combination with letrozole in patients with advanced breast cancer:\nresults of a phase I study with pharmacokinetics. Eur J Cancer 2008;44:84-91.\n11.\nAmerican Cancer Society. Breast Cancer Facts & Figures 2011-2012. Atlanta:\nAmerican\nCancer\nSociety\nInc.;\nhttp://www.cancer.org/acs/groups/content/@\nepidemiologysurveilance/documents/document/acspc-030975.pdf\n(accessed 7/11/2012)\n12.\nBuzdar AU. Endocrine therapy in the treatment of metastatic breast cancer.\nSemin Oncol 2001;28:291-304.\n13.\nCampos SM, Winer EP. Hormonal therapy in postmenopausal women with\nbreast cancer. Oncology 2003;64:289-99.\n14.\nSparano J, Pasqualini JR, eds. Breast cancer : prognosis, treatment, and\nprevention. New York: Marcel Dekker; 2002.\n15.\nWiner EP, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology\ntechnology assessment on the use of aromatase inhibitors as adjuvant therapy for\npostmenopausal women with hormone receptor-positive breast cancer: status report\n2004. J Clin Oncol 2005;23:619-29.\n16.\nBerry J. Are all aromatase inhibitors the same? A review of controlled clinical\ntrials in breast cancer. Clin Ther 2005;27:1671-84.

\n

17.\nHowell A, Robertson JF, Quaresma Albano J, et al. Fulvestrant, formerly ICI\n182,780, is as effective as anastrozole in postmenopausal women with advanced\nbreast cancer progressing after prior endocrine treatment. J Clin Oncol 2002;20:3396403.\n18.\nOsborne CK, Pippen J, Jones SE, et al. Double-blind, randomized trial\ncomparing the efficacy and tolerability of fulvestrant versus anastrozole in\npostmenopausal women with advanced breast cancer progressing on prior endocrine\ntherapy: results of a North American trial. J Clin Oncol 2002;20:3386-95.\n19.\nMauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK.\nFulvestrant (Faslodex®) versus anastrozole for the second-line treatment of advanced\nbreast cancer in subgroups of postmenopausal women with visceral and non-visceral\nmetastases: combined results from two multicentre trials. Eur J Cancer 2003;39:122833.\n20.\nHowell A, Robertson JF, Abram P, et al. Comparison of fulvestrant versus\ntamoxifen for the treatment of advanced breast cancer in postmenopausal women\npreviously untreated with endocrine therapy: a multinational, double-blind, randomized\ntrial. J Clin Oncol 2004;22:1605-13.\n21.\nIngle JN, Suman VJ, Rowland KM, et al. Fulvestrant in women with advanced\nbreast cancer after progression on prior aromatase inhibitor therapy: North Central\nCancer Treatment Group Trial N0032. J Clin Oncol 2006;24:1052-6.\n22.\nPerey L, Paridaens R, Hawle H, et al. Clinical benefit of fulvestrant in\npostmenopausal women with advanced breast cancer and primary or acquired\nresistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical\nCancer Research Trial (SAKK 21/00). Ann Oncol 2007;18:64-9.\n23.\nChia S, Gradishar W, Mauriac L, et al. Double-blind, randomized placebo\ncontrolled trial of fulvestrant compared with exemestane after prior nonsteroidal\naromatase inhibitor therapy in postmenopausal women with hormone receptor-positive,\nadvanced breast cancer: results from EFECT. J Clin Oncol 2008;26:1664-70.\n24.\nDi Leo A, Jerusalem G, Petruzelka L, et al. CONFIRM: A Phase III,\nRandomized, Parallel-Group Trial Comparing Fulvestrant 250 mg vs Fulvestrant 500\nmg in Postmenopausal Women with Estrogen Receptor-Positive Advanced Breast\nCancer. J Clin Oncol. 2010 Oct 20; 28(30):4594-600.\n25.\nBoulay A, Lane HA. The mammalian target of rapamycin kinase and tumor\ngrowth inhibition. Recent Results Cancer Res 2007;172:99-124.\n26.\nWullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism.\nCell 2006;124(3):471-84.\n27.\nManning BD, Cantley LC. AKT/PKB signaling: navigating downstream. Cell\n2007;129(7):1261-74.\n28.\nWang L, Harris TE, Roth RA, Lawrence JC, Jr. PRAS40 regulates mTORC1\nkinase activity by functioning as a direct inhibitor of substrate binding. J Biol Chem\n2007;282(27):20036-44.\n29.\nWitzig TE, Geyer SM, Ghobrial I, et al. Phase II trial of single-agent\ntemsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 2005;\n23(23):5347-56.

\n

30.\nLane HA, Wood JM, McSheehy PM, et al. mTOR inhibitor RAD001 (everolimus)\nhas antiangiogenic/vascular properties distinct from a VEGFR tyrosine kinase inhibitor.\nClin Cancer Res 2009;15(5):1612-22.\n31.\nMabuchi S, Altomare DA, Cheung M, et al. RAD001 inhibits human ovarian\ncancer cell proliferation, enhances cisplatin-induced apoptosis, and prolongs survival in\nan ovarian cancer model. Clin Cancer Res 2007;13(14):4261-70.\n32.\nGalanis E, Buckner JC, Maurer MJ, et al. Phase II trial of temsirolimus (CCI779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group\nStudy. J Clin Oncol 2005;23:5294-304.\n33.\nO’Reilly T, McSheehy PM. Biomarker Development for the Clinical Activity of\nthe mTOR Inhibitor everolimus (RAD001): Processes, Limitations, and Further\nProposals. Tran Oncol; 2010 Apr; 3(2):65-79.\n34.\nHuang S, Houghton PJ. Inhibitors of mammalian target of rapamycin as novel\nantitumor agents: from bench to clinic. Curr Opin Investig Drugs. 2002 Feb; 3(2):295304.\n35.\nZitzmann K, De Toni EN, Brand S, et al. The novel mTOR inhibitor RAD001\n(everolimus) induces antiproliferative effects in human pancreatic neuroendocrine\ntumor cells. Neuroendocrinology 2007;85(1):54-60.\n36.\nZeng Z, Sarbassov dos D, Samudio IJ, et al. Rapamycin derivatives reduce\nmTORC2 signaling and inhibit AKT activation in AML. Blood 2007;109(8):3509-12.\n37.\nHaritunians T, Mori A, O'Kelly J, Luong QT, Giles FJ, Koeffler HP.\nAntiproliferative activity of RAD001 (everolimus) as a single agent and combined with\nother agents in mantle cell lymphoma. Leukemia 2007;21(2):333-9.\n38.\nIkezoe T, Nishioka C, Bandobashi K, et al. Longitudinal inhibition of\nPI3K/Akt/mTOR signaling by LY294002 and rapamycin induces growth arrest of adult\nT-cell leukemia cells. Leuk Res 2007;31(5):673-82.\n39.\nWanner K, Hipp S, Oelsner M, et al. Mammalian target of rapamycin inhibition\ninduces cell cycle arrest in diffuse large B cell lymphoma (DLBCL) cells and sensitises\nDLBCL cells to rituximab. Br J Haematol 2006;134(5):475-84.\n40.\nTuncyurek P, Mayer JM, Klug F, et al. Everolimus and mycophenolate mofetil\nsensitize human pancreatic cancer cells to gemcitabine in vitro: a novel adjunct to\nstandard chemotherapy? Eur Surg Res 2007;39(6):380-7.\n41.\nTreeck O, Wackwitz B, Haus U, Ortmann O. Effects of a combined treatment\nwith mTOR inhibitor RAD001 and tamoxifen in vitro on growth and apoptosis of human\ncancer cells. Gynecol Oncol 2006;102(2):292-9.\n42.\nSieghart W, Fuereder T, Schmid K, et al. Mammalian target of rapamycin\npathway activity in hepatocellular carcinomas of patients undergoing liver\ntransplantation. Transplantation 2007;83(4):425-32.\n43.\nLu CH, Wyszomierski SL, Tseng LM, et al. Preclinical testing of clinically\napplicable strategies for overcoming trastuzumab resistance caused by PTEN\ndeficiency. Clin Cancer Res 2007;13(9):5883-8.\n44.\nTorres-Arzayus MI, Yuan J, DellaGatta JL, Lane H, Kung AL, Brown M.\nTargeting the AIB1 oncogene through mammalian target of rapamycin inhibition in the\nmammary gland. Cancer Res 2006;66(23):11381-8.

\n

45.\nRossi F, Ehlers I, Agosti V, et al. Oncogenic Kit signaling and therapeutic\nintervention in a mouse model of gastrointestinal stromal tumor. Proc Natl Acad Sci U\nS A 2006;103(34):12843-8.\n46.\nLane H, Tanaka C, Kovarik J, et al. Preclinical and clinical pharmacokinetic /\npharmacodynamic (PK/PD) modeling to help define an optimal biological dose for the\noral mTOR inhibitor, RAD001, in oncology [abstract]. J Clin Oncol; 2003; 22:237A.\n47.\nTabernero J, Rojo F, Calvo E, et al. Dose- and schedule-dependent inhibition of\nthe mammalian target of rapamycin pathway with everolimus: A phase I tumor\npharmacodynamic study in patients with advanced solid tumors. J Clin Oncol\n2008;28:10.\n48.\nhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312965\n.htm (accessed 8/1/2012)\n49.\nBaselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal\nhormone-receptor-positive advanced breast cancer. N Engl J Med 2012 Feb\n9;366(6):520-9. Epub 2011 Dec 7. PubMed PMID: 22149876\n50.\nSanchez CG, Ma CX, Crowder RJ, et al. Preclinical modeling of combined\nphosphatidylinositol-3-kinase inhibition with endocrine therapy for estrogen receptorpositive breast cancer. Breast Cancer Res 2011 Mar 1;13(2):R21.\n51.\nHammond ME, Hayes DF, Wolff AC, et al. American society of clinical\noncology/college of American pathologists guideline recommendations for\nimmunohistochemical testing of estrogen and progesterone receptors in breast cancer.\nOncol Pract. 2010 Jul;6(4):195-7. Epub 2010 Jun 23 PMCID: PMC2900870 PMID:\n21037871.\n52.\nWolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical\nOncology/College of American Pathologists guideline recommendations for human\nepidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan\n1;25(1):118-45. Epub 2006 Dec 11. American Society of Clinical Oncology; College of\nAmerican Pathologists. American Society of Clinical Oncology, Alexandria, VA, USA.)\nPMID: 17159189.\n53.\nYeo W, Lam KC, Zee B, et al. Hepatitis B reactivation in patients with\nhepatocellular carcinoma undergoing systemic chemotherapy. Ann Oncol\n2004;15:1661-6.\n54.\nLoomba R, Rowley A, Wesley R, et al. Systematic review: the effect of\npreventive lamivudine on hepatitis B reactivation during chemotherapy. Ann Intern Med\n2008;148(7):519-28.\n55.\nDivers J, RN BSN, Texas Oncology. Management of Stomatitis Associated with\nmTOR Inhibitors in Hormone Receptor-Positive HER2-Negative Advanced Breast\nCancer: Clinical Experiences from a Single Center. Presented at the 38th Annual\nOncology Nurses’ Society Congress, April 25-28, 2013. Novartis Internal\nCommunication.\n56.\nEisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria\nin solid tumours: revised RECIST guideline (Version 1.1). Eur J Cancer 2009;45:22847.\n57.\nBubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for\nphase II clinical trials in androgen-independent prostate cancer: recommendations from\nthe Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461-7.

\n

58.\nScher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for\npatients with progressive prostate cancer and castrate levels of testosterone:\nrecommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol\n2008;26:1148-59.\n59.\nRustin GJ, Quinn M, Thigpen T, et al. Re: New guidelines to evaluate the\nresponse to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst\n2004;96:487-8.\n60.\nVergote I, Rustin GJ, Eisenhauer EA, et al. Re: new guidelines to evaluate the\nresponse to treatment in solid tumors [ovarian cancer]. Gynecologic Cancer Intergroup.\nJ Natl Cancer Inst 2000;92:1534-5.\n61.\nOken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the\nEastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55.

\n

20 Investigator’s Statement\n1.

\n

I have carefully read this protocol entitled “Randomized, Double-Blind,\nPlacebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus\nEverolimus in Post Menopausal Patients with Hormone-Receptor\nPositive Metastatic Breast Center Resistant to Aromatase Inhibitor\nTherapy, Version 2.0 dated 1/22/2014” (Protocol number PrE0102)\nand agree that it contains all the necessary information required to\nconduct the study. I agree to conduct the study as outlined in the protocol.

\n

2.

\n

I agree to conduct this study according to the moral, ethical and scientific\nprinciples governing clinical research as set out in the Declaration of\nHelsinki, the principles of GCP as described in 21 CFR and any applicable\nlocal requirements.

\n

3.

\n

I understand that this trial and any subsequent changes to this trial will not\nbe initiated without approval of the appropriate Institutional Review Board,\nand that all administrative requirements of the governing body of the\ninstitution will be complied with fully.

\n

4.

\n

Informed written consent will be obtained from all participating patients in\naccordance with institutional and FDA requirements as specified in Title\n21, Code of Federal Regulations, Part 50.

\n

5.

\n

I understand that my signature on the Case Report Form indicates that I\nhave carefully reviewed each page and accept full responsibility for the\ncontents thereof.

\n

6.

\n

I understand that the information presented in this study protocol is\nconfidential, and I hereby assure that no information based on the conduct\nof the study will be released without prior consent from PrECOG, LLC\nunless this requirement is superseded by the Food and Drug\nAdministration.

\n

Principal Investigator:\nPI Name:\nSite Name:\nSignature of PI:\nDate of Signature:

\n

\\\nMMM

\n

\\\nDD

\n

YYYY

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_87", - "extensionAttributes": [], - "name": "NCI_20", - "text": "

See section 20 Investigator's Statement.

", - "instanceType": "NarrativeContentItem" - } - ], - "abbreviations": [], - "administrableProducts": [], - "medicalDevices": [], - "productOrganizationRoles": [], - "dictionaries": [], - "conditions": [], - "notes": [], - "instanceType": "StudyVersion" - } - ], - "documentedBy": [ - { - "id": "StudyDefinitionDocument_1", - "extensionAttributes": [], - "name": "NCT01797120.pdf", - "label": "", - "description": "", - "language": {}, - "type": {}, - "templateName": "", - "versions": [ - { - "id": "StudyDefinitionDocumentVersion_1", - "extensionAttributes": [], - "version": "1", - "status": {}, - "dateValues": [], - "contents": [ - { - "id": "NarrativeContent_1", - "extensionAttributes": [], - "name": "NC_1", - "sectionNumber": "1", - "sectionTitle": "Introduction", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_2", - "NarrativeContent_3", - "NarrativeContent_4", - "NarrativeContent_8", - "NarrativeContent_12" - ], - "previousId": null, - "nextId": "NarrativeContent_13", - "contentItemId": "NarrativeContentItem_1", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_2", - "extensionAttributes": [], - "name": "NC_1_1", - "sectionNumber": "1.1", - "sectionTitle": "Background and Rationale", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_3", - "contentItemId": "NarrativeContentItem_2", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_3", - "extensionAttributes": [], - "name": "NC_1_2", - "sectionNumber": "1.2", - "sectionTitle": "Breast Cancer", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_2", - "nextId": "NarrativeContent_4", - "contentItemId": "NarrativeContentItem_3", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_4", - "extensionAttributes": [], - "name": "NC_1_3", - "sectionNumber": "1.3", - "sectionTitle": "Endocrine Therapy for Breast Cancer", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_5", - "NarrativeContent_6", - "NarrativeContent_7" - ], - "previousId": "NarrativeContent_3", - "nextId": "NarrativeContent_8", - "contentItemId": "NarrativeContentItem_4", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_5", - "extensionAttributes": [], - "name": "NC_1_3_1", - "sectionNumber": "1.3.1", - "sectionTitle": "Fulvestrant for Post Menopausal Women with Breast Cancer", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_6", - "contentItemId": "NarrativeContentItem_5", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_6", - "extensionAttributes": [], - "name": "NC_1_3_2", - "sectionNumber": "1.3.2", - "sectionTitle": "Fulvestrant for Aromatase Inhibitor (AI) Resistant Disease", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_5", - "nextId": "NarrativeContent_7", - "contentItemId": "NarrativeContentItem_6", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_7", - "extensionAttributes": [], - "name": "NC_1_3_3", - "sectionNumber": "1.3.3", - "sectionTitle": "Rationale for Fulvestrant for this Trial", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_6", - "nextId": null, - "contentItemId": "NarrativeContentItem_7", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_8", - "extensionAttributes": [], - "name": "NC_1_4", - "sectionNumber": "1.4", - "sectionTitle": "Everolimus (RAD001)", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_9", - "NarrativeContent_10", - "NarrativeContent_11" - ], - "previousId": "NarrativeContent_4", - "nextId": "NarrativeContent_12", - "contentItemId": "NarrativeContentItem_8", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_9", - "extensionAttributes": [], - "name": "NC_1_4_1", - "sectionNumber": "1.4.1", - "sectionTitle": "mTOR Pathway and Mechanism of Action", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_10", - "contentItemId": "NarrativeContentItem_9", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_10", - "extensionAttributes": [], - "name": "NC_1_4_2", - "sectionNumber": "1.4.2", - "sectionTitle": "Pre-Clinical Safety", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_9", - "nextId": "NarrativeContent_11", - "contentItemId": "NarrativeContentItem_10", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_11", - "extensionAttributes": [], - "name": "NC_1_4_3", - "sectionNumber": "1.4.3", - "sectionTitle": "Clinical Experience", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_10", - "nextId": null, - "contentItemId": "NarrativeContentItem_11", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_12", - "extensionAttributes": [], - "name": "NC_1_5", - "sectionNumber": "1.5", - "sectionTitle": "Rationale and Study Design", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_8", - "nextId": null, - "contentItemId": "NarrativeContentItem_12", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_13", - "extensionAttributes": [], - "name": "NC_2", - "sectionNumber": "2", - "sectionTitle": "Objectives", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_14", - "NarrativeContent_15" - ], - "previousId": "NarrativeContent_1", - "nextId": "NarrativeContent_16", - "contentItemId": "NarrativeContentItem_13", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_14", - "extensionAttributes": [], - "name": "NC_2_1", - "sectionNumber": "2.1", - "sectionTitle": "Primary Objective", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_15", - "contentItemId": "NarrativeContentItem_14", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_15", - "extensionAttributes": [], - "name": "NC_2_2", - "sectionNumber": "2.2", - "sectionTitle": "Secondary Objectives", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_14", - "nextId": null, - "contentItemId": "NarrativeContentItem_15", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_16", - "extensionAttributes": [], - "name": "NC_3", - "sectionNumber": "3", - "sectionTitle": "Selection of Patients", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_17" - ], - "previousId": "NarrativeContent_13", - "nextId": "NarrativeContent_18", - "contentItemId": "NarrativeContentItem_16", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_17", - "extensionAttributes": [], - "name": "NC_3_1", - "sectionNumber": "3.1", - "sectionTitle": "Eligibility Criteria", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": null, - "contentItemId": "NarrativeContentItem_17", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_18", - "extensionAttributes": [], - "name": "NC_4", - "sectionNumber": "4", - "sectionTitle": "Randomization Procedures", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_19", - "NarrativeContent_20", - "NarrativeContent_21" - ], - "previousId": "NarrativeContent_16", - "nextId": "NarrativeContent_22", - "contentItemId": "NarrativeContentItem_18", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_19", - "extensionAttributes": [], - "name": "NC_4_1", - "sectionNumber": "4.1", - "sectionTitle": "Ethics", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_20", - "contentItemId": "NarrativeContentItem_19", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_20", - "extensionAttributes": [], - "name": "NC_4_2", - "sectionNumber": "4.2", - "sectionTitle": "Regulatory Requirements", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_19", - "nextId": "NarrativeContent_21", - "contentItemId": "NarrativeContentItem_20", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_21", - "extensionAttributes": [], - "name": "NC_4_3", - "sectionNumber": "4.3", - "sectionTitle": "Patient Randomization", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_20", - "nextId": null, - "contentItemId": "NarrativeContentItem_21", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_22", - "extensionAttributes": [], - "name": "NC_5", - "sectionNumber": "5", - "sectionTitle": "Treatment Plan", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_23", - "NarrativeContent_24", - "NarrativeContent_27", - "NarrativeContent_33", - "NarrativeContent_34", - "NarrativeContent_35" - ], - "previousId": "NarrativeContent_18", - "nextId": "NarrativeContent_36", - "contentItemId": "NarrativeContentItem_22", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_23", - "extensionAttributes": [], - "name": "NC_5_1", - "sectionNumber": "5.1", - "sectionTitle": "Administration Schedule", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_24", - "contentItemId": "NarrativeContentItem_23", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_24", - "extensionAttributes": [], - "name": "NC_5_2", - "sectionNumber": "5.2", - "sectionTitle": "Dosing and Administration", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_25", - "NarrativeContent_26" - ], - "previousId": "NarrativeContent_23", - "nextId": "NarrativeContent_27", - "contentItemId": "NarrativeContentItem_24", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_25", - "extensionAttributes": [], - "name": "NC_5_2_1", - "sectionNumber": "5.2.1", - "sectionTitle": "Fulvestrant (Arm A and Arm B)", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_26", - "contentItemId": "NarrativeContentItem_25", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_26", - "extensionAttributes": [], - "name": "NC_5_2_2", - "sectionNumber": "5.2.2", - "sectionTitle": "Everolimus or Placebo (Arm A and Arm B)", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_25", - "nextId": null, - "contentItemId": "NarrativeContentItem_26", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_27", - "extensionAttributes": [], - "name": "NC_5_3", - "sectionNumber": "5.3", - "sectionTitle": "Dose Modifications and Toxicity Management", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_28", - "NarrativeContent_29", - "NarrativeContent_30", - "NarrativeContent_31", - "NarrativeContent_32" - ], - "previousId": "NarrativeContent_24", - "nextId": "NarrativeContent_33", - "contentItemId": "NarrativeContentItem_27", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_28", - "extensionAttributes": [], - "name": "NC_5_3_1", - "sectionNumber": "5.3.1", - "sectionTitle": "Dose Modifications General Guidelines for Everolimus/Placebo", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_29", - "contentItemId": "NarrativeContentItem_28", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_29", - "extensionAttributes": [], - "name": "NC_5_3_2", - "sectionNumber": "5.3.2", - "sectionTitle": "Common Adverse Events Associated with Everolimus", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_28", - "nextId": "NarrativeContent_30", - "contentItemId": "NarrativeContentItem_29", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_30", - "extensionAttributes": [], - "name": "NC_5_3_3", - "sectionNumber": "5.3.3", - "sectionTitle": "Concomitant Therapies", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_29", - "nextId": "NarrativeContent_31", - "contentItemId": "NarrativeContentItem_30", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_31", - "extensionAttributes": [], - "name": "NC_5_3_4", - "sectionNumber": "5.3.4", - "sectionTitle": "Prohibited Therapies and Restrictions", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_30", - "nextId": "NarrativeContent_32", - "contentItemId": "NarrativeContentItem_31", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_32", - "extensionAttributes": [], - "name": "NC_5_3_5", - "sectionNumber": "5.3.5", - "sectionTitle": "Administration of Everolimus and CYP3A4 Inhibitors/Inducers", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_31", - "nextId": null, - "contentItemId": "NarrativeContentItem_32", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_33", - "extensionAttributes": [], - "name": "NC_5_4", - "sectionNumber": "5.4", - "sectionTitle": "Supportive Care", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_27", - "nextId": "NarrativeContent_34", - "contentItemId": "NarrativeContentItem_33", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_34", - "extensionAttributes": [], - "name": "NC_5_5", - "sectionNumber": "5.5", - "sectionTitle": "Duration of Therapy", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_33", - "nextId": "NarrativeContent_35", - "contentItemId": "NarrativeContentItem_34", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_35", - "extensionAttributes": [], - "name": "NC_5_6", - "sectionNumber": "5.6", - "sectionTitle": "Withdrawal of Patients from Study", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_34", - "nextId": null, - "contentItemId": "NarrativeContentItem_35", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_36", - "extensionAttributes": [], - "name": "NC_6", - "sectionNumber": "6", - "sectionTitle": "Measurement of Effect", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_37" - ], - "previousId": "NarrativeContent_22", - "nextId": "NarrativeContent_44", - "contentItemId": "NarrativeContentItem_36", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_37", - "extensionAttributes": [], - "name": "NC_6_1", - "sectionNumber": "6.1", - "sectionTitle": "Antitumor Effect - Solid Tumors", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_38", - "NarrativeContent_39", - "NarrativeContent_40", - "NarrativeContent_41", - "NarrativeContent_42", - "NarrativeContent_43" - ], - "previousId": null, - "nextId": null, - "contentItemId": "NarrativeContentItem_37", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_38", - "extensionAttributes": [], - "name": "NC_6_1_1", - "sectionNumber": "6.1.1", - "sectionTitle": "Definitions", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_39", - "contentItemId": "NarrativeContentItem_38", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_39", - "extensionAttributes": [], - "name": "NC_6_1_2", - "sectionNumber": "6.1.2", - "sectionTitle": "Disease Parameters", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_38", - "nextId": "NarrativeContent_40", - "contentItemId": "NarrativeContentItem_39", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_40", - "extensionAttributes": [], - "name": "NC_6_1_3", - "sectionNumber": "6.1.3", - "sectionTitle": "Methods for Evaluation of Measurable Disease", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_39", - "nextId": "NarrativeContent_41", - "contentItemId": "NarrativeContentItem_40", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_41", - "extensionAttributes": [], - "name": "NC_6_1_4", - "sectionNumber": "6.1.4", - "sectionTitle": "Response Criteria", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_40", - "nextId": "NarrativeContent_42", - "contentItemId": "NarrativeContentItem_41", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_42", - "extensionAttributes": [], - "name": "NC_6_1_5", - "sectionNumber": "6.1.5", - "sectionTitle": "Duration of Response", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_41", - "nextId": "NarrativeContent_43", - "contentItemId": "NarrativeContentItem_42", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_43", - "extensionAttributes": [], - "name": "NC_6_1_6", - "sectionNumber": "6.1.6", - "sectionTitle": "Progression-Free Survival", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_42", - "nextId": null, - "contentItemId": "NarrativeContentItem_43", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_44", - "extensionAttributes": [], - "name": "NC_7", - "sectionNumber": "7", - "sectionTitle": "Study Parameters", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_45" - ], - "previousId": "NarrativeContent_36", - "nextId": "NarrativeContent_51", - "contentItemId": "NarrativeContentItem_44", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_45", - "extensionAttributes": [], - "name": "NC_7_1", - "sectionNumber": "7.1", - "sectionTitle": "Procedures by Visit", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_46", - "NarrativeContent_47", - "NarrativeContent_48", - "NarrativeContent_49", - "NarrativeContent_50" - ], - "previousId": null, - "nextId": null, - "contentItemId": "NarrativeContentItem_45", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_46", - "extensionAttributes": [], - "name": "NC_7_1_1", - "sectionNumber": "7.1.1", - "sectionTitle": "Pre-Study", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_47", - "contentItemId": "NarrativeContentItem_46", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_47", - "extensionAttributes": [], - "name": "NC_7_1_2", - "sectionNumber": "7.1.2", - "sectionTitle": "Induction Phase", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_46", - "nextId": "NarrativeContent_48", - "contentItemId": "NarrativeContentItem_47", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_48", - "extensionAttributes": [], - "name": "NC_7_1_3", - "sectionNumber": "7.1.3", - "sectionTitle": "End of Induction Phase / End of Treatment", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_47", - "nextId": "NarrativeContent_49", - "contentItemId": "NarrativeContentItem_48", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_49", - "extensionAttributes": [], - "name": "NC_7_1_4", - "sectionNumber": "7.1.4", - "sectionTitle": "Continuation Phase", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_48", - "nextId": "NarrativeContent_50", - "contentItemId": "NarrativeContentItem_49", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_50", - "extensionAttributes": [], - "name": "NC_7_1_5", - "sectionNumber": "7.1.5", - "sectionTitle": "Follow-Up Off-Therapy", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_49", - "nextId": null, - "contentItemId": "NarrativeContentItem_50", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_51", - "extensionAttributes": [], - "name": "NC_8", - "sectionNumber": "8", - "sectionTitle": "Drug Formulation and Procurement", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_52", - "NarrativeContent_59" - ], - "previousId": "NarrativeContent_44", - "nextId": "NarrativeContent_60", - "contentItemId": "NarrativeContentItem_51", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_52", - "extensionAttributes": [], - "name": "NC_8_1", - "sectionNumber": "8.1", - "sectionTitle": "Everolimus", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_53", - "NarrativeContent_54", - "NarrativeContent_55", - "NarrativeContent_56", - "NarrativeContent_57", - "NarrativeContent_58" - ], - "previousId": null, - "nextId": "NarrativeContent_59", - "contentItemId": "NarrativeContentItem_52", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_53", - "extensionAttributes": [], - "name": "NC_8_1_1", - "sectionNumber": "8.1.1", - "sectionTitle": "Packaging and Labeling", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_54", - "contentItemId": "NarrativeContentItem_53", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_54", - "extensionAttributes": [], - "name": "NC_8_1_2", - "sectionNumber": "8.1.2", - "sectionTitle": "Storage Requirements/Stability", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_53", - "nextId": "NarrativeContent_55", - "contentItemId": "NarrativeContentItem_54", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_55", - "extensionAttributes": [], - "name": "NC_8_1_3", - "sectionNumber": "8.1.3", - "sectionTitle": "Handling, Dispensing and Administration", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_54", - "nextId": "NarrativeContent_56", - "contentItemId": "NarrativeContentItem_55", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_56", - "extensionAttributes": [], - "name": "NC_8_1_4", - "sectionNumber": "8.1.4", - "sectionTitle": "Side Effects", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_55", - "nextId": "NarrativeContent_57", - "contentItemId": "NarrativeContentItem_56", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_57", - "extensionAttributes": [], - "name": "NC_8_1_5", - "sectionNumber": "8.1.5", - "sectionTitle": "Investigational Product Records at Investigational Site(s)", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_56", - "nextId": "NarrativeContent_58", - "contentItemId": "NarrativeContentItem_57", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_58", - "extensionAttributes": [], - "name": "NC_8_1_6", - "sectionNumber": "8.1.6", - "sectionTitle": "Return and Destruction of Investigational Product", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_57", - "nextId": null, - "contentItemId": "NarrativeContentItem_58", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_59", - "extensionAttributes": [], - "name": "NC_8_2", - "sectionNumber": "8.2", - "sectionTitle": "Fulvestrant", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_52", - "nextId": null, - "contentItemId": "NarrativeContentItem_59", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_60", - "extensionAttributes": [], - "name": "NC_9", - "sectionNumber": "9", - "sectionTitle": "Statistical Considerations", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_61", - "NarrativeContent_62", - "NarrativeContent_63" - ], - "previousId": "NarrativeContent_51", - "nextId": "NarrativeContent_64", - "contentItemId": "NarrativeContentItem_60", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_61", - "extensionAttributes": [], - "name": "NC_9_1", - "sectionNumber": "9.1", - "sectionTitle": "Primary Endpoint Analysis", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_62", - "contentItemId": "NarrativeContentItem_61", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_62", - "extensionAttributes": [], - "name": "NC_9_2", - "sectionNumber": "9.2", - "sectionTitle": "Safety Analyses", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_61", - "nextId": "NarrativeContent_63", - "contentItemId": "NarrativeContentItem_62", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_63", - "extensionAttributes": [], - "name": "NC_9_3", - "sectionNumber": "9.3", - "sectionTitle": "Analyses of Other Secondary Endpoints", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_62", - "nextId": null, - "contentItemId": "NarrativeContentItem_63", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_64", - "extensionAttributes": [], - "name": "NC_10", - "sectionNumber": "10", - "sectionTitle": "Adverse Event Reporting", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_65", - "NarrativeContent_66", - "NarrativeContent_69" - ], - "previousId": "NarrativeContent_60", - "nextId": "NarrativeContent_70", - "contentItemId": "NarrativeContentItem_64", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_65", - "extensionAttributes": [], - "name": "NC_10_1", - "sectionNumber": "10.1", - "sectionTitle": "Collection of Safety Information", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_66", - "contentItemId": "NarrativeContentItem_65", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_66", - "extensionAttributes": [], - "name": "NC_10_2", - "sectionNumber": "10.2", - "sectionTitle": "Handling of Serious Adverse Events (SAEs)", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_67", - "NarrativeContent_68" - ], - "previousId": "NarrativeContent_65", - "nextId": "NarrativeContent_69", - "contentItemId": "NarrativeContentItem_66", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_67", - "extensionAttributes": [], - "name": "NC_10_2_1", - "sectionNumber": "10.2.1", - "sectionTitle": "SAE Definitions", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_68", - "contentItemId": "NarrativeContentItem_67", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_68", - "extensionAttributes": [], - "name": "NC_10_2_2", - "sectionNumber": "10.2.2", - "sectionTitle": "SAE Reporting Requirements", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_67", - "nextId": null, - "contentItemId": "NarrativeContentItem_68", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_69", - "extensionAttributes": [], - "name": "NC_10_3", - "sectionNumber": "10.3", - "sectionTitle": "Reporting of Second Primary Cancers", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_66", - "nextId": null, - "contentItemId": "NarrativeContentItem_69", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_70", - "extensionAttributes": [], - "name": "NC_11", - "sectionNumber": "11", - "sectionTitle": "Administrative", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_71", - "NarrativeContent_72", - "NarrativeContent_73", - "NarrativeContent_74", - "NarrativeContent_75", - "NarrativeContent_76", - "NarrativeContent_77", - "NarrativeContent_78" - ], - "previousId": "NarrativeContent_64", - "nextId": "NarrativeContent_79", - "contentItemId": "NarrativeContentItem_70", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_71", - "extensionAttributes": [], - "name": "NC_11_1", - "sectionNumber": "11.1", - "sectionTitle": "Protocol Compliance", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_72", - "contentItemId": "NarrativeContentItem_71", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_72", - "extensionAttributes": [], - "name": "NC_11_2", - "sectionNumber": "11.2", - "sectionTitle": "Institutional Review Board", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_71", - "nextId": "NarrativeContent_73", - "contentItemId": "NarrativeContentItem_72", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_73", - "extensionAttributes": [], - "name": "NC_11_3", - "sectionNumber": "11.3", - "sectionTitle": "Informed Consent Procedures", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_72", - "nextId": "NarrativeContent_74", - "contentItemId": "NarrativeContentItem_73", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_74", - "extensionAttributes": [], - "name": "NC_11_4", - "sectionNumber": "11.4", - "sectionTitle": "Safety Communication", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_73", - "nextId": "NarrativeContent_75", - "contentItemId": "NarrativeContentItem_74", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_75", - "extensionAttributes": [], - "name": "NC_11_5", - "sectionNumber": "11.5", - "sectionTitle": "Monitoring", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_74", - "nextId": "NarrativeContent_76", - "contentItemId": "NarrativeContentItem_75", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_76", - "extensionAttributes": [], - "name": "NC_11_6", - "sectionNumber": "11.6", - "sectionTitle": "Study Records", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_75", - "nextId": "NarrativeContent_77", - "contentItemId": "NarrativeContentItem_76", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_77", - "extensionAttributes": [], - "name": "NC_11_7", - "sectionNumber": "11.7", - "sectionTitle": "Electronic Case Report Form (eCRF) Information", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_76", - "nextId": "NarrativeContent_78", - "contentItemId": "NarrativeContentItem_77", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_78", - "extensionAttributes": [], - "name": "NC_11_8", - "sectionNumber": "11.8", - "sectionTitle": "Records Retention", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_77", - "nextId": null, - "contentItemId": "NarrativeContentItem_78", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_79", - "extensionAttributes": [], - "name": "NC_12", - "sectionNumber": "12", - "sectionTitle": "Glossary of Terms and List of Abbreviations", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_70", - "nextId": "NarrativeContent_80", - "contentItemId": "NarrativeContentItem_79", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_80", - "extensionAttributes": [], - "name": "NC_13", - "sectionNumber": "13", - "sectionTitle": "Appendix A: Eligibility Checklist", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_79", - "nextId": "NarrativeContent_81", - "contentItemId": "NarrativeContentItem_80", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_81", - "extensionAttributes": [], - "name": "NC_14", - "sectionNumber": "14", - "sectionTitle": "Appendix B: ECOG Performance Status Scale", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_80", - "nextId": "NarrativeContent_82", - "contentItemId": "NarrativeContentItem_81", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_82", - "extensionAttributes": [], - "name": "NC_15", - "sectionNumber": "15", - "sectionTitle": "Appendix C: Medications that can Inhibit/Induce CYP3A4 and PgP", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_81", - "nextId": "NarrativeContent_83", - "contentItemId": "NarrativeContentItem_82", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_83", - "extensionAttributes": [], - "name": "NC_16", - "sectionNumber": "16", - "sectionTitle": "Appendix D: New York Heart Association (NYHA) Cardiac Classification", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_82", - "nextId": "NarrativeContent_84", - "contentItemId": "NarrativeContentItem_83", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_84", - "extensionAttributes": [], - "name": "NC_17", - "sectionNumber": "17", - "sectionTitle": "Appendix E: CTEP Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_83", - "nextId": "NarrativeContent_85", - "contentItemId": "NarrativeContentItem_84", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_85", - "extensionAttributes": [], - "name": "NC_18", - "sectionNumber": "18", - "sectionTitle": "Appendix F: Patient Pill Diary", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_84", - "nextId": "NarrativeContent_86", - "contentItemId": "NarrativeContentItem_85", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_86", - "extensionAttributes": [], - "name": "NC_19", - "sectionNumber": "19", - "sectionTitle": "References", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_85", - "nextId": "NarrativeContent_87", - "contentItemId": "NarrativeContentItem_86", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_87", - "extensionAttributes": [], - "name": "NC_20", - "sectionNumber": "20", - "sectionTitle": "Investigator's Statement", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_86", - "nextId": null, - "contentItemId": "NarrativeContentItem_87", - "instanceType": "NarrativeContent" - } - ], - "notes": [], - "instanceType": "StudyDefitionDocumentVersion" - } - ], - "childIds": [], - "notes": [], - "instanceType": "StudyDefinitionDocument" - } - ], - "instanceType": "Study" - }, - "usdmVersion": "4.0", - "systemName": "SOA Workbench", - "systemVersion": "1.5.0" -} diff --git a/output/json/NCT01797120-dds-latest.json b/output/json/NCT01797120-dds-latest.json index 4ae61aa..9814346 100644 --- a/output/json/NCT01797120-dds-latest.json +++ b/output/json/NCT01797120-dds-latest.json @@ -3,7 +3,7 @@ "name": "MDV None", "description": "Data Definitions for None", "fileOID": "ODM.DEFINE-JSON.None.Version1.Design1", - "creationDateTime": "2026-08-06T13:27:49.607773+00:00", + "creationDateTime": "2026-08-11T12:09:21.260985+00:00", "odmVersion": "1.3.2", "fileType": "Snapshot", "originator": "Define-JSON Processor", @@ -2789,25 +2789,25 @@ "implementsConcept": "CONC.BiomedicalConcept_120" }, { - "OID": "IG.TA", - "name": "TA", - "description": "Trial Arms", - "domain": "TA", + "OID": "IG.EC", + "name": "EC", + "description": "Exposure as Collected", + "domain": "EC", "purpose": "Tabulation", - "structure": "One record per planned Element per Arm", - "isReferenceData": true, + "structure": "One record per protocol-specified study treatment, collected-dosing interval, per subject, per mood", + "isReferenceData": false, "keySequence": [ "STUDYID", - "ARMCD", - "ETCD" + "USUBJID", + "ECSEQ" ], "standard": "STD.SDTMIG", "observationClass": { - "name": "TRIAL DESIGN" + "name": "INTERVENTIONS" }, "items": [ { - "OID": "IT.TA.STUDYID", + "OID": "IT.EC.STUDYID", "mandatory": true, "name": "STUDYID", "description": "Study Identifier", @@ -2820,7 +2820,7 @@ } }, { - "OID": "IT.TA.DOMAIN", + "OID": "IT.EC.DOMAIN", "mandatory": true, "name": "DOMAIN", "description": "Domain Abbreviation", @@ -2833,40 +2833,38 @@ } }, { - "OID": "IT.TA.ARMCD", + "OID": "IT.EC.USUBJID", "mandatory": true, - "name": "ARMCD", - "description": "Planned Arm Code", - "role": "Topic", + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", "dataType": "text", "length": null, "origin": { "type": "Assigned", "source": "Sponsor" - }, - "codeList": "CL.ARMCD" + } }, { - "OID": "IT.TA.ARM", + "OID": "IT.EC.ECSEQ", "mandatory": true, - "name": "ARM", - "description": "Description of Planned Arm", - "role": "Synonym Qualifier", - "dataType": "text", + "name": "ECSEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", "length": null, "origin": { - "type": "Assigned", + "type": "Derived", "source": "Sponsor" - }, - "codeList": "CL.ARM" + } }, { - "OID": "IT.TA.TAETORD", - "mandatory": true, - "name": "TAETORD", - "description": "Planned Order of Element within Arm", - "role": "Timing", - "dataType": "integer", + "OID": "IT.EC.ECREFID", + "mandatory": false, + "name": "ECREFID", + "description": "Reference ID", + "role": "Identifier", + "dataType": "text", "length": null, "origin": { "type": "Collected", @@ -2874,181 +2872,202 @@ } }, { - "OID": "IT.TA.ETCD", + "OID": "IT.EC.ECTRT", "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Record Qualifier", + "name": "ECTRT", + "description": "Name of Treatment", + "role": "Topic", "dataType": "text", - "length": null, + "length": 200, "origin": { "type": "Collected", "source": "Investigator" - }, - "codeList": "CL.ETCD" + } }, { - "OID": "IT.TA.ELEMENT", + "OID": "IT.EC.ECDOSE", "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, + "name": "ECDOSE", + "description": "Dose", + "role": "Record Qualifier", + "dataType": "integer", + "length": 20, "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" + "type": "Collected", + "source": "Investigator" + } }, { - "OID": "IT.TA.TABRANCH", + "OID": "IT.EC.ECDOSTXT", "mandatory": false, - "name": "TABRANCH", - "description": "Branch", - "role": "Rule", + "name": "ECDOSTXT", + "description": "Dose Description", + "role": "Record Qualifier", "dataType": "text", - "length": null, + "length": 100, "origin": { - "type": "Assigned", - "source": "Sponsor" + "type": "Collected", + "source": "Investigator" } }, { - "OID": "IT.TA.TATRANS", + "OID": "IT.EC.ECDOSU", "mandatory": false, - "name": "TATRANS", - "description": "Transition Rule", - "role": "Rule", + "name": "ECDOSU", + "description": "Dose Units", + "role": "Variable Qualifier", "dataType": "text", - "length": null, + "length": 200, "origin": { - "type": "Assigned", - "source": "Sponsor" - } + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.UNIT" }, { - "OID": "IT.TA.EPOCH", - "mandatory": true, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", + "OID": "IT.EC.ECDOSFRM", + "mandatory": false, + "name": "ECDOSFRM", + "description": "Dose Form", + "role": "Variable Qualifier", "dataType": "text", - "length": null, + "length": 200, "origin": { - "type": "Derived", - "source": "Sponsor" + "type": "Collected", + "source": "Investigator" }, - "codeList": "CL.EPOCH" - } - ] - }, - { - "OID": "IG.TE", - "name": "TE", - "description": "Trial Elements", - "domain": "TE", - "purpose": "Tabulation", - "structure": "One record per planned Element", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ + "codeList": "CL.FRM" + }, { - "OID": "IT.TE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", + "OID": "IT.EC.ECDOSFRQ", + "mandatory": false, + "name": "ECDOSFRQ", + "description": "Dosing Frequency per Interval", + "role": "Record Qualifier", "dataType": "text", - "length": null, + "length": 200, "origin": { - "type": "Assigned", - "source": "Sponsor" - } + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.FREQ" }, { - "OID": "IT.TE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", + "OID": "IT.EC.ECDOSRGM", + "mandatory": false, + "name": "ECDOSRGM", + "description": "Intended Dose Regimen", + "role": "Record Qualifier", "dataType": "text", "length": null, "origin": { - "type": "Assigned", - "source": "Sponsor" + "type": "Collected", + "source": "Investigator" } }, { - "OID": "IT.TE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", + "OID": "IT.EC.ECROUTE", + "mandatory": false, + "name": "ECROUTE", + "description": "Route of Administration", + "role": "Variable Qualifier", "dataType": "text", - "length": null, + "length": 200, "origin": { - "type": "Assigned", - "source": "Sponsor" + "type": "Collected", + "source": "Investigator" }, - "codeList": "CL.ETCD" + "codeList": "CL.ROUTE" }, { - "OID": "IT.TE.ELEMENT", - "mandatory": true, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", + "OID": "IT.EC.ECLOC", + "mandatory": false, + "name": "ECLOC", + "description": "Location of Dose Administration", + "role": "Record Qualifier", "dataType": "text", - "length": null, + "length": 200, "origin": { - "type": "Assigned", - "source": "Sponsor" + "type": "Collected", + "source": "Investigator" }, - "codeList": "CL.ELEMENT" + "codeList": "CL.LOC" }, { - "OID": "IT.TE.TESTRL", - "mandatory": true, - "name": "TESTRL", - "description": "Rule for Start of Element", - "role": "Rule", + "OID": "IT.EC.ECLAT", + "mandatory": false, + "name": "ECLAT", + "description": "Laterality", + "role": "Variable Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.LAT" + }, + { + "OID": "IT.EC.ECDIR", + "mandatory": false, + "name": "ECDIR", + "description": "Directionality", + "role": "Variable Qualifier", "dataType": "text", "length": null, "origin": { - "type": "Assigned", - "source": "Sponsor" + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.DIR" + }, + { + "OID": "IT.EC.ECSTDTC", + "mandatory": false, + "name": "ECSTDTC", + "description": "Start Date/Time of Treatment", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.EC.ECENDTC", + "mandatory": false, + "name": "ECENDTC", + "description": "End Date/Time of Treatment", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" } } - ] + ], + "implementsConcept": "CONC.BiomedicalConcept_126" }, { - "OID": "IG.SV", - "name": "SV", - "description": "Subject Visits", - "domain": "SV", + "OID": "IG.AE", + "name": "AE", + "description": "Adverse Events", + "domain": "AE", "purpose": "Tabulation", - "structure": "One record per actual or planned visit per subject", + "structure": "One record per adverse event per subject", "isReferenceData": false, "keySequence": [ "STUDYID", "USUBJID", - "VISITNUM" + "AESEQ" ], "standard": "STD.SDTMIG", "observationClass": { - "name": "SPECIAL-PURPOSE" + "name": "EVENTS" }, "items": [ { - "OID": "IT.SV.STUDYID", + "OID": "IT.AE.STUDYID", "mandatory": true, "name": "STUDYID", "description": "Study Identifier", @@ -3061,7 +3080,7 @@ } }, { - "OID": "IT.SV.DOMAIN", + "OID": "IT.AE.DOMAIN", "mandatory": true, "name": "DOMAIN", "description": "Domain Abbreviation", @@ -3074,7 +3093,7 @@ } }, { - "OID": "IT.SV.USUBJID", + "OID": "IT.AE.USUBJID", "mandatory": true, "name": "USUBJID", "description": "Unique Subject Identifier", @@ -3087,24 +3106,37 @@ } }, { - "OID": "IT.SV.VISITNUM", + "OID": "IT.AE.AESEQ", "mandatory": true, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Topic", - "dataType": "integer", + "name": "AESEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", "length": null, "origin": { - "type": "Assigned", + "type": "Derived", "source": "Sponsor" } }, { - "OID": "IT.SV.VISIT", + "OID": "IT.AE.AETERM", + "mandatory": true, + "name": "AETERM", + "description": "Reported Term for the Adverse Event", + "role": "Topic", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AELLT", "mandatory": false, - "name": "VISIT", - "description": "Visit Name", - "role": "Synonym Qualifier", + "name": "AELLT", + "description": "Lowest Level Term", + "role": "Variable Qualifier", "dataType": "text", "length": null, "origin": { @@ -3113,1467 +3145,1683 @@ } }, { - "OID": "IT.SV.SVPRESP", + "OID": "IT.AE.AELLTCD", "mandatory": false, - "name": "SVPRESP", - "description": "Pre-specified", + "name": "AELLTCD", + "description": "Lowest Level Term Code", "role": "Variable Qualifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AEDECOD", + "mandatory": true, + "name": "AEDECOD", + "description": "Dictionary-Derived Term", + "role": "Synonym Qualifier", "dataType": "text", + "length": 200, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AEPTCD", + "mandatory": false, + "name": "AEPTCD", + "description": "Preferred Term Code", + "role": "Variable Qualifier", + "dataType": "integer", "length": null, "origin": { "type": "Assigned", "source": "Sponsor" - }, - "codeList": "CL.NY" + } }, { - "OID": "IT.SV.SVOCCUR", + "OID": "IT.AE.AEHLT", "mandatory": false, - "name": "SVOCCUR", - "description": "Occurrence", - "role": "Record Qualifier", + "name": "AEHLT", + "description": "High Level Term", + "role": "Variable Qualifier", "dataType": "text", "length": null, "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" + "type": "Assigned", + "source": "Sponsor" + } }, { - "OID": "IT.SV.SVCNTMOD", + "OID": "IT.AE.AEHLTCD", "mandatory": false, - "name": "SVCNTMOD", - "description": "Contact Mode", - "role": "Record Qualifier", - "dataType": "text", + "name": "AEHLTCD", + "description": "High Level Term Code", + "role": "Variable Qualifier", + "dataType": "integer", "length": null, "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.CNTMODE" + "type": "Assigned", + "source": "Sponsor" + } }, { - "OID": "IT.SV.SVSTDTC", + "OID": "IT.AE.AEHLGT", "mandatory": false, - "name": "SVSTDTC", - "description": "Start Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", + "name": "AEHLGT", + "description": "High Level Group Term", + "role": "Variable Qualifier", + "dataType": "text", + "length": null, "origin": { - "type": "Collected", - "source": "Investigator" + "type": "Assigned", + "source": "Sponsor" } }, { - "OID": "IT.SV.SVENDTC", + "OID": "IT.AE.AEHLGTCD", "mandatory": false, - "name": "SVENDTC", - "description": "End Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", + "name": "AEHLGTCD", + "description": "High Level Group Term Code", + "role": "Variable Qualifier", + "dataType": "integer", + "length": null, "origin": { - "type": "Collected", - "source": "Investigator" + "type": "Assigned", + "source": "Sponsor" } - } - ] - }, - { - "OID": "IG.SE", - "name": "SE", - "description": "Subject Elements", - "domain": "SE", - "purpose": "Tabulation", - "structure": "One record per actual Element per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SESTDTC" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ + }, { - "OID": "IT.SE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", + "OID": "IT.AE.AECAT", + "mandatory": false, + "name": "AECAT", + "description": "Category for Adverse Event", + "role": "Grouping Qualifier", "dataType": "text", - "length": null, + "length": 200, "origin": { "type": "Assigned", "source": "Sponsor" } }, { - "OID": "IT.SE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", + "OID": "IT.AE.AESCAT", + "mandatory": false, + "name": "AESCAT", + "description": "Subcategory for Adverse Event", + "role": "Grouping Qualifier", "dataType": "text", - "length": null, + "length": 200, "origin": { "type": "Assigned", "source": "Sponsor" } }, { - "OID": "IT.SE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", + "OID": "IT.AE.AEPRESP", + "mandatory": false, + "name": "AEPRESP", + "description": "Pre-Specified Adverse Event", + "role": "Variable Qualifier", "dataType": "text", - "length": null, + "length": 1, "origin": { "type": "Assigned", "source": "Sponsor" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.AE.AEBODSYS", + "mandatory": false, + "name": "AEBODSYS", + "description": "Body System or Organ Class", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" } }, { - "OID": "IT.SE.SESEQ", - "mandatory": true, - "name": "SESEQ", - "description": "Sequence Number", - "role": "Identifier", + "OID": "IT.AE.AEBDSYCD", + "mandatory": false, + "name": "AEBDSYCD", + "description": "Body System or Organ Class Code", + "role": "Variable Qualifier", "dataType": "integer", "length": null, "origin": { - "type": "Derived", + "type": "Assigned", "source": "Sponsor" } }, { - "OID": "IT.SE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", + "OID": "IT.AE.AESOC", + "mandatory": false, + "name": "AESOC", + "description": "Primary System Organ Class", + "role": "Variable Qualifier", "dataType": "text", "length": null, "origin": { "type": "Assigned", "source": "Sponsor" - }, - "codeList": "CL.ETCD" + } }, { - "OID": "IT.SE.ELEMENT", + "OID": "IT.AE.AESOCCD", "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", + "name": "AESOCCD", + "description": "Primary System Organ Class Code", + "role": "Variable Qualifier", + "dataType": "integer", "length": null, "origin": { "type": "Assigned", "source": "Sponsor" + } + }, + { + "OID": "IT.AE.AELOC", + "mandatory": false, + "name": "AELOC", + "description": "Location of Event", + "role": "Record Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" }, - "codeList": "CL.ELEMENT" + "codeList": "CL.LOC" }, { - "OID": "IT.SE.EPOCH", + "OID": "IT.AE.AESEV", "mandatory": false, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", + "name": "AESEV", + "description": "Severity/Intensity", + "role": "Record Qualifier", "dataType": "text", - "length": null, + "length": 200, "origin": { - "type": "Derived", - "source": "Sponsor" + "type": "Collected", + "source": "Investigator" }, - "codeList": "CL.EPOCH" + "codeList": "CL.AESEV" }, { - "OID": "IT.SE.SESTDTC", - "mandatory": true, - "name": "SESTDTC", - "description": "Start Date/Time of Element", - "role": "Timing", - "dataType": "datetime", + "OID": "IT.AE.AESER", + "mandatory": false, + "name": "AESER", + "description": "Serious Event", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.AE.AEACN", + "mandatory": false, + "name": "AEACN", + "description": "Action Taken with Study Treatment", + "role": "Record Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.ACN" + }, + { + "OID": "IT.AE.AEACNOTH", + "mandatory": false, + "name": "AEACNOTH", + "description": "Other Action Taken", + "role": "Record Qualifier", + "dataType": "text", + "length": 200, "origin": { "type": "Collected", "source": "Investigator" } }, { - "OID": "IT.SE.SEENDTC", + "OID": "IT.AE.AEREL", "mandatory": false, - "name": "SEENDTC", - "description": "End Date/Time of Element", - "role": "Timing", - "dataType": "datetime", + "name": "AEREL", + "description": "Causality", + "role": "Record Qualifier", + "dataType": "text", + "length": 200, "origin": { "type": "Collected", "source": "Investigator" } - } - ] - } - ], - "conditions": [ - { - "OID": "COND.TS.TSPARMCD.4b2c750e", - "rangeChecks": [ + }, { - "comparator": "EQ", - "checkValues": [ - "COMPTRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.82dcbb4a", - "rangeChecks": [ + "OID": "IT.AE.AERELNST", + "mandatory": false, + "name": "AERELNST", + "description": "Relationship to Non-Study Treatment", + "role": "Record Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, { - "comparator": "EQ", - "checkValues": [ - "INDIC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.de0404c1", - "rangeChecks": [ + "OID": "IT.AE.AEPATT", + "mandatory": false, + "name": "AEPATT", + "description": "Pattern of Adverse Event", + "role": "Record Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, { - "comparator": "EQ", - "checkValues": [ - "INTTYPE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.1d8ed13f", - "rangeChecks": [ + "OID": "IT.AE.AEOUT", + "mandatory": false, + "name": "AEOUT", + "description": "Outcome of Adverse Event", + "role": "Record Qualifier", + "dataType": "text", + "length": 200, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.OUT" + }, { - "comparator": "EQ", - "checkValues": [ - "NARMS" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.cccc9db0", - "rangeChecks": [ + "OID": "IT.AE.AESCAN", + "mandatory": false, + "name": "AESCAN", + "description": "Involves Cancer", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, { - "comparator": "EQ", - "checkValues": [ - "OBJPRIM" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.863c5858", - "rangeChecks": [ + "OID": "IT.AE.AESCONG", + "mandatory": false, + "name": "AESCONG", + "description": "Congenital Anomaly or Birth Defect", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, { - "comparator": "EQ", - "checkValues": [ - "OBJSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.69b92c86", - "rangeChecks": [ + "OID": "IT.AE.AESDISAB", + "mandatory": false, + "name": "AESDISAB", + "description": "Persist or Signif Disability/Incapacity", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, { - "comparator": "EQ", - "checkValues": [ - "OUTMSPRI" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.df99032e", - "rangeChecks": [ + "OID": "IT.AE.AESDTH", + "mandatory": false, + "name": "AESDTH", + "description": "Results in Death", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, { - "comparator": "EQ", - "checkValues": [ - "OUTMSSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.5b1e67a5", - "rangeChecks": [ + "OID": "IT.AE.AESHOSP", + "mandatory": false, + "name": "AESHOSP", + "description": "Requires or Prolongs Hospitalization", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, { - "comparator": "EQ", - "checkValues": [ - "SPONSOR" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.90f47ac3", - "rangeChecks": [ + "OID": "IT.AE.AESLIFE", + "mandatory": false, + "name": "AESLIFE", + "description": "Is Life Threatening", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, { - "comparator": "EQ", - "checkValues": [ - "TITLE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.e2190e21", - "rangeChecks": [ + "OID": "IT.AE.AESOD", + "mandatory": false, + "name": "AESOD", + "description": "Occurred with Overdose", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, { - "comparator": "EQ", - "checkValues": [ - "TRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - } - ], - "whereClauses": [ - { - "OID": "WC.TS.8c559472", - "conditions": [ - "COND.TS.TSPARMCD.4b2c750e" - ] - }, - { - "OID": "WC.TS.e5769859", - "conditions": [ - "COND.TS.TSPARMCD.82dcbb4a" - ] - }, - { - "OID": "WC.TS.d3e89d3f", - "conditions": [ - "COND.TS.TSPARMCD.de0404c1" - ] - }, - { - "OID": "WC.TS.efd2a465", - "conditions": [ - "COND.TS.TSPARMCD.1d8ed13f" - ] - }, - { - "OID": "WC.TS.fe255586", - "conditions": [ - "COND.TS.TSPARMCD.cccc9db0" - ] - }, - { - "OID": "WC.TS.62794b6c", - "conditions": [ - "COND.TS.TSPARMCD.863c5858" - ] - }, - { - "OID": "WC.TS.4266ae9d", - "conditions": [ - "COND.TS.TSPARMCD.69b92c86" - ] - }, - { - "OID": "WC.TS.1d6311e2", - "conditions": [ - "COND.TS.TSPARMCD.df99032e" - ] - }, - { - "OID": "WC.TS.e06f8db5", - "conditions": [ - "COND.TS.TSPARMCD.5b1e67a5" - ] - }, - { - "OID": "WC.TS.d94c6616", - "conditions": [ - "COND.TS.TSPARMCD.90f47ac3" - ] - }, - { - "OID": "WC.TS.d368cfb2", - "conditions": [ - "COND.TS.TSPARMCD.e2190e21" - ] - } - ], - "codeLists": [ - { - "OID": "CL.ARMCD", - "name": "ARM Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IT.AE.AESMIE", + "mandatory": false, + "name": "AESMIE", + "description": "Other Medically Important Serious Event", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.AE.AECONTRT", + "mandatory": false, + "name": "AECONTRT", + "description": "Concomitant or Additional Trtmnt Given", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, + { + "OID": "IT.AE.AETOXGR", + "mandatory": false, + "name": "AETOXGR", + "description": "Standard Toxicity Grade", + "role": "Record Qualifier", + "dataType": "text", + "length": 1, + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AESTDTC", + "mandatory": false, + "name": "AESTDTC", + "description": "Start Date/Time of Adverse Event", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.AE.AEENDTC", + "mandatory": false, + "name": "AEENDTC", + "description": "End Date/Time of Adverse Event", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, { - "codedValue": "ARM A" + "OID": "IT.AE.AEENRF", + "mandatory": false, + "name": "AEENRF", + "description": "End Relative to Reference Period", + "role": "Timing", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" }, { - "codedValue": "ARM B" + "OID": "IT.AE.AEENRTPT", + "mandatory": false, + "name": "AEENRTPT", + "description": "End Relative to Reference Time Point", + "role": "Timing", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.STENRF" + }, + { + "OID": "IT.AE.AEENTPT", + "mandatory": false, + "name": "AEENTPT", + "description": "End Reference Time Point", + "role": "Timing", + "dataType": "text", + "length": 20, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } } - ] + ], + "implementsConcept": "CONC.BiomedicalConcept_127" }, { - "OID": "CL.ARM", - "name": "ARM", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IG.TA", + "name": "TA", + "description": "Trial Arms", + "domain": "TA", + "purpose": "Tabulation", + "structure": "One record per planned Element per Arm", + "isReferenceData": true, + "keySequence": [ + "STUDYID", + "ARMCD", + "ETCD" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "TRIAL DESIGN" + }, + "items": [ { - "codedValue": "ARM A" + "OID": "IT.TA.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } }, { - "codedValue": "ARM B" - } - ] - }, - { - "OID": "CL.ELEMENT", - "name": "Description of Element", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IT.TA.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, { - "codedValue": "Screening" + "OID": "IT.TA.ARMCD", + "mandatory": true, + "name": "ARMCD", + "description": "Planned Arm Code", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ARMCD" }, { - "codedValue": "Induction: Fulvestrant + Everolimus" + "OID": "IT.TA.ARM", + "mandatory": true, + "name": "ARM", + "description": "Description of Planned Arm", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ARM" }, { - "codedValue": "Induction: Fulvestrant + Placebo" + "OID": "IT.TA.TAETORD", + "mandatory": true, + "name": "TAETORD", + "description": "Planned Order of Element within Arm", + "role": "Timing", + "dataType": "integer", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + } }, { - "codedValue": "Continuation: Fulvestrant + Everolimus" + "OID": "IT.TA.ETCD", + "mandatory": true, + "name": "ETCD", + "description": "Element Code", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.ETCD" }, { - "codedValue": "Continuation: Fulvestrant alone" + "OID": "IT.TA.ELEMENT", + "mandatory": false, + "name": "ELEMENT", + "description": "Description of Element", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ELEMENT" }, { - "codedValue": "Follow-Up Off-Therapy" + "OID": "IT.TA.TABRANCH", + "mandatory": false, + "name": "TABRANCH", + "description": "Branch", + "role": "Rule", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TA.TATRANS", + "mandatory": false, + "name": "TATRANS", + "description": "Transition Rule", + "role": "Rule", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, + { + "OID": "IT.TA.EPOCH", + "mandatory": true, + "name": "EPOCH", + "description": "Epoch", + "role": "Timing", + "dataType": "text", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + }, + "codeList": "CL.EPOCH" } ] }, { - "OID": "CL.ETCD", - "name": "Element Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SCREENING_ELEMENT", - "decode": "Screening" - }, + "OID": "IG.TE", + "name": "TE", + "description": "Trial Elements", + "domain": "TE", + "purpose": "Tabulation", + "structure": "One record per planned Element", + "isReferenceData": true, + "keySequence": [ + "STUDYID", + "ETCD" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "TRIAL DESIGN" + }, + "items": [ { - "codedValue": "INDUCTION_EVE_FUL", - "decode": "Induction: Fulvestrant + Everolimus" + "OID": "IT.TE.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } }, { - "codedValue": "INDUCTION_PBO_FUL", - "decode": "Induction: Fulvestrant + Placebo" + "OID": "IT.TE.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } }, { - "codedValue": "CONTINUATION_EVE_FUL", - "decode": "Continuation: Fulvestrant + Everolimus" + "OID": "IT.TE.ETCD", + "mandatory": true, + "name": "ETCD", + "description": "Element Code", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ETCD" }, { - "codedValue": "CONTINUATION_FUL", - "decode": "Continuation: Fulvestrant alone" + "OID": "IT.TE.ELEMENT", + "mandatory": true, + "name": "ELEMENT", + "description": "Description of Element", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ELEMENT" }, { - "codedValue": "FOLLOW_UP_ELEMENT", - "decode": "Follow-Up Off-Therapy" + "OID": "IT.TE.TESTRL", + "mandatory": true, + "name": "TESTRL", + "description": "Rule for Start of Element", + "role": "Rule", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } } ] }, { - "OID": "CL.EPOCH", - "name": "Epoch", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99079", - "codeSystem": "nci:ExtCodeID" - } + "OID": "IG.SV", + "name": "SV", + "description": "Subject Visits", + "domain": "SV", + "purpose": "Tabulation", + "structure": "One record per actual or planned visit per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "VISITNUM" ], - "codeListItems": [ + "standard": "STD.SDTMIG", + "observationClass": { + "name": "SPECIAL-PURPOSE" + }, + "items": [ { - "codedValue": "Pre-Study Phase", - "coding": { - "code": "C202487", - "codeSystem": "nci:ExtCodeID" + "OID": "IT.SV.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" } }, { - "codedValue": "Induction Phase", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" + "OID": "IT.SV.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" } }, { - "codedValue": "Continuation Phase", - "coding": { - "code": "C123452", - "codeSystem": "nci:ExtCodeID" + "OID": "IT.SV.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" } }, { - "codedValue": "Follow-up Off Therapy", - "coding": { - "code": "C202578", - "codeSystem": "nci:ExtCodeID" + "OID": "IT.SV.VISITNUM", + "mandatory": true, + "name": "VISITNUM", + "description": "Visit Number", + "role": "Topic", + "dataType": "integer", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" } - } - ] - }, - { - "OID": "CL.ad42d7e1", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + }, { - "codedValue": "INFORMED CONSENT OBTAINED", - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED" - } - ] - } - ] - }, - { - "OID": "CL.65a3e8d0", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IT.SV.VISIT", + "mandatory": false, + "name": "VISIT", + "description": "Visit Name", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, { - "codedValue": "ELIGIBILITY CRITERIA MET", - "coding": [ - { - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ELIGIBILITY CRITERIA MET" - } - ] - } - ] - }, - { - "OID": "CL.7cfd6cc5", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IT.SV.SVPRESP", + "mandatory": false, + "name": "SVPRESP", + "description": "Pre-specified", + "role": "Variable Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.NY" + }, { - "codedValue": "mmHg", - "coding": [ - { - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg" - } - ] - } - ] - }, - { - "OID": "CL.20024ecd", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IT.SV.SVOCCUR", + "mandatory": false, + "name": "SVOCCUR", + "description": "Occurrence", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.NY" + }, { - "codedValue": "beats/min", - "coding": [ - { - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min" - } - ] - } - ] - }, - { - "OID": "CL.9e69169e", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IT.SV.SVCNTMOD", + "mandatory": false, + "name": "SVCNTMOD", + "description": "Contact Mode", + "role": "Record Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Collected", + "source": "Investigator" + }, + "codeList": "CL.CNTMODE" + }, + { + "OID": "IT.SV.SVSTDTC", + "mandatory": false, + "name": "SVSTDTC", + "description": "Start Date/Time of Observation", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, { - "codedValue": "SERUM OR PLASMA", - "coding": [ - { - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA" - } - ] + "OID": "IT.SV.SVENDTC", + "mandatory": false, + "name": "SVENDTC", + "description": "End Date/Time of Observation", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } } ] }, { - "OID": "CL.b6e07c4c", - "name": "TSPARMCD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IG.SE", + "name": "SE", + "description": "Subject Elements", + "domain": "SE", + "purpose": "Tabulation", + "structure": "One record per actual Element per subject", + "isReferenceData": false, + "keySequence": [ + "STUDYID", + "USUBJID", + "SESTDTC" + ], + "standard": "STD.SDTMIG", + "observationClass": { + "name": "SPECIAL-PURPOSE" + }, + "items": [ { - "codedValue": "RANDOM", - "coding": [ - { - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "RANDOM" - } - ] - } - ] - }, - { - "OID": "CL.3705a725", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IT.SE.STUDYID", + "mandatory": true, + "name": "STUDYID", + "description": "Study Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, { - "codedValue": "s", - "coding": [ - { - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s" - } - ] - } - ] - }, - { - "OID": "CL.af8f8a19", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IT.SE.DOMAIN", + "mandatory": true, + "name": "DOMAIN", + "description": "Domain Abbreviation", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, { - "codedValue": "BLOOD", - "coding": [ - { - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD" - } - ] - } - ] - }, - { - "OID": "CL.dab673be", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IT.SE.USUBJID", + "mandatory": true, + "name": "USUBJID", + "description": "Unique Subject Identifier", + "role": "Identifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + } + }, { - "codedValue": "RATIO", - "coding": [ - { - "code": "C44256", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RATIO" - } - ] - } - ] - }, - { - "OID": "CL.0fe19c26", - "name": "TUORRES Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "IT.SE.SESEQ", + "mandatory": true, + "name": "SESEQ", + "description": "Sequence Number", + "role": "Identifier", + "dataType": "integer", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + } + }, { - "codedValue": "TARGET", - "coding": [ - { - "code": "C94520", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "TARGET" - } - ] + "OID": "IT.SE.ETCD", + "mandatory": true, + "name": "ETCD", + "description": "Element Code", + "role": "Topic", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ETCD" + }, + { + "OID": "IT.SE.ELEMENT", + "mandatory": false, + "name": "ELEMENT", + "description": "Description of Element", + "role": "Synonym Qualifier", + "dataType": "text", + "length": null, + "origin": { + "type": "Assigned", + "source": "Sponsor" + }, + "codeList": "CL.ELEMENT" + }, + { + "OID": "IT.SE.EPOCH", + "mandatory": false, + "name": "EPOCH", + "description": "Epoch", + "role": "Timing", + "dataType": "text", + "length": null, + "origin": { + "type": "Derived", + "source": "Sponsor" + }, + "codeList": "CL.EPOCH" + }, + { + "OID": "IT.SE.SESTDTC", + "mandatory": true, + "name": "SESTDTC", + "description": "Start Date/Time of Element", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } + }, + { + "OID": "IT.SE.SEENDTC", + "mandatory": false, + "name": "SEENDTC", + "description": "End Date/Time of Element", + "role": "Timing", + "dataType": "datetime", + "origin": { + "type": "Collected", + "source": "Investigator" + } } ] - }, + } + ], + "conditions": [ { - "OID": "CL.5183f82c", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "COND.TS.TSPARMCD.4b2c750e", + "rangeChecks": [ { - "codedValue": "URINE", - "coding": [ - { - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE" - } - ] + "comparator": "EQ", + "checkValues": [ + "COMPTRT" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" } ] }, { - "OID": "CL.1aeb2034", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "COND.TS.TSPARMCD.82dcbb4a", + "rangeChecks": [ { - "codedValue": "ERYTHROCYTES", - "coding": [ - { - "code": "C12521", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ERYTHROCYTES" - } - ] + "comparator": "EQ", + "checkValues": [ + "INDIC" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" } ] }, { - "OID": "CL.68e5ab5a", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "COND.TS.TSPARMCD.de0404c1", + "rangeChecks": [ { - "codedValue": "10^9/L", - "coding": [ - { - "code": "C67255", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^9/L" - } - ] + "comparator": "EQ", + "checkValues": [ + "INTTYPE" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" } ] }, { - "OID": "CL.2c53325c", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "COND.TS.TSPARMCD.1d8ed13f", + "rangeChecks": [ { - "codedValue": "10^6/L", - "coding": [ - { - "code": "C67452", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^6/L" - } - ] + "comparator": "EQ", + "checkValues": [ + "NARMS" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" } ] }, { - "OID": "CL.a00fe0a9", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ + "OID": "COND.TS.TSPARMCD.cccc9db0", + "rangeChecks": [ { - "codedValue": "fL", - "coding": [ - { - "code": "C64780", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "fL" - } - ] + "comparator": "EQ", + "checkValues": [ + "OBJPRIM" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" } ] }, { - "OID": "CL.NCOMPLT", - "name": "Completion/Reason for Non-Completion", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66727", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ + "OID": "COND.TS.TSPARMCD.863c5858", + "rangeChecks": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "comparator": "EQ", + "checkValues": [ + "OBJSEC" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" } ] }, { - "OID": "CL.DSCAT", - "name": "Category of Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74558", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ + "OID": "COND.TS.TSPARMCD.69b92c86", + "rangeChecks": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "comparator": "EQ", + "checkValues": [ + "OUTMSPRI" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" } ] }, { - "OID": "CL.ONCRTSCD", - "name": "Oncology Response Assessment Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96782", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ + "OID": "COND.TS.TSPARMCD.df99032e", + "rangeChecks": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "comparator": "EQ", + "checkValues": [ + "OUTMSSEC" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" } ] }, { - "OID": "CL.ONCRTS", - "name": "Oncology Response Assessment Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96781", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ + "OID": "COND.TS.TSPARMCD.5b1e67a5", + "rangeChecks": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "comparator": "EQ", + "checkValues": [ + "SPONSOR" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" } ] }, { - "OID": "CL.ONCRSCAT", - "name": "Category of Oncology Response Assessment", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C124298", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ + "OID": "COND.TS.TSPARMCD.90f47ac3", + "rangeChecks": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "comparator": "EQ", + "checkValues": [ + "TITLE" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" } ] }, { - "OID": "CL.ONCRSR", - "name": "Oncology Response Assessment Result", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96785", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ + "OID": "COND.TS.TSPARMCD.e2190e21", + "rangeChecks": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "comparator": "EQ", + "checkValues": [ + "TRT" + ], + "item": "IT.TS.TSPARMCD", + "softHard": "Soft" } ] - }, + } + ], + "whereClauses": [ { - "OID": "CL.EVAL", - "name": "Evaluator", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C78735", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } + "OID": "WC.TS.8c559472", + "conditions": [ + "COND.TS.TSPARMCD.4b2c750e" ] }, { - "OID": "CL.MEDEVAL", - "name": "Medical Evaluator Identifier", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96777", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } + "OID": "WC.TS.e5769859", + "conditions": [ + "COND.TS.TSPARMCD.82dcbb4a" ] }, { - "OID": "CL.VSTESTCD", - "name": "Vital Signs Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66741", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } + "OID": "WC.TS.d3e89d3f", + "conditions": [ + "COND.TS.TSPARMCD.de0404c1" ] }, { - "OID": "CL.VSTEST", - "name": "Vital Signs Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67153", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } + "OID": "WC.TS.efd2a465", + "conditions": [ + "COND.TS.TSPARMCD.1d8ed13f" ] }, { - "OID": "CL.POSITION", - "name": "Position", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71148", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } + "OID": "WC.TS.fe255586", + "conditions": [ + "COND.TS.TSPARMCD.cccc9db0" ] }, { - "OID": "CL.VSRESU", - "name": "Units for Vital Signs Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66770", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } + "OID": "WC.TS.62794b6c", + "conditions": [ + "COND.TS.TSPARMCD.863c5858" ] }, { - "OID": "CL.LOC", - "name": "Anatomical Location", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74456", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } + "OID": "WC.TS.4266ae9d", + "conditions": [ + "COND.TS.TSPARMCD.69b92c86" ] }, { - "OID": "CL.LAT", - "name": "Laterality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99073", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } + "OID": "WC.TS.1d6311e2", + "conditions": [ + "COND.TS.TSPARMCD.df99032e" ] }, { - "OID": "CL.NY", - "name": "No Yes Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } + "OID": "WC.TS.e06f8db5", + "conditions": [ + "COND.TS.TSPARMCD.5b1e67a5" ] }, { - "OID": "CL.LBTESTCD", - "name": "Laboratory Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C65047", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } + "OID": "WC.TS.d94c6616", + "conditions": [ + "COND.TS.TSPARMCD.90f47ac3" ] }, { - "OID": "CL.LBTEST", - "name": "Laboratory Test Name", + "OID": "WC.TS.d368cfb2", + "conditions": [ + "COND.TS.TSPARMCD.e2190e21" + ] + } + ], + "codeLists": [ + { + "OID": "CL.ARMCD", + "name": "ARM Code", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67154", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "ARM A" + }, + { + "codedValue": "ARM B" } ] }, { - "OID": "CL.UNIT", - "name": "Unit", + "OID": "CL.ARM", + "name": "ARM", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71620", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "ARM A" + }, + { + "codedValue": "ARM B" } ] }, { - "OID": "CL.FRM", - "name": "Dosage Form", + "OID": "CL.ELEMENT", + "name": "Description of Element", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66726", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "Screening" + }, + { + "codedValue": "Induction: Fulvestrant + Everolimus" + }, + { + "codedValue": "Induction: Fulvestrant + Placebo" + }, + { + "codedValue": "Continuation: Fulvestrant + Everolimus" + }, + { + "codedValue": "Continuation: Fulvestrant alone" + }, + { + "codedValue": "Follow-Up Off-Therapy" } ] }, { - "OID": "CL.FREQ", - "name": "Frequency", + "OID": "CL.ETCD", + "name": "Element Code", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71113", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "SCREENING_ELEMENT", + "decode": "Screening" + }, + { + "codedValue": "INDUCTION_EVE_FUL", + "decode": "Induction: Fulvestrant + Everolimus" + }, + { + "codedValue": "INDUCTION_PBO_FUL", + "decode": "Induction: Fulvestrant + Placebo" + }, + { + "codedValue": "CONTINUATION_EVE_FUL", + "decode": "Continuation: Fulvestrant + Everolimus" + }, + { + "codedValue": "CONTINUATION_FUL", + "decode": "Continuation: Fulvestrant alone" + }, + { + "codedValue": "FOLLOW_UP_ELEMENT", + "decode": "Follow-Up Off-Therapy" } ] }, { - "OID": "CL.ROUTE", - "name": "Route of Administration Response", + "OID": "CL.EPOCH", + "name": "Epoch", "dataType": "text", "standard": "STD.SDTMCT", "coding": [ { - "code": "C66729", + "code": "C99079", "codeSystem": "nci:ExtCodeID" } ], "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "Pre-Study Phase", + "coding": { + "code": "C202487", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Induction Phase", + "coding": { + "code": "C101526", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Continuation Phase", + "coding": { + "code": "C123452", + "codeSystem": "nci:ExtCodeID" + } + }, + { + "codedValue": "Follow-up Off Therapy", + "coding": { + "code": "C202578", + "codeSystem": "nci:ExtCodeID" + } } ] }, { - "OID": "CL.STENRF", - "name": "Relation to Reference Period", + "OID": "CL.ad42d7e1", + "name": "DSDECOD Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66728", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "INFORMED CONSENT OBTAINED", + "coding": [ + { + "code": "C16735", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "INFORMED CONSENT OBTAINED" + } + ] } ] }, { - "OID": "CL.TSPARMCD", - "name": "Trial Summary Parameter Test Code", + "OID": "CL.65a3e8d0", + "name": "DSDECOD Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66738", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "RANDOM", - "decode": "Trial is Randomized", - "coding": { - "code": "C25196", - "codeSystem": "nci:ExtCodeID" - } + "codedValue": "ELIGIBILITY CRITERIA MET", + "coding": [ + { + "code": "C132447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ELIGIBILITY CRITERIA MET" + } + ] } ] }, { - "OID": "CL.TSPARM", - "name": "Trial Summary Parameter Test Name", + "OID": "CL.7cfd6cc5", + "name": "VSORRESU Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67152", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "Trial is Randomized", - "decode": "Trial is Randomized", - "coding": { - "code": "C25196", - "codeSystem": "nci:ExtCodeID" - } + "codedValue": "mmHg", + "coding": [ + { + "code": "C49670", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "mmHg" + } + ] } ] }, { - "OID": "CL.DICTNAM", - "name": "Dictionary Name", + "OID": "CL.20024ecd", + "name": "VSORRESU Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66788", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "beats/min", + "coding": [ + { + "code": "C49673", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "beats/min" + } + ] } ] }, { - "OID": "CL.TRTESTCD", - "name": "Tumor or Lesion Properties Test Code", + "OID": "CL.9e69169e", + "name": "LBSPEC Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96779", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "SERUM OR PLASMA", + "coding": [ + { + "code": "C105706", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "SERUM OR PLASMA" + } + ] } ] }, { - "OID": "CL.TRTEST", - "name": "Tumor or Lesion Properties Test Name", + "OID": "CL.b6e07c4c", + "name": "TSPARMCD Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96778", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "RANDOM", + "coding": [ + { + "code": "C25196", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "RANDOM" + } + ] } ] }, { - "OID": "CL.TRPROPRS", - "name": "Tumor or Lesion Properties Test Result", + "OID": "CL.3705a725", + "name": "LBORRESU Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ + "isNonStandard": true, + "codeListItems": [ { - "code": "C124309", - "codeSystem": "nci:ExtCodeID" + "codedValue": "s", + "coding": [ + { + "code": "C42535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "s" + } + ] } - ], + ] + }, + { + "OID": "CL.af8f8a19", + "name": "LBSPEC Response Codes", + "dataType": "text", + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "BLOOD", + "coding": [ + { + "code": "C12434", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "BLOOD" + } + ] } ] }, { - "OID": "CL.METHOD", - "name": "Method", + "OID": "CL.dab673be", + "name": "LBORRESU Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ + "isNonStandard": true, + "codeListItems": [ { - "code": "C85492", - "codeSystem": "nci:ExtCodeID" + "codedValue": "RATIO", + "coding": [ + { + "code": "C44256", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "RATIO" + } + ] } - ], + ] + }, + { + "OID": "CL.0fe19c26", + "name": "TUORRES Response Codes", + "dataType": "text", + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "TARGET", + "coding": [ + { + "code": "C94520", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "TARGET" + } + ] } ] }, { - "OID": "CL.TUTESTCD", - "name": "Tumor or Lesion Identification Test Code", + "OID": "CL.5183f82c", + "name": "LBSPEC Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96784", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "URINE", + "coding": [ + { + "code": "C13283", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "URINE" + } + ] } ] }, { - "OID": "CL.TUTEST", - "name": "Tumor or Lesion Identification Test Name", + "OID": "CL.1aeb2034", + "name": "LBSPEC Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96783", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "ERYTHROCYTES", + "coding": [ + { + "code": "C12521", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "ERYTHROCYTES" + } + ] } ] }, { - "OID": "CL.TUIDRS", - "name": "Tumor or Lesion Identification Test Results", + "OID": "CL.68e5ab5a", + "name": "LBORRESU Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C123650", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "10^9/L", + "coding": [ + { + "code": "C67255", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "10^9/L" + } + ] } ] }, { - "OID": "CL.DIR", - "name": "Directionality", + "OID": "CL.2c53325c", + "name": "LBORRESU Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99074", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "10^6/L", + "coding": [ + { + "code": "C67452", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "10^6/L" + } + ] } ] }, { - "OID": "CL.URNSTSCD", - "name": "Urinary System Test Code", + "OID": "CL.a00fe0a9", + "name": "LBORRESU Response Codes", "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129942", - "codeSystem": "nci:ExtCodeID" - } - ], + "isNonStandard": true, "codeListItems": [ { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" + "codedValue": "fL", + "coding": [ + { + "code": "C64780", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "fL" + } + ] } ] }, { - "OID": "CL.URNSTS", - "name": "Urinary System Test Name", + "OID": "CL.NCOMPLT", + "name": "Completion/Reason for Non-Completion", "dataType": "text", "standard": "STD.SDTMCT", "coding": [ { - "code": "C129941", + "code": "C66727", "codeSystem": "nci:ExtCodeID" } ], @@ -4585,13 +4833,13 @@ ] }, { - "OID": "CL.RETESTCD", - "name": "Respiratory Test Code", + "OID": "CL.DSCAT", + "name": "Category of Disposition Event", "dataType": "text", "standard": "STD.SDTMCT", "coding": [ { - "code": "C111106", + "code": "C74558", "codeSystem": "nci:ExtCodeID" } ], @@ -4603,13 +4851,13 @@ ] }, { - "OID": "CL.RETEST", - "name": "Respiratory Test Name", + "OID": "CL.ONCRTSCD", + "name": "Oncology Response Assessment Test Code", "dataType": "text", "standard": "STD.SDTMCT", "coding": [ { - "code": "C111107", + "code": "C96782", "codeSystem": "nci:ExtCodeID" } ], @@ -4621,13 +4869,13 @@ ] }, { - "OID": "CL.MBTESTCD", - "name": "Microbiology Test Code", + "OID": "CL.ONCRTS", + "name": "Oncology Response Assessment Test Name", "dataType": "text", "standard": "STD.SDTMCT", "coding": [ { - "code": "C120527", + "code": "C96781", "codeSystem": "nci:ExtCodeID" } ], @@ -4639,13 +4887,13 @@ ] }, { - "OID": "CL.MBTEST", - "name": "Microbiology Test Name", + "OID": "CL.ONCRSCAT", + "name": "Category of Oncology Response Assessment", "dataType": "text", "standard": "STD.SDTMCT", "coding": [ { - "code": "C120528", + "code": "C124298", "codeSystem": "nci:ExtCodeID" } ], @@ -4657,13 +4905,13 @@ ] }, { - "OID": "CL.MBFTSDTL", - "name": "Microbiology Findings Test Details", + "OID": "CL.ONCRSR", + "name": "Oncology Response Assessment Result", "dataType": "text", "standard": "STD.SDTMCT", "coding": [ { - "code": "C174225", + "code": "C96785", "codeSystem": "nci:ExtCodeID" } ], @@ -4675,1554 +4923,1139 @@ ] }, { - "OID": "CL.SPECTYPE", - "name": "Specimen Type", + "OID": "CL.EVAL", + "name": "Evaluator", "dataType": "text", "standard": "STD.SDTMCT", "coding": [ { - "code": "C78734", + "code": "C78735", "codeSystem": "nci:ExtCodeID" } ], "codeListItems": [ { - "codedValue": "SERUM OR PLASMA", - "decode": "Ser/Plas", - "coding": { - "code": "C105706", - "codeSystem": "nci:ExtCodeID" - } + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CL.CNTMODE", - "name": "Mode of Subject Contact", + "OID": "CL.MEDEVAL", + "name": "Medical Evaluator Identifier", "dataType": "text", "standard": "STD.SDTMCT", "coding": [ { - "code": "C171445", + "code": "C96777", "codeSystem": "nci:ExtCodeID" } ], "codeListItems": [ { - "codedValue": "IN PERSON", - "decode": "In-Person", - "coding": { - "code": "C175574", - "codeSystem": "nci:ExtCodeID" - } + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] - } - ], - "methods": [], - "comments": [], - "standards": [ - { - "OID": "STD.SDTMIG", - "name": "SDTMIG", - "type": "IG", - "version": "3.4", - "status": "FINAL" }, { - "OID": "STD.SDTMCT", - "name": "CDISC/NCI", - "type": "CT", - "version": "2026-03-27", - "status": "FINAL", - "publishingSet": "SDTM" - } - ], - "annotatedCRF": [], - "concepts": [ - { - "OID": "CONC.BiomedicalConcept_1", - "name": "Informed Consent", - "label": "Informed Consent", - "aliases": [ - "Informed Consent Obtained" - ], - "href": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, + "OID": "CL.VSTESTCD", + "name": "Vital Signs Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] + "code": "C66741", + "codeSystem": "nci:ExtCodeID" } ], - "coding": [ + "codeListItems": [ { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent" + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_2", - "name": "Eligibility Criteria Met By Subject", - "label": "Eligibility Criteria Met By Subject", - "aliases": [ - "Eligibility Criteria Met" - ], - "href": "/mdr/bc/biomedicalconcepts/C132447", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.65a3e8d0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, + "OID": "CL.VSTEST", + "name": "Vital Signs Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] + "code": "C67153", + "codeSystem": "nci:ExtCodeID" } ], - "coding": [ + "codeListItems": [ { - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Eligibility Criteria Met By Subject" + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_5", - "name": "ECOG - Performance Status", - "label": "ECOG - Performance Status", - "aliases": [ - "ECOG1-Performance Status", - "ECOG101", - "ECOG - Performance Status" - ], - "href": "/mdr/bc/biomedicalconcepts/C102408", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, + "OID": "CL.POSITION", + "name": "Position", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] + "code": "C71148", + "codeSystem": "nci:ExtCodeID" } ], - "coding": [ + "codeListItems": [ { - "code": "C102408", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG - Performance Status" + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_6", - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], + "OID": "CL.VSRESU", + "name": "Units for Vital Signs Results", + "dataType": "text", + "standard": "STD.SDTMCT", "coding": [ { - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding" + "code": "C66770", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_7", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "aliases": [ - "SYSBP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, + "OID": "CL.LOC", + "name": "Anatomical Location", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, + "code": "C74456", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LAT", + "name": "Laterality", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] + "code": "C99073", + "codeSystem": "nci:ExtCodeID" } ], - "coding": [ + "codeListItems": [ { - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure" + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_8", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "aliases": [ - "DIABP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, + "OID": "CL.NY", + "name": "No Yes Response", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, + "code": "C66742", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.LBTESTCD", + "name": "Laboratory Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] + "code": "C65047", + "codeSystem": "nci:ExtCodeID" } ], - "coding": [ + "codeListItems": [ { - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure" + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_9", - "name": "Heart Rate", - "label": "Heart Rate", - "aliases": [ - "HR" + "OID": "CL.LBTEST", + "name": "Laboratory Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C67154", + "codeSystem": "nci:ExtCodeID" + } ], - "href": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.UNIT", + "name": "Unit", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, + "code": "C71620", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.FRM", + "name": "Dosage Form", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, + "code": "C66726", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.FREQ", + "name": "Frequency", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] + "code": "C71113", + "codeSystem": "nci:ExtCodeID" } ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.ROUTE", + "name": "Route of Administration Response", + "dataType": "text", + "standard": "STD.SDTMCT", "coding": [ { - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate" + "code": "C66729", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_10", - "name": "Body Temperature", - "label": "Body Temperature", - "aliases": [ - "Temperature" + "OID": "CL.STENRF", + "name": "Relation to Reference Period", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66728", + "codeSystem": "nci:ExtCodeID" + } ], - "href": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TSPARMCD", + "name": "Trial Summary Parameter Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, + "code": "C66738", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, + "codedValue": "RANDOM", + "decode": "Trial is Randomized", + "coding": { + "code": "C25196", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.TSPARM", + "name": "Trial Summary Parameter Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] + "code": "C67152", + "codeSystem": "nci:ExtCodeID" } ], + "codeListItems": [ + { + "codedValue": "Trial is Randomized", + "decode": "Trial is Randomized", + "coding": { + "code": "C25196", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.DICTNAM", + "name": "Dictionary Name", + "dataType": "text", + "standard": "STD.SDTMCT", "coding": [ { - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Body Temperature" + "code": "C66788", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_11", - "name": "Body Weight", - "label": "Body Weight", - "aliases": [ - "WEIGHT" + "OID": "CL.TRTESTCD", + "name": "Tumor or Lesion Properties Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C96779", + "codeSystem": "nci:ExtCodeID" + } ], - "href": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TRTEST", + "name": "Tumor or Lesion Properties Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, + "code": "C96778", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TRPROPRS", + "name": "Tumor or Lesion Properties Test Result", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C124309", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ + { + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.METHOD", + "name": "Method", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] + "code": "C85492", + "codeSystem": "nci:ExtCodeID" } ], - "coding": [ + "codeListItems": [ { - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight" + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_18", - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "aliases": [ - "ALT", - "SGPT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ + "OID": "CL.TUTESTCD", + "name": "Tumor or Lesion Identification Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, + "code": "C96784", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TUTEST", + "name": "Tumor or Lesion Identification Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, + "code": "C96783", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.TUIDRS", + "name": "Tumor or Lesion Identification Test Results", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] + "code": "C123650", + "codeSystem": "nci:ExtCodeID" } ], - "coding": [ + "codeListItems": [ { - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement" + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_19", - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "aliases": [ - "AST", - "SGOT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ + "OID": "CL.DIR", + "name": "Directionality", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, + "code": "C99074", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.URNSTSCD", + "name": "Urinary System Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, + "code": "C129942", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.URNSTS", + "name": "Urinary System Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] + "code": "C129941", + "codeSystem": "nci:ExtCodeID" } ], - "coding": [ + "codeListItems": [ { - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement" + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_20", - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "aliases": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "href": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ + "OID": "CL.RETESTCD", + "name": "Respiratory Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, + "code": "C111106", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.RETEST", + "name": "Respiratory Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, + "code": "C111107", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.MBTESTCD", + "name": "Microbiology Test Code", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] + "code": "C120527", + "codeSystem": "nci:ExtCodeID" } ], - "coding": [ + "codeListItems": [ { - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement" + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_21", - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "aliases": [ - "Creatinine" + "OID": "CL.MBTEST", + "name": "Microbiology Test Name", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C120528", + "codeSystem": "nci:ExtCodeID" + } ], - "href": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.MBFTSDTL", + "name": "Microbiology Findings Test Details", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, + "code": "C174225", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.SPECTYPE", + "name": "Specimen Type", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, + "code": "C78734", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] + "codedValue": "SERUM OR PLASMA", + "decode": "Ser/Plas", + "coding": { + "code": "C105706", + "codeSystem": "nci:ExtCodeID" + } + } + ] + }, + { + "OID": "CL.AESEV", + "name": "Severity/Intensity Scale for Adverse Events", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ + { + "code": "C66769", + "codeSystem": "nci:ExtCodeID" } ], - "coding": [ + "codeListItems": [ { - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement" + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" } ] }, { - "OID": "CONC.BiomedicalConcept_22", - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "aliases": [ - "Albumin" - ], - "href": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ + "OID": "CL.ACN", + "name": "Action Taken with Study Treatment", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, + "code": "C66767", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.OUT", + "name": "Outcome of Event", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, + "code": "C66768", + "codeSystem": "nci:ExtCodeID" + } + ], + "codeListItems": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, + "codedValue": "__PLACEHOLDER__", + "decode": "__PLACEHOLDER__" + } + ] + }, + { + "OID": "CL.CNTMODE", + "name": "Mode of Subject Contact", + "dataType": "text", + "standard": "STD.SDTMCT", + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] + "code": "C171445", + "codeSystem": "nci:ExtCodeID" } ], - "coding": [ + "codeListItems": [ { - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement" + "codedValue": "IN PERSON", + "decode": "In-Person", + "coding": { + "code": "C175574", + "codeSystem": "nci:ExtCodeID" + } } ] + } + ], + "methods": [], + "comments": [], + "standards": [ + { + "OID": "STD.SDTMIG", + "name": "SDTMIG", + "type": "IG", + "version": "3.4", + "status": "FINAL" }, { - "OID": "CONC.BiomedicalConcept_50", - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", + "OID": "STD.SDTMCT", + "name": "CDISC/NCI", + "type": "CT", + "version": "2026-03-27", + "status": "FINAL", + "publishingSet": "SDTM" + } + ], + "annotatedCRF": [], + "concepts": [ + { + "OID": "CONC.BiomedicalConcept_1", + "name": "Informed Consent", + "label": "Informed Consent", "aliases": [ - "Concomitant Medication" + "Informed Consent Obtained" ], - "href": "/mdr/bc/biomedicalconcepts/C53630", + "href": "/mdr/bc/biomedicalconcepts/C16735", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "CMTRT", - "label": "CMTRT", + "OID": "CONCPROP.BiomedicalConceptProperty_227", + "name": "DSDECOD", + "label": "DSDECOD", "mandatory": true, "coding": [ { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", + "code": "C82977", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" } - ] + ], + "codeList": "CL.ad42d7e1" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_228", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, "coding": [ { - "code": "C83221", + "code": "C82571", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "CMDOSU", - "label": "CMDOSU", + "OID": "CONCPROP.BiomedicalConceptProperty_229", + "name": "DSSTDTC", + "label": "DSSTDTC", "mandatory": false, "coding": [ { - "code": "C83034", + "code": "C82517", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, + "code": "C16735", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Informed Consent" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_2", + "name": "Eligibility Criteria Met By Subject", + "label": "Eligibility Criteria Met By Subject", + "aliases": [ + "Eligibility Criteria Met" + ], + "href": "/mdr/bc/biomedicalconcepts/C132447", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_239", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, "coding": [ { - "code": "C83110", + "code": "C82977", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" + "codeSystemVersion": "2026-05-26", + "decode": "Dictionary-derived Term" } - ] + ], + "codeList": "CL.65a3e8d0" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_240", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, "coding": [ { - "code": "C83042", + "code": "C82571", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" + "codeSystemVersion": "2026-05-26", + "decode": "Reported Event Term" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "CMROUTE", - "label": "CMROUTE", + "OID": "CONCPROP.BiomedicalConceptProperty_241", + "name": "DSSTDTC", + "label": "DSSTDTC", "mandatory": false, "coding": [ { - "code": "C83120", + "code": "C82517", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Start Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "CMSTDTC", - "label": "CMSTDTC", + "code": "C132447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-12-12", + "decode": "Eligibility Criteria Met By Subject" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_5", + "name": "ECOG - Performance Status", + "label": "ECOG - Performance Status", + "aliases": [ + "ECOG1-Performance Status", + "ECOG101", + "ECOG - Performance Status" + ], + "href": "/mdr/bc/biomedicalconcepts/C102408", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_250", + "name": "RSORRES", + "label": "RSORRES", "mandatory": false, "coding": [ { - "code": "C83235", + "code": "C91106", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" + "codeSystemVersion": "2026-05-26", + "decode": "Clinical or Research Assessment Answer" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "CMENDTC", - "label": "CMENDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_251", + "name": "RSDTC", + "label": "RSDTC", "mandatory": false, "coding": [ { - "code": "C83225", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "CMSTRF", - "label": "CMSTRF", + "code": "C102408", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-23", + "decode": "ECOG - Performance Status" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_7", + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "aliases": [ + "SYSBP" + ], + "href": "/mdr/bc/biomedicalconcepts/C25298", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_252", + "name": "VSORRES", + "label": "VSORRES", "mandatory": false, "coding": [ { - "code": "C82559", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "CMSTRTPT", - "label": "CMSTRTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_253", + "name": "VSORRESU", + "label": "VSORRESU", "mandatory": false, "coding": [ { - "code": "C82560", + "code": "C49669", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" } - ] + ], + "codeList": "CL.7cfd6cc5" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "CMSTTPT", - "label": "CMSTTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_254", + "name": "VSPOS", + "label": "VSPOS", "mandatory": false, "coding": [ { - "code": "C82575", + "code": "C62164", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "CMENRF", - "label": "CMENRF", + "OID": "CONCPROP.BiomedicalConceptProperty_255", + "name": "VSLOC", + "label": "VSLOC", "mandatory": false, "coding": [ { - "code": "C82557", + "code": "C13717", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "CMENRTPT", - "label": "CMENRTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_256", + "name": "VSLAT", + "label": "VSLAT", "mandatory": false, "coding": [ { - "code": "C82558", + "code": "C25185", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "CMENTPT", - "label": "CMENTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_257", + "name": "VSDTC", + "label": "VSDTC", "mandatory": false, "coding": [ { - "code": "C82574", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] } ], "coding": [ { - "code": "C53630", + "code": "C25298", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy" + "codeSystemVersion": "2025-12-16", + "decode": "Systolic Blood Pressure" } ] }, { - "OID": "CONC.BiomedicalConcept_51", - "name": "Randomization", - "label": "Randomization", + "OID": "CONC.BiomedicalConcept_8", + "name": "Diastolic Blood Pressure", + "label": "Diastolic Blood Pressure", "aliases": [ - "randomization", - "RANDOM", - "Randomized", - "Trial is Randomized", - "randomized" + "DIABP" ], - "href": "/mdr/bc/biomedicalconcepts/C25196", + "href": "/mdr/bc/biomedicalconcepts/C25299", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "TSPARMCD", - "label": "TSPARMCD", + "OID": "CONCPROP.BiomedicalConceptProperty_258", + "name": "VSORRES", + "label": "VSORRES", "mandatory": false, "coding": [ { - "code": "C83445", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } - ], - "codeList": "CL.b6e07c4c" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "TSPARM", - "label": "TSPARM", + "OID": "CONCPROP.BiomedicalConceptProperty_259", + "name": "VSORRESU", + "label": "VSORRESU", "mandatory": false, "coding": [ { - "code": "C49691", + "code": "C49669", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Pressure" } ], - "codeList": "CL.b6e07c4c" + "codeList": "CL.7cfd6cc5" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "TSVAL", - "label": "TSVAL", + "OID": "CONCPROP.BiomedicalConceptProperty_260", + "name": "VSPOS", + "label": "VSPOS", "mandatory": false, "coding": [ { - "code": "C83447", + "code": "C62164", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "TSVALCD", - "label": "TSVALCD", + "OID": "CONCPROP.BiomedicalConceptProperty_261", + "name": "VSLOC", + "label": "VSLOC", "mandatory": false, "coding": [ { - "code": "C117458", + "code": "C13717", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" + "codeSystemVersion": "2026-05-26", + "decode": "Anatomic Site" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "TSVCDREF", - "label": "TSVCDREF", + "OID": "CONCPROP.BiomedicalConceptProperty_262", + "name": "VSLAT", + "label": "VSLAT", "mandatory": false, "coding": [ { - "code": "C117460", + "code": "C25185", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "TSVCDVER", - "label": "TSVCDVER", + "OID": "CONCPROP.BiomedicalConceptProperty_263", + "name": "VSDTC", + "label": "VSDTC", "mandatory": false, "coding": [ { - "code": "C117461", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] } ], "coding": [ { - "code": "C25196", + "code": "C25299", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Randomization" + "codeSystemVersion": "2025-12-16", + "decode": "Diastolic Blood Pressure" } ] }, { - "OID": "CONC.BiomedicalConcept_52", - "name": "Prothrombin Time", - "label": "Prothrombin Time", + "OID": "CONC.BiomedicalConcept_9", + "name": "Heart Rate", + "label": "Heart Rate", "aliases": [ - "PT" + "HR" ], - "href": "/mdr/bc/biomedicalconcepts/C62656", + "href": "/mdr/bc/biomedicalconcepts/C49677", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_341", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_264", + "name": "VSORRES", + "label": "VSORRES", "mandatory": false, "coding": [ { @@ -6234,53 +6067,66 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_342", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_265", + "name": "VSORRESU", + "label": "VSORRESU", "mandatory": false, "coding": [ { - "code": "C42574", + "code": "C73688", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" + "decode": "Count per Minute" } ], - "codeList": "CL.3705a725" + "codeList": "CL.20024ecd" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_343", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_266", + "name": "VSPOS", + "label": "VSPOS", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C62164", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Body Position" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_344", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_267", + "name": "VSLOC", + "label": "VSLOC", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C13717", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Anatomic Site" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_345", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_268", + "name": "VSLAT", + "label": "VSLAT", + "mandatory": false, + "coding": [ + { + "code": "C25185", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_269", + "name": "VSDTC", + "label": "VSDTC", "mandatory": false, "coding": [ { @@ -6294,27 +6140,26 @@ ], "coding": [ { - "code": "C62656", + "code": "C49677", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-12-16", - "decode": "Prothrombin Time" + "decode": "Heart Rate" } ] }, { - "OID": "CONC.BiomedicalConcept_53", - "name": "International Normalized Ratio of Prothrombin Time", - "label": "International Normalized Ratio of Prothrombin Time", + "OID": "CONC.BiomedicalConcept_10", + "name": "Body Temperature", + "label": "Body Temperature", "aliases": [ - "INR", - "Prothrombin Intl. Normalized Ratio" + "Temperature" ], - "href": "/mdr/bc/biomedicalconcepts/C64805", + "href": "/mdr/bc/biomedicalconcepts/C174446", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_270", + "name": "VSORRES", + "label": "VSORRES", "mandatory": false, "coding": [ { @@ -6326,39 +6171,37 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_271", + "name": "VSORRESU", + "label": "VSORRESU", "mandatory": false, "coding": [ { - "code": "C42574", + "code": "C44276", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" + "decode": "Unit of Temperature" } - ], - "codeList": "CL.dab673be" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_272", + "name": "VSLOC", + "label": "VSLOC", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C13717", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Anatomic Site" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_273", + "name": "VSDTC", + "label": "VSDTC", "mandatory": false, "coding": [ { @@ -6372,26 +6215,26 @@ ], "coding": [ { - "code": "C64805", + "code": "C174446", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "International Normalized Ratio of Prothrombin Time" + "codeSystemVersion": "2024-12-16", + "decode": "Body Temperature" } ] }, { - "OID": "CONC.BiomedicalConcept_54", - "name": "Activated Partial Thromboplastin Time", - "label": "Activated Partial Thromboplastin Time", + "OID": "CONC.BiomedicalConcept_11", + "name": "Body Weight", + "label": "Body Weight", "aliases": [ - "APTT" + "WEIGHT" ], - "href": "/mdr/bc/biomedicalconcepts/C38462", + "href": "/mdr/bc/biomedicalconcepts/C81328", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_274", + "name": "VSORRES", + "label": "VSORRES", "mandatory": false, "coding": [ { @@ -6403,39 +6246,23 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.3705a725" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_275", + "name": "VSORRESU", + "label": "VSORRESU", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C48208", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Unit of Weight" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_276", + "name": "VSDTC", + "label": "VSDTC", "mandatory": false, "coding": [ { @@ -6449,24 +6276,25 @@ ], "coding": [ { - "code": "C38462", + "code": "C81328", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Activated Partial Thromboplastin Time" + "codeSystemVersion": "2025-11-18", + "decode": "Body Weight" } ] }, { - "OID": "CONC.BiomedicalConcept_55", - "name": "Glucose Measurement", - "label": "Glucose Measurement", + "OID": "CONC.BiomedicalConcept_18", + "name": "Alanine Aminotransferase Measurement", + "label": "Alanine Aminotransferase Measurement", "aliases": [ - "Glucose" + "ALT", + "SGPT" ], - "href": "/mdr/bc/biomedicalconcepts/C105585", + "href": "/mdr/bc/biomedicalconcepts/C64433", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_354", + "OID": "CONCPROP.BiomedicalConceptProperty_277", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -6480,21 +6308,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_355", + "OID": "CONCPROP.BiomedicalConceptProperty_278", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C67365", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Unit of Catalytic Activity Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_356", + "OID": "CONCPROP.BiomedicalConceptProperty_279", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -6506,24 +6334,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_358", + "OID": "CONCPROP.BiomedicalConceptProperty_280", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -6537,7 +6351,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_359", + "OID": "CONCPROP.BiomedicalConceptProperty_281", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -6553,25 +6367,25 @@ ], "coding": [ { - "code": "C105585", + "code": "C64433", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement" + "codeSystemVersion": "2025-07-01", + "decode": "Alanine Aminotransferase Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_56", - "name": "Triglyceride Measurement", - "label": "Triglyceride Measurement", + "OID": "CONC.BiomedicalConcept_19", + "name": "Aspartate Aminotransferase Measurement", + "label": "Aspartate Aminotransferase Measurement", "aliases": [ - "TRIG", - "Triglycerides" + "AST", + "SGOT" ], - "href": "/mdr/bc/biomedicalconcepts/C64812", + "href": "/mdr/bc/biomedicalconcepts/C64467", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_360", + "OID": "CONCPROP.BiomedicalConceptProperty_282", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -6585,21 +6399,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_361", + "OID": "CONCPROP.BiomedicalConceptProperty_283", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C67365", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Unit of Catalytic Activity Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_362", + "OID": "CONCPROP.BiomedicalConceptProperty_284", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -6614,7 +6428,7 @@ "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_363", + "OID": "CONCPROP.BiomedicalConceptProperty_285", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -6628,7 +6442,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_364", + "OID": "CONCPROP.BiomedicalConceptProperty_286", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -6644,26 +6458,25 @@ ], "coding": [ { - "code": "C64812", + "code": "C64467", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Triglyceride Measurement" + "decode": "Aspartate Aminotransferase Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_57", - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", + "OID": "CONC.BiomedicalConcept_20", + "name": "Total Bilirubin Measurement", + "label": "Total Bilirubin Measurement", "aliases": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" + "Bilirubin", + "Total Bilirubin Level" ], - "href": "/mdr/bc/biomedicalconcepts/C105586", + "href": "/mdr/bc/biomedicalconcepts/C38037", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_365", + "OID": "CONCPROP.BiomedicalConceptProperty_287", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -6677,7 +6490,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_366", + "OID": "CONCPROP.BiomedicalConceptProperty_288", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, @@ -6691,7 +6504,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_367", + "OID": "CONCPROP.BiomedicalConceptProperty_289", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -6706,7 +6519,7 @@ "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_368", + "OID": "CONCPROP.BiomedicalConceptProperty_290", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -6720,7 +6533,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_369", + "OID": "CONCPROP.BiomedicalConceptProperty_291", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -6736,25 +6549,24 @@ ], "coding": [ { - "code": "C105586", + "code": "C38037", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement" + "decode": "Total Bilirubin Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_58", - "name": "High Density Lipoprotein Cholesterol Measurement", - "label": "High Density Lipoprotein Cholesterol Measurement", + "OID": "CONC.BiomedicalConcept_21", + "name": "Creatinine Measurement", + "label": "Creatinine Measurement", "aliases": [ - "HDL", - "HDL Cholesterol" + "Creatinine" ], - "href": "/mdr/bc/biomedicalconcepts/C105587", + "href": "/mdr/bc/biomedicalconcepts/C64547", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_370", + "OID": "CONCPROP.BiomedicalConceptProperty_292", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -6768,7 +6580,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_371", + "OID": "CONCPROP.BiomedicalConceptProperty_293", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, @@ -6782,7 +6594,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_372", + "OID": "CONCPROP.BiomedicalConceptProperty_294", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -6797,7 +6609,7 @@ "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_373", + "OID": "CONCPROP.BiomedicalConceptProperty_295", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -6811,7 +6623,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_374", + "OID": "CONCPROP.BiomedicalConceptProperty_296", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -6827,25 +6639,24 @@ ], "coding": [ { - "code": "C105587", + "code": "C64547", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "High Density Lipoprotein Cholesterol Measurement" + "decode": "Creatinine Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_59", - "name": "Low Density Lipoprotein Cholesterol Measurement", - "label": "Low Density Lipoprotein Cholesterol Measurement", + "OID": "CONC.BiomedicalConcept_22", + "name": "Albumin Measurement", + "label": "Albumin Measurement", "aliases": [ - "LDL", - "LDL Cholesterol" + "Albumin" ], - "href": "/mdr/bc/biomedicalconcepts/C105588", + "href": "/mdr/bc/biomedicalconcepts/C64431", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_375", + "OID": "CONCPROP.BiomedicalConceptProperty_297", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -6859,7 +6670,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_376", + "OID": "CONCPROP.BiomedicalConceptProperty_298", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, @@ -6873,7 +6684,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_377", + "OID": "CONCPROP.BiomedicalConceptProperty_299", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -6888,7 +6699,7 @@ "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_378", + "OID": "CONCPROP.BiomedicalConceptProperty_300", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -6902,7 +6713,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_379", + "OID": "CONCPROP.BiomedicalConceptProperty_301", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -6918,406 +6729,404 @@ ], "coding": [ { - "code": "C105588", + "code": "C64431", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Low Density Lipoprotein Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_60", - "name": "ECOG Clinical Classification Question", - "label": "ECOG Clinical Classification Question", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C101874", - "properties": [], - "coding": [ - { - "code": "C101874", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG Clinical Classification Question" + "decode": "Albumin Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_61", - "name": "Leukocyte Count", - "label": "Leukocyte Count", + "OID": "CONC.BiomedicalConcept_50", + "name": "Concomitant Therapy", + "label": "Concomitant Therapy", "aliases": [ - "WBC", - "White Blood Cells" + "Concomitant Medication" ], - "href": "/mdr/bc/biomedicalconcepts/C51948", + "href": "/mdr/bc/biomedicalconcepts/C53630", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_380", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_317", + "name": "CMTRT", + "label": "CMTRT", + "mandatory": true, + "coding": [ + { + "code": "C70902", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_318", + "name": "CMDECOD", + "label": "CMDECOD", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C83345", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_381", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_319", + "name": "CMCLAS", + "label": "CMCLAS", "mandatory": false, "coding": [ { - "code": "C67391", + "code": "C83219", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Class" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_382", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_320", + "name": "CMINDC", + "label": "CMINDC", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C83085", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Indication" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_383", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_321", + "name": "CMDOSE", + "label": "CMDOSE", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C83221", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_384", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_322", + "name": "CMDOSTXT", + "label": "CMDOSTXT", + "mandatory": false, + "coding": [ + { + "code": "C83221", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_323", + "name": "CMDOSU", + "label": "CMDOSU", + "mandatory": false, + "coding": [ + { + "code": "C83034", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Unit" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_324", + "name": "CMDOSFRM", + "label": "CMDOSFRM", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C83110", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Form" } ] - } - ], - "coding": [ - { - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_62", - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "aliases": [ - "RBC", - "Red Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ + }, { - "OID": "CONCPROP.BiomedicalConceptProperty_385", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_325", + "name": "CMDOSFRQ", + "label": "CMDOSFRQ", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C83042", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Frequency" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_386", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_326", + "name": "CMROUTE", + "label": "CMROUTE", "mandatory": false, "coding": [ { - "code": "C67391", + "code": "C83120", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Route of Administration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_387", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_327", + "name": "CMSTDTC", + "label": "CMSTDTC", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C83235", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Start Date Time" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_388", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_328", + "name": "CMENDTC", + "label": "CMENDTC", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C83225", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use End Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_389", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_329", + "name": "CMSTRF", + "label": "CMSTRF", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C82559", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" } ] - } - ], - "coding": [ - { - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_63", - "name": "Platelet Count", - "label": "Platelet Count", - "aliases": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ + }, { - "OID": "CONCPROP.BiomedicalConceptProperty_390", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_330", + "name": "CMSTRTPT", + "label": "CMSTRTPT", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C82560", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_391", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_331", + "name": "CMSTTPT", + "label": "CMSTTPT", "mandatory": false, "coding": [ { - "code": "C67391", + "code": "C82575", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_392", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_332", + "name": "CMENRF", + "label": "CMENRF", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C82557", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_393", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_333", + "name": "CMENRTPT", + "label": "CMENRTPT", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C82558", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_394", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_334", + "name": "CMENTPT", + "label": "CMENTPT", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C82574", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" } ] } ], "coding": [ { - "code": "C51951", + "code": "C53630", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count" + "decode": "Concomitant Therapy" } ] }, { - "OID": "CONC.BiomedicalConcept_64", - "name": "Potassium Measurement", - "label": "Potassium Measurement", + "OID": "CONC.BiomedicalConcept_51", + "name": "Randomization", + "label": "Randomization", "aliases": [ - "Potassium", - "K" + "randomization", + "RANDOM", + "Randomized", + "Trial is Randomized", + "randomized" ], - "href": "/mdr/bc/biomedicalconcepts/C64853", + "href": "/mdr/bc/biomedicalconcepts/C25196", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_395", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_335", + "name": "TSPARMCD", + "label": "TSPARMCD", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C83445", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Code" } - ] + ], + "codeList": "CL.b6e07c4c" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_396", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_336", + "name": "TSPARM", + "label": "TSPARM", "mandatory": false, "coding": [ { - "code": "C64567", + "code": "C49691", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter" + } + ], + "codeList": "CL.b6e07c4c" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_337", + "name": "TSVAL", + "label": "TSVAL", + "mandatory": false, + "coding": [ + { + "code": "C83447", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_397", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_338", + "name": "TSVALCD", + "label": "TSVALCD", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C117458", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_398", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_339", + "name": "TSVCDREF", + "label": "TSVCDREF", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C117460", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_399", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_340", + "name": "TSVCDVER", + "label": "TSVCDVER", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C117461", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology" } ] } ], "coding": [ { - "code": "C64853", + "code": "C25196", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement" + "decode": "Randomization" } ] }, { - "OID": "CONC.BiomedicalConcept_65", - "name": "Sodium Measurement", - "label": "Sodium Measurement", + "OID": "CONC.BiomedicalConcept_52", + "name": "Prothrombin Time", + "label": "Prothrombin Time", "aliases": [ - "Sodium", - "NA" + "PT" ], - "href": "/mdr/bc/biomedicalconcepts/C64809", + "href": "/mdr/bc/biomedicalconcepts/C62656", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_400", + "OID": "CONCPROP.BiomedicalConceptProperty_341", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -7331,21 +7140,22 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_401", + "OID": "CONCPROP.BiomedicalConceptProperty_342", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C64567", + "code": "C42574", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" + "decode": "Unit of Time" } - ] + ], + "codeList": "CL.3705a725" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_402", + "OID": "CONCPROP.BiomedicalConceptProperty_343", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -7360,7 +7170,7 @@ "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_403", + "OID": "CONCPROP.BiomedicalConceptProperty_344", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -7374,7 +7184,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_404", + "OID": "CONCPROP.BiomedicalConceptProperty_345", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -7390,25 +7200,25 @@ ], "coding": [ { - "code": "C64809", + "code": "C62656", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement" + "codeSystemVersion": "2025-12-16", + "decode": "Prothrombin Time" } ] }, { - "OID": "CONC.BiomedicalConcept_66", - "name": "Chloride Measurement", - "label": "Chloride Measurement", + "OID": "CONC.BiomedicalConcept_53", + "name": "International Normalized Ratio of Prothrombin Time", + "label": "International Normalized Ratio of Prothrombin Time", "aliases": [ - "Chloride", - "CL" + "INR", + "Prothrombin Intl. Normalized Ratio" ], - "href": "/mdr/bc/biomedicalconcepts/C64495", + "href": "/mdr/bc/biomedicalconcepts/C64805", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_405", + "OID": "CONCPROP.BiomedicalConceptProperty_346", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -7422,21 +7232,22 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_406", + "OID": "CONCPROP.BiomedicalConceptProperty_347", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C64567", + "code": "C42574", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" + "decode": "Unit of Time" } - ] + ], + "codeList": "CL.dab673be" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_407", + "OID": "CONCPROP.BiomedicalConceptProperty_348", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -7451,21 +7262,7 @@ "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_408", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_409", + "OID": "CONCPROP.BiomedicalConceptProperty_349", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -7481,25 +7278,24 @@ ], "coding": [ { - "code": "C64495", + "code": "C64805", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement" + "codeSystemVersion": "2025-12-16", + "decode": "International Normalized Ratio of Prothrombin Time" } ] }, { - "OID": "CONC.BiomedicalConcept_67", - "name": "Carbon Dioxide Measurement", - "label": "Carbon Dioxide Measurement", + "OID": "CONC.BiomedicalConcept_54", + "name": "Activated Partial Thromboplastin Time", + "label": "Activated Partial Thromboplastin Time", "aliases": [ - "Carbon Dioxide", - "CO2" + "APTT" ], - "href": "/mdr/bc/biomedicalconcepts/C64545", + "href": "/mdr/bc/biomedicalconcepts/C38462", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_410", + "OID": "CONCPROP.BiomedicalConceptProperty_350", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -7513,21 +7309,22 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_411", + "OID": "CONCPROP.BiomedicalConceptProperty_351", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C64567", + "code": "C42574", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" + "decode": "Unit of Time" } - ] + ], + "codeList": "CL.3705a725" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_412", + "OID": "CONCPROP.BiomedicalConceptProperty_352", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -7542,21 +7339,7 @@ "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_413", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_414", + "OID": "CONCPROP.BiomedicalConceptProperty_353", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -7572,25 +7355,24 @@ ], "coding": [ { - "code": "C64545", + "code": "C38462", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Carbon Dioxide Measurement" + "codeSystemVersion": "2025-12-16", + "decode": "Activated Partial Thromboplastin Time" } ] }, { - "OID": "CONC.BiomedicalConcept_68", - "name": "Calcium Measurement", - "label": "Calcium Measurement", + "OID": "CONC.BiomedicalConcept_55", + "name": "Glucose Measurement", + "label": "Glucose Measurement", "aliases": [ - "Calcium", - "CA" + "Glucose" ], - "href": "/mdr/bc/biomedicalconcepts/C64488", + "href": "/mdr/bc/biomedicalconcepts/C105585", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_415", + "OID": "CONCPROP.BiomedicalConceptProperty_354", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -7604,7 +7386,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_416", + "OID": "CONCPROP.BiomedicalConceptProperty_355", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, @@ -7618,7 +7400,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_417", + "OID": "CONCPROP.BiomedicalConceptProperty_356", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -7633,7 +7415,21 @@ "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_418", + "OID": "CONCPROP.BiomedicalConceptProperty_357", + "name": "LBMETHOD", + "label": "LBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_358", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -7647,7 +7443,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_419", + "OID": "CONCPROP.BiomedicalConceptProperty_359", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -7663,24 +7459,25 @@ ], "coding": [ { - "code": "C64488", + "code": "C105585", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement" + "codeSystemVersion": "2025-09-23", + "decode": "Glucose Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_69", - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", + "OID": "CONC.BiomedicalConcept_56", + "name": "Triglyceride Measurement", + "label": "Triglyceride Measurement", "aliases": [ - "Urea Nitrogen" + "TRIG", + "Triglycerides" ], - "href": "/mdr/bc/biomedicalconcepts/C125949", + "href": "/mdr/bc/biomedicalconcepts/C64812", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_420", + "OID": "CONCPROP.BiomedicalConceptProperty_360", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -7694,7 +7491,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_421", + "OID": "CONCPROP.BiomedicalConceptProperty_361", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, @@ -7708,7 +7505,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_422", + "OID": "CONCPROP.BiomedicalConceptProperty_362", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -7723,7 +7520,7 @@ "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_423", + "OID": "CONCPROP.BiomedicalConceptProperty_363", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -7737,7 +7534,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_424", + "OID": "CONCPROP.BiomedicalConceptProperty_364", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -7753,24 +7550,26 @@ ], "coding": [ { - "code": "C125949", + "code": "C64812", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement" + "decode": "Triglyceride Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_70", - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", + "OID": "CONC.BiomedicalConcept_57", + "name": "Cholesterol Measurement", + "label": "Cholesterol Measurement", "aliases": [ - "Protein" + "CHOL", + "Cholesterol", + "Total Cholesterol" ], - "href": "/mdr/bc/biomedicalconcepts/C64858", + "href": "/mdr/bc/biomedicalconcepts/C105586", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_425", + "OID": "CONCPROP.BiomedicalConceptProperty_365", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -7784,7 +7583,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_426", + "OID": "CONCPROP.BiomedicalConceptProperty_366", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, @@ -7798,7 +7597,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_427", + "OID": "CONCPROP.BiomedicalConceptProperty_367", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -7813,7 +7612,7 @@ "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_428", + "OID": "CONCPROP.BiomedicalConceptProperty_368", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -7827,7 +7626,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_429", + "OID": "CONCPROP.BiomedicalConceptProperty_369", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -7843,24 +7642,25 @@ ], "coding": [ { - "code": "C64858", + "code": "C105586", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement" + "decode": "Cholesterol Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_71", - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", + "OID": "CONC.BiomedicalConcept_58", + "name": "High Density Lipoprotein Cholesterol Measurement", + "label": "High Density Lipoprotein Cholesterol Measurement", "aliases": [ - "Alkaline Phosphatase" + "HDL", + "HDL Cholesterol" ], - "href": "/mdr/bc/biomedicalconcepts/C64432", + "href": "/mdr/bc/biomedicalconcepts/C105587", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_430", + "OID": "CONCPROP.BiomedicalConceptProperty_370", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -7874,21 +7674,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_431", + "OID": "CONCPROP.BiomedicalConceptProperty_371", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C67365", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_432", + "OID": "CONCPROP.BiomedicalConceptProperty_372", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -7903,7 +7703,7 @@ "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_433", + "OID": "CONCPROP.BiomedicalConceptProperty_373", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -7917,7 +7717,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_434", + "OID": "CONCPROP.BiomedicalConceptProperty_374", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -7933,25 +7733,25 @@ ], "coding": [ { - "code": "C64432", + "code": "C105587", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement" + "decode": "High Density Lipoprotein Cholesterol Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_72", - "name": "Urate Measurement", - "label": "Urate Measurement", + "OID": "CONC.BiomedicalConcept_59", + "name": "Low Density Lipoprotein Cholesterol Measurement", + "label": "Low Density Lipoprotein Cholesterol Measurement", "aliases": [ - "Urate", - "Uric Acid" + "LDL", + "LDL Cholesterol" ], - "href": "/mdr/bc/biomedicalconcepts/C64814", + "href": "/mdr/bc/biomedicalconcepts/C105588", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_435", + "OID": "CONCPROP.BiomedicalConceptProperty_375", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -7965,7 +7765,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_436", + "OID": "CONCPROP.BiomedicalConceptProperty_376", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, @@ -7979,7 +7779,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_437", + "OID": "CONCPROP.BiomedicalConceptProperty_377", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -7994,7 +7794,7 @@ "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_438", + "OID": "CONCPROP.BiomedicalConceptProperty_378", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -8008,7 +7808,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_439", + "OID": "CONCPROP.BiomedicalConceptProperty_379", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -8024,607 +7824,546 @@ ], "coding": [ { - "code": "C64814", + "code": "C105588", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement" + "decode": "Low Density Lipoprotein Cholesterol Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_78", - "name": "Solicited Medical History", - "label": "Solicited Medical History", + "OID": "CONC.BiomedicalConcept_61", + "name": "Leukocyte Count", + "label": "Leukocyte Count", "aliases": [ - "Medical History", - "Medical History Collection" + "WBC", + "White Blood Cells" ], - "href": "/mdr/bc/biomedicalconcepts/C200145", + "href": "/mdr/bc/biomedicalconcepts/C51948", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_552", - "name": "MHTERM", - "label": "MHTERM", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_553", - "name": "MHDECOD", - "label": "MHDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_554", - "name": "MHSTDTC", - "label": "MHSTDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_380", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { - "code": "C83338", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event Start Date Time" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_555", - "name": "MHENDTC", - "label": "MHENDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_381", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C83330", + "code": "C67391", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event End Date Time" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_556", - "name": "MHENRF", - "label": "MHENRF", + "OID": "CONCPROP.BiomedicalConceptProperty_382", + "name": "LBSPEC", + "label": "LBSPEC", "mandatory": false, "coding": [ { - "code": "C82557", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Period" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_557", - "name": "MHENRTPT", - "label": "MHENRTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_383", + "name": "LBFAST", + "label": "LBFAST", "mandatory": false, "coding": [ { - "code": "C82558", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Time Point" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_558", - "name": "MHENTPT", - "label": "MHENTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_384", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { - "code": "C82574", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Reference End Time Point End" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] } ], "coding": [ { - "code": "C200145", + "code": "C51948", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Solicited Medical History" + "codeSystemVersion": "2025-12-16", + "decode": "Leukocyte Count" } ] }, { - "OID": "CONC.BiomedicalConcept_79", - "name": "Unsolicited Adverse Event", - "label": "Unsolicited Adverse Event", + "OID": "CONC.BiomedicalConcept_62", + "name": "Erythrocyte Count", + "label": "Erythrocyte Count", "aliases": [ - "Adverse Event" + "RBC", + "Red Blood Cells" ], - "href": "/mdr/bc/biomedicalconcepts/C179176", + "href": "/mdr/bc/biomedicalconcepts/C51946", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_559", - "name": "Adverse Event Verbatim Description", - "label": "Adverse Event Verbatim Description", - "mandatory": true, - "coding": [ - { - "code": "C78541", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Verbatim Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_560", - "name": "Adverse Event Dictionary Derived Term", - "label": "Adverse Event Dictionary Derived Term", - "mandatory": true, - "coding": [ - { - "code": "C83344", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_561", - "name": "Adverse Event Category", - "label": "Adverse Event Category", - "mandatory": true, - "coding": [ - { - "code": "C83198", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_562", - "name": "Adverse Event Subcategory", - "label": "Adverse Event Subcategory", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_385", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C83212", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Subcategory" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_563", - "name": "Adverse Event Location", - "label": "Adverse Event Location", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_386", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C83205", + "code": "C67391", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Location" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_564", - "name": "Severity of Adverse Event", - "label": "Severity of Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_387", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C53253", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Severity of Adverse Event" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_565", - "name": "Seriousness of Adverse Event", - "label": "Seriousness of Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_388", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C53252", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Seriousness of Adverse Event" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_566", - "name": "Adverse Event Toxicity Grade", - "label": "Adverse Event Toxicity Grade", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_389", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C78605", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Toxicity Grade" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_567", - "name": "Adverse Event Action Taken with Study Treatment", - "label": "Adverse Event Action Taken with Study Treatment", - "mandatory": true, - "coding": [ - { - "code": "C83013", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Action Taken with Study Treatment" - } - ] - }, + "code": "C51946", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Erythrocyte Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_63", + "name": "Platelet Count", + "label": "Platelet Count", + "aliases": [ + "Thrombocytes", + "Platelets", + "Anucleated Thrombocytes" + ], + "href": "/mdr/bc/biomedicalconcepts/C51951", + "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_568", - "name": "Other Actions taken in Response to Adverse Event", - "label": "Other Actions taken in Response to Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_390", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C83109", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Other Actions taken in Response to Adverse Event" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_569", - "name": "Adverse Event Attribution to Product or Procedure", - "label": "Adverse Event Attribution to Product or Procedure", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_391", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C41358", + "code": "C67391", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Attribution to Product or Procedure" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Number Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_570", - "name": "Adverse Event Relationship to Non Study Treatment", - "label": "Adverse Event Relationship to Non Study Treatment", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_392", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C83210", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Relationship to Non Study Treatment" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_571", - "name": "Adverse Event Pattern", - "label": "Adverse Event Pattern", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_393", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C83208", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Pattern" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_572", - "name": "Adverse Event Outcome", - "label": "Adverse Event Outcome", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_394", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C49489", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Outcome" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_573", - "name": "Adverse Event Involves Cancer", - "label": "Adverse Event Involves Cancer", - "mandatory": true, - "coding": [ - { - "code": "C83211", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Involves Cancer" - } - ] - }, + "code": "C51951", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Platelet Count" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_64", + "name": "Potassium Measurement", + "label": "Potassium Measurement", + "aliases": [ + "Potassium", + "K" + ], + "href": "/mdr/bc/biomedicalconcepts/C64853", + "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_574", - "name": "Adverse Event Seriousness Due to Congenital Anomaly", - "label": "Adverse Event Seriousness Due to Congenital Anomaly", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_395", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C83117", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_575", - "name": "Disabling Adverse Event", - "label": "Disabling Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_396", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C113380", + "code": "C64567", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Disabling Adverse Event" + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_576", - "name": "Death Related to Adverse Event", - "label": "Death Related to Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_397", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C48275", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Death Related to Adverse Event" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_577", - "name": "Adverse Event associated with Hospitalization", - "label": "Adverse Event associated with Hospitalization", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_398", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C83052", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event associated with Hospitalization" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_578", - "name": "Life Threatening Adverse Event", - "label": "Life Threatening Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_399", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C84266", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Life Threatening Adverse Event" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_579", - "name": "Adverse Event Occurred with Overdose", - "label": "Adverse Event Occurred with Overdose", - "mandatory": true, + "code": "C64853", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Potassium Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_65", + "name": "Sodium Measurement", + "label": "Sodium Measurement", + "aliases": [ + "Sodium", + "NA" + ], + "href": "/mdr/bc/biomedicalconcepts/C64809", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_400", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C83214", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Occurred with Overdose" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_580", - "name": "Adverse Event Associated with Serious Medical Event", - "label": "Adverse Event Associated with Serious Medical Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_401", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C83053", + "code": "C64567", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Associated with Serious Medical Event" + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_581", - "name": "Adverse Event Concomitant Treatment", - "label": "Adverse Event Concomitant Treatment", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_402", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C83199", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Concomitant Treatment" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_582", - "name": "Adverse Event Start Date Time", - "label": "Adverse Event Start Date Time", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_403", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C83215", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Start Date Time" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_583", - "name": "Adverse Event End Date Time", - "label": "Adverse Event End Date Time", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_404", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C83201", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event End Date Time" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] } ], "coding": [ { - "code": "C179176", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Unsolicited Adverse Event" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_80", - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "coding": [ - { - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_81", - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "coding": [ - { - "code": "C83119", + "code": "C64809", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding" + "codeSystemVersion": "2025-07-01", + "decode": "Sodium Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_82", - "name": "New Lesion Progression", - "label": "New Lesion Progression", + "OID": "CONC.BiomedicalConcept_66", + "name": "Chloride Measurement", + "label": "Chloride Measurement", "aliases": [ - "NEWLPROG" + "Chloride", + "CL" ], - "href": "/mdr/bc/biomedicalconcepts/C103420", + "href": "/mdr/bc/biomedicalconcepts/C64495", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_440", - "name": "Category", - "label": "Category", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_405", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C25372", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Category" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_441", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_406", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C64567", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Observation Result" + "codeSystemVersion": "2026-05-26", + "decode": "Molarity Unit" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_442", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_407", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C51824", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Evaluator" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_443", - "name": "Evaluator Identifier", - "label": "Evaluator Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_408", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C117043", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Evaluator Identifier" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_444", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_409", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", + "codeSystemVersion": "2026-05-26", "decode": "Collection Date Time" } ] @@ -8632,139 +8371,176 @@ ], "coding": [ { - "code": "C103420", + "code": "C64495", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "New Lesion Progression" + "codeSystemVersion": "2025-07-01", + "decode": "Chloride Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_83", - "name": "Lymph Node State", - "label": "Lymph Node State", + "OID": "CONC.BiomedicalConcept_67", + "name": "Carbon Dioxide Measurement", + "label": "Carbon Dioxide Measurement", "aliases": [ - "LNSTATE" + "Carbon Dioxide", + "CO2" ], - "href": "/mdr/bc/biomedicalconcepts/C124448", + "href": "/mdr/bc/biomedicalconcepts/C64545", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_445", - "name": "Tumor Results Link Identifier", - "label": "Tumor Results Link Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_410", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C117413", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Link Identifier" + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_446", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_411", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C51824", + "code": "C64567", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" + "decode": "Molarity Unit" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_447", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_412", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C82535", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Test Method" + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_448", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_413", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C93566", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_449", - "name": "Tumor Results Reference Identifier", - "label": "Tumor Results Reference Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_414", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C117419", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Reference Identifier" + "decode": "Collection Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_450", - "name": "Tumor Results Group Identifier", - "label": "Tumor Results Group Identifier", - "mandatory": true, + "code": "C64545", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Carbon Dioxide Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_68", + "name": "Calcium Measurement", + "label": "Calcium Measurement", + "aliases": [ + "Calcium", + "CA" + ], + "href": "/mdr/bc/biomedicalconcepts/C64488", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_415", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C117411", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Group Identifier" + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_451", - "name": "Tumor Results Link Group", - "label": "Tumor Results Link Group", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_416", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C117412", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Link Group" + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_452", - "name": "Evaluator Identifier", - "label": "Evaluator Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_417", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C117043", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.af8f8a19" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_418", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_453", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_419", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { "code": "C82515", @@ -8777,27 +8553,27 @@ ], "coding": [ { - "code": "C124448", + "code": "C64488", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Lymph Node State" + "codeSystemVersion": "2025-07-01", + "decode": "Calcium Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_84", - "name": "Non-Target Indicator", - "label": "Non-Target Indicator", + "OID": "CONC.BiomedicalConcept_69", + "name": "Urea Nitrogen Measurement", + "label": "Urea Nitrogen Measurement", "aliases": [ - "NTIND" + "Urea Nitrogen" ], - "href": "/mdr/bc/biomedicalconcepts/C161483", + "href": "/mdr/bc/biomedicalconcepts/C125949", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_454", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_420", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { "code": "C70856", @@ -8808,38 +8584,53 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_455", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_421", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C51824", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_456", - "name": "Evaluator Identifier", - "label": "Evaluator Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_422", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_423", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C117043", + "code": "C93566", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_457", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_424", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { "code": "C82515", @@ -8852,386 +8643,487 @@ ], "coding": [ { - "code": "C161483", + "code": "C125949", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Non-Target Indicator" + "codeSystemVersion": "2025-07-01", + "decode": "Urea Nitrogen Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_85", - "name": "Target Indicator", - "label": "Target Indicator", + "OID": "CONC.BiomedicalConcept_70", + "name": "Total Protein Measurement", + "label": "Total Protein Measurement", "aliases": [ - "TIND" + "Protein" ], - "href": "/mdr/bc/biomedicalconcepts/C178053", + "href": "/mdr/bc/biomedicalconcepts/C64858", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_458", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_425", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_459", - "name": "Evaluator Identifier", - "label": "Evaluator Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_426", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C117043", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_460", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_427", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C51824", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_428", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_461", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_429", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Collection Date Time" } ] } ], "coding": [ { - "code": "C178053", + "code": "C64858", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Target Indicator" + "codeSystemVersion": "2025-07-01", + "decode": "Total Protein Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_86", - "name": "Confluent Tumor Masses Assessment", - "label": "Confluent Tumor Masses Assessment", + "OID": "CONC.BiomedicalConcept_71", + "name": "Alkaline Phosphatase Measurement", + "label": "Alkaline Phosphatase Measurement", "aliases": [ - "TUMERGE", - "Tumor Merged" + "Alkaline Phosphatase" ], - "href": "/mdr/bc/biomedicalconcepts/C225437", + "href": "/mdr/bc/biomedicalconcepts/C64432", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_462", - "name": "Result Anatomical Location", - "label": "Result Anatomical Location", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_430", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C170500", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location" + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_463", - "name": "Tumor Identifier Reference Identifier", - "label": "Tumor Identifier Reference Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_431", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C117442", + "code": "C67365", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier" + "decode": "Unit of Catalytic Activity Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_464", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_432", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_465", - "name": "Directionality", - "label": "Directionality", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_433", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C54215", + "code": "C93566", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Directionality" + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_466", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_434", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Collection Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_467", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, + "code": "C64432", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Alkaline Phosphatase Measurement" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_72", + "name": "Urate Measurement", + "label": "Urate Measurement", + "aliases": [ + "Urate", + "Uric Acid" + ], + "href": "/mdr/bc/biomedicalconcepts/C64814", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_435", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C82535", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Test Method" + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_468", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_436", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C51824", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_469", - "name": "Evaluator Identifier", - "label": "Evaluator Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_437", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C117043", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_470", - "name": "Laterality", - "label": "Laterality", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_438", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C25185", + "code": "C93566", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Laterality" + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_471", - "name": "Tumor Identifier Link Identifier", - "label": "Tumor Identifier Link Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_439", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C117436", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier" + "decode": "Collection Date Time" } ] } ], "coding": [ { - "code": "C225437", + "code": "C64814", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Confluent Tumor Masses Assessment" + "codeSystemVersion": "2025-07-01", + "decode": "Urate Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_87", - "name": "Tumor Fragmentation Assessment", - "label": "Tumor Fragmentation Assessment", + "OID": "CONC.BiomedicalConcept_78", + "name": "Solicited Medical History", + "label": "Solicited Medical History", "aliases": [ - "TUSPLIT", - "Tumor Split" + "Medical History", + "Medical History Collection" ], - "href": "/mdr/bc/biomedicalconcepts/C225438", + "href": "/mdr/bc/biomedicalconcepts/C200145", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_472", - "name": "Directionality", - "label": "Directionality", + "OID": "CONCPROP.BiomedicalConceptProperty_552", + "name": "MHTERM", + "label": "MHTERM", "mandatory": true, "coding": [ { - "code": "C54215", + "code": "C83118", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Directionality" + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_473", - "name": "Laterality", - "label": "Laterality", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_553", + "name": "MHDECOD", + "label": "MHDECOD", + "mandatory": false, "coding": [ { - "code": "C25185", + "code": "C83346", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_474", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_554", + "name": "MHSTDTC", + "label": "MHSTDTC", + "mandatory": false, "coding": [ { - "code": "C51824", + "code": "C83338", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event Start Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_475", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_555", + "name": "MHENDTC", + "label": "MHENDTC", + "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C83330", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event End Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_476", - "name": "Result Anatomical Location", - "label": "Result Anatomical Location", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_556", + "name": "MHENRF", + "label": "MHENRF", + "mandatory": false, "coding": [ { - "code": "C170500", + "code": "C82557", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location" + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Period" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_477", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_557", + "name": "MHENRTPT", + "label": "MHENRTPT", + "mandatory": false, "coding": [ { - "code": "C82535", + "code": "C82558", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Time Point" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_478", - "name": "Tumor Identifier Link Identifier", - "label": "Tumor Identifier Link Identifier", + "OID": "CONCPROP.BiomedicalConceptProperty_558", + "name": "MHENTPT", + "label": "MHENTPT", + "mandatory": false, + "coding": [ + { + "code": "C82574", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-12-16", + "decode": "Reference End Time Point End" + } + ] + } + ], + "coding": [ + { + "code": "C200145", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Solicited Medical History" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_80", + "name": "Physical Examination Finding", + "label": "Physical Examination Finding", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C83119", + "properties": [], + "coding": [ + { + "code": "C83119", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-04-02", + "decode": "Physical Examination Finding" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_81", + "name": "Physical Examination Finding", + "label": "Physical Examination Finding", + "aliases": null, + "href": "/mdr/bc/biomedicalconcepts/C83119", + "properties": [], + "coding": [ + { + "code": "C83119", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-04-02", + "decode": "Physical Examination Finding" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_82", + "name": "New Lesion Progression", + "label": "New Lesion Progression", + "aliases": [ + "NEWLPROG" + ], + "href": "/mdr/bc/biomedicalconcepts/C103420", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_440", + "name": "Category", + "label": "Category", "mandatory": true, "coding": [ { - "code": "C117436", + "code": "C25372", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier" + "codeSystemVersion": "2024-06-27", + "decode": "Category" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_479", - "name": "Tumor Identifier Reference Identifier", - "label": "Tumor Identifier Reference Identifier", + "OID": "CONCPROP.BiomedicalConceptProperty_441", + "name": "Observation Result", + "label": "Observation Result", "mandatory": true, "coding": [ { - "code": "C117442", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier" + "codeSystemVersion": "2024-06-27", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_480", - "name": "Collection Date Time", - "label": "Collection Date Time", + "OID": "CONCPROP.BiomedicalConceptProperty_442", + "name": "Evaluator", + "label": "Evaluator", "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C51824", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2024-06-27", + "decode": "Evaluator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_481", + "OID": "CONCPROP.BiomedicalConceptProperty_443", "name": "Evaluator Identifier", "label": "Evaluator Identifier", "mandatory": true, @@ -9239,162 +9131,161 @@ { "code": "C117043", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", + "codeSystemVersion": "2024-06-27", "decode": "Evaluator Identifier" } ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_444", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Collection Date Time" + } + ] } ], "coding": [ { - "code": "C225438", + "code": "C103420", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Fragmentation Assessment" + "codeSystemVersion": "2024-06-27", + "decode": "New Lesion Progression" } ] }, { - "OID": "CONC.BiomedicalConcept_88", - "name": "Tumor Identification", - "label": "Tumor Identification", + "OID": "CONC.BiomedicalConcept_83", + "name": "Lymph Node State", + "label": "Lymph Node State", "aliases": [ - "TUMIDENT" + "LNSTATE" ], - "href": "/mdr/bc/biomedicalconcepts/C94523", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_482", - "name": "TUORRES", - "label": "TUORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.0fe19c26" - }, + "href": "/mdr/bc/biomedicalconcepts/C124448", + "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_483", - "name": "TULOC", - "label": "TULOC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_445", + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", + "mandatory": true, "coding": [ { - "code": "C170500", + "code": "C117413", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location" + "decode": "Tumor Results Link Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_484", - "name": "TULAT", - "label": "TULAT", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_446", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, "coding": [ { - "code": "C25185", + "code": "C51824", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Laterality" + "decode": "Evaluator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_485", - "name": "TUDIR", - "label": "TUDIR", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_447", + "name": "Test Method", + "label": "Test Method", + "mandatory": true, "coding": [ { - "code": "C54215", + "code": "C82535", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Directionality" + "decode": "Test Method" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_486", - "name": "TUMETHOD", - "label": "TUMETHOD", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_448", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, "coding": [ { - "code": "C82535", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Test Method" + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_487", - "name": "TUEVAL", - "label": "TUEVAL", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_449", + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "mandatory": true, "coding": [ { - "code": "C51824", + "code": "C117419", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" + "decode": "Tumor Results Reference Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_488", - "name": "TUEVALID", - "label": "TUEVALID", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_450", + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "mandatory": true, "coding": [ { - "code": "C117043", + "code": "C117411", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" + "decode": "Tumor Results Group Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_489", - "name": "TUREFID", - "label": "TUREFID", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_451", + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "mandatory": true, "coding": [ { - "code": "C117442", + "code": "C117412", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier" + "decode": "Tumor Results Link Group" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_490", - "name": "TULNKID", - "label": "TULNKID", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_452", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "mandatory": true, "coding": [ { - "code": "C117436", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier" + "decode": "Evaluator Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_491", - "name": "TUDTC", - "label": "TUDTC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_453", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, "coding": [ { "code": "C82515", @@ -9407,28 +9298,27 @@ ], "coding": [ { - "code": "C94523", + "code": "C124448", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identification" + "decode": "Lymph Node State" } ] }, { - "OID": "CONC.BiomedicalConcept_89", - "name": "Response in Target Lesion", - "label": "Response in Target Lesion", + "OID": "CONC.BiomedicalConcept_84", + "name": "Non-Target Indicator", + "label": "Non-Target Indicator", "aliases": [ - "TRGRESP", - "Target Response" + "NTIND" ], - "href": "/mdr/bc/biomedicalconcepts/C94534", + "href": "/mdr/bc/biomedicalconcepts/C161483", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_492", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_454", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, "coding": [ { "code": "C70856", @@ -9439,10 +9329,10 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_493", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_455", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, "coding": [ { "code": "C51824", @@ -9453,10 +9343,10 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_494", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_456", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "mandatory": true, "coding": [ { "code": "C117043", @@ -9467,10 +9357,10 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_495", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_457", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, "coding": [ { "code": "C82515", @@ -9483,128 +9373,156 @@ ], "coding": [ { - "code": "C94534", + "code": "C161483", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Target Lesion" + "codeSystemVersion": "2026-05-26", + "decode": "Non-Target Indicator" } ] }, { - "OID": "CONC.BiomedicalConcept_90", - "name": "Response in Non-Target Lesion", - "label": "Response in Non-Target Lesion", + "OID": "CONC.BiomedicalConcept_85", + "name": "Target Indicator", + "label": "Target Indicator", "aliases": [ - "NTRGRESP", - "Non-Target Response" + "TIND" ], - "href": "/mdr/bc/biomedicalconcepts/C94535", + "href": "/mdr/bc/biomedicalconcepts/C178053", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_496", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_458", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, "coding": [ { - "code": "C70856", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_497", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_459", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "mandatory": true, "coding": [ { - "code": "C51824", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" + "decode": "Evaluator Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_498", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_460", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, "coding": [ { - "code": "C117043", + "code": "C51824", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" + "decode": "Evaluator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_499", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_461", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Observation Result" } ] } ], "coding": [ { - "code": "C94535", + "code": "C178053", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Non-Target Lesion" + "codeSystemVersion": "2026-05-26", + "decode": "Target Indicator" } ] }, { - "OID": "CONC.BiomedicalConcept_91", - "name": "Best Overall Response", - "label": "Best Overall Response", + "OID": "CONC.BiomedicalConcept_86", + "name": "Confluent Tumor Masses Assessment", + "label": "Confluent Tumor Masses Assessment", "aliases": [ - "BESTRESP" + "TUMERGE", + "Tumor Merged" ], - "href": "/mdr/bc/biomedicalconcepts/C94536", + "href": "/mdr/bc/biomedicalconcepts/C225437", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_500", - "name": "Disease Response Link Group", - "label": "Disease Response Link Group", + "OID": "CONCPROP.BiomedicalConceptProperty_462", + "name": "Result Anatomical Location", + "label": "Result Anatomical Location", + "mandatory": true, + "coding": [ + { + "code": "C170500", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Result Anatomical Location" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_463", + "name": "Tumor Identifier Reference Identifier", + "label": "Tumor Identifier Reference Identifier", + "mandatory": true, + "coding": [ + { + "code": "C117442", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Reference Identifier" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_464", + "name": "Collection Date Time", + "label": "Collection Date Time", "mandatory": true, "coding": [ { - "code": "C117394", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Disease Response Link Group" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_501", - "name": "Category", - "label": "Category", + "OID": "CONCPROP.BiomedicalConceptProperty_465", + "name": "Directionality", + "label": "Directionality", "mandatory": true, "coding": [ { - "code": "C25372", + "code": "C54215", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Category" + "codeSystemVersion": "2026-05-26", + "decode": "Directionality" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_502", + "OID": "CONCPROP.BiomedicalConceptProperty_466", "name": "Observation Result", "label": "Observation Result", "mandatory": true, @@ -9612,13 +9530,27 @@ { "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", + "codeSystemVersion": "2026-05-26", "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_503", + "OID": "CONCPROP.BiomedicalConceptProperty_467", + "name": "Test Method", + "label": "Test Method", + "mandatory": true, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_468", "name": "Evaluator", "label": "Evaluator", "mandatory": true, @@ -9626,13 +9558,13 @@ { "code": "C51824", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", + "codeSystemVersion": "2026-05-26", "decode": "Evaluator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_504", + "OID": "CONCPROP.BiomedicalConceptProperty_469", "name": "Evaluator Identifier", "label": "Evaluator Identifier", "mandatory": true, @@ -9640,91 +9572,92 @@ { "code": "C117043", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", + "codeSystemVersion": "2026-05-26", "decode": "Evaluator Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_505", - "name": "Clinical Trial Epoch", - "label": "Clinical Trial Epoch", + "OID": "CONCPROP.BiomedicalConceptProperty_470", + "name": "Laterality", + "label": "Laterality", "mandatory": true, "coding": [ { - "code": "C71738", + "code": "C25185", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Clinical Trial Epoch" + "codeSystemVersion": "2026-05-26", + "decode": "Laterality" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_506", - "name": "Collection Date Time", - "label": "Collection Date Time", + "OID": "CONCPROP.BiomedicalConceptProperty_471", + "name": "Tumor Identifier Link Identifier", + "label": "Tumor Identifier Link Identifier", "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C117436", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Collection Date Time" + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identifier Link Identifier" } ] } ], "coding": [ { - "code": "C94536", + "code": "C225437", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Best Overall Response" + "codeSystemVersion": "2026-05-26", + "decode": "Confluent Tumor Masses Assessment" } ] }, { - "OID": "CONC.BiomedicalConcept_92", - "name": "Overall Response", - "label": "Overall Response", + "OID": "CONC.BiomedicalConcept_87", + "name": "Tumor Fragmentation Assessment", + "label": "Tumor Fragmentation Assessment", "aliases": [ - "OVRLRESP" + "TUSPLIT", + "Tumor Split" ], - "href": "/mdr/bc/biomedicalconcepts/C96613", + "href": "/mdr/bc/biomedicalconcepts/C225438", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_507", - "name": "RSLNKGRP", - "label": "RSLNKGRP", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_472", + "name": "Directionality", + "label": "Directionality", + "mandatory": true, "coding": [ { - "code": "C117394", + "code": "C54215", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Disease Response Link Group" + "decode": "Directionality" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_508", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_473", + "name": "Laterality", + "label": "Laterality", + "mandatory": true, "coding": [ { - "code": "C70856", + "code": "C25185", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Laterality" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_509", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_474", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, "coding": [ { "code": "C51824", @@ -9735,128 +9668,127 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_510", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_475", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, "coding": [ { - "code": "C117043", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_511", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_476", + "name": "Result Anatomical Location", + "label": "Result Anatomical Location", + "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C170500", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Result Anatomical Location" } ] - } - ], - "coding": [ - { - "code": "C96613", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Overall Response" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_93", - "name": "Tumor Status", - "label": "Tumor Status", - "aliases": [ - "TUMSTATE", - "Tumor State" - ], - "href": "/mdr/bc/biomedicalconcepts/C96643", - "properties": [ + }, { - "OID": "CONCPROP.BiomedicalConceptProperty_512", - "name": "Collection Date Time", - "label": "Collection Date Time", + "OID": "CONCPROP.BiomedicalConceptProperty_477", + "name": "Test Method", + "label": "Test Method", "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C82535", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Test Method" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_513", - "name": "Tumor Results Group Identifier", - "label": "Tumor Results Group Identifier", + "OID": "CONCPROP.BiomedicalConceptProperty_478", + "name": "Tumor Identifier Link Identifier", + "label": "Tumor Identifier Link Identifier", "mandatory": true, "coding": [ { - "code": "C117411", + "code": "C117436", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Group Identifier" + "decode": "Tumor Identifier Link Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_514", - "name": "Tumor Results Reference Identifier", - "label": "Tumor Results Reference Identifier", + "OID": "CONCPROP.BiomedicalConceptProperty_479", + "name": "Tumor Identifier Reference Identifier", + "label": "Tumor Identifier Reference Identifier", "mandatory": true, "coding": [ { - "code": "C117419", + "code": "C117442", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Reference Identifier" + "decode": "Tumor Identifier Reference Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_515", - "name": "Tumor Results Link Group", - "label": "Tumor Results Link Group", + "OID": "CONCPROP.BiomedicalConceptProperty_480", + "name": "Collection Date Time", + "label": "Collection Date Time", "mandatory": true, "coding": [ { - "code": "C117412", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Link Group" + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_516", - "name": "Tumor Results Link Identifier", - "label": "Tumor Results Link Identifier", + "OID": "CONCPROP.BiomedicalConceptProperty_481", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", "mandatory": true, "coding": [ { - "code": "C117413", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Link Identifier" + "decode": "Evaluator Identifier" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_517", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, + "code": "C225438", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Fragmentation Assessment" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_88", + "name": "Tumor Identification", + "label": "Tumor Identification", + "aliases": [ + "TUMIDENT" + ], + "href": "/mdr/bc/biomedicalconcepts/C94523", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_482", + "name": "TUORRES", + "label": "TUORRES", + "mandatory": false, "coding": [ { "code": "C70856", @@ -9864,144 +9796,126 @@ "codeSystemVersion": "2026-05-26", "decode": "Observation Result" } - ] + ], + "codeList": "CL.0fe19c26" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_518", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_483", + "name": "TULOC", + "label": "TULOC", + "mandatory": false, "coding": [ { - "code": "C82535", + "code": "C170500", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Test Method" + "decode": "Result Anatomical Location" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_519", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_484", + "name": "TULAT", + "label": "TULAT", + "mandatory": false, "coding": [ { - "code": "C51824", + "code": "C25185", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" + "decode": "Laterality" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_520", - "name": "Evaluator Identifier", - "label": "Evaluator Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_485", + "name": "TUDIR", + "label": "TUDIR", + "mandatory": false, "coding": [ { - "code": "C117043", + "code": "C54215", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" + "decode": "Directionality" } ] - } - ], - "coding": [ - { - "code": "C96643", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Status" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_94", - "name": "Longest Diameter", - "label": "Longest Diameter", - "aliases": [ - "LDIAM" - ], - "href": "/mdr/bc/biomedicalconcepts/C96684", - "properties": [ + }, { - "OID": "CONCPROP.BiomedicalConceptProperty_521", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_486", + "name": "TUMETHOD", + "label": "TUMETHOD", + "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C82535", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Test Method" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_522", - "name": "Tumor Results Group Identifier", - "label": "Tumor Results Group Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_487", + "name": "TUEVAL", + "label": "TUEVAL", + "mandatory": false, "coding": [ { - "code": "C117411", + "code": "C51824", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Group Identifier" + "decode": "Evaluator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_523", - "name": "Tumor Results Reference Identifier", - "label": "Tumor Results Reference Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_488", + "name": "TUEVALID", + "label": "TUEVALID", + "mandatory": false, "coding": [ { - "code": "C117419", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Reference Identifier" + "decode": "Evaluator Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_524", - "name": "Tumor Results Link Group", - "label": "Tumor Results Link Group", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_489", + "name": "TUREFID", + "label": "TUREFID", + "mandatory": false, "coding": [ { - "code": "C117412", + "code": "C117442", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Link Group" + "decode": "Tumor Identifier Reference Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_525", - "name": "Tumor Results Link Identifier", - "label": "Tumor Results Link Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_490", + "name": "TULNKID", + "label": "TULNKID", + "mandatory": false, "coding": [ { - "code": "C117413", + "code": "C117436", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Link Identifier" + "decode": "Tumor Identifier Link Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_526", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_491", + "name": "TUDTC", + "label": "TUDTC", + "mandatory": false, "coding": [ { "code": "C82515", @@ -10010,26 +9924,46 @@ "decode": "Collection Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_527", - "name": "Evaluator Identifier", - "label": "Evaluator Identifier", - "mandatory": true, + "code": "C94523", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Identification" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_89", + "name": "Response in Target Lesion", + "label": "Response in Target Lesion", + "aliases": [ + "TRGRESP", + "Target Response" + ], + "href": "/mdr/bc/biomedicalconcepts/C94534", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_492", + "name": "RSORRES", + "label": "RSORRES", + "mandatory": false, "coding": [ { - "code": "C117043", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_528", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_493", + "name": "RSEVAL", + "label": "RSEVAL", + "mandatory": false, "coding": [ { "code": "C51824", @@ -10040,72 +9974,72 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_529", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_494", + "name": "RSEVALID", + "label": "RSEVALID", + "mandatory": false, "coding": [ { - "code": "C82535", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Test Method" + "decode": "Evaluator Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_530", - "name": "Unit of Length", - "label": "Unit of Length", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_495", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, "coding": [ { - "code": "C42578", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Length" + "decode": "Collection Date Time" } ] } ], "coding": [ { - "code": "C96684", + "code": "C94534", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Longest Diameter" + "codeSystemVersion": "2024-06-27", + "decode": "Response in Target Lesion" } ] }, { - "OID": "CONC.BiomedicalConcept_95", - "name": "Longest Perpendicular", - "label": "Longest Perpendicular", + "OID": "CONC.BiomedicalConcept_90", + "name": "Response in Non-Target Lesion", + "label": "Response in Non-Target Lesion", "aliases": [ - "LPERP", - "Short Axis Diameter" + "NTRGRESP", + "Non-Target Response" ], - "href": "/mdr/bc/biomedicalconcepts/C96685", + "href": "/mdr/bc/biomedicalconcepts/C94535", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_531", - "name": "Evaluator Identifier", - "label": "Evaluator Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_496", + "name": "RSORRES", + "label": "RSORRES", + "mandatory": false, "coding": [ { - "code": "C117043", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_532", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_497", + "name": "RSEVAL", + "label": "RSEVAL", + "mandatory": false, "coding": [ { "code": "C51824", @@ -10116,49 +10050,82 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_533", - "name": "Tumor Results Reference Identifier", - "label": "Tumor Results Reference Identifier", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_498", + "name": "RSEVALID", + "label": "RSEVALID", + "mandatory": false, "coding": [ { - "code": "C117419", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Reference Identifier" + "decode": "Evaluator Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_534", - "name": "Tumor Results Link Group", - "label": "Tumor Results Link Group", + "OID": "CONCPROP.BiomedicalConceptProperty_499", + "name": "RSDTC", + "label": "RSDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C94535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "Response in Non-Target Lesion" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_91", + "name": "Best Overall Response", + "label": "Best Overall Response", + "aliases": [ + "BESTRESP" + ], + "href": "/mdr/bc/biomedicalconcepts/C94536", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_500", + "name": "Disease Response Link Group", + "label": "Disease Response Link Group", "mandatory": true, "coding": [ { - "code": "C117412", + "code": "C117394", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Link Group" + "codeSystemVersion": "2024-06-27", + "decode": "Disease Response Link Group" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_535", - "name": "Tumor Results Link Identifier", - "label": "Tumor Results Link Identifier", + "OID": "CONCPROP.BiomedicalConceptProperty_501", + "name": "Category", + "label": "Category", "mandatory": true, "coding": [ { - "code": "C117413", + "code": "C25372", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Link Identifier" + "codeSystemVersion": "2024-06-27", + "decode": "Category" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_536", + "OID": "CONCPROP.BiomedicalConceptProperty_502", "name": "Observation Result", "label": "Observation Result", "mandatory": true, @@ -10166,91 +10133,104 @@ { "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", + "codeSystemVersion": "2024-06-27", "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_537", - "name": "Unit of Length", - "label": "Unit of Length", + "OID": "CONCPROP.BiomedicalConceptProperty_503", + "name": "Evaluator", + "label": "Evaluator", "mandatory": true, "coding": [ { - "code": "C42578", + "code": "C51824", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Length" + "codeSystemVersion": "2024-06-27", + "decode": "Evaluator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_538", - "name": "Collection Date Time", - "label": "Collection Date Time", + "OID": "CONCPROP.BiomedicalConceptProperty_504", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C117043", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2024-06-27", + "decode": "Evaluator Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_539", - "name": "Tumor Results Group Identifier", - "label": "Tumor Results Group Identifier", + "OID": "CONCPROP.BiomedicalConceptProperty_505", + "name": "Clinical Trial Epoch", + "label": "Clinical Trial Epoch", "mandatory": true, "coding": [ { - "code": "C117411", + "code": "C71738", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Group Identifier" + "codeSystemVersion": "2024-06-27", + "decode": "Clinical Trial Epoch" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_540", - "name": "Test Method", - "label": "Test Method", + "OID": "CONCPROP.BiomedicalConceptProperty_506", + "name": "Collection Date Time", + "label": "Collection Date Time", "mandatory": true, "coding": [ { - "code": "C82535", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" + "codeSystemVersion": "2024-06-27", + "decode": "Collection Date Time" } ] } ], "coding": [ { - "code": "C96685", + "code": "C94536", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Longest Perpendicular" + "codeSystemVersion": "2024-06-27", + "decode": "Best Overall Response" } ] }, { - "OID": "CONC.BiomedicalConcept_96", - "name": "pH", - "label": "pH", + "OID": "CONC.BiomedicalConcept_92", + "name": "Overall Response", + "label": "Overall Response", "aliases": [ - "PH", - "potential of Hydrogen" + "OVRLRESP" ], - "href": "/mdr/bc/biomedicalconcepts/C45997", + "href": "/mdr/bc/biomedicalconcepts/C96613", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_541", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_507", + "name": "RSLNKGRP", + "label": "RSLNKGRP", + "mandatory": false, + "coding": [ + { + "code": "C117394", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Disease Response Link Group" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_508", + "name": "RSORRES", + "label": "RSORRES", "mandatory": false, "coding": [ { @@ -10262,38 +10242,37 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_542", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_509", + "name": "RSEVAL", + "label": "RSEVAL", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C51824", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Evaluator" } - ], - "codeList": "CL.5183f82c" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_543", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_510", + "name": "RSEVALID", + "label": "RSEVALID", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Evaluator Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_544", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_511", + "name": "RSDTC", + "label": "RSDTC", "mandatory": false, "coding": [ { @@ -10307,90 +10286,98 @@ ], "coding": [ { - "code": "C45997", + "code": "C96613", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "pH" + "codeSystemVersion": "2024-06-27", + "decode": "Overall Response" } ] }, { - "OID": "CONC.BiomedicalConcept_97", - "name": "Color Assessment", - "label": "Color Assessment", + "OID": "CONC.BiomedicalConcept_93", + "name": "Tumor Status", + "label": "Tumor Status", "aliases": [ - "COLOR", - "Color" + "TUMSTATE", + "Tumor State" ], - "href": "/mdr/bc/biomedicalconcepts/C64546", + "href": "/mdr/bc/biomedicalconcepts/C96643", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_545", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_512", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, "coding": [ { - "code": "C70856", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_546", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_513", + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "mandatory": true, "coding": [ { - "code": "C70713", + "code": "C117411", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Tumor Results Group Identifier" } - ], - "codeList": "CL.5183f82c" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_547", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_514", + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C117419", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Tumor Results Reference Identifier" } ] - } - ], - "coding": [ + }, { - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_98", - "name": "Specific Gravity", - "label": "Specific Gravity", - "aliases": [ - "SPGRAV" - ], - "href": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ + "OID": "CONCPROP.BiomedicalConceptProperty_515", + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "mandatory": true, + "coding": [ + { + "code": "C117412", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Link Group" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_516", + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", + "mandatory": true, + "coding": [ + { + "code": "C117413", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Link Identifier" + } + ] + }, { - "OID": "CONCPROP.BiomedicalConceptProperty_548", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_517", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, "coding": [ { "code": "C70856", @@ -10401,76 +10388,71 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_549", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_518", + "name": "Test Method", + "label": "Test Method", + "mandatory": true, "coding": [ { - "code": "C70713", + "code": "C82535", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Test Method" } - ], - "codeList": "CL.5183f82c" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_550", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_519", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, "coding": [ { - "code": "C93566", + "code": "C51824", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Evaluator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_551", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_520", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Evaluator Identifier" } ] } ], "coding": [ { - "code": "C64832", + "code": "C96643", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity" + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Status" } ] }, { - "OID": "CONC.BiomedicalConcept_99", - "name": "Hematocrit Measurement", - "label": "Hematocrit Measurement", + "OID": "CONC.BiomedicalConcept_94", + "name": "Longest Diameter", + "label": "Longest Diameter", "aliases": [ - "Hematocrit", - "Packed Cell Volume", - "PCV", - "Erythrocyte Volume Fraction", - "EVF" + "LDIAM" ], - "href": "/mdr/bc/biomedicalconcepts/C64796", + "href": "/mdr/bc/biomedicalconcepts/C96684", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_584", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_521", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, "coding": [ { "code": "C70856", @@ -10481,268 +10463,226 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_585", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_522", + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "mandatory": true, "coding": [ { - "code": "C69174", + "code": "C117411", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume Fraction" + "decode": "Tumor Results Group Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_586", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_523", + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "mandatory": true, "coding": [ { - "code": "C70713", + "code": "C117419", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Tumor Results Reference Identifier" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_587", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_524", + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "mandatory": true, "coding": [ { - "code": "C93566", + "code": "C117412", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Tumor Results Link Group" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_588", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_525", + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", + "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C117413", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Tumor Results Link Identifier" } ] - } - ], - "coding": [ - { - "code": "C64796", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hematocrit Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_100", - "name": "Hemoglobin Measurement", - "label": "Hemoglobin Measurement", - "aliases": [ - "Hemoglobin", - "HGB" - ], - "href": "/mdr/bc/biomedicalconcepts/C64848", - "properties": [ + }, { - "OID": "CONCPROP.BiomedicalConceptProperty_589", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_526", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, "coding": [ { - "code": "C70856", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_590", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_527", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "mandatory": true, "coding": [ { - "code": "C64571", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Concentration" + "decode": "Evaluator Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_591", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_528", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, "coding": [ { - "code": "C70713", + "code": "C51824", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Evaluator" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_592", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_529", + "name": "Test Method", + "label": "Test Method", + "mandatory": true, "coding": [ { - "code": "C93566", + "code": "C82535", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Test Method" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_593", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_530", + "name": "Unit of Length", + "label": "Unit of Length", + "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C42578", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Unit of Length" } ] } ], "coding": [ { - "code": "C64848", + "code": "C96684", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin Measurement" + "codeSystemVersion": "2026-05-26", + "decode": "Longest Diameter" } ] }, { - "OID": "CONC.BiomedicalConcept_101", - "name": "Erythrocyte Mean Corpuscular Hemoglobin", - "label": "Erythrocyte Mean Corpuscular Hemoglobin", + "OID": "CONC.BiomedicalConcept_95", + "name": "Longest Perpendicular", + "label": "Longest Perpendicular", "aliases": [ - "RBC Mean Corpuscular Hemoglobin", - "MCH" + "LPERP", + "Short Axis Diameter" ], - "href": "/mdr/bc/biomedicalconcepts/C64797", + "href": "/mdr/bc/biomedicalconcepts/C96685", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_594", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_531", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "mandatory": true, "coding": [ { - "code": "C70856", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Evaluator Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_595", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_532", + "name": "Evaluator", + "label": "Evaluator", + "mandatory": true, "coding": [ { - "code": "C25709", + "code": "C51824", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Measure" + "decode": "Evaluator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_596", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_533", + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "mandatory": true, "coding": [ { - "code": "C70713", + "code": "C117419", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Tumor Results Reference Identifier" } - ], - "codeList": "CL.1aeb2034" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_597", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_534", + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "mandatory": true, "coding": [ { - "code": "C93566", + "code": "C117412", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Tumor Results Link Group" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_598", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_535", + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", + "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C117413", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Tumor Results Link Identifier" } ] - } - ], - "coding": [ - { - "code": "C64797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Hemoglobin" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_102", - "name": "Lymphocyte Count", - "label": "Lymphocyte Count", - "aliases": [ - "Lymphocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C51949", - "properties": [ + }, { - "OID": "CONCPROP.BiomedicalConceptProperty_599", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_536", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, "coding": [ { "code": "C70856", @@ -10753,83 +10693,83 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_600", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_537", + "name": "Unit of Length", + "label": "Unit of Length", + "mandatory": true, "coding": [ { - "code": "C67391", + "code": "C42578", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" + "decode": "Unit of Length" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_601", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_538", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, "coding": [ { - "code": "C70713", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Collection Date Time" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_602", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_539", + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "mandatory": true, "coding": [ { - "code": "C93566", + "code": "C117411", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Tumor Results Group Identifier" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_603", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_540", + "name": "Test Method", + "label": "Test Method", + "mandatory": true, "coding": [ { - "code": "C82515", + "code": "C82535", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Test Method" } ] } ], "coding": [ { - "code": "C51949", + "code": "C96685", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Lymphocyte Count" + "codeSystemVersion": "2026-05-26", + "decode": "Longest Perpendicular" } ] }, { - "OID": "CONC.BiomedicalConcept_103", - "name": "Monocyte Count", - "label": "Monocyte Count", + "OID": "CONC.BiomedicalConcept_96", + "name": "pH", + "label": "pH", "aliases": [ - "Monocytes" + "PH", + "potential of Hydrogen" ], - "href": "/mdr/bc/biomedicalconcepts/C64823", + "href": "/mdr/bc/biomedicalconcepts/C45997", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_604", + "OID": "CONCPROP.BiomedicalConceptProperty_541", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -10843,21 +10783,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_605", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_606", + "OID": "CONCPROP.BiomedicalConceptProperty_542", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -10869,10 +10795,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.af8f8a19" + "codeList": "CL.5183f82c" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_607", + "OID": "CONCPROP.BiomedicalConceptProperty_543", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -10886,7 +10812,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_608", + "OID": "CONCPROP.BiomedicalConceptProperty_544", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -10902,26 +10828,25 @@ ], "coding": [ { - "code": "C64823", + "code": "C45997", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Monocyte Count" + "decode": "pH" } ] }, { - "OID": "CONC.BiomedicalConcept_104", - "name": "Absolute Neutrophil Count", - "label": "Absolute Neutrophil Count", + "OID": "CONC.BiomedicalConcept_97", + "name": "Color Assessment", + "label": "Color Assessment", "aliases": [ - "Neutrophils", - "Total Neutrophil Count", - "NEUT" + "COLOR", + "Color" ], - "href": "/mdr/bc/biomedicalconcepts/C63321", + "href": "/mdr/bc/biomedicalconcepts/C64546", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_609", + "OID": "CONCPROP.BiomedicalConceptProperty_545", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -10935,22 +10860,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_610", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.68e5ab5a" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_611", + "OID": "CONCPROP.BiomedicalConceptProperty_546", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -10962,24 +10872,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_612", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] + "codeList": "CL.5183f82c" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_613", + "OID": "CONCPROP.BiomedicalConceptProperty_547", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -10995,53 +10891,38 @@ ], "coding": [ { - "code": "C63321", + "code": "C64546", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Neutrophil Count" + "codeSystemVersion": "2025-11-18", + "decode": "Color Assessment" } ] }, { - "OID": "CONC.BiomedicalConcept_105", - "name": "Absolute Basophil Count", - "label": "Absolute Basophil Count", + "OID": "CONC.BiomedicalConcept_98", + "name": "Specific Gravity", + "label": "Specific Gravity", "aliases": [ - "Basophils", - "Total Basophil Count" + "SPGRAV" ], - "href": "/mdr/bc/biomedicalconcepts/C64470", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_614", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_615", - "name": "LBORRESU", - "label": "LBORRESU", + "href": "/mdr/bc/biomedicalconcepts/C64832", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_548", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { - "code": "C67391", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_616", + "OID": "CONCPROP.BiomedicalConceptProperty_549", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -11053,10 +10934,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.af8f8a19" + "codeList": "CL.5183f82c" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_617", + "OID": "CONCPROP.BiomedicalConceptProperty_550", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -11070,7 +10951,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_618", + "OID": "CONCPROP.BiomedicalConceptProperty_551", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -11086,24 +10967,28 @@ ], "coding": [ { - "code": "C64470", + "code": "C64832", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Absolute Basophil Count" + "decode": "Specific Gravity" } ] }, { - "OID": "CONC.BiomedicalConcept_106", - "name": "Eosinophil Count", - "label": "Eosinophil Count", + "OID": "CONC.BiomedicalConcept_99", + "name": "Hematocrit Measurement", + "label": "Hematocrit Measurement", "aliases": [ - "Eosinophils" + "Hematocrit", + "Packed Cell Volume", + "PCV", + "Erythrocyte Volume Fraction", + "EVF" ], - "href": "/mdr/bc/biomedicalconcepts/C64550", + "href": "/mdr/bc/biomedicalconcepts/C64796", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_619", + "OID": "CONCPROP.BiomedicalConceptProperty_584", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -11117,21 +11002,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_620", + "OID": "CONCPROP.BiomedicalConceptProperty_585", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C67391", + "code": "C69174", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" + "decode": "Unit of Volume Fraction" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_621", + "OID": "CONCPROP.BiomedicalConceptProperty_586", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -11146,7 +11031,7 @@ "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_622", + "OID": "CONCPROP.BiomedicalConceptProperty_587", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -11160,7 +11045,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_623", + "OID": "CONCPROP.BiomedicalConceptProperty_588", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -11176,26 +11061,25 @@ ], "coding": [ { - "code": "C64550", + "code": "C64796", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Eosinophil Count" + "decode": "Hematocrit Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_107", - "name": "Neutrophil Band Form Count", - "label": "Neutrophil Band Form Count", + "OID": "CONC.BiomedicalConcept_100", + "name": "Hemoglobin Measurement", + "label": "Hemoglobin Measurement", "aliases": [ - "Neutrophil Bands", - "Bands", - "NEUTB" + "Hemoglobin", + "HGB" ], - "href": "/mdr/bc/biomedicalconcepts/C64830", + "href": "/mdr/bc/biomedicalconcepts/C64848", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_624", + "OID": "CONCPROP.BiomedicalConceptProperty_589", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -11209,22 +11093,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_625", + "OID": "CONCPROP.BiomedicalConceptProperty_590", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C67391", + "code": "C64571", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" + "decode": "Unit of Mass Concentration" } - ], - "codeList": "CL.2c53325c" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_626", + "OID": "CONCPROP.BiomedicalConceptProperty_591", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -11239,7 +11122,7 @@ "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_627", + "OID": "CONCPROP.BiomedicalConceptProperty_592", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -11253,7 +11136,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_628", + "OID": "CONCPROP.BiomedicalConceptProperty_593", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -11269,26 +11152,27 @@ ], "coding": [ { - "code": "C64830", + "code": "C64848", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Neutrophil Band Form Count" + "decode": "Hemoglobin Measurement" } ] }, { - "OID": "CONC.BiomedicalConcept_108", - "name": "Forced Vital Capacity", - "label": "Forced Vital Capacity", + "OID": "CONC.BiomedicalConcept_101", + "name": "Erythrocyte Mean Corpuscular Hemoglobin", + "label": "Erythrocyte Mean Corpuscular Hemoglobin", "aliases": [ - "FVC" + "RBC Mean Corpuscular Hemoglobin", + "MCH" ], - "href": "/mdr/bc/biomedicalconcepts/C111361", + "href": "/mdr/bc/biomedicalconcepts/C64797", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_629", - "name": "REORRES", - "label": "REORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_594", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { @@ -11300,88 +11184,52 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_630", - "name": "REORRESU", - "label": "REORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_595", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C44279", + "code": "C25709", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" + "decode": "Unit of Measure" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_631", - "name": "REDTC", - "label": "REDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111361", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Forced Vital Capacity" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_109", - "name": "Forced Expiratory Volume in 1 Second", - "label": "Forced Expiratory Volume in 1 Second", - "aliases": [ - "FEV1", - "FEV1%VC", - "Forced Expiratory Volume 1 Test", - "PFT/FEV1", - "Pulmonary Function Test/Forced Expiratory Volume 1" - ], - "href": "/mdr/bc/biomedicalconcepts/C38084", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_632", - "name": "REORRES", - "label": "REORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_596", + "name": "LBSPEC", + "label": "LBSPEC", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.1aeb2034" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_633", - "name": "REORRESU", - "label": "REORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_597", + "name": "LBFAST", + "label": "LBFAST", "mandatory": false, "coding": [ { - "code": "C44279", + "code": "C93566", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_634", - "name": "REDTC", - "label": "REDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_598", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { @@ -11395,28 +11243,26 @@ ], "coding": [ { - "code": "C38084", + "code": "C64797", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Forced Expiratory Volume in 1 Second" + "codeSystemVersion": "2025-07-01", + "decode": "Erythrocyte Mean Corpuscular Hemoglobin" } ] }, { - "OID": "CONC.BiomedicalConcept_110", - "name": "Forced Expiratory Volume in 6 Seconds", - "label": "Forced Expiratory Volume in 6 Seconds", + "OID": "CONC.BiomedicalConcept_102", + "name": "Lymphocyte Count", + "label": "Lymphocyte Count", "aliases": [ - "FEV6", - "Forced Expiratory Volume 6", - "Forced Expiratory Volume 6 Test" + "Lymphocytes" ], - "href": "/mdr/bc/biomedicalconcepts/C47843", + "href": "/mdr/bc/biomedicalconcepts/C51949", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_635", - "name": "REORRES", - "label": "REORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_599", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { @@ -11428,84 +11274,52 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_636", - "name": "REORRESU", - "label": "REORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_600", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C44279", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" + "decode": "Unit of Number Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_637", - "name": "REDTC", - "label": "REDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C47843", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Forced Expiratory Volume in 6 Seconds" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_111", - "name": "Peak Expiratory Flow", - "label": "Peak Expiratory Flow", - "aliases": [ - "PEF" - ], - "href": "/mdr/bc/biomedicalconcepts/C41372", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_638", - "name": "REORRES", - "label": "REORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_601", + "name": "LBSPEC", + "label": "LBSPEC", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_639", - "name": "REORRESU", - "label": "REORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_602", + "name": "LBFAST", + "label": "LBFAST", "mandatory": false, "coding": [ { - "code": "C48568", + "code": "C93566", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volumetric Flow Rate" + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_640", - "name": "REDTC", - "label": "REDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_603", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { @@ -11519,27 +11333,26 @@ ], "coding": [ { - "code": "C41372", + "code": "C51949", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Peak Expiratory Flow" + "codeSystemVersion": "2025-07-01", + "decode": "Lymphocyte Count" } ] }, { - "OID": "CONC.BiomedicalConcept_112", - "name": "Tidal Volume", - "label": "Tidal Volume", + "OID": "CONC.BiomedicalConcept_103", + "name": "Monocyte Count", + "label": "Monocyte Count", "aliases": [ - "TIDALVOL", - "TV" + "Monocytes" ], - "href": "/mdr/bc/biomedicalconcepts/C111324", + "href": "/mdr/bc/biomedicalconcepts/C64823", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_641", - "name": "REORRES", - "label": "REORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_604", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { @@ -11551,84 +11364,52 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_642", - "name": "REORRESU", - "label": "REORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_605", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C44279", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" + "decode": "Unit of Number Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_643", - "name": "REDTC", - "label": "REDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111324", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Tidal Volume" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_113", - "name": "Inspiratory Capacity", - "label": "Inspiratory Capacity", - "aliases": [ - "IC" - ], - "href": "/mdr/bc/biomedicalconcepts/C111362", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_644", - "name": "REORRES", - "label": "REORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_606", + "name": "LBSPEC", + "label": "LBSPEC", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_645", - "name": "REORRESU", - "label": "REORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_607", + "name": "LBFAST", + "label": "LBFAST", "mandatory": false, "coding": [ { - "code": "C44279", + "code": "C93566", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_646", - "name": "REDTC", - "label": "REDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_608", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { @@ -11642,26 +11423,28 @@ ], "coding": [ { - "code": "C111362", + "code": "C64823", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Inspiratory Capacity" + "codeSystemVersion": "2025-07-01", + "decode": "Monocyte Count" } ] }, { - "OID": "CONC.BiomedicalConcept_114", - "name": "Expiratory Reserve Volume", - "label": "Expiratory Reserve Volume", + "OID": "CONC.BiomedicalConcept_104", + "name": "Absolute Neutrophil Count", + "label": "Absolute Neutrophil Count", "aliases": [ - "ERV" + "Neutrophils", + "Total Neutrophil Count", + "NEUT" ], - "href": "/mdr/bc/biomedicalconcepts/C111200", + "href": "/mdr/bc/biomedicalconcepts/C63321", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_647", - "name": "REORRES", - "label": "REORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_609", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { @@ -11673,23 +11456,53 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_648", - "name": "REORRESU", - "label": "REORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_610", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C44279", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" + "decode": "Unit of Number Concentration" + } + ], + "codeList": "CL.68e5ab5a" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_611", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.af8f8a19" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_612", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_649", - "name": "REDTC", - "label": "REDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_613", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { @@ -11703,26 +11516,27 @@ ], "coding": [ { - "code": "C111200", + "code": "C63321", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Expiratory Reserve Volume" + "codeSystemVersion": "2025-07-01", + "decode": "Absolute Neutrophil Count" } ] }, { - "OID": "CONC.BiomedicalConcept_115", - "name": "Inspiratory Reserve Volume", - "label": "Inspiratory Reserve Volume", + "OID": "CONC.BiomedicalConcept_105", + "name": "Absolute Basophil Count", + "label": "Absolute Basophil Count", "aliases": [ - "IRV" + "Basophils", + "Total Basophil Count" ], - "href": "/mdr/bc/biomedicalconcepts/C111237", + "href": "/mdr/bc/biomedicalconcepts/C64470", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_650", - "name": "REORRES", - "label": "REORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_614", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { @@ -11734,84 +11548,52 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_651", - "name": "REORRESU", - "label": "REORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_615", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C44279", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" + "decode": "Unit of Number Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_652", - "name": "REDTC", - "label": "REDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111237", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Inspiratory Reserve Volume" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_116", - "name": "Slow Vital Capacity", - "label": "Slow Vital Capacity", - "aliases": [ - "SVC" - ], - "href": "/mdr/bc/biomedicalconcepts/C111315", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_653", - "name": "REORRES", - "label": "REORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_616", + "name": "LBSPEC", + "label": "LBSPEC", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C70713", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_654", - "name": "REORRESU", - "label": "REORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_617", + "name": "LBFAST", + "label": "LBFAST", "mandatory": false, "coding": [ { - "code": "C44279", + "code": "C93566", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_655", - "name": "REDTC", - "label": "REDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_618", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { @@ -11825,27 +11607,26 @@ ], "coding": [ { - "code": "C111315", + "code": "C64470", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Slow Vital Capacity" + "codeSystemVersion": "2025-07-01", + "decode": "Absolute Basophil Count" } ] }, { - "OID": "CONC.BiomedicalConcept_117", - "name": "Diffusion Capacity of the Lung for Carbon Monoxide/Alveolar Volume Ratio", - "label": "Diffusion Capacity of the Lung for Carbon Monoxide/Alveolar Volume Ratio", + "OID": "CONC.BiomedicalConcept_106", + "name": "Eosinophil Count", + "label": "Eosinophil Count", "aliases": [ - "DLCO/VA", - "DLCOVA" + "Eosinophils" ], - "href": "/mdr/bc/biomedicalconcepts/C120830", + "href": "/mdr/bc/biomedicalconcepts/C64550", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_656", - "name": "REORRES", - "label": "REORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_619", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { @@ -11857,23 +11638,52 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_657", - "name": "REORRESU", - "label": "REORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_620", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C48570", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit" + "decode": "Unit of Number Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_658", - "name": "REDTC", - "label": "REDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_621", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.af8f8a19" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_622", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_623", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { @@ -11887,25 +11697,26 @@ ], "coding": [ { - "code": "C120830", + "code": "C64550", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Diffusion Capacity of the Lung for Carbon Monoxide/Alveolar Volume Ratio" + "codeSystemVersion": "2025-07-01", + "decode": "Eosinophil Count" } ] }, { - "OID": "CONC.BiomedicalConcept_118", - "name": "Phosphate Measurement", - "label": "Phosphate Measurement", + "OID": "CONC.BiomedicalConcept_107", + "name": "Neutrophil Band Form Count", + "label": "Neutrophil Band Form Count", "aliases": [ - "Phosphorus", - "Phosphate" + "Neutrophil Bands", + "Bands", + "NEUTB" ], - "href": "/mdr/bc/biomedicalconcepts/C64857", + "href": "/mdr/bc/biomedicalconcepts/C64830", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_659", + "OID": "CONCPROP.BiomedicalConceptProperty_624", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -11919,21 +11730,22 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_660", + "OID": "CONCPROP.BiomedicalConceptProperty_625", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Unit of Number Concentration" } - ] + ], + "codeList": "CL.2c53325c" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_661", + "OID": "CONCPROP.BiomedicalConceptProperty_626", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -11945,10 +11757,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.9e69169e" + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_662", + "OID": "CONCPROP.BiomedicalConceptProperty_627", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -11962,7 +11774,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_663", + "OID": "CONCPROP.BiomedicalConceptProperty_628", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -11978,208 +11790,311 @@ ], "coding": [ { - "code": "C64857", + "code": "C64830", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2025-07-01", - "decode": "Phosphate Measurement" + "decode": "Neutrophil Band Form Count" } ] }, { - "OID": "CONC.BiomedicalConcept_119", - "name": "Hepatitis B Surface Antibody Measurement", - "label": "Hepatitis B Surface Antibody Measurement", + "OID": "CONC.BiomedicalConcept_108", + "name": "Forced Vital Capacity", + "label": "Forced Vital Capacity", "aliases": [ - "HBV Surface Antibody", - "HBV Surface Antibody Measurement" + "FVC" ], - "href": "/mdr/bc/biomedicalconcepts/C74711", + "href": "/mdr/bc/biomedicalconcepts/C111361", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_664", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_629", + "name": "REORRES", + "label": "REORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_630", + "name": "REORRESU", + "label": "REORRESU", + "mandatory": false, + "coding": [ + { + "code": "C44279", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_631", + "name": "REDTC", + "label": "REDTC", + "mandatory": false, "coding": [ { "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", + "codeSystemVersion": "2026-05-26", "decode": "Collection Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_665", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, + "code": "C111361", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Forced Vital Capacity" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_109", + "name": "Forced Expiratory Volume in 1 Second", + "label": "Forced Expiratory Volume in 1 Second", + "aliases": [ + "FEV1", + "FEV1%VC", + "Forced Expiratory Volume 1 Test", + "PFT/FEV1", + "Pulmonary Function Test/Forced Expiratory Volume 1" + ], + "href": "/mdr/bc/biomedicalconcepts/C38084", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_632", + "name": "REORRES", + "label": "REORRES", + "mandatory": false, "coding": [ { "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", + "codeSystemVersion": "2026-05-26", "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_666", - "name": "Unit of Concentration", - "label": "Unit of Concentration", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_633", + "name": "REORRESU", + "label": "REORRESU", + "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C44279", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Unit of Concentration" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_667", - "name": "Measurement, Test or Examination Detail", - "label": "Measurement, Test or Examination Detail", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_634", + "name": "REDTC", + "label": "REDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], + "coding": [ + { + "code": "C38084", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Forced Expiratory Volume in 1 Second" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_110", + "name": "Forced Expiratory Volume in 6 Seconds", + "label": "Forced Expiratory Volume in 6 Seconds", + "aliases": [ + "FEV6", + "Forced Expiratory Volume 6", + "Forced Expiratory Volume 6 Test" + ], + "href": "/mdr/bc/biomedicalconcepts/C47843", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_635", + "name": "REORRES", + "label": "REORRES", + "mandatory": false, "coding": [ { - "code": "C117062", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Measurement, Test or Examination Detail" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_668", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_636", + "name": "REORRESU", + "label": "REORRESU", + "mandatory": false, "coding": [ { - "code": "C82535", + "code": "C44279", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Test Method" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_669", - "name": "Biospecimen Type", - "label": "Biospecimen Type", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_637", + "name": "REDTC", + "label": "REDTC", + "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Biospecimen Type" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] } ], "coding": [ { - "code": "C74711", + "code": "C47843", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Hepatitis B Surface Antibody Measurement" + "codeSystemVersion": "2026-03-31", + "decode": "Forced Expiratory Volume in 6 Seconds" } ] }, { - "OID": "CONC.BiomedicalConcept_120", - "name": "Hepatitis C Virus RNA Measurement", - "label": "Hepatitis C Virus RNA Measurement", + "OID": "CONC.BiomedicalConcept_111", + "name": "Peak Expiratory Flow", + "label": "Peak Expiratory Flow", "aliases": [ - "HCRNA", - "Hepatitis C RNA" + "PEF" ], - "href": "/mdr/bc/biomedicalconcepts/C142330", + "href": "/mdr/bc/biomedicalconcepts/C41372", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_670", - "name": "MBTSTDTL", - "label": "MBTSTDTL", + "OID": "CONCPROP.BiomedicalConceptProperty_638", + "name": "REORRES", + "label": "REORRES", "mandatory": false, "coding": [ { - "code": "C117062", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Measurement, Test or Examination Detail" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_671", - "name": "MBORRES", - "label": "MBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_639", + "name": "REORRESU", + "label": "REORRESU", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C48568", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volumetric Flow Rate" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_672", - "name": "MBORRESU", - "label": "MBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_640", + "name": "REDTC", + "label": "REDTC", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Unit of Concentration" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_673", - "name": "MBSPEC", - "label": "MBSPEC", + "code": "C41372", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Peak Expiratory Flow" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_112", + "name": "Tidal Volume", + "label": "Tidal Volume", + "aliases": [ + "TIDALVOL", + "TV" + ], + "href": "/mdr/bc/biomedicalconcepts/C111324", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_641", + "name": "REORRES", + "label": "REORRES", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Biospecimen Type" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } - ], - "codeList": "CL.9e69169e" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_674", - "name": "MBMETHOD", - "label": "MBMETHOD", + "OID": "CONCPROP.BiomedicalConceptProperty_642", + "name": "REORRESU", + "label": "REORRESU", "mandatory": false, "coding": [ { - "code": "C82535", + "code": "C44279", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Test Method" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_675", - "name": "MBDTC", - "label": "MBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_643", + "name": "REDTC", + "label": "REDTC", "mandatory": false, "coding": [ { "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", + "codeSystemVersion": "2026-05-26", "decode": "Collection Date Time" } ] @@ -12187,105 +12102,121 @@ ], "coding": [ { - "code": "C142330", + "code": "C111324", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Hepatitis C Virus RNA Measurement" + "codeSystemVersion": "2026-03-31", + "decode": "Tidal Volume" } ] }, { - "OID": "CONC.BiomedicalConcept_121", - "name": "Hepatitis B DNA Measurement", - "label": "Hepatitis B DNA Measurement", + "OID": "CONC.BiomedicalConcept_113", + "name": "Inspiratory Capacity", + "label": "Inspiratory Capacity", "aliases": [ - "HBDNA", - "HBV DNA", - "HBV DNA Measurement" + "IC" ], - "href": "/mdr/bc/biomedicalconcepts/C103404", + "href": "/mdr/bc/biomedicalconcepts/C111362", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_676", - "name": "MBTSTDTL", - "label": "MBTSTDTL", + "OID": "CONCPROP.BiomedicalConceptProperty_644", + "name": "REORRES", + "label": "REORRES", "mandatory": false, "coding": [ { - "code": "C117062", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Measurement, Test or Examination Detail" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_677", - "name": "MBORRES", - "label": "MBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_645", + "name": "REORRESU", + "label": "REORRESU", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C44279", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_678", - "name": "MBORRESU", - "label": "MBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_646", + "name": "REDTC", + "label": "REDTC", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Unit of Concentration" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] - }, + } + ], + "coding": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_679", - "name": "MBSPEC", - "label": "MBSPEC", + "code": "C111362", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Inspiratory Capacity" + } + ] + }, + { + "OID": "CONC.BiomedicalConcept_114", + "name": "Expiratory Reserve Volume", + "label": "Expiratory Reserve Volume", + "aliases": [ + "ERV" + ], + "href": "/mdr/bc/biomedicalconcepts/C111200", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_647", + "name": "REORRES", + "label": "REORRES", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Biospecimen Type" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } - ], - "codeList": "CL.9e69169e" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_680", - "name": "MBMETHOD", - "label": "MBMETHOD", + "OID": "CONCPROP.BiomedicalConceptProperty_648", + "name": "REORRESU", + "label": "REORRESU", "mandatory": false, "coding": [ { - "code": "C82535", + "code": "C44279", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Test Method" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume" } ] }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_681", - "name": "MBDTC", - "label": "MBDTC", + { + "OID": "CONCPROP.BiomedicalConceptProperty_649", + "name": "REDTC", + "label": "REDTC", "mandatory": false, "coding": [ { "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", + "codeSystemVersion": "2026-05-26", "decode": "Collection Date Time" } ] @@ -12293,27 +12224,26 @@ ], "coding": [ { - "code": "C103404", + "code": "C111200", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Hepatitis B DNA Measurement" + "codeSystemVersion": "2026-03-31", + "decode": "Expiratory Reserve Volume" } ] }, { - "OID": "CONC.BiomedicalConcept_122", - "name": "Erythrocyte Mean Corpuscular Volume", - "label": "Erythrocyte Mean Corpuscular Volume", + "OID": "CONC.BiomedicalConcept_115", + "name": "Inspiratory Reserve Volume", + "label": "Inspiratory Reserve Volume", "aliases": [ - "RBC Mean Corpuscular Volume", - "MCV" + "IRV" ], - "href": "/mdr/bc/biomedicalconcepts/C64799", + "href": "/mdr/bc/biomedicalconcepts/C111237", "properties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_682", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_650", + "name": "REORRES", + "label": "REORRES", "mandatory": false, "coding": [ { @@ -12325,9 +12255,9 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_683", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_651", + "name": "REORRESU", + "label": "REORRESU", "mandatory": false, "coding": [ { @@ -12336,42 +12266,12 @@ "codeSystemVersion": "2026-05-26", "decode": "Unit of Volume" } - ], - "codeList": "CL.a00fe0a9" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_684", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1aeb2034" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_685", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_686", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_652", + "name": "REDTC", + "label": "REDTC", "mandatory": false, "coding": [ { @@ -12382,567 +12282,798 @@ } ] } - ], - "coding": [ - { - "code": "C64799", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Volume" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_123", - "name": "Pulmonary Function Test", - "label": "Pulmonary Function Test", - "aliases": [ - "Pulmonary Function Test", - "lung function test", - "PFT", - "Pulmonary Function Testing" - ], - "href": "/mdr/bc/biomedicalconcepts/C38081", - "properties": [], - "coding": [ - { - "code": "C38081", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Pulmonary Function Test" - } - ] - } - ], - "conceptProperties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.65a3e8d0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, + ], "coding": [ { - "code": "C13717", + "code": "C111237", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" + "codeSystemVersion": "2026-03-31", + "decode": "Inspiratory Reserve Volume" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ + "OID": "CONC.BiomedicalConcept_116", + "name": "Slow Vital Capacity", + "label": "Slow Vital Capacity", + "aliases": [ + "SVC" + ], + "href": "/mdr/bc/biomedicalconcepts/C111315", + "properties": [ { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" + "OID": "CONCPROP.BiomedicalConceptProperty_653", + "name": "REORRES", + "label": "REORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_654", + "name": "REORRESU", + "label": "REORRESU", + "mandatory": false, + "coding": [ + { + "code": "C44279", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_655", + "name": "REDTC", + "label": "REDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, + ], "coding": [ { - "code": "C82515", + "code": "C111315", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2026-03-31", + "decode": "Slow Vital Capacity" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, + "OID": "CONC.BiomedicalConcept_118", + "name": "Phosphate Measurement", + "label": "Phosphate Measurement", + "aliases": [ + "Phosphorus", + "Phosphate" + ], + "href": "/mdr/bc/biomedicalconcepts/C64857", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_659", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_660", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_661", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_662", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_663", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], "coding": [ { - "code": "C70856", + "code": "C64857", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2025-07-01", + "decode": "Phosphate Measurement" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ + "OID": "CONC.BiomedicalConcept_119", + "name": "Hepatitis B Surface Antibody Measurement", + "label": "Hepatitis B Surface Antibody Measurement", + "aliases": [ + "HBV Surface Antibody", + "HBV Surface Antibody Measurement" + ], + "href": "/mdr/bc/biomedicalconcepts/C74711", + "properties": [ { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" + "OID": "CONCPROP.BiomedicalConceptProperty_664", + "name": "Collection Date Time", + "label": "Collection Date Time", + "mandatory": true, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Collection Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_665", + "name": "Observation Result", + "label": "Observation Result", + "mandatory": true, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_666", + "name": "Unit of Concentration", + "label": "Unit of Concentration", + "mandatory": true, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_667", + "name": "Measurement, Test or Examination Detail", + "label": "Measurement, Test or Examination Detail", + "mandatory": true, + "coding": [ + { + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Measurement, Test or Examination Detail" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_668", + "name": "Test Method", + "label": "Test Method", + "mandatory": true, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_669", + "name": "Biospecimen Type", + "label": "Biospecimen Type", + "mandatory": true, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Biospecimen Type" + } + ] } ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, "coding": [ { - "code": "C62164", + "code": "C74711", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" + "codeSystemVersion": "2026-07-14", + "decode": "Hepatitis B Surface Antibody Measurement" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ + "OID": "CONC.BiomedicalConcept_120", + "name": "Hepatitis C Virus RNA Measurement", + "label": "Hepatitis C Virus RNA Measurement", + "aliases": [ + "HCRNA", + "Hepatitis C RNA" + ], + "href": "/mdr/bc/biomedicalconcepts/C142330", + "properties": [ { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ + "OID": "CONCPROP.BiomedicalConceptProperty_670", + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "mandatory": false, + "coding": [ + { + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Measurement, Test or Examination Detail" + } + ] + }, { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ + "OID": "CONCPROP.BiomedicalConceptProperty_671", + "name": "MBORRES", + "label": "MBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Observation Result" + } + ] + }, { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "OID": "CONCPROP.BiomedicalConceptProperty_672", + "name": "MBORRESU", + "label": "MBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_673", + "name": "MBSPEC", + "label": "MBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_674", + "name": "MBMETHOD", + "label": "MBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_675", + "name": "MBDTC", + "label": "MBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Collection Date Time" + } + ] } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, + ], "coding": [ { - "code": "C70856", + "code": "C142330", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2026-07-14", + "decode": "Hepatitis C Virus RNA Measurement" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ + "OID": "CONC.BiomedicalConcept_121", + "name": "Hepatitis B DNA Measurement", + "label": "Hepatitis B DNA Measurement", + "aliases": [ + "HBDNA", + "HBV DNA", + "HBV DNA Measurement" + ], + "href": "/mdr/bc/biomedicalconcepts/C103404", + "properties": [ { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" + "OID": "CONCPROP.BiomedicalConceptProperty_676", + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "mandatory": false, + "coding": [ + { + "code": "C117062", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Measurement, Test or Examination Detail" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_677", + "name": "MBORRES", + "label": "MBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_678", + "name": "MBORRESU", + "label": "MBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C48207", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Unit of Concentration" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_679", + "name": "MBSPEC", + "label": "MBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.9e69169e" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_680", + "name": "MBMETHOD", + "label": "MBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_681", + "name": "MBDTC", + "label": "MBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Collection Date Time" + } + ] } ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, "coding": [ { - "code": "C62164", + "code": "C103404", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" + "codeSystemVersion": "2026-07-14", + "decode": "Hepatitis B DNA Measurement" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, + "OID": "CONC.BiomedicalConcept_122", + "name": "Erythrocyte Mean Corpuscular Volume", + "label": "Erythrocyte Mean Corpuscular Volume", + "aliases": [ + "RBC Mean Corpuscular Volume", + "MCV" + ], + "href": "/mdr/bc/biomedicalconcepts/C64799", + "properties": [ + { + "OID": "CONCPROP.BiomedicalConceptProperty_682", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, + "coding": [ + { + "code": "C70856", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_683", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, + "coding": [ + { + "code": "C44279", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Volume" + } + ], + "codeList": "CL.a00fe0a9" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_684", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, + "coding": [ + { + "code": "C70713", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" + } + ], + "codeList": "CL.1aeb2034" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_685", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, + "coding": [ + { + "code": "C93566", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_686", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, + "coding": [ + { + "code": "C82515", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" + } + ] + } + ], "coding": [ { - "code": "C13717", + "code": "C64799", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" + "codeSystemVersion": "2025-07-01", + "decode": "Erythrocyte Mean Corpuscular Volume" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, + "OID": "CONC.BiomedicalConcept_124", + "name": "Solicited Medical History", + "label": "Solicited Medical History", + "aliases": [ + "Medical History", + "Medical History Collection" + ], + "href": "/mdr/bc/biomedicalconcepts/C200145", + "properties": [], "coding": [ { - "code": "C25185", + "code": "C200145", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" + "codeSystemVersion": "2026-07-14", + "decode": "Solicited Medical History" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, + "OID": "CONC.BiomedicalConcept_125", + "name": "Magnesium Measurement", + "label": "Magnesium Measurement", + "aliases": [ + "Magnesium", + "MG" + ], + "href": "/mdr/bc/biomedicalconcepts/C64840", + "properties": [], "coding": [ { - "code": "C82515", + "code": "C64840", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2026-07-14", + "decode": "Magnesium Measurement" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, + "OID": "CONC.BiomedicalConcept_126", + "name": "Exposure as Collected Domain", + "label": "Exposure as Collected Domain", + "aliases": [ + "EC", + "Exposure as Collected" + ], + "href": "/mdr/bc/biomedicalconcepts/C117466", + "properties": [], "coding": [ { - "code": "C70856", + "code": "C117466", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2023-10-03", + "decode": "Exposure as Collected Domain" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, + "OID": "CONC.BiomedicalConcept_127", + "name": "Solicited Adverse Event", + "label": "Solicited Adverse Event", + "aliases": [ + "Adverse Event" + ], + "href": "/mdr/bc/biomedicalconcepts/C179175", + "properties": [], "coding": [ { - "code": "C44276", + "code": "C179175", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" + "codeSystemVersion": "2025-07-01", + "decode": "Solicited Adverse Event" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, + "OID": "CONC.BiomedicalConcept_128", + "name": "Body Height", + "label": "Body Height", + "aliases": [ + "HEIGHT" + ], + "href": "/mdr/bc/biomedicalconcepts/C164634", + "properties": [], "coding": [ { - "code": "C13717", + "code": "C164634", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" + "codeSystemVersion": "2025-11-18", + "decode": "Body Height" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, + "OID": "CONC.BiomedicalConcept_129", + "name": "Carbon Monoxide Diffusing Capability Test", + "label": "Carbon Monoxide Diffusing Capability Test", + "aliases": [ + "Diffusion Capacity of Lung for CO", + "DLCO", + "TLCO", + "Transfer Factor of Lung for CO", + "Diffusion Capacity of the Lung for Carbon Monoxide", + "PFT/DLCO", + "Pulmonary Function Test/Carbon Monoxide Diffusing Capability" + ], + "href": "/mdr/bc/biomedicalconcepts/C38083", + "properties": [], "coding": [ { - "code": "C82515", + "code": "C38083", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2026-03-31", + "decode": "Carbon Monoxide Diffusing Capability Test" } ] - }, + } + ], + "conceptProperties": [ { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_227", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, "coding": [ { - "code": "C70856", + "code": "C82977", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Dictionary-derived Term" } - ] + ], + "codeList": "CL.ad42d7e1" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_228", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, "coding": [ { - "code": "C48208", + "code": "C82571", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" + "decode": "Reported Event Term" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "VSDTC", - "label": "VSDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_229", + "name": "DSSTDTC", + "label": "DSSTDTC", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C82517", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Observation Start Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_239", + "name": "DSDECOD", + "label": "DSDECOD", + "mandatory": true, "coding": [ { - "code": "C70856", + "code": "C82977", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Dictionary-derived Term" } - ] + ], + "codeList": "CL.65a3e8d0" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, + "OID": "CONCPROP.BiomedicalConceptProperty_240", + "name": "DSTERM", + "label": "DSTERM", + "mandatory": true, "coding": [ { - "code": "C67365", + "code": "C82571", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" + "decode": "Reported Event Term" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_241", + "name": "DSSTDTC", + "label": "DSSTDTC", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C82517", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Observation Start Date Time" } - ], - "codeList": "CL.9e69169e" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_250", + "name": "RSORRES", + "label": "RSORRES", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C91106", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Clinical or Research Assessment Answer" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_251", + "name": "RSDTC", + "label": "RSDTC", "mandatory": false, "coding": [ { @@ -12954,9 +13085,9 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_252", + "name": "VSORRES", + "label": "VSORRES", "mandatory": false, "coding": [ { @@ -12968,52 +13099,66 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_253", + "name": "VSORRESU", + "label": "VSORRESU", "mandatory": false, "coding": [ { - "code": "C67365", + "code": "C49669", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" + "decode": "Unit of Pressure" + } + ], + "codeList": "CL.7cfd6cc5" + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_254", + "name": "VSPOS", + "label": "VSPOS", + "mandatory": false, + "coding": [ + { + "code": "C62164", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Body Position" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_255", + "name": "VSLOC", + "label": "VSLOC", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C13717", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Anatomic Site" } - ], - "codeList": "CL.9e69169e" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_256", + "name": "VSLAT", + "label": "VSLAT", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C25185", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Laterality" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_257", + "name": "VSDTC", + "label": "VSDTC", "mandatory": false, "coding": [ { @@ -13025,9 +13170,9 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_258", + "name": "VSORRES", + "label": "VSORRES", "mandatory": false, "coding": [ { @@ -13039,544 +13184,545 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_259", + "name": "VSORRESU", + "label": "VSORRESU", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C49669", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Unit of Pressure" } - ] + ], + "codeList": "CL.7cfd6cc5" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_260", + "name": "VSPOS", + "label": "VSPOS", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C62164", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Body Position" } - ], - "codeList": "CL.9e69169e" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_261", + "name": "VSLOC", + "label": "VSLOC", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C13717", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Anatomic Site" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_262", + "name": "VSLAT", + "label": "VSLAT", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C25185", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Laterality" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_263", + "name": "VSDTC", + "label": "VSDTC", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_264", + "name": "VSORRES", + "label": "VSORRES", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_265", + "name": "VSORRESU", + "label": "VSORRESU", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C73688", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Count per Minute" } ], - "codeList": "CL.9e69169e" + "codeList": "CL.20024ecd" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_266", + "name": "VSPOS", + "label": "VSPOS", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C62164", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Body Position" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_267", + "name": "VSLOC", + "label": "VSLOC", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C13717", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Anatomic Site" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_268", + "name": "VSLAT", + "label": "VSLAT", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C25185", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "decode": "Laterality" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_269", + "name": "VSDTC", + "label": "VSDTC", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C82515", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_270", + "name": "VSORRES", + "label": "VSORRES", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C70856", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "decode": "Observation Result" } - ], - "codeList": "CL.9e69169e" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_271", + "name": "VSORRESU", + "label": "VSORRESU", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C44276", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "decode": "Unit of Temperature" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_272", + "name": "VSLOC", + "label": "VSLOC", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C13717", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "decode": "Anatomic Site" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_273", + "name": "VSDTC", + "label": "VSDTC", + "mandatory": false, "coding": [ { - "code": "C70902", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "CMDECOD", - "label": "CMDECOD", + "OID": "CONCPROP.BiomedicalConceptProperty_274", + "name": "VSORRES", + "label": "VSORRES", "mandatory": false, "coding": [ { - "code": "C83345", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "CMCLAS", - "label": "CMCLAS", + "OID": "CONCPROP.BiomedicalConceptProperty_275", + "name": "VSORRESU", + "label": "VSORRESU", "mandatory": false, "coding": [ { - "code": "C83219", + "code": "C48208", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Weight" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "CMINDC", - "label": "CMINDC", + "OID": "CONCPROP.BiomedicalConceptProperty_276", + "name": "VSDTC", + "label": "VSDTC", "mandatory": false, "coding": [ { - "code": "C83085", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "CMDOSE", - "label": "CMDOSE", + "OID": "CONCPROP.BiomedicalConceptProperty_277", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { - "code": "C83221", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "CMDOSTXT", - "label": "CMDOSTXT", + "OID": "CONCPROP.BiomedicalConceptProperty_278", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C83221", + "code": "C67365", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "CMDOSU", - "label": "CMDOSU", + "OID": "CONCPROP.BiomedicalConceptProperty_279", + "name": "LBSPEC", + "label": "LBSPEC", "mandatory": false, "coding": [ { - "code": "C83034", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "CMDOSFRM", - "label": "CMDOSFRM", + "OID": "CONCPROP.BiomedicalConceptProperty_280", + "name": "LBFAST", + "label": "LBFAST", "mandatory": false, "coding": [ { - "code": "C83110", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", + "OID": "CONCPROP.BiomedicalConceptProperty_281", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { - "code": "C83042", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "CMROUTE", - "label": "CMROUTE", + "OID": "CONCPROP.BiomedicalConceptProperty_282", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { - "code": "C83120", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "CMSTDTC", - "label": "CMSTDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_283", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C83235", + "code": "C67365", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "CMENDTC", - "label": "CMENDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_284", + "name": "LBSPEC", + "label": "LBSPEC", "mandatory": false, "coding": [ { - "code": "C83225", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "CMSTRF", - "label": "CMSTRF", + "OID": "CONCPROP.BiomedicalConceptProperty_285", + "name": "LBFAST", + "label": "LBFAST", "mandatory": false, "coding": [ { - "code": "C82559", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "CMSTRTPT", - "label": "CMSTRTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_286", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { - "code": "C82560", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "CMSTTPT", - "label": "CMSTTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_287", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { - "code": "C82575", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "CMENRF", - "label": "CMENRF", + "OID": "CONCPROP.BiomedicalConceptProperty_288", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C82557", + "code": "C48207", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "CMENRTPT", - "label": "CMENRTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_289", + "name": "LBSPEC", + "label": "LBSPEC", "mandatory": false, "coding": [ { - "code": "C82558", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "CMENTPT", - "label": "CMENTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_290", + "name": "LBFAST", + "label": "LBFAST", "mandatory": false, "coding": [ { - "code": "C82574", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "TSPARMCD", - "label": "TSPARMCD", + "OID": "CONCPROP.BiomedicalConceptProperty_291", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { - "code": "C83445", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } - ], - "codeList": "CL.b6e07c4c" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "TSPARM", - "label": "TSPARM", + "OID": "CONCPROP.BiomedicalConceptProperty_292", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { - "code": "C49691", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } - ], - "codeList": "CL.b6e07c4c" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "TSVAL", - "label": "TSVAL", + "OID": "CONCPROP.BiomedicalConceptProperty_293", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C83447", + "code": "C48207", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "TSVALCD", - "label": "TSVALCD", + "OID": "CONCPROP.BiomedicalConceptProperty_294", + "name": "LBSPEC", + "label": "LBSPEC", "mandatory": false, "coding": [ { - "code": "C117458", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "TSVCDREF", - "label": "TSVCDREF", + "OID": "CONCPROP.BiomedicalConceptProperty_295", + "name": "LBFAST", + "label": "LBFAST", "mandatory": false, "coding": [ { - "code": "C117460", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "TSVCDVER", - "label": "TSVCDVER", + "OID": "CONCPROP.BiomedicalConceptProperty_296", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { - "code": "C117461", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_341", + "OID": "CONCPROP.BiomedicalConceptProperty_297", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -13590,22 +13736,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_342", + "OID": "CONCPROP.BiomedicalConceptProperty_298", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C42574", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" + "decode": "Unit of Concentration" } - ], - "codeList": "CL.3705a725" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_343", + "OID": "CONCPROP.BiomedicalConceptProperty_299", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -13617,10 +13762,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.af8f8a19" + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_344", + "OID": "CONCPROP.BiomedicalConceptProperty_300", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -13634,7 +13779,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_345", + "OID": "CONCPROP.BiomedicalConceptProperty_301", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -13648,279 +13793,345 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_317", + "name": "CMTRT", + "label": "CMTRT", + "mandatory": true, + "coding": [ + { + "code": "C70902", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Agent" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_318", + "name": "CMDECOD", + "label": "CMDECOD", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C83345", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_319", + "name": "CMCLAS", + "label": "CMCLAS", "mandatory": false, "coding": [ { - "code": "C42574", + "code": "C83219", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Class" } - ], - "codeList": "CL.dab673be" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_320", + "name": "CMINDC", + "label": "CMINDC", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C83085", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Indication" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_321", + "name": "CMDOSE", + "label": "CMDOSE", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C83221", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_322", + "name": "CMDOSTXT", + "label": "CMDOSTXT", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C83221", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_323", + "name": "CMDOSU", + "label": "CMDOSU", "mandatory": false, "coding": [ { - "code": "C42574", + "code": "C83034", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Unit" } - ], - "codeList": "CL.3705a725" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_324", + "name": "CMDOSFRM", + "label": "CMDOSFRM", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C83110", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Form" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_325", + "name": "CMDOSFRQ", + "label": "CMDOSFRQ", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C83042", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Dose Frequency" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_354", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_326", + "name": "CMROUTE", + "label": "CMROUTE", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C83120", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Route of Administration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_355", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_327", + "name": "CMSTDTC", + "label": "CMSTDTC", + "mandatory": false, + "coding": [ + { + "code": "C83235", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use Start Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_328", + "name": "CMENDTC", + "label": "CMENDTC", + "mandatory": false, + "coding": [ + { + "code": "C83225", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Concomitant Medication Use End Date Time" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_329", + "name": "CMSTRF", + "label": "CMSTRF", + "mandatory": false, + "coding": [ + { + "code": "C82559", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Period" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_330", + "name": "CMSTRTPT", + "label": "CMSTRTPT", + "mandatory": false, + "coding": [ + { + "code": "C82560", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_331", + "name": "CMSTTPT", + "label": "CMSTTPT", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C82575", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "codeSystemVersion": "2025-07-01", + "decode": "Reference Start Time Point" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_356", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_332", + "name": "CMENRF", + "label": "CMENRF", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C82557", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Period" } - ], - "codeList": "CL.af8f8a19" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBMETHOD", - "label": "LBMETHOD", + "OID": "CONCPROP.BiomedicalConceptProperty_333", + "name": "CMENRTPT", + "label": "CMENRTPT", "mandatory": false, "coding": [ { - "code": "C82535", + "code": "C82558", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" + "codeSystemVersion": "2025-07-01", + "decode": "End Relative to Reference Time Point" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_358", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_334", + "name": "CMENTPT", + "label": "CMENTPT", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C82574", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "codeSystemVersion": "2025-07-01", + "decode": "Reference End Time Point End" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_359", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_335", + "name": "TSPARMCD", + "label": "TSPARMCD", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C83445", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Code" } - ] + ], + "codeList": "CL.b6e07c4c" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_360", - "name": "LBORRES", - "label": "LBORRES", + "OID": "CONCPROP.BiomedicalConceptProperty_336", + "name": "TSPARM", + "label": "TSPARM", "mandatory": false, "coding": [ { - "code": "C70856", + "code": "C49691", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter" } - ] + ], + "codeList": "CL.b6e07c4c" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_361", - "name": "LBORRESU", - "label": "LBORRESU", + "OID": "CONCPROP.BiomedicalConceptProperty_337", + "name": "TSVAL", + "label": "TSVAL", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C83447", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", + "OID": "CONCPROP.BiomedicalConceptProperty_338", + "name": "TSVALCD", + "label": "TSVALCD", "mandatory": false, "coding": [ { - "code": "C70713", + "code": "C117458", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Value Code" } - ], - "codeList": "CL.9e69169e" + ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", + "OID": "CONCPROP.BiomedicalConceptProperty_339", + "name": "TSVCDREF", + "label": "TSVCDREF", "mandatory": false, "coding": [ { - "code": "C93566", + "code": "C117460", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_340", + "name": "TSVCDVER", + "label": "TSVCDVER", "mandatory": false, "coding": [ { - "code": "C82515", + "code": "C117461", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" + "codeSystemVersion": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_365", + "OID": "CONCPROP.BiomedicalConceptProperty_341", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -13934,21 +14145,22 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_366", + "OID": "CONCPROP.BiomedicalConceptProperty_342", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C42574", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Unit of Time" } - ] + ], + "codeList": "CL.3705a725" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_367", + "OID": "CONCPROP.BiomedicalConceptProperty_343", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -13960,10 +14172,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.9e69169e" + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_368", + "OID": "CONCPROP.BiomedicalConceptProperty_344", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -13977,7 +14189,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_369", + "OID": "CONCPROP.BiomedicalConceptProperty_345", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -13991,7 +14203,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_370", + "OID": "CONCPROP.BiomedicalConceptProperty_346", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14005,21 +14217,22 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_371", + "OID": "CONCPROP.BiomedicalConceptProperty_347", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C42574", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Unit of Time" } - ] + ], + "codeList": "CL.dab673be" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_372", + "OID": "CONCPROP.BiomedicalConceptProperty_348", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14031,24 +14244,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_373", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_374", + "OID": "CONCPROP.BiomedicalConceptProperty_349", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14062,7 +14261,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_375", + "OID": "CONCPROP.BiomedicalConceptProperty_350", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14076,21 +14275,22 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_376", + "OID": "CONCPROP.BiomedicalConceptProperty_351", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C42574", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Unit of Time" } - ] + ], + "codeList": "CL.3705a725" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_377", + "OID": "CONCPROP.BiomedicalConceptProperty_352", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14102,24 +14302,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_378", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_379", + "OID": "CONCPROP.BiomedicalConceptProperty_353", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14133,7 +14319,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_380", + "OID": "CONCPROP.BiomedicalConceptProperty_354", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14147,21 +14333,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_381", + "OID": "CONCPROP.BiomedicalConceptProperty_355", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C67391", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_382", + "OID": "CONCPROP.BiomedicalConceptProperty_356", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14176,7 +14362,21 @@ "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_383", + "OID": "CONCPROP.BiomedicalConceptProperty_357", + "name": "LBMETHOD", + "label": "LBMETHOD", + "mandatory": false, + "coding": [ + { + "code": "C82535", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method" + } + ] + }, + { + "OID": "CONCPROP.BiomedicalConceptProperty_358", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14190,7 +14390,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_384", + "OID": "CONCPROP.BiomedicalConceptProperty_359", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14204,7 +14404,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_385", + "OID": "CONCPROP.BiomedicalConceptProperty_360", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14218,21 +14418,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_386", + "OID": "CONCPROP.BiomedicalConceptProperty_361", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C67391", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_387", + "OID": "CONCPROP.BiomedicalConceptProperty_362", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14244,10 +14444,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.af8f8a19" + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_388", + "OID": "CONCPROP.BiomedicalConceptProperty_363", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14261,7 +14461,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_389", + "OID": "CONCPROP.BiomedicalConceptProperty_364", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14275,7 +14475,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_390", + "OID": "CONCPROP.BiomedicalConceptProperty_365", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14289,21 +14489,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_391", + "OID": "CONCPROP.BiomedicalConceptProperty_366", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C67391", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_392", + "OID": "CONCPROP.BiomedicalConceptProperty_367", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14315,10 +14515,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.af8f8a19" + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_393", + "OID": "CONCPROP.BiomedicalConceptProperty_368", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14332,7 +14532,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_394", + "OID": "CONCPROP.BiomedicalConceptProperty_369", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14346,7 +14546,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_395", + "OID": "CONCPROP.BiomedicalConceptProperty_370", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14360,21 +14560,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_396", + "OID": "CONCPROP.BiomedicalConceptProperty_371", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C64567", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_397", + "OID": "CONCPROP.BiomedicalConceptProperty_372", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14386,10 +14586,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.af8f8a19" + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_398", + "OID": "CONCPROP.BiomedicalConceptProperty_373", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14403,7 +14603,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_399", + "OID": "CONCPROP.BiomedicalConceptProperty_374", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14417,7 +14617,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_400", + "OID": "CONCPROP.BiomedicalConceptProperty_375", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14431,21 +14631,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_401", + "OID": "CONCPROP.BiomedicalConceptProperty_376", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C64567", + "code": "C48207", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_402", + "OID": "CONCPROP.BiomedicalConceptProperty_377", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14457,10 +14657,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.af8f8a19" + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_403", + "OID": "CONCPROP.BiomedicalConceptProperty_378", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14474,7 +14674,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_404", + "OID": "CONCPROP.BiomedicalConceptProperty_379", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14488,7 +14688,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_405", + "OID": "CONCPROP.BiomedicalConceptProperty_380", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14502,21 +14702,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_406", + "OID": "CONCPROP.BiomedicalConceptProperty_381", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C64567", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" + "decode": "Unit of Number Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_407", + "OID": "CONCPROP.BiomedicalConceptProperty_382", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14531,7 +14731,7 @@ "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_408", + "OID": "CONCPROP.BiomedicalConceptProperty_383", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14545,7 +14745,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_409", + "OID": "CONCPROP.BiomedicalConceptProperty_384", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14559,7 +14759,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_410", + "OID": "CONCPROP.BiomedicalConceptProperty_385", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14573,21 +14773,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_411", + "OID": "CONCPROP.BiomedicalConceptProperty_386", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C64567", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" + "decode": "Unit of Number Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_412", + "OID": "CONCPROP.BiomedicalConceptProperty_387", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14602,7 +14802,7 @@ "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_413", + "OID": "CONCPROP.BiomedicalConceptProperty_388", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14616,7 +14816,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_414", + "OID": "CONCPROP.BiomedicalConceptProperty_389", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14630,7 +14830,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_415", + "OID": "CONCPROP.BiomedicalConceptProperty_390", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14644,21 +14844,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_416", + "OID": "CONCPROP.BiomedicalConceptProperty_391", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C67391", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Unit of Number Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_417", + "OID": "CONCPROP.BiomedicalConceptProperty_392", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14673,7 +14873,7 @@ "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_418", + "OID": "CONCPROP.BiomedicalConceptProperty_393", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14687,7 +14887,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_419", + "OID": "CONCPROP.BiomedicalConceptProperty_394", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14701,7 +14901,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_420", + "OID": "CONCPROP.BiomedicalConceptProperty_395", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14715,21 +14915,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_421", + "OID": "CONCPROP.BiomedicalConceptProperty_396", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C64567", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Molarity Unit" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_422", + "OID": "CONCPROP.BiomedicalConceptProperty_397", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14741,10 +14941,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.9e69169e" + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_423", + "OID": "CONCPROP.BiomedicalConceptProperty_398", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14758,7 +14958,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_424", + "OID": "CONCPROP.BiomedicalConceptProperty_399", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14772,7 +14972,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_425", + "OID": "CONCPROP.BiomedicalConceptProperty_400", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14786,21 +14986,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_426", + "OID": "CONCPROP.BiomedicalConceptProperty_401", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C64567", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Molarity Unit" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_427", + "OID": "CONCPROP.BiomedicalConceptProperty_402", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14812,10 +15012,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.9e69169e" + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_428", + "OID": "CONCPROP.BiomedicalConceptProperty_403", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14829,7 +15029,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_429", + "OID": "CONCPROP.BiomedicalConceptProperty_404", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14843,7 +15043,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_430", + "OID": "CONCPROP.BiomedicalConceptProperty_405", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14857,21 +15057,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_431", + "OID": "CONCPROP.BiomedicalConceptProperty_406", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C67365", + "code": "C64567", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" + "decode": "Molarity Unit" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_432", + "OID": "CONCPROP.BiomedicalConceptProperty_407", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14883,10 +15083,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.9e69169e" + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_433", + "OID": "CONCPROP.BiomedicalConceptProperty_408", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14900,7 +15100,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_434", + "OID": "CONCPROP.BiomedicalConceptProperty_409", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14914,7 +15114,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_435", + "OID": "CONCPROP.BiomedicalConceptProperty_410", "name": "LBORRES", "label": "LBORRES", "mandatory": false, @@ -14928,21 +15128,21 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_436", + "OID": "CONCPROP.BiomedicalConceptProperty_411", "name": "LBORRESU", "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C48207", + "code": "C64567", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" + "decode": "Molarity Unit" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_437", + "OID": "CONCPROP.BiomedicalConceptProperty_412", "name": "LBSPEC", "label": "LBSPEC", "mandatory": false, @@ -14954,10 +15154,10 @@ "decode": "Biospecimen Type" } ], - "codeList": "CL.9e69169e" + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_438", + "OID": "CONCPROP.BiomedicalConceptProperty_413", "name": "LBFAST", "label": "LBFAST", "mandatory": false, @@ -14971,7 +15171,7 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_439", + "OID": "CONCPROP.BiomedicalConceptProperty_414", "name": "LBDTC", "label": "LBDTC", "mandatory": false, @@ -14985,450 +15185,455 @@ ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_552", - "name": "MHTERM", - "label": "MHTERM", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_415", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C83118", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_553", - "name": "MHDECOD", - "label": "MHDECOD", + "OID": "CONCPROP.BiomedicalConceptProperty_416", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C83346", + "code": "C48207", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_554", - "name": "MHSTDTC", - "label": "MHSTDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_417", + "name": "LBSPEC", + "label": "LBSPEC", "mandatory": false, "coding": [ { - "code": "C83338", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event Start Date Time" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.af8f8a19" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_555", - "name": "MHENDTC", - "label": "MHENDTC", + "OID": "CONCPROP.BiomedicalConceptProperty_418", + "name": "LBFAST", + "label": "LBFAST", "mandatory": false, "coding": [ { - "code": "C83330", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event End Date Time" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_556", - "name": "MHENRF", - "label": "MHENRF", + "OID": "CONCPROP.BiomedicalConceptProperty_419", + "name": "LBDTC", + "label": "LBDTC", "mandatory": false, "coding": [ { - "code": "C82557", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Period" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_557", - "name": "MHENRTPT", - "label": "MHENRTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_420", + "name": "LBORRES", + "label": "LBORRES", "mandatory": false, "coding": [ { - "code": "C82558", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Time Point" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_558", - "name": "MHENTPT", - "label": "MHENTPT", + "OID": "CONCPROP.BiomedicalConceptProperty_421", + "name": "LBORRESU", + "label": "LBORRESU", "mandatory": false, "coding": [ { - "code": "C82574", + "code": "C48207", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Reference End Time Point End" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_559", - "name": "Adverse Event Verbatim Description", - "label": "Adverse Event Verbatim Description", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_422", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C78541", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Verbatim Description" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_560", - "name": "Adverse Event Dictionary Derived Term", - "label": "Adverse Event Dictionary Derived Term", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_423", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C83344", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Dictionary Derived Term" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_561", - "name": "Adverse Event Category", - "label": "Adverse Event Category", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_424", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C83198", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Category" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_562", - "name": "Adverse Event Subcategory", - "label": "Adverse Event Subcategory", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_425", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C83212", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Subcategory" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_563", - "name": "Adverse Event Location", - "label": "Adverse Event Location", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_426", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C83205", + "code": "C48207", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Location" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_564", - "name": "Severity of Adverse Event", - "label": "Severity of Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_427", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C53253", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Severity of Adverse Event" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_565", - "name": "Seriousness of Adverse Event", - "label": "Seriousness of Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_428", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C53252", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Seriousness of Adverse Event" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_566", - "name": "Adverse Event Toxicity Grade", - "label": "Adverse Event Toxicity Grade", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_429", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C78605", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Toxicity Grade" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_567", - "name": "Adverse Event Action Taken with Study Treatment", - "label": "Adverse Event Action Taken with Study Treatment", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_430", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C83013", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Action Taken with Study Treatment" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_568", - "name": "Other Actions taken in Response to Adverse Event", - "label": "Other Actions taken in Response to Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_431", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C83109", + "code": "C67365", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Other Actions taken in Response to Adverse Event" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_569", - "name": "Adverse Event Attribution to Product or Procedure", - "label": "Adverse Event Attribution to Product or Procedure", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_432", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C41358", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Attribution to Product or Procedure" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_570", - "name": "Adverse Event Relationship to Non Study Treatment", - "label": "Adverse Event Relationship to Non Study Treatment", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_433", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C83210", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Relationship to Non Study Treatment" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_571", - "name": "Adverse Event Pattern", - "label": "Adverse Event Pattern", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_434", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C83208", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Pattern" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_572", - "name": "Adverse Event Outcome", - "label": "Adverse Event Outcome", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_435", + "name": "LBORRES", + "label": "LBORRES", + "mandatory": false, "coding": [ { - "code": "C49489", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Outcome" + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_573", - "name": "Adverse Event Involves Cancer", - "label": "Adverse Event Involves Cancer", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_436", + "name": "LBORRESU", + "label": "LBORRESU", + "mandatory": false, "coding": [ { - "code": "C83211", + "code": "C48207", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Involves Cancer" + "codeSystemVersion": "2026-05-26", + "decode": "Unit of Concentration" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_574", - "name": "Adverse Event Seriousness Due to Congenital Anomaly", - "label": "Adverse Event Seriousness Due to Congenital Anomaly", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_437", + "name": "LBSPEC", + "label": "LBSPEC", + "mandatory": false, "coding": [ { - "code": "C83117", + "code": "C70713", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly" + "codeSystemVersion": "2026-05-26", + "decode": "Biospecimen Type" } - ] + ], + "codeList": "CL.9e69169e" }, { - "OID": "CONCPROP.BiomedicalConceptProperty_575", - "name": "Disabling Adverse Event", - "label": "Disabling Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_438", + "name": "LBFAST", + "label": "LBFAST", + "mandatory": false, "coding": [ { - "code": "C113380", + "code": "C93566", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Disabling Adverse Event" + "codeSystemVersion": "2026-05-26", + "decode": "Fasting Status Indicator" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_576", - "name": "Death Related to Adverse Event", - "label": "Death Related to Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_439", + "name": "LBDTC", + "label": "LBDTC", + "mandatory": false, "coding": [ { - "code": "C48275", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Death Related to Adverse Event" + "codeSystemVersion": "2026-05-26", + "decode": "Collection Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_577", - "name": "Adverse Event associated with Hospitalization", - "label": "Adverse Event associated with Hospitalization", + "OID": "CONCPROP.BiomedicalConceptProperty_552", + "name": "MHTERM", + "label": "MHTERM", "mandatory": true, "coding": [ { - "code": "C83052", + "code": "C83118", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event associated with Hospitalization" + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Reported Term" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_578", - "name": "Life Threatening Adverse Event", - "label": "Life Threatening Adverse Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_553", + "name": "MHDECOD", + "label": "MHDECOD", + "mandatory": false, "coding": [ { - "code": "C84266", + "code": "C83346", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Life Threatening Adverse Event" + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Dictionary Derived Term" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_579", - "name": "Adverse Event Occurred with Overdose", - "label": "Adverse Event Occurred with Overdose", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_554", + "name": "MHSTDTC", + "label": "MHSTDTC", + "mandatory": false, "coding": [ { - "code": "C83214", + "code": "C83338", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Occurred with Overdose" + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event Start Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_580", - "name": "Adverse Event Associated with Serious Medical Event", - "label": "Adverse Event Associated with Serious Medical Event", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_555", + "name": "MHENDTC", + "label": "MHENDTC", + "mandatory": false, "coding": [ { - "code": "C83053", + "code": "C83330", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Associated with Serious Medical Event" + "codeSystemVersion": "2025-12-16", + "decode": "Medical History Event End Date Time" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_581", - "name": "Adverse Event Concomitant Treatment", - "label": "Adverse Event Concomitant Treatment", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_556", + "name": "MHENRF", + "label": "MHENRF", + "mandatory": false, "coding": [ { - "code": "C83199", + "code": "C82557", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Concomitant Treatment" + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Period" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_582", - "name": "Adverse Event Start Date Time", - "label": "Adverse Event Start Date Time", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_557", + "name": "MHENRTPT", + "label": "MHENRTPT", + "mandatory": false, "coding": [ { - "code": "C83215", + "code": "C82558", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Start Date Time" + "codeSystemVersion": "2025-12-16", + "decode": "End Relative to Reference Time Point" } ] }, { - "OID": "CONCPROP.BiomedicalConceptProperty_583", - "name": "Adverse Event End Date Time", - "label": "Adverse Event End Date Time", - "mandatory": true, + "OID": "CONCPROP.BiomedicalConceptProperty_558", + "name": "MHENTPT", + "label": "MHENTPT", + "mandatory": false, "coding": [ { - "code": "C83201", + "code": "C82574", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event End Date Time" + "codeSystemVersion": "2025-12-16", + "decode": "Reference End Time Point End" } ] }, @@ -18023,48 +18228,6 @@ } ] }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_656", - "name": "REORRES", - "label": "REORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_657", - "name": "REORRESU", - "label": "REORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48570", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_658", - "name": "REDTC", - "label": "REDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, { "OID": "CONCPROP.BiomedicalConceptProperty_659", "name": "LBORRES", diff --git a/output/json/NCT01797120-define-20260618T1514.json b/output/json/NCT01797120-define-20260618T1514.json deleted file mode 100644 index 61b2f4e..0000000 --- a/output/json/NCT01797120-define-20260618T1514.json +++ /dev/null @@ -1,11197 +0,0 @@ -{ - "OID": "MDV.None.Version1.Design1", - "name": "MDV None", - "description": "Data Definitions for None", - "fileOID": "ODM.DEFINE-JSON.None.Version1.Design1", - "creationDateTime": "2026-06-18T15:14:46.008763+00:00", - "odmVersion": "1.3.2", - "fileType": "Snapshot", - "originator": "Define-JSON Processor", - "context": "Other", - "defineVersion": "2.1.0", - "studyOID": "ODM.None.Version1.Design1", - "studyName": null, - "studyDescription": "Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", - "protocolName": null, - "itemGroups": [ - { - "OID": "IG.DS", - "name": "DS", - "description": "Disposition", - "domain": "DS", - "purpose": "Tabulation", - "structure": "One record per disposition status or protocol milestone per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "DSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.DS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSSEQ", - "mandatory": true, - "name": "DSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSTERM", - "mandatory": true, - "name": "DSTERM", - "description": "Reported Term for the Disposition Event", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_2", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSDECOD", - "mandatory": true, - "name": "DSDECOD", - "description": "Standardized Disposition Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_1", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NCOMPLT" - }, - { - "OID": "IT.DS.DSCAT", - "mandatory": false, - "name": "DSCAT", - "description": "Category for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSCAT" - }, - { - "OID": "IT.DS.DSSCAT", - "mandatory": false, - "name": "DSSCAT", - "description": "Subcategory for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSSCAT" - }, - { - "OID": "IT.DS.DSSTDTC", - "mandatory": false, - "name": "DSSTDTC", - "description": "Start Date/Time of Disposition Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_3", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSSTDY", - "mandatory": false, - "name": "DSSTDY", - "description": "Study Day of Start of Disposition Event", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_1" - }, - { - "OID": "IG.RS", - "name": "RS", - "description": "Disease Response and Clin Classification", - "domain": "RS", - "purpose": "Tabulation", - "structure": "One record per response assessment or clinical classification assessment per time point per visit per subject per assessor per medical evaluator", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "RSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.RS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSSEQ", - "mandatory": true, - "name": "RSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSLNKGRP", - "mandatory": false, - "name": "RSLNKGRP", - "description": "Link Group ID", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSTESTCD", - "mandatory": true, - "name": "RSTESTCD", - "description": "Assessment Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRTSCD" - }, - { - "OID": "IT.RS.RSTEST", - "mandatory": true, - "name": "RSTEST", - "description": "Assessment Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRTS" - }, - { - "OID": "IT.RS.RSCAT", - "mandatory": false, - "name": "RSCAT", - "description": "Category for Assessment", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRSCAT" - }, - { - "OID": "IT.RS.RSORRES", - "mandatory": false, - "name": "RSORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_15", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.RS.RSSTRESC", - "mandatory": false, - "name": "RSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.ONCRSR" - }, - { - "OID": "IT.RS.RSSTRESN", - "mandatory": false, - "name": "RSSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSEVAL", - "mandatory": false, - "name": "RSEVAL", - "description": "Evaluator", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EVAL" - }, - { - "OID": "IT.RS.RSEVALID", - "mandatory": false, - "name": "RSEVALID", - "description": "Evaluator Identifier", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Vendor" - }, - "codeList": "CL.MEDEVAL" - }, - { - "OID": "IT.RS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.RS.RSDTC", - "mandatory": false, - "name": "RSDTC", - "description": "Date/Time of Assessment", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_16", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_5" - }, - { - "OID": "IG.VS", - "name": "VS", - "description": "Vital Signs", - "domain": "VS", - "purpose": "Tabulation", - "structure": "One record per vital sign measurement per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.VS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSEQ", - "mandatory": true, - "name": "VSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSTESTCD", - "mandatory": true, - "name": "VSTESTCD", - "description": "Vital Signs Test Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTESTCD" - }, - { - "OID": "IT.VS.VSTEST", - "mandatory": true, - "name": "VSTEST", - "description": "Vital Signs Test Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTEST" - }, - { - "OID": "IT.VS.VSPOS", - "mandatory": false, - "name": "VSPOS", - "description": "Vital Signs Position of Subject", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_19", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.POSITION" - }, - { - "OID": "IT.VS.VSORRES", - "mandatory": false, - "name": "VSORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_17", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSORRESU", - "mandatory": false, - "name": "VSORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_18", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSSTRESC", - "mandatory": false, - "name": "VSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESN", - "mandatory": false, - "name": "VSSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESU", - "mandatory": false, - "name": "VSSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSLOC", - "mandatory": false, - "name": "VSLOC", - "description": "Location of Vital Signs Measurement", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_20", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.VS.VSLAT", - "mandatory": false, - "name": "VSLAT", - "description": "Laterality", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_21", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.VS.VSLOBXFL", - "mandatory": false, - "name": "VSLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.VS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSDTC", - "mandatory": false, - "name": "VSDTC", - "description": "Date/Time of Measurements", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_22", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_7" - }, - { - "OID": "IG.UR", - "name": "UR", - "description": "Urinary System Findings", - "domain": "UR", - "purpose": "Tabulation", - "structure": "One record per finding per location per per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "URSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.UR.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URSEQ", - "mandatory": true, - "name": "URSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URTESTCD", - "mandatory": true, - "name": "URTESTCD", - "description": "Short Name of Urinary Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTSCD" - }, - { - "OID": "IT.UR.URTEST", - "mandatory": true, - "name": "URTEST", - "description": "Name of Urinary Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTS" - }, - { - "OID": "IT.UR.URORRES", - "mandatory": false, - "name": "URORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URSTRESC", - "mandatory": false, - "name": "URSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URMETHOD", - "mandatory": false, - "name": "URMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.UR.URLOBXFL", - "mandatory": false, - "name": "URLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.UR.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URDTC", - "mandatory": false, - "name": "URDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_27" - }, - { - "OID": "IG.CM", - "name": "CM", - "description": "Concomitant/Prior Medications", - "domain": "CM", - "purpose": "Tabulation", - "structure": "One record per recorded intervention occurrence or constant-dosing interval per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "CMSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.CM.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSEQ", - "mandatory": true, - "name": "CMSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMTRT", - "mandatory": true, - "name": "CMTRT", - "description": "Reported Name of Drug, Med, or Therapy", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_82", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDECOD", - "mandatory": false, - "name": "CMDECOD", - "description": "Standardized Medication Name", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_83", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCAT", - "mandatory": false, - "name": "CMCAT", - "description": "Category for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSCAT", - "mandatory": false, - "name": "CMSCAT", - "description": "Subcategory for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMPRESP", - "mandatory": false, - "name": "CMPRESP", - "description": "CM Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMOCCUR", - "mandatory": false, - "name": "CMOCCUR", - "description": "CM Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMINDC", - "mandatory": false, - "name": "CMINDC", - "description": "Indication", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_85", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMCLAS", - "mandatory": false, - "name": "CMCLAS", - "description": "Medication Class", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_84", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCLASCD", - "mandatory": false, - "name": "CMCLASCD", - "description": "Medication Class Code", - "role": "Variable Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMDOSE", - "mandatory": false, - "name": "CMDOSE", - "description": "Dose per Administration", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_86", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSTXT", - "mandatory": false, - "name": "CMDOSTXT", - "description": "Dose Description", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_87", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSU", - "mandatory": false, - "name": "CMDOSU", - "description": "Dose Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_88", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.CM.CMDOSFRM", - "mandatory": false, - "name": "CMDOSFRM", - "description": "Dose Form", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_89", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FRM" - }, - { - "OID": "IT.CM.CMDOSFRQ", - "mandatory": false, - "name": "CMDOSFRQ", - "description": "Dosing Frequency per Interval", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_90", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.CM.CMROUTE", - "mandatory": false, - "name": "CMROUTE", - "description": "Route of Administration", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_91", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ROUTE" - }, - { - "OID": "IT.CM.CMSTDTC", - "mandatory": false, - "name": "CMSTDTC", - "description": "Start Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_92", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMENDTC", - "mandatory": false, - "name": "CMENDTC", - "description": "End Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_93", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMSTRF", - "mandatory": false, - "name": "CMSTRF", - "description": "Start Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_94", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENRF", - "mandatory": false, - "name": "CMENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_97", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTRTPT", - "mandatory": false, - "name": "CMSTRTPT", - "description": "Start Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_95", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTTPT", - "mandatory": false, - "name": "CMSTTPT", - "description": "Start Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_96", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMENRTPT", - "mandatory": false, - "name": "CMENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_98", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENTPT", - "mandatory": false, - "name": "CMENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_99", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_50" - }, - { - "OID": "IG.TS", - "name": "TS", - "description": "Trial Summary", - "domain": "TS", - "purpose": "Tabulation", - "structure": "One record per trial summary parameter value", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "TSPARMCD", - "TSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSSEQ", - "mandatory": true, - "name": "TSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSPARMCD", - "mandatory": true, - "name": "TSPARMCD", - "description": "Trial Summary Parameter Short Name", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_236", - "dataType": "text", - "length": null, - "codeList": "CL.TSPARMCD" - }, - { - "OID": "IT.TS.TSPARM", - "mandatory": true, - "name": "TSPARM", - "description": "Trial Summary Parameter", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_237", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TSPARM" - }, - { - "OID": "IT.TS.TSVAL", - "mandatory": false, - "name": "TSVAL", - "description": "Parameter Value", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_238", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVALCD", - "mandatory": false, - "name": "TSVALCD", - "description": "Parameter Value Code", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_239", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVCDREF", - "mandatory": false, - "name": "TSVCDREF", - "description": "Name of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_240", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DICTNAM" - }, - { - "OID": "IT.TS.TSVCDVER", - "mandatory": false, - "name": "TSVCDVER", - "description": "Version of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_241", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_51", - "slices": [ - { - "OID": "VL.TS.TSPARMCD", - "name": "VL_TS_TSPARMCD", - "type": "ValueList", - "wasDerivedFrom": "IT.TS.TSPARMCD", - "items": [ - { - "OID": "IT.TS.TSPARMCD.COMPTRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.54cd02f1" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INDIC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.9cdae039" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INTTYPE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e3ae16cd" - ] - }, - { - "OID": "IT.TS.TSPARMCD.NARMS", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.89c0d243" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJPRIM", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.7a056c75" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.36721696" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSPRI", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d8b84608" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.1d3cd461" - ] - }, - { - "OID": "IT.TS.TSPARMCD.SPONSOR", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.51236927" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TITLE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.43684533" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.1948fed3" - ] - } - ] - } - ] - }, - { - "OID": "IG.TU", - "name": "TU", - "description": "Tumor/Lesion Identification", - "domain": "TU", - "purpose": "Tabulation", - "structure": "One record per identified tumor per subject per assessor", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "TUSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.TU.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUSEQ", - "mandatory": true, - "name": "TUSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUREFID", - "mandatory": false, - "name": "TUREFID", - "description": "Reference ID", - "role": "Identifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_285", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TULNKID", - "mandatory": false, - "name": "TULNKID", - "description": "Link ID", - "role": "Identifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_286", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUTESTCD", - "mandatory": true, - "name": "TUTESTCD", - "description": "Tumor/Lesion ID Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TUTESTCD" - }, - { - "OID": "IT.TU.TUTEST", - "mandatory": true, - "name": "TUTEST", - "description": "Tumor/Lesion ID Test Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TUTEST" - }, - { - "OID": "IT.TU.TUORRES", - "mandatory": false, - "name": "TUORRES", - "description": "Tumor/Lesion ID Result", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_278", - "dataType": "text", - "length": 24, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TU.TUSTRESC", - "mandatory": false, - "name": "TUSTRESC", - "description": "Tumor/Lesion ID Result Std. Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 24, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.TUIDRS" - }, - { - "OID": "IT.TU.TULOC", - "mandatory": false, - "name": "TULOC", - "description": "Location of the Tumor/Lesion", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_279", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.TU.TULAT", - "mandatory": false, - "name": "TULAT", - "description": "Laterality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_280", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.TU.TUDIR", - "mandatory": false, - "name": "TUDIR", - "description": "Directionality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_281", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DIR" - }, - { - "OID": "IT.TU.TUMETHOD", - "mandatory": false, - "name": "TUMETHOD", - "description": "Method of Identification", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_282", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.TU.TULOBXFL", - "mandatory": false, - "name": "TULOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.TU.TUEVAL", - "mandatory": false, - "name": "TUEVAL", - "description": "Evaluator", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_283", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EVAL" - }, - { - "OID": "IT.TU.TUEVALID", - "mandatory": false, - "name": "TUEVALID", - "description": "Evaluator Identifier", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_284", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Vendor" - }, - "codeList": "CL.MEDEVAL" - }, - { - "OID": "IT.TU.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TU.TUDTC", - "mandatory": false, - "name": "TUDTC", - "description": "Date/Time of Tumor/Lesion Identification", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_287", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_74" - }, - { - "OID": "IG.TA", - "name": "TA", - "description": "Trial Arms", - "domain": "TA", - "purpose": "Tabulation", - "structure": "One record per planned Element per Arm", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ARMCD", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TA.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.ARMCD", - "mandatory": true, - "name": "ARMCD", - "description": "Planned Arm Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARMCD" - }, - { - "OID": "IT.TA.ARM", - "mandatory": true, - "name": "ARM", - "description": "Description of Planned Arm", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARM" - }, - { - "OID": "IT.TA.TAETORD", - "mandatory": true, - "name": "TAETORD", - "description": "Planned Order of Element within Arm", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TA.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TA.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TA.TABRANCH", - "mandatory": false, - "name": "TABRANCH", - "description": "Branch", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.TATRANS", - "mandatory": false, - "name": "TATRANS", - "description": "Transition Rule", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.EPOCH", - "mandatory": true, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - } - ] - }, - { - "OID": "IG.TE", - "name": "TE", - "description": "Trial Elements", - "domain": "TE", - "purpose": "Tabulation", - "structure": "One record per planned Element", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TE.ELEMENT", - "mandatory": true, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TE.TESTRL", - "mandatory": true, - "name": "TESTRL", - "description": "Rule for Start of Element", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ] - }, - { - "OID": "IG.SV", - "name": "SV", - "description": "Subject Visits", - "domain": "SV", - "purpose": "Tabulation", - "structure": "One record per actual or planned visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VISITNUM" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SV.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISITNUM", - "mandatory": true, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Topic", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISIT", - "mandatory": false, - "name": "VISIT", - "description": "Visit Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.SVPRESP", - "mandatory": false, - "name": "SVPRESP", - "description": "Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVOCCUR", - "mandatory": false, - "name": "SVOCCUR", - "description": "Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVCNTMOD", - "mandatory": false, - "name": "SVCNTMOD", - "description": "Contact Mode", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.CNTMODE" - }, - { - "OID": "IT.SV.SVSTDTC", - "mandatory": false, - "name": "SVSTDTC", - "description": "Start Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SV.SVENDTC", - "mandatory": false, - "name": "SVENDTC", - "description": "End Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - }, - { - "OID": "IG.SE", - "name": "SE", - "description": "Subject Elements", - "domain": "SE", - "purpose": "Tabulation", - "structure": "One record per actual Element per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SESTDTC" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.SESEQ", - "mandatory": true, - "name": "SESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.SE.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.SE.EPOCH", - "mandatory": false, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - }, - { - "OID": "IT.SE.SESTDTC", - "mandatory": true, - "name": "SESTDTC", - "description": "Start Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SE.SEENDTC", - "mandatory": false, - "name": "SEENDTC", - "description": "End Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - } - ], - "conditions": [ - { - "OID": "COND.TS.TSPARMCD.cd7838e7", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "COMPTRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.204aa07d", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INDIC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.fd076a8d", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INTTYPE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.770c1610", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "NARMS" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.eb0c9bb2", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJPRIM" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.5ca3cd0c", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.a724d633", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSPRI" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.b313e712", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.2e2517d1", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "SPONSOR" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.52dad99f", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TITLE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.185bd9b1", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - } - ], - "whereClauses": [ - { - "OID": "WC.TS.54cd02f1", - "conditions": [ - "COND.TS.TSPARMCD.cd7838e7" - ] - }, - { - "OID": "WC.TS.9cdae039", - "conditions": [ - "COND.TS.TSPARMCD.204aa07d" - ] - }, - { - "OID": "WC.TS.e3ae16cd", - "conditions": [ - "COND.TS.TSPARMCD.fd076a8d" - ] - }, - { - "OID": "WC.TS.89c0d243", - "conditions": [ - "COND.TS.TSPARMCD.770c1610" - ] - }, - { - "OID": "WC.TS.7a056c75", - "conditions": [ - "COND.TS.TSPARMCD.eb0c9bb2" - ] - }, - { - "OID": "WC.TS.36721696", - "conditions": [ - "COND.TS.TSPARMCD.5ca3cd0c" - ] - }, - { - "OID": "WC.TS.d8b84608", - "conditions": [ - "COND.TS.TSPARMCD.a724d633" - ] - }, - { - "OID": "WC.TS.1d3cd461", - "conditions": [ - "COND.TS.TSPARMCD.b313e712" - ] - }, - { - "OID": "WC.TS.51236927", - "conditions": [ - "COND.TS.TSPARMCD.2e2517d1" - ] - }, - { - "OID": "WC.TS.43684533", - "conditions": [ - "COND.TS.TSPARMCD.52dad99f" - ] - }, - { - "OID": "WC.TS.1948fed3", - "conditions": [ - "COND.TS.TSPARMCD.185bd9b1" - ] - } - ], - "codeLists": [ - { - "OID": "CL.ARMCD", - "name": "ARM Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Fulvestrant + Everolimus" - }, - { - "codedValue": "Fulvestrant + Placebo" - } - ] - }, - { - "OID": "CL.ARM", - "name": "ARM", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Fulvestrant + Everolimus" - }, - { - "codedValue": "Fulvestrant + Placebo" - } - ] - }, - { - "OID": "CL.ELEMENT", - "name": "Description of Element", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Screening Period" - }, - { - "codedValue": "Everolimus Treatment Period" - }, - { - "codedValue": "Placebo Treatment Period" - }, - { - "codedValue": "Follow-Up Period" - } - ] - }, - { - "OID": "CL.ETCD", - "name": "Element Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Screening Period", - "decode": "Screening Period" - }, - { - "codedValue": "Everolimus Treatment Period", - "decode": "Everolimus Treatment Period" - }, - { - "codedValue": "Placebo Treatment Period", - "decode": "Placebo Treatment Period" - }, - { - "codedValue": "Follow-Up Period", - "decode": "Follow-Up Period" - } - ] - }, - { - "OID": "CL.EPOCH", - "name": "Epoch", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99079", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "Pre-Study Phase", - "coding": { - "code": "C202487", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Induction Phase", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Continuation Phase", - "coding": { - "code": "C123452", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Follow-up Off Therapy", - "coding": { - "code": "C202578", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.a30c10b2", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "INFORMED CONSENT OBTAINED", - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED" - } - ] - } - ] - }, - { - "OID": "CL.360cba0f", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ELIGIBILITY CRITERIA MET", - "coding": [ - { - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ELIGIBILITY CRITERIA MET" - } - ] - } - ] - }, - { - "OID": "CL.5991b40f", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "mmHg", - "coding": [ - { - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg" - } - ] - } - ] - }, - { - "OID": "CL.cbd6ad98", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "beats/min", - "coding": [ - { - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min" - } - ] - } - ] - }, - { - "OID": "CL.2148028d", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SERUM OR PLASMA", - "coding": [ - { - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA" - } - ] - } - ] - }, - { - "OID": "CL.64329559", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "URINE", - "coding": [ - { - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE" - } - ] - } - ] - }, - { - "OID": "CL.89f4952d", - "name": "TSPARMCD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "RANDOM", - "coding": [ - { - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "RANDOM" - } - ] - } - ] - }, - { - "OID": "CL.37516e43", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "s", - "coding": [ - { - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s" - } - ] - } - ] - }, - { - "OID": "CL.1f6d4af1", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "BLOOD", - "coding": [ - { - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD" - } - ] - } - ] - }, - { - "OID": "CL.5ca5bb18", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "RATIO", - "coding": [ - { - "code": "C44256", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RATIO" - } - ] - } - ] - }, - { - "OID": "CL.f6f992be", - "name": "TUORRES Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "TARGET", - "coding": [ - { - "code": "C94520", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "TARGET" - } - ] - } - ] - }, - { - "OID": "CL.NCOMPLT", - "name": "Completion/Reason for Non-Completion", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66727", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSCAT", - "name": "Category of Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74558", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSSCAT", - "name": "Subcategory for Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C170443", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRTSCD", - "name": "Oncology Response Assessment Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96782", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRTS", - "name": "Oncology Response Assessment Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96781", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRSCAT", - "name": "Category of Oncology Response Assessment", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C124298", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRSR", - "name": "Oncology Response Assessment Result", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96785", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EVAL", - "name": "Evaluator", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C78735", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MEDEVAL", - "name": "Medical Evaluator Identifier", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96777", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTESTCD", - "name": "Vital Signs Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66741", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTEST", - "name": "Vital Signs Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67153", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.POSITION", - "name": "Position", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71148", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSRESU", - "name": "Units for Vital Signs Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66770", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LOC", - "name": "Anatomical Location", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74456", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LAT", - "name": "Laterality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99073", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY", - "name": "No Yes Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTESTCD", - "name": "Laboratory Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C65047", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTEST", - "name": "Laboratory Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67154", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.UNIT", - "name": "Unit", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71620", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.URNSTSCD", - "name": "Urinary System Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129942", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.URNSTS", - "name": "Urinary System Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129941", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.METHOD", - "name": "Method", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C85492", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FRM", - "name": "Dosage Form", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66726", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FREQ", - "name": "Frequency", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71113", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ROUTE", - "name": "Route of Administration Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66729", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.STENRF", - "name": "Relation to Reference Period", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66728", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TSPARMCD", - "name": "Trial Summary Parameter Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66738", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "RANDOM", - "decode": "Trial is Randomized", - "coding": { - "code": "C25196", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.TSPARM", - "name": "Trial Summary Parameter Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67152", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "Trial is Randomized", - "decode": "Trial is Randomized", - "coding": { - "code": "C25196", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.DICTNAM", - "name": "Dictionary Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66788", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUTESTCD", - "name": "Tumor or Lesion Identification Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96784", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUTEST", - "name": "Tumor or Lesion Identification Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96783", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUIDRS", - "name": "Tumor or Lesion Identification Test Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C123650", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DIR", - "name": "Directionality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99074", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.CNTMODE", - "name": "Mode of Subject Contact", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C171445", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "IN PERSON", - "decode": "In-Person", - "coding": { - "code": "C175574", - "codeSystem": "nci:ExtCodeID" - } - } - ] - } - ], - "methods": [], - "comments": [], - "standards": [ - { - "OID": "STD.SDTMIG", - "name": "SDTMIG", - "type": "IG", - "version": "3.4", - "status": "FINAL" - }, - { - "OID": "STD.SDTMCT", - "name": "CDISC/NCI", - "type": "CT", - "version": "2026-03-27", - "status": "FINAL", - "publishingSet": "SDTM" - } - ], - "annotatedCRF": [], - "concepts": [ - { - "OID": "CONC.BiomedicalConcept_1", - "name": "Informed Consent", - "label": "Informed Consent", - "aliases": [ - "Informed Consent Obtained" - ], - "href": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.a30c10b2" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_2", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_3", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_2", - "name": "Eligibility Criteria Met By Subject", - "label": "Eligibility Criteria Met By Subject", - "aliases": [ - "Eligibility Criteria Met" - ], - "href": "/mdr/bc/biomedicalconcepts/C132447", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_4", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.360cba0f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_5", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_6", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Eligibility Criteria Met By Subject" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_3", - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "aliases": [ - "MHYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C85522", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_7", - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_8", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_4", - "name": "Medical History Reported Term [RETIRED]", - "label": "Medical History Reported Term [RETIRED]", - "aliases": [ - "Medical History", - "MHTERM" - ], - "href": "/mdr/bc/biomedicalconcepts/C83118", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_9", - "name": "Medical History Dictionary Derived Term", - "label": "Medical History Dictionary Derived Term", - "mandatory": true, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_10", - "name": "Medical History Occurrence", - "label": "Medical History Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C83067", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_11", - "name": "Medical History Pre-specified", - "label": "Medical History Pre-specified", - "mandatory": true, - "coding": [ - { - "code": "C87897", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Pre-specified" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_12", - "name": "Medical History Reported Term", - "label": "Medical History Reported Term", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_13", - "name": "Medical History Category", - "label": "Medical History Category", - "mandatory": true, - "coding": [ - { - "code": "C83018", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_14", - "name": "Medical History Subcategory", - "label": "Medical History Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C83143", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Subcategory" - } - ] - } - ], - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_5", - "name": "ECOG - Performance Status", - "label": "ECOG - Performance Status", - "aliases": [ - "ECOG1-Performance Status", - "ECOG101", - "ECOG - Performance Status" - ], - "href": "/mdr/bc/biomedicalconcepts/C102408", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_15", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_16", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C102408", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG - Performance Status" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_6", - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "coding": [ - { - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_7", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "aliases": [ - "SYSBP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_17", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_18", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_19", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_20", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_21", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_22", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_8", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "aliases": [ - "DIABP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_23", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_24", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_25", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_26", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_27", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_28", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_9", - "name": "Heart Rate", - "label": "Heart Rate", - "aliases": [ - "HR" - ], - "href": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_29", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_30", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_31", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_32", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_33", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_34", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_10", - "name": "Body Temperature", - "label": "Body Temperature", - "aliases": [ - "Temperature" - ], - "href": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_35", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_36", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_37", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_38", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Body Temperature" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_11", - "name": "Body Weight", - "label": "Body Weight", - "aliases": [ - "WEIGHT" - ], - "href": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_39", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_40", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_41", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_18", - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "aliases": [ - "ALT", - "SGPT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_42", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_43", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_44", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_45", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_46", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_19", - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "aliases": [ - "AST", - "SGOT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_47", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_48", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_49", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_50", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_51", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_20", - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "aliases": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "href": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_52", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_53", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_54", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_55", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_56", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_21", - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "aliases": [ - "Creatinine" - ], - "href": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_57", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_58", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_59", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_60", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_61", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_22", - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "aliases": [ - "Albumin" - ], - "href": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_62", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_63", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_64", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_65", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_66", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_26", - "name": "pH", - "label": "pH", - "aliases": [ - "PH", - "potential of Hydrogen" - ], - "href": "/mdr/bc/biomedicalconcepts/C45997", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_67", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_68", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_69", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_70", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C45997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "pH" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_27", - "name": "Color Assessment", - "label": "Color Assessment", - "aliases": [ - "COLOR", - "Color" - ], - "href": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_71", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_72", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_73", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_28", - "name": "Specific Gravity", - "label": "Specific Gravity", - "aliases": [ - "SPGRAV" - ], - "href": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_74", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_75", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_76", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_77", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_47", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "aliases": [ - "AEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_78", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_79", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_48", - "name": "Adverse Event", - "label": "Adverse Event", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "coding": [ - { - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_49", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "aliases": [ - "CMYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_80", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_81", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_50", - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "aliases": [ - "Concomitant Medication" - ], - "href": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_82", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_83", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_84", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_85", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_86", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_87", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_88", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_89", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_90", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_91", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_92", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_93", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_94", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_95", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_96", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_97", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_98", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_99", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_51", - "name": "Randomization", - "label": "Randomization", - "aliases": [ - "randomization", - "RANDOM", - "Randomized", - "Trial is Randomized", - "randomized" - ], - "href": "/mdr/bc/biomedicalconcepts/C25196", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_236", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.89f4952d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_237", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.89f4952d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_238", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ], - "coding": [ - { - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "RANDOM" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_52", - "name": "Prothrombin Time", - "label": "Prothrombin Time", - "aliases": [ - "PT" - ], - "href": "/mdr/bc/biomedicalconcepts/C62656", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_106", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_107", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.37516e43" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_108", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_109", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ], - "codeList": "CL.360cba0f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_110", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C62656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Prothrombin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_53", - "name": "International Normalized Ratio of Prothrombin Time", - "label": "International Normalized Ratio of Prothrombin Time", - "aliases": [ - "INR", - "Prothrombin Intl. Normalized Ratio" - ], - "href": "/mdr/bc/biomedicalconcepts/C64805", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_111", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_112", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.5ca5bb18" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_113", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_114", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64805", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "International Normalized Ratio of Prothrombin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_54", - "name": "Activated Partial Thromboplastin Time", - "label": "Activated Partial Thromboplastin Time", - "aliases": [ - "APTT" - ], - "href": "/mdr/bc/biomedicalconcepts/C38462", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_115", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_116", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.37516e43" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_117", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_118", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38462", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Activated Partial Thromboplastin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_55", - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "aliases": [ - "Glucose" - ], - "href": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_56", - "name": "Triglyceride Measurement", - "label": "Triglyceride Measurement", - "aliases": [ - "TRIG", - "Triglycerides" - ], - "href": "/mdr/bc/biomedicalconcepts/C64812", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_125", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_126", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_127", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_128", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_129", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64812", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triglyceride Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_57", - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "aliases": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_58", - "name": "High Density Lipoprotein Cholesterol Measurement", - "label": "High Density Lipoprotein Cholesterol Measurement", - "aliases": [ - "HDL", - "HDL Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105587", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_135", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_136", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_137", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_138", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_139", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105587", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "High Density Lipoprotein Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_59", - "name": "Low Density Lipoprotein Cholesterol Measurement", - "label": "Low Density Lipoprotein Cholesterol Measurement", - "aliases": [ - "LDL", - "LDL Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105588", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_140", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_141", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_142", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_143", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_144", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.cbd6ad98" - } - ], - "coding": [ - { - "code": "C105588", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Low Density Lipoprotein Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_60", - "name": "ECOG Clinical Classification Question", - "label": "ECOG Clinical Classification Question", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C101874", - "properties": [], - "coding": [ - { - "code": "C101874", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG Clinical Classification Question" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_61", - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "aliases": [ - "WBC", - "White Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_145", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_146", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_147", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_148", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_149", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_62", - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "aliases": [ - "RBC", - "Red Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_150", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_151", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_152", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_153", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_154", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_63", - "name": "Platelet Count", - "label": "Platelet Count", - "aliases": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_155", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_156", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_157", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_158", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_159", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_64", - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "aliases": [ - "Potassium", - "K" - ], - "href": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_65", - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "aliases": [ - "Sodium", - "NA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_66", - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "aliases": [ - "Chloride", - "CL" - ], - "href": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_170", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_171", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_172", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_173", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_174", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_67", - "name": "Carbon Dioxide Measurement", - "label": "Carbon Dioxide Measurement", - "aliases": [ - "Carbon Dioxide", - "CO2" - ], - "href": "/mdr/bc/biomedicalconcepts/C64545", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64545", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Carbon Dioxide Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_68", - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "aliases": [ - "Calcium", - "CA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_180", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_181", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_182", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_183", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_184", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_69", - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "aliases": [ - "Urea Nitrogen" - ], - "href": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_185", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_186", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_187", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_188", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_189", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_70", - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "aliases": [ - "Protein" - ], - "href": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_71", - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "aliases": [ - "Alkaline Phosphatase" - ], - "href": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_195", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_196", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_197", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_198", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_199", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.64329559" - } - ], - "coding": [ - { - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_72", - "name": "Urate Measurement", - "label": "Urate Measurement", - "aliases": [ - "Urate", - "Uric Acid" - ], - "href": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_73", - "name": "Tumor Size Measurement", - "label": "Tumor Size Measurement", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C106303", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_205", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_206", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Observation Result" - } - ], - "codeList": "CL.37516e43" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_207", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_208", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_209", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_210", - "name": "Specimen Anatomic Site", - "label": "Specimen Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C171435", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Specimen Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_211", - "name": "Biospecimen Type", - "label": "Biospecimen Type", - "mandatory": true, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_212", - "name": "Unit of Length", - "label": "Unit of Length", - "mandatory": true, - "coding": [ - { - "code": "C42578", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Unit of Length" - } - ], - "codeList": "CL.37516e43" - } - ], - "coding": [ - { - "code": "C106303", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Tumor Size Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_74", - "name": "Tumor Identification", - "label": "Tumor Identification", - "aliases": [ - "TUMIDENT" - ], - "href": "/mdr/bc/biomedicalconcepts/C94523", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "TUORRES", - "label": "TUORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.f6f992be" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "TULOC", - "label": "TULOC", - "mandatory": false, - "coding": [ - { - "code": "C170500", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "TULAT", - "label": "TULAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "TUDIR", - "label": "TUDIR", - "mandatory": false, - "coding": [ - { - "code": "C54215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "TUMETHOD", - "label": "TUMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "TUEVAL", - "label": "TUEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "TUEVALID", - "label": "TUEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "TUREFID", - "label": "TUREFID", - "mandatory": false, - "coding": [ - { - "code": "C117442", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "TULNKID", - "label": "TULNKID", - "mandatory": false, - "coding": [ - { - "code": "C117436", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "TUDTC", - "label": "TUDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C94523", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identification" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_75", - "name": "Response in Non-Target Lesion", - "label": "Response in Non-Target Lesion", - "aliases": [ - "NTRGRESP", - "Non-Target Response" - ], - "href": "/mdr/bc/biomedicalconcepts/C94535", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_223", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_224", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_225", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_226", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C94535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Non-Target Lesion" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_76", - "name": "Response in Target Lesion", - "label": "Response in Target Lesion", - "aliases": [ - "TRGRESP", - "Target Response" - ], - "href": "/mdr/bc/biomedicalconcepts/C94534", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_230", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C94534", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Target Lesion" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_77", - "name": "Overall Response", - "label": "Overall Response", - "aliases": [ - "OVRLRESP" - ], - "href": "/mdr/bc/biomedicalconcepts/C96613", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_231", - "name": "RSLNKGRP", - "label": "RSLNKGRP", - "mandatory": false, - "coding": [ - { - "code": "C117394", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Disease Response Link Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_232", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_233", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_234", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ], - "codeList": "CL.89f4952d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_235", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.89f4952d" - } - ], - "coding": [ - { - "code": "C96613", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Overall Response" - } - ] - } - ], - "conceptProperties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.a30c10b2" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_2", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_3", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_4", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.360cba0f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_5", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_6", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_7", - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_8", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_9", - "name": "Medical History Dictionary Derived Term", - "label": "Medical History Dictionary Derived Term", - "mandatory": true, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_10", - "name": "Medical History Occurrence", - "label": "Medical History Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C83067", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_11", - "name": "Medical History Pre-specified", - "label": "Medical History Pre-specified", - "mandatory": true, - "coding": [ - { - "code": "C87897", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Pre-specified" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_12", - "name": "Medical History Reported Term", - "label": "Medical History Reported Term", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_13", - "name": "Medical History Category", - "label": "Medical History Category", - "mandatory": true, - "coding": [ - { - "code": "C83018", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_14", - "name": "Medical History Subcategory", - "label": "Medical History Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C83143", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_15", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_16", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_17", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_18", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_19", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_20", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_21", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_22", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_23", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_24", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_25", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_26", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_27", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_28", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_29", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_30", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_31", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_32", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_33", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_34", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_35", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_36", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_37", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_38", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_39", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_40", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_41", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_42", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_43", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_44", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_45", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_46", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_47", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_48", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_49", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_50", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_51", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_52", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_53", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_54", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_55", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_56", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_57", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_58", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_59", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_60", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_61", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_62", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_63", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_64", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_65", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_66", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_67", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_68", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_69", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_70", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_71", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_72", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_73", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_74", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_75", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_76", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_77", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_78", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_79", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_80", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_81", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_82", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_83", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_84", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_85", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_86", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_87", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_88", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_89", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_90", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_91", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_92", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_93", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_94", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_95", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_96", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_97", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_98", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_99", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_236", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.89f4952d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_237", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.89f4952d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_238", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_106", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_107", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.37516e43" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_108", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_109", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ], - "codeList": "CL.360cba0f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_110", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_111", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_112", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.5ca5bb18" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_113", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_114", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_115", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_116", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.37516e43" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_117", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_118", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_125", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_126", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_127", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_128", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_129", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_135", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_136", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_137", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_138", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ], - "codeList": "CL.5991b40f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_139", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_140", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_141", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_142", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_143", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_144", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.cbd6ad98" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_145", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_146", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_147", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_148", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_149", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_150", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_151", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_152", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_153", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_154", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_155", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_156", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_157", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_158", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_159", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_170", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_171", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_172", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_173", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_174", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_180", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_181", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_182", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1f6d4af1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_183", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_184", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_185", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_186", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_187", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_188", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_189", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_195", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_196", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_197", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_198", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_199", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.64329559" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.2148028d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_205", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_206", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Observation Result" - } - ], - "codeList": "CL.37516e43" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_207", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_208", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_209", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_210", - "name": "Specimen Anatomic Site", - "label": "Specimen Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C171435", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Specimen Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_211", - "name": "Biospecimen Type", - "label": "Biospecimen Type", - "mandatory": true, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_212", - "name": "Unit of Length", - "label": "Unit of Length", - "mandatory": true, - "coding": [ - { - "code": "C42578", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Unit of Length" - } - ], - "codeList": "CL.37516e43" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "TUORRES", - "label": "TUORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.f6f992be" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "TULOC", - "label": "TULOC", - "mandatory": false, - "coding": [ - { - "code": "C170500", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "TULAT", - "label": "TULAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "TUDIR", - "label": "TUDIR", - "mandatory": false, - "coding": [ - { - "code": "C54215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "TUMETHOD", - "label": "TUMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "TUEVAL", - "label": "TUEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "TUEVALID", - "label": "TUEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "TUREFID", - "label": "TUREFID", - "mandatory": false, - "coding": [ - { - "code": "C117442", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "TULNKID", - "label": "TULNKID", - "mandatory": false, - "coding": [ - { - "code": "C117436", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "TUDTC", - "label": "TUDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_223", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_224", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_225", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_226", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_230", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_231", - "name": "RSLNKGRP", - "label": "RSLNKGRP", - "mandatory": false, - "coding": [ - { - "code": "C117394", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Disease Response Link Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_232", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_233", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_234", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ], - "codeList": "CL.89f4952d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_235", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ], - "codeList": "CL.89f4952d" - } - ] -} diff --git a/output/json/NCT01797120-define-20260630T1224.json b/output/json/NCT01797120-define-20260630T1224.json deleted file mode 100644 index ace4e2a..0000000 --- a/output/json/NCT01797120-define-20260630T1224.json +++ /dev/null @@ -1,4215 +0,0 @@ -{ - "OID": "MDV.None.Version1.Design1", - "name": "MDV None", - "description": "Data Definitions for None", - "fileOID": "ODM.DEFINE-JSON.None.Version1.Design1", - "creationDateTime": "2026-06-30T12:24:30.926271+00:00", - "odmVersion": "1.3.2", - "fileType": "Snapshot", - "originator": "Define-JSON Processor", - "context": "Other", - "defineVersion": "2.1.0", - "studyOID": "ODM.None.Version1.Design1", - "studyName": null, - "studyDescription": "Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", - "protocolName": null, - "itemGroups": [ - { - "OID": "IG.DS", - "name": "DS", - "description": "Disposition", - "domain": "DS", - "purpose": "Tabulation", - "structure": "One record per disposition status or protocol milestone per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "DSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.DS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSSEQ", - "mandatory": true, - "name": "DSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSTERM", - "mandatory": true, - "name": "DSTERM", - "description": "Reported Term for the Disposition Event", - "role": "Topic", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSDECOD", - "mandatory": true, - "name": "DSDECOD", - "description": "Standardized Disposition Term", - "role": "Synonym Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NCOMPLT" - }, - { - "OID": "IT.DS.DSCAT", - "mandatory": false, - "name": "DSCAT", - "description": "Category for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSCAT" - }, - { - "OID": "IT.DS.DSSCAT", - "mandatory": false, - "name": "DSSCAT", - "description": "Subcategory for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSSCAT" - }, - { - "OID": "IT.DS.DSSTDTC", - "mandatory": false, - "name": "DSSTDTC", - "description": "Start Date/Time of Disposition Event", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSSTDY", - "mandatory": false, - "name": "DSSTDY", - "description": "Study Day of Start of Disposition Event", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_1" - }, - { - "OID": "IG.RS", - "name": "RS", - "description": "Disease Response and Clin Classification", - "domain": "RS", - "purpose": "Tabulation", - "structure": "One record per response assessment or clinical classification assessment per time point per visit per subject per assessor per medical evaluator", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "RSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.RS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSSEQ", - "mandatory": true, - "name": "RSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSLNKGRP", - "mandatory": false, - "name": "RSLNKGRP", - "description": "Link Group ID", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSTESTCD", - "mandatory": true, - "name": "RSTESTCD", - "description": "Assessment Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRTSCD" - }, - { - "OID": "IT.RS.RSTEST", - "mandatory": true, - "name": "RSTEST", - "description": "Assessment Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRTS" - }, - { - "OID": "IT.RS.RSCAT", - "mandatory": false, - "name": "RSCAT", - "description": "Category for Assessment", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRSCAT" - }, - { - "OID": "IT.RS.RSORRES", - "mandatory": false, - "name": "RSORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.RS.RSSTRESC", - "mandatory": false, - "name": "RSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.ONCRSR" - }, - { - "OID": "IT.RS.RSSTRESN", - "mandatory": false, - "name": "RSSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSEVAL", - "mandatory": false, - "name": "RSEVAL", - "description": "Evaluator", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EVAL" - }, - { - "OID": "IT.RS.RSEVALID", - "mandatory": false, - "name": "RSEVALID", - "description": "Evaluator Identifier", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Vendor" - }, - "codeList": "CL.MEDEVAL" - }, - { - "OID": "IT.RS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.RS.RSDTC", - "mandatory": false, - "name": "RSDTC", - "description": "Date/Time of Assessment", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_5" - }, - { - "OID": "IG.VS", - "name": "VS", - "description": "Vital Signs", - "domain": "VS", - "purpose": "Tabulation", - "structure": "One record per vital sign measurement per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.VS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSEQ", - "mandatory": true, - "name": "VSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSTESTCD", - "mandatory": true, - "name": "VSTESTCD", - "description": "Vital Signs Test Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTESTCD" - }, - { - "OID": "IT.VS.VSTEST", - "mandatory": true, - "name": "VSTEST", - "description": "Vital Signs Test Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTEST" - }, - { - "OID": "IT.VS.VSPOS", - "mandatory": false, - "name": "VSPOS", - "description": "Vital Signs Position of Subject", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.POSITION" - }, - { - "OID": "IT.VS.VSORRES", - "mandatory": false, - "name": "VSORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSORRESU", - "mandatory": false, - "name": "VSORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSSTRESC", - "mandatory": false, - "name": "VSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESN", - "mandatory": false, - "name": "VSSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESU", - "mandatory": false, - "name": "VSSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSLOC", - "mandatory": false, - "name": "VSLOC", - "description": "Location of Vital Signs Measurement", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.VS.VSLAT", - "mandatory": false, - "name": "VSLAT", - "description": "Laterality", - "role": "Result Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.VS.VSLOBXFL", - "mandatory": false, - "name": "VSLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.VS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSDTC", - "mandatory": false, - "name": "VSDTC", - "description": "Date/Time of Measurements", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_7" - }, - { - "OID": "IG.UR", - "name": "UR", - "description": "Urinary System Findings", - "domain": "UR", - "purpose": "Tabulation", - "structure": "One record per finding per location per per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "URSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.UR.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URSEQ", - "mandatory": true, - "name": "URSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URTESTCD", - "mandatory": true, - "name": "URTESTCD", - "description": "Short Name of Urinary Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTSCD" - }, - { - "OID": "IT.UR.URTEST", - "mandatory": true, - "name": "URTEST", - "description": "Name of Urinary Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTS" - }, - { - "OID": "IT.UR.URORRES", - "mandatory": false, - "name": "URORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URSTRESC", - "mandatory": false, - "name": "URSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URMETHOD", - "mandatory": false, - "name": "URMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.UR.URLOBXFL", - "mandatory": false, - "name": "URLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.UR.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URDTC", - "mandatory": false, - "name": "URDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_27" - }, - { - "OID": "IG.CM", - "name": "CM", - "description": "Concomitant/Prior Medications", - "domain": "CM", - "purpose": "Tabulation", - "structure": "One record per recorded intervention occurrence or constant-dosing interval per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "CMSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.CM.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSEQ", - "mandatory": true, - "name": "CMSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMTRT", - "mandatory": true, - "name": "CMTRT", - "description": "Reported Name of Drug, Med, or Therapy", - "role": "Topic", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDECOD", - "mandatory": false, - "name": "CMDECOD", - "description": "Standardized Medication Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCAT", - "mandatory": false, - "name": "CMCAT", - "description": "Category for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSCAT", - "mandatory": false, - "name": "CMSCAT", - "description": "Subcategory for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMPRESP", - "mandatory": false, - "name": "CMPRESP", - "description": "CM Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMOCCUR", - "mandatory": false, - "name": "CMOCCUR", - "description": "CM Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMINDC", - "mandatory": false, - "name": "CMINDC", - "description": "Indication", - "role": "Record Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMCLAS", - "mandatory": false, - "name": "CMCLAS", - "description": "Medication Class", - "role": "Variable Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCLASCD", - "mandatory": false, - "name": "CMCLASCD", - "description": "Medication Class Code", - "role": "Variable Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMDOSE", - "mandatory": false, - "name": "CMDOSE", - "description": "Dose per Administration", - "role": "Record Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSTXT", - "mandatory": false, - "name": "CMDOSTXT", - "description": "Dose Description", - "role": "Record Qualifier", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSU", - "mandatory": false, - "name": "CMDOSU", - "description": "Dose Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.CM.CMDOSFRM", - "mandatory": false, - "name": "CMDOSFRM", - "description": "Dose Form", - "role": "Variable Qualifier", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FRM" - }, - { - "OID": "IT.CM.CMDOSFRQ", - "mandatory": false, - "name": "CMDOSFRQ", - "description": "Dosing Frequency per Interval", - "role": "Record Qualifier", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.CM.CMROUTE", - "mandatory": false, - "name": "CMROUTE", - "description": "Route of Administration", - "role": "Variable Qualifier", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ROUTE" - }, - { - "OID": "IT.CM.CMSTDTC", - "mandatory": false, - "name": "CMSTDTC", - "description": "Start Date/Time of Medication", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMENDTC", - "mandatory": false, - "name": "CMENDTC", - "description": "End Date/Time of Medication", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMSTRF", - "mandatory": false, - "name": "CMSTRF", - "description": "Start Relative to Reference Period", - "role": "Timing", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENRF", - "mandatory": false, - "name": "CMENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTRTPT", - "mandatory": false, - "name": "CMSTRTPT", - "description": "Start Relative to Reference Time Point", - "role": "Timing", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTTPT", - "mandatory": false, - "name": "CMSTTPT", - "description": "Start Reference Time Point", - "role": "Timing", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMENRTPT", - "mandatory": false, - "name": "CMENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENTPT", - "mandatory": false, - "name": "CMENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_50" - }, - { - "OID": "IG.TS", - "name": "TS", - "description": "Trial Summary", - "domain": "TS", - "purpose": "Tabulation", - "structure": "One record per trial summary parameter value", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "TSPARMCD", - "TSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSSEQ", - "mandatory": true, - "name": "TSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSPARMCD", - "mandatory": true, - "name": "TSPARMCD", - "description": "Trial Summary Parameter Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "codeList": "CL.TSPARMCD" - }, - { - "OID": "IT.TS.TSPARM", - "mandatory": true, - "name": "TSPARM", - "description": "Trial Summary Parameter", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TSPARM" - }, - { - "OID": "IT.TS.TSVAL", - "mandatory": false, - "name": "TSVAL", - "description": "Parameter Value", - "role": "Result Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVALCD", - "mandatory": false, - "name": "TSVALCD", - "description": "Parameter Value Code", - "role": "Result Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVCDREF", - "mandatory": false, - "name": "TSVCDREF", - "description": "Name of the Reference Terminology", - "role": "Result Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DICTNAM" - }, - { - "OID": "IT.TS.TSVCDVER", - "mandatory": false, - "name": "TSVCDVER", - "description": "Version of the Reference Terminology", - "role": "Result Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_51", - "slices": [ - { - "OID": "VL.TS.TSPARMCD", - "name": "VL_TS_TSPARMCD", - "type": "ValueList", - "wasDerivedFrom": "IT.TS.TSPARMCD", - "items": [ - { - "OID": "IT.TS.TSPARMCD.COMPTRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.8c559472" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INDIC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e5769859" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INTTYPE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d3e89d3f" - ] - }, - { - "OID": "IT.TS.TSPARMCD.NARMS", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.efd2a465" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJPRIM", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.fe255586" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.62794b6c" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSPRI", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.4266ae9d" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.1d6311e2" - ] - }, - { - "OID": "IT.TS.TSPARMCD.SPONSOR", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e06f8db5" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TITLE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d94c6616" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d368cfb2" - ] - } - ] - } - ] - }, - { - "OID": "IG.TU", - "name": "TU", - "description": "Tumor/Lesion Identification", - "domain": "TU", - "purpose": "Tabulation", - "structure": "One record per identified tumor per subject per assessor", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "TUSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.TU.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUSEQ", - "mandatory": true, - "name": "TUSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUREFID", - "mandatory": false, - "name": "TUREFID", - "description": "Reference ID", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TULNKID", - "mandatory": false, - "name": "TULNKID", - "description": "Link ID", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUTESTCD", - "mandatory": true, - "name": "TUTESTCD", - "description": "Tumor/Lesion ID Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TUTESTCD" - }, - { - "OID": "IT.TU.TUTEST", - "mandatory": true, - "name": "TUTEST", - "description": "Tumor/Lesion ID Test Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TUTEST" - }, - { - "OID": "IT.TU.TUORRES", - "mandatory": false, - "name": "TUORRES", - "description": "Tumor/Lesion ID Result", - "role": "Result Qualifier", - "dataType": "text", - "length": 24, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TU.TUSTRESC", - "mandatory": false, - "name": "TUSTRESC", - "description": "Tumor/Lesion ID Result Std. Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 24, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.TUIDRS" - }, - { - "OID": "IT.TU.TULOC", - "mandatory": false, - "name": "TULOC", - "description": "Location of the Tumor/Lesion", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.TU.TULAT", - "mandatory": false, - "name": "TULAT", - "description": "Laterality", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.TU.TUDIR", - "mandatory": false, - "name": "TUDIR", - "description": "Directionality", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DIR" - }, - { - "OID": "IT.TU.TUMETHOD", - "mandatory": false, - "name": "TUMETHOD", - "description": "Method of Identification", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.TU.TULOBXFL", - "mandatory": false, - "name": "TULOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.TU.TUEVAL", - "mandatory": false, - "name": "TUEVAL", - "description": "Evaluator", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EVAL" - }, - { - "OID": "IT.TU.TUEVALID", - "mandatory": false, - "name": "TUEVALID", - "description": "Evaluator Identifier", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Vendor" - }, - "codeList": "CL.MEDEVAL" - }, - { - "OID": "IT.TU.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TU.TUDTC", - "mandatory": false, - "name": "TUDTC", - "description": "Date/Time of Tumor/Lesion Identification", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_74" - }, - { - "OID": "IG.TA", - "name": "TA", - "description": "Trial Arms", - "domain": "TA", - "purpose": "Tabulation", - "structure": "One record per planned Element per Arm", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ARMCD", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TA.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.ARMCD", - "mandatory": true, - "name": "ARMCD", - "description": "Planned Arm Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARMCD" - }, - { - "OID": "IT.TA.ARM", - "mandatory": true, - "name": "ARM", - "description": "Description of Planned Arm", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARM" - }, - { - "OID": "IT.TA.TAETORD", - "mandatory": true, - "name": "TAETORD", - "description": "Planned Order of Element within Arm", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TA.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TA.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TA.TABRANCH", - "mandatory": false, - "name": "TABRANCH", - "description": "Branch", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.TATRANS", - "mandatory": false, - "name": "TATRANS", - "description": "Transition Rule", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.EPOCH", - "mandatory": true, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - } - ] - }, - { - "OID": "IG.TE", - "name": "TE", - "description": "Trial Elements", - "domain": "TE", - "purpose": "Tabulation", - "structure": "One record per planned Element", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TE.ELEMENT", - "mandatory": true, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TE.TESTRL", - "mandatory": true, - "name": "TESTRL", - "description": "Rule for Start of Element", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ] - }, - { - "OID": "IG.SV", - "name": "SV", - "description": "Subject Visits", - "domain": "SV", - "purpose": "Tabulation", - "structure": "One record per actual or planned visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VISITNUM" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SV.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISITNUM", - "mandatory": true, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Topic", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISIT", - "mandatory": false, - "name": "VISIT", - "description": "Visit Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.SVPRESP", - "mandatory": false, - "name": "SVPRESP", - "description": "Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVOCCUR", - "mandatory": false, - "name": "SVOCCUR", - "description": "Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVCNTMOD", - "mandatory": false, - "name": "SVCNTMOD", - "description": "Contact Mode", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.CNTMODE" - }, - { - "OID": "IT.SV.SVSTDTC", - "mandatory": false, - "name": "SVSTDTC", - "description": "Start Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SV.SVENDTC", - "mandatory": false, - "name": "SVENDTC", - "description": "End Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - }, - { - "OID": "IG.SE", - "name": "SE", - "description": "Subject Elements", - "domain": "SE", - "purpose": "Tabulation", - "structure": "One record per actual Element per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SESTDTC" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.SESEQ", - "mandatory": true, - "name": "SESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.SE.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.SE.EPOCH", - "mandatory": false, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - }, - { - "OID": "IT.SE.SESTDTC", - "mandatory": true, - "name": "SESTDTC", - "description": "Start Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SE.SEENDTC", - "mandatory": false, - "name": "SEENDTC", - "description": "End Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - } - ], - "conditions": [ - { - "OID": "COND.TS.TSPARMCD.4b2c750e", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "COMPTRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.82dcbb4a", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INDIC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.de0404c1", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INTTYPE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.1d8ed13f", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "NARMS" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.cccc9db0", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJPRIM" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.863c5858", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.69b92c86", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSPRI" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.df99032e", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.5b1e67a5", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "SPONSOR" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.90f47ac3", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TITLE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.e2190e21", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - } - ], - "whereClauses": [ - { - "OID": "WC.TS.8c559472", - "conditions": [ - "COND.TS.TSPARMCD.4b2c750e" - ] - }, - { - "OID": "WC.TS.e5769859", - "conditions": [ - "COND.TS.TSPARMCD.82dcbb4a" - ] - }, - { - "OID": "WC.TS.d3e89d3f", - "conditions": [ - "COND.TS.TSPARMCD.de0404c1" - ] - }, - { - "OID": "WC.TS.efd2a465", - "conditions": [ - "COND.TS.TSPARMCD.1d8ed13f" - ] - }, - { - "OID": "WC.TS.fe255586", - "conditions": [ - "COND.TS.TSPARMCD.cccc9db0" - ] - }, - { - "OID": "WC.TS.62794b6c", - "conditions": [ - "COND.TS.TSPARMCD.863c5858" - ] - }, - { - "OID": "WC.TS.4266ae9d", - "conditions": [ - "COND.TS.TSPARMCD.69b92c86" - ] - }, - { - "OID": "WC.TS.1d6311e2", - "conditions": [ - "COND.TS.TSPARMCD.df99032e" - ] - }, - { - "OID": "WC.TS.e06f8db5", - "conditions": [ - "COND.TS.TSPARMCD.5b1e67a5" - ] - }, - { - "OID": "WC.TS.d94c6616", - "conditions": [ - "COND.TS.TSPARMCD.90f47ac3" - ] - }, - { - "OID": "WC.TS.d368cfb2", - "conditions": [ - "COND.TS.TSPARMCD.e2190e21" - ] - } - ], - "codeLists": [ - { - "OID": "CL.ARMCD", - "name": "ARM Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ARM A" - }, - { - "codedValue": "ARM B" - } - ] - }, - { - "OID": "CL.ARM", - "name": "ARM", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ARM A" - }, - { - "codedValue": "ARM B" - } - ] - }, - { - "OID": "CL.ELEMENT", - "name": "Description of Element", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Screening" - }, - { - "codedValue": "Induction: Fulvestrant + Everolimus" - }, - { - "codedValue": "Induction: Fulvestrant + Placebo" - }, - { - "codedValue": "Continuation: Fulvestrant + Everolimus" - }, - { - "codedValue": "Continuation: Fulvestrant alone" - }, - { - "codedValue": "Follow-Up Off-Therapy" - } - ] - }, - { - "OID": "CL.ETCD", - "name": "Element Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SCREENING_ELEMENT", - "decode": "Screening" - }, - { - "codedValue": "INDUCTION_EVE_FUL", - "decode": "Induction: Fulvestrant + Everolimus" - }, - { - "codedValue": "INDUCTION_PBO_FUL", - "decode": "Induction: Fulvestrant + Placebo" - }, - { - "codedValue": "CONTINUATION_EVE_FUL", - "decode": "Continuation: Fulvestrant + Everolimus" - }, - { - "codedValue": "CONTINUATION_FUL", - "decode": "Continuation: Fulvestrant alone" - }, - { - "codedValue": "FOLLOW_UP_ELEMENT", - "decode": "Follow-Up Off-Therapy" - } - ] - }, - { - "OID": "CL.EPOCH", - "name": "Epoch", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99079", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "Pre-Study Phase", - "coding": { - "code": "C202487", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Induction Phase", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Continuation Phase", - "coding": { - "code": "C123452", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Follow-up Off Therapy", - "coding": { - "code": "C202578", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.NCOMPLT", - "name": "Completion/Reason for Non-Completion", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66727", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSCAT", - "name": "Category of Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74558", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSSCAT", - "name": "Subcategory for Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C170443", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRTSCD", - "name": "Oncology Response Assessment Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96782", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRTS", - "name": "Oncology Response Assessment Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96781", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRSCAT", - "name": "Category of Oncology Response Assessment", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C124298", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRSR", - "name": "Oncology Response Assessment Result", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96785", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EVAL", - "name": "Evaluator", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C78735", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MEDEVAL", - "name": "Medical Evaluator Identifier", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96777", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTESTCD", - "name": "Vital Signs Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66741", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTEST", - "name": "Vital Signs Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67153", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.POSITION", - "name": "Position", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71148", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSRESU", - "name": "Units for Vital Signs Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66770", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LOC", - "name": "Anatomical Location", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74456", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LAT", - "name": "Laterality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99073", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY", - "name": "No Yes Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTESTCD", - "name": "Laboratory Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C65047", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTEST", - "name": "Laboratory Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67154", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.UNIT", - "name": "Unit", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71620", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.URNSTSCD", - "name": "Urinary System Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129942", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.URNSTS", - "name": "Urinary System Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129941", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.METHOD", - "name": "Method", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C85492", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FRM", - "name": "Dosage Form", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66726", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FREQ", - "name": "Frequency", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71113", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ROUTE", - "name": "Route of Administration Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66729", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.STENRF", - "name": "Relation to Reference Period", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66728", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TSPARMCD", - "name": "Trial Summary Parameter Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66738", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TSPARM", - "name": "Trial Summary Parameter Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67152", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DICTNAM", - "name": "Dictionary Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66788", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUTESTCD", - "name": "Tumor or Lesion Identification Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96784", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUTEST", - "name": "Tumor or Lesion Identification Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96783", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUIDRS", - "name": "Tumor or Lesion Identification Test Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C123650", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DIR", - "name": "Directionality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99074", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.CNTMODE", - "name": "Mode of Subject Contact", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C171445", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "IN PERSON", - "decode": "In-Person", - "coding": { - "code": "C175574", - "codeSystem": "nci:ExtCodeID" - } - } - ] - } - ], - "methods": [], - "comments": [], - "standards": [ - { - "OID": "STD.SDTMIG", - "name": "SDTMIG", - "type": "IG", - "version": "3.4", - "status": "FINAL" - }, - { - "OID": "STD.SDTMCT", - "name": "CDISC/NCI", - "type": "CT", - "version": "2026-03-27", - "status": "FINAL", - "publishingSet": "SDTM" - } - ], - "annotatedCRF": [], - "concepts": [ - { - "OID": "CONC.BiomedicalConcept_1", - "name": "Informed Consent", - "label": "Informed Consent", - "aliases": [ - "Informed Consent Obtained" - ], - "href": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [], - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_2", - "name": "Eligibility Criteria Met By Subject", - "label": "Eligibility Criteria Met By Subject", - "aliases": [ - "Eligibility Criteria Met" - ], - "href": "/mdr/bc/biomedicalconcepts/C132447", - "properties": [], - "coding": [ - { - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Eligibility Criteria Met By Subject" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_3", - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "aliases": [ - "MHYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C85522", - "properties": [], - "coding": [ - { - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_4", - "name": "Medical History Reported Term [RETIRED]", - "label": "Medical History Reported Term [RETIRED]", - "aliases": [ - "Medical History", - "MHTERM" - ], - "href": "/mdr/bc/biomedicalconcepts/C83118", - "properties": [], - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_5", - "name": "ECOG - Performance Status", - "label": "ECOG - Performance Status", - "aliases": [ - "ECOG1-Performance Status", - "ECOG101", - "ECOG - Performance Status" - ], - "href": "/mdr/bc/biomedicalconcepts/C102408", - "properties": [], - "coding": [ - { - "code": "C102408", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG - Performance Status" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_6", - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "coding": [ - { - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_7", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "aliases": [ - "SYSBP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [], - "coding": [ - { - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_8", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "aliases": [ - "DIABP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [], - "coding": [ - { - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_9", - "name": "Heart Rate", - "label": "Heart Rate", - "aliases": [ - "HR" - ], - "href": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [], - "coding": [ - { - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_10", - "name": "Body Temperature", - "label": "Body Temperature", - "aliases": [ - "Temperature" - ], - "href": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [], - "coding": [ - { - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Body Temperature" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_11", - "name": "Body Weight", - "label": "Body Weight", - "aliases": [ - "WEIGHT" - ], - "href": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [], - "coding": [ - { - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_18", - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "aliases": [ - "ALT", - "SGPT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [], - "coding": [ - { - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_19", - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "aliases": [ - "AST", - "SGOT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [], - "coding": [ - { - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_20", - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "aliases": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "href": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [], - "coding": [ - { - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_21", - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "aliases": [ - "Creatinine" - ], - "href": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [], - "coding": [ - { - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_22", - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "aliases": [ - "Albumin" - ], - "href": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [], - "coding": [ - { - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_26", - "name": "pH", - "label": "pH", - "aliases": [ - "PH", - "potential of Hydrogen" - ], - "href": "/mdr/bc/biomedicalconcepts/C45997", - "properties": [], - "coding": [ - { - "code": "C45997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "pH" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_27", - "name": "Color Assessment", - "label": "Color Assessment", - "aliases": [ - "COLOR", - "Color" - ], - "href": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [], - "coding": [ - { - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_28", - "name": "Specific Gravity", - "label": "Specific Gravity", - "aliases": [ - "SPGRAV" - ], - "href": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [], - "coding": [ - { - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_47", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "aliases": [ - "AEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [], - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_48", - "name": "Adverse Event", - "label": "Adverse Event", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "coding": [ - { - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_49", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "aliases": [ - "CMYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [], - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_50", - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "aliases": [ - "Concomitant Medication" - ], - "href": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [], - "coding": [ - { - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_51", - "name": "Randomization", - "label": "Randomization", - "aliases": [ - "randomization", - "RANDOM", - "Randomized", - "Trial is Randomized", - "randomized" - ], - "href": "/mdr/bc/biomedicalconcepts/C25196", - "properties": [], - "coding": [ - { - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Randomization" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_52", - "name": "Prothrombin Time", - "label": "Prothrombin Time", - "aliases": [ - "PT" - ], - "href": "/mdr/bc/biomedicalconcepts/C62656", - "properties": [], - "coding": [ - { - "code": "C62656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Prothrombin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_53", - "name": "International Normalized Ratio of Prothrombin Time", - "label": "International Normalized Ratio of Prothrombin Time", - "aliases": [ - "INR", - "Prothrombin Intl. Normalized Ratio" - ], - "href": "/mdr/bc/biomedicalconcepts/C64805", - "properties": [], - "coding": [ - { - "code": "C64805", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "International Normalized Ratio of Prothrombin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_54", - "name": "Activated Partial Thromboplastin Time", - "label": "Activated Partial Thromboplastin Time", - "aliases": [ - "APTT" - ], - "href": "/mdr/bc/biomedicalconcepts/C38462", - "properties": [], - "coding": [ - { - "code": "C38462", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Activated Partial Thromboplastin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_55", - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "aliases": [ - "Glucose" - ], - "href": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [], - "coding": [ - { - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_56", - "name": "Triglyceride Measurement", - "label": "Triglyceride Measurement", - "aliases": [ - "TRIG", - "Triglycerides" - ], - "href": "/mdr/bc/biomedicalconcepts/C64812", - "properties": [], - "coding": [ - { - "code": "C64812", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triglyceride Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_57", - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "aliases": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [], - "coding": [ - { - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_58", - "name": "High Density Lipoprotein Cholesterol Measurement", - "label": "High Density Lipoprotein Cholesterol Measurement", - "aliases": [ - "HDL", - "HDL Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105587", - "properties": [], - "coding": [ - { - "code": "C105587", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "High Density Lipoprotein Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_59", - "name": "Low Density Lipoprotein Cholesterol Measurement", - "label": "Low Density Lipoprotein Cholesterol Measurement", - "aliases": [ - "LDL", - "LDL Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105588", - "properties": [], - "coding": [ - { - "code": "C105588", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Low Density Lipoprotein Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_60", - "name": "ECOG Clinical Classification Question", - "label": "ECOG Clinical Classification Question", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C101874", - "properties": [], - "coding": [ - { - "code": "C101874", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG Clinical Classification Question" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_61", - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "aliases": [ - "WBC", - "White Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [], - "coding": [ - { - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_62", - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "aliases": [ - "RBC", - "Red Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [], - "coding": [ - { - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_63", - "name": "Platelet Count", - "label": "Platelet Count", - "aliases": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [], - "coding": [ - { - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_64", - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "aliases": [ - "Potassium", - "K" - ], - "href": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [], - "coding": [ - { - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_65", - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "aliases": [ - "Sodium", - "NA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [], - "coding": [ - { - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_66", - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "aliases": [ - "Chloride", - "CL" - ], - "href": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [], - "coding": [ - { - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_67", - "name": "Carbon Dioxide Measurement", - "label": "Carbon Dioxide Measurement", - "aliases": [ - "Carbon Dioxide", - "CO2" - ], - "href": "/mdr/bc/biomedicalconcepts/C64545", - "properties": [], - "coding": [ - { - "code": "C64545", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Carbon Dioxide Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_68", - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "aliases": [ - "Calcium", - "CA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [], - "coding": [ - { - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_69", - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "aliases": [ - "Urea Nitrogen" - ], - "href": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [], - "coding": [ - { - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_70", - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "aliases": [ - "Protein" - ], - "href": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [], - "coding": [ - { - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_71", - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "aliases": [ - "Alkaline Phosphatase" - ], - "href": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [], - "coding": [ - { - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_72", - "name": "Urate Measurement", - "label": "Urate Measurement", - "aliases": [ - "Urate", - "Uric Acid" - ], - "href": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [], - "coding": [ - { - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_73", - "name": "Tumor Size Measurement", - "label": "Tumor Size Measurement", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C106303", - "properties": [], - "coding": [ - { - "code": "C106303", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Tumor Size Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_74", - "name": "Tumor Identification", - "label": "Tumor Identification", - "aliases": [ - "TUMIDENT" - ], - "href": "/mdr/bc/biomedicalconcepts/C94523", - "properties": [], - "coding": [ - { - "code": "C94523", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identification" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_75", - "name": "Response in Non-Target Lesion", - "label": "Response in Non-Target Lesion", - "aliases": [ - "NTRGRESP", - "Non-Target Response" - ], - "href": "/mdr/bc/biomedicalconcepts/C94535", - "properties": [], - "coding": [ - { - "code": "C94535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Non-Target Lesion" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_76", - "name": "Response in Target Lesion", - "label": "Response in Target Lesion", - "aliases": [ - "TRGRESP", - "Target Response" - ], - "href": "/mdr/bc/biomedicalconcepts/C94534", - "properties": [], - "coding": [ - { - "code": "C94534", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Target Lesion" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_77", - "name": "Overall Response", - "label": "Overall Response", - "aliases": [ - "OVRLRESP" - ], - "href": "/mdr/bc/biomedicalconcepts/C96613", - "properties": [], - "coding": [ - { - "code": "C96613", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Overall Response" - } - ] - } - ], - "conceptProperties": [] -} diff --git a/output/json/NCT01797120-define-20260716T1138.json b/output/json/NCT01797120-define-20260716T1138.json deleted file mode 100644 index 9d6955f..0000000 --- a/output/json/NCT01797120-define-20260716T1138.json +++ /dev/null @@ -1,11183 +0,0 @@ -{ - "OID": "MDV.None.Version1.Design1", - "name": "MDV None", - "description": "Data Definitions for None", - "fileOID": "ODM.DEFINE-JSON.None.Version1.Design1", - "creationDateTime": "2026-07-16T11:38:41.433296+00:00", - "odmVersion": "1.3.2", - "fileType": "Snapshot", - "originator": "Define-JSON Processor", - "context": "Other", - "defineVersion": "2.1.0", - "studyOID": "ODM.None.Version1.Design1", - "studyName": null, - "studyDescription": "Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", - "protocolName": null, - "itemGroups": [ - { - "OID": "IG.DS", - "name": "DS", - "description": "Disposition", - "domain": "DS", - "purpose": "Tabulation", - "structure": "One record per disposition status or protocol milestone per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "DSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.DS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSSEQ", - "mandatory": true, - "name": "DSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSTERM", - "mandatory": true, - "name": "DSTERM", - "description": "Reported Term for the Disposition Event", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_228", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSDECOD", - "mandatory": true, - "name": "DSDECOD", - "description": "Standardized Disposition Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_227", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NCOMPLT" - }, - { - "OID": "IT.DS.DSCAT", - "mandatory": false, - "name": "DSCAT", - "description": "Category for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSCAT" - }, - { - "OID": "IT.DS.DSSCAT", - "mandatory": false, - "name": "DSSCAT", - "description": "Subcategory for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSSCAT" - }, - { - "OID": "IT.DS.DSSTDTC", - "mandatory": false, - "name": "DSSTDTC", - "description": "Start Date/Time of Disposition Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_229", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSSTDY", - "mandatory": false, - "name": "DSSTDY", - "description": "Study Day of Start of Disposition Event", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_1" - }, - { - "OID": "IG.RS", - "name": "RS", - "description": "Disease Response and Clin Classification", - "domain": "RS", - "purpose": "Tabulation", - "structure": "One record per response assessment or clinical classification assessment per time point per visit per subject per assessor per medical evaluator", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "RSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.RS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSSEQ", - "mandatory": true, - "name": "RSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSLNKGRP", - "mandatory": false, - "name": "RSLNKGRP", - "description": "Link Group ID", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSTESTCD", - "mandatory": true, - "name": "RSTESTCD", - "description": "Assessment Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRTSCD" - }, - { - "OID": "IT.RS.RSTEST", - "mandatory": true, - "name": "RSTEST", - "description": "Assessment Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRTS" - }, - { - "OID": "IT.RS.RSCAT", - "mandatory": false, - "name": "RSCAT", - "description": "Category for Assessment", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRSCAT" - }, - { - "OID": "IT.RS.RSORRES", - "mandatory": false, - "name": "RSORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_250", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.RS.RSSTRESC", - "mandatory": false, - "name": "RSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.ONCRSR" - }, - { - "OID": "IT.RS.RSSTRESN", - "mandatory": false, - "name": "RSSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSEVAL", - "mandatory": false, - "name": "RSEVAL", - "description": "Evaluator", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EVAL" - }, - { - "OID": "IT.RS.RSEVALID", - "mandatory": false, - "name": "RSEVALID", - "description": "Evaluator Identifier", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Vendor" - }, - "codeList": "CL.MEDEVAL" - }, - { - "OID": "IT.RS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.RS.RSDTC", - "mandatory": false, - "name": "RSDTC", - "description": "Date/Time of Assessment", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_251", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_5" - }, - { - "OID": "IG.VS", - "name": "VS", - "description": "Vital Signs", - "domain": "VS", - "purpose": "Tabulation", - "structure": "One record per vital sign measurement per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.VS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSEQ", - "mandatory": true, - "name": "VSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSTESTCD", - "mandatory": true, - "name": "VSTESTCD", - "description": "Vital Signs Test Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTESTCD" - }, - { - "OID": "IT.VS.VSTEST", - "mandatory": true, - "name": "VSTEST", - "description": "Vital Signs Test Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTEST" - }, - { - "OID": "IT.VS.VSPOS", - "mandatory": false, - "name": "VSPOS", - "description": "Vital Signs Position of Subject", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_254", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.POSITION" - }, - { - "OID": "IT.VS.VSORRES", - "mandatory": false, - "name": "VSORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_252", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSORRESU", - "mandatory": false, - "name": "VSORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_253", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSSTRESC", - "mandatory": false, - "name": "VSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESN", - "mandatory": false, - "name": "VSSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESU", - "mandatory": false, - "name": "VSSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSLOC", - "mandatory": false, - "name": "VSLOC", - "description": "Location of Vital Signs Measurement", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_255", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.VS.VSLAT", - "mandatory": false, - "name": "VSLAT", - "description": "Laterality", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_256", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.VS.VSLOBXFL", - "mandatory": false, - "name": "VSLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.VS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSDTC", - "mandatory": false, - "name": "VSDTC", - "description": "Date/Time of Measurements", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_257", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_7" - }, - { - "OID": "IG.UR", - "name": "UR", - "description": "Urinary System Findings", - "domain": "UR", - "purpose": "Tabulation", - "structure": "One record per finding per location per per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "URSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.UR.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URSEQ", - "mandatory": true, - "name": "URSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URTESTCD", - "mandatory": true, - "name": "URTESTCD", - "description": "Short Name of Urinary Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTSCD" - }, - { - "OID": "IT.UR.URTEST", - "mandatory": true, - "name": "URTEST", - "description": "Name of Urinary Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTS" - }, - { - "OID": "IT.UR.URORRES", - "mandatory": false, - "name": "URORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URSTRESC", - "mandatory": false, - "name": "URSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URMETHOD", - "mandatory": false, - "name": "URMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.UR.URLOBXFL", - "mandatory": false, - "name": "URLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.UR.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URDTC", - "mandatory": false, - "name": "URDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_27" - }, - { - "OID": "IG.CM", - "name": "CM", - "description": "Concomitant/Prior Medications", - "domain": "CM", - "purpose": "Tabulation", - "structure": "One record per recorded intervention occurrence or constant-dosing interval per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "CMSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.CM.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSEQ", - "mandatory": true, - "name": "CMSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMTRT", - "mandatory": true, - "name": "CMTRT", - "description": "Reported Name of Drug, Med, or Therapy", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_317", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDECOD", - "mandatory": false, - "name": "CMDECOD", - "description": "Standardized Medication Name", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_318", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCAT", - "mandatory": false, - "name": "CMCAT", - "description": "Category for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSCAT", - "mandatory": false, - "name": "CMSCAT", - "description": "Subcategory for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMPRESP", - "mandatory": false, - "name": "CMPRESP", - "description": "CM Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMOCCUR", - "mandatory": false, - "name": "CMOCCUR", - "description": "CM Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMINDC", - "mandatory": false, - "name": "CMINDC", - "description": "Indication", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_320", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMCLAS", - "mandatory": false, - "name": "CMCLAS", - "description": "Medication Class", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_319", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCLASCD", - "mandatory": false, - "name": "CMCLASCD", - "description": "Medication Class Code", - "role": "Variable Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMDOSE", - "mandatory": false, - "name": "CMDOSE", - "description": "Dose per Administration", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_321", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSTXT", - "mandatory": false, - "name": "CMDOSTXT", - "description": "Dose Description", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_322", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSU", - "mandatory": false, - "name": "CMDOSU", - "description": "Dose Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_323", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.CM.CMDOSFRM", - "mandatory": false, - "name": "CMDOSFRM", - "description": "Dose Form", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_324", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FRM" - }, - { - "OID": "IT.CM.CMDOSFRQ", - "mandatory": false, - "name": "CMDOSFRQ", - "description": "Dosing Frequency per Interval", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_325", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.CM.CMROUTE", - "mandatory": false, - "name": "CMROUTE", - "description": "Route of Administration", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_326", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ROUTE" - }, - { - "OID": "IT.CM.CMSTDTC", - "mandatory": false, - "name": "CMSTDTC", - "description": "Start Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_327", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMENDTC", - "mandatory": false, - "name": "CMENDTC", - "description": "End Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_328", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMSTRF", - "mandatory": false, - "name": "CMSTRF", - "description": "Start Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_329", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENRF", - "mandatory": false, - "name": "CMENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_332", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTRTPT", - "mandatory": false, - "name": "CMSTRTPT", - "description": "Start Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_330", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTTPT", - "mandatory": false, - "name": "CMSTTPT", - "description": "Start Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_331", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMENRTPT", - "mandatory": false, - "name": "CMENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_333", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENTPT", - "mandatory": false, - "name": "CMENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_334", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_50" - }, - { - "OID": "IG.TS", - "name": "TS", - "description": "Trial Summary", - "domain": "TS", - "purpose": "Tabulation", - "structure": "One record per trial summary parameter value", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "TSPARMCD", - "TSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSSEQ", - "mandatory": true, - "name": "TSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSPARMCD", - "mandatory": true, - "name": "TSPARMCD", - "description": "Trial Summary Parameter Short Name", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_335", - "dataType": "text", - "length": null, - "codeList": "CL.TSPARMCD" - }, - { - "OID": "IT.TS.TSPARM", - "mandatory": true, - "name": "TSPARM", - "description": "Trial Summary Parameter", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_336", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TSPARM" - }, - { - "OID": "IT.TS.TSVAL", - "mandatory": false, - "name": "TSVAL", - "description": "Parameter Value", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_337", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVALCD", - "mandatory": false, - "name": "TSVALCD", - "description": "Parameter Value Code", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_338", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVCDREF", - "mandatory": false, - "name": "TSVCDREF", - "description": "Name of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_339", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DICTNAM" - }, - { - "OID": "IT.TS.TSVCDVER", - "mandatory": false, - "name": "TSVCDVER", - "description": "Version of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_340", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_51", - "slices": [ - { - "OID": "VL.TS.TSPARMCD", - "name": "VL_TS_TSPARMCD", - "type": "ValueList", - "wasDerivedFrom": "IT.TS.TSPARMCD", - "items": [ - { - "OID": "IT.TS.TSPARMCD.COMPTRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.8c559472" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INDIC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e5769859" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INTTYPE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d3e89d3f" - ] - }, - { - "OID": "IT.TS.TSPARMCD.NARMS", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.efd2a465" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJPRIM", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.fe255586" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.62794b6c" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSPRI", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.4266ae9d" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.1d6311e2" - ] - }, - { - "OID": "IT.TS.TSPARMCD.SPONSOR", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e06f8db5" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TITLE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d94c6616" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d368cfb2" - ] - } - ] - } - ] - }, - { - "OID": "IG.TU", - "name": "TU", - "description": "Tumor/Lesion Identification", - "domain": "TU", - "purpose": "Tabulation", - "structure": "One record per identified tumor per subject per assessor", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "TUSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.TU.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUSEQ", - "mandatory": true, - "name": "TUSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUREFID", - "mandatory": false, - "name": "TUREFID", - "description": "Reference ID", - "role": "Identifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_455", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TULNKID", - "mandatory": false, - "name": "TULNKID", - "description": "Link ID", - "role": "Identifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_456", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUTESTCD", - "mandatory": true, - "name": "TUTESTCD", - "description": "Tumor/Lesion ID Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TUTESTCD" - }, - { - "OID": "IT.TU.TUTEST", - "mandatory": true, - "name": "TUTEST", - "description": "Tumor/Lesion ID Test Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TUTEST" - }, - { - "OID": "IT.TU.TUORRES", - "mandatory": false, - "name": "TUORRES", - "description": "Tumor/Lesion ID Result", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_448", - "dataType": "text", - "length": 24, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TU.TUSTRESC", - "mandatory": false, - "name": "TUSTRESC", - "description": "Tumor/Lesion ID Result Std. Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 24, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.TUIDRS" - }, - { - "OID": "IT.TU.TULOC", - "mandatory": false, - "name": "TULOC", - "description": "Location of the Tumor/Lesion", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_449", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.TU.TULAT", - "mandatory": false, - "name": "TULAT", - "description": "Laterality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_450", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.TU.TUDIR", - "mandatory": false, - "name": "TUDIR", - "description": "Directionality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_451", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DIR" - }, - { - "OID": "IT.TU.TUMETHOD", - "mandatory": false, - "name": "TUMETHOD", - "description": "Method of Identification", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_452", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.TU.TULOBXFL", - "mandatory": false, - "name": "TULOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.TU.TUEVAL", - "mandatory": false, - "name": "TUEVAL", - "description": "Evaluator", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_453", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EVAL" - }, - { - "OID": "IT.TU.TUEVALID", - "mandatory": false, - "name": "TUEVALID", - "description": "Evaluator Identifier", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_454", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Vendor" - }, - "codeList": "CL.MEDEVAL" - }, - { - "OID": "IT.TU.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TU.TUDTC", - "mandatory": false, - "name": "TUDTC", - "description": "Date/Time of Tumor/Lesion Identification", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_457", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_74" - }, - { - "OID": "IG.TA", - "name": "TA", - "description": "Trial Arms", - "domain": "TA", - "purpose": "Tabulation", - "structure": "One record per planned Element per Arm", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ARMCD", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TA.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.ARMCD", - "mandatory": true, - "name": "ARMCD", - "description": "Planned Arm Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARMCD" - }, - { - "OID": "IT.TA.ARM", - "mandatory": true, - "name": "ARM", - "description": "Description of Planned Arm", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARM" - }, - { - "OID": "IT.TA.TAETORD", - "mandatory": true, - "name": "TAETORD", - "description": "Planned Order of Element within Arm", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TA.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TA.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TA.TABRANCH", - "mandatory": false, - "name": "TABRANCH", - "description": "Branch", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.TATRANS", - "mandatory": false, - "name": "TATRANS", - "description": "Transition Rule", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.EPOCH", - "mandatory": true, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - } - ] - }, - { - "OID": "IG.TE", - "name": "TE", - "description": "Trial Elements", - "domain": "TE", - "purpose": "Tabulation", - "structure": "One record per planned Element", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TE.ELEMENT", - "mandatory": true, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TE.TESTRL", - "mandatory": true, - "name": "TESTRL", - "description": "Rule for Start of Element", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ] - }, - { - "OID": "IG.SV", - "name": "SV", - "description": "Subject Visits", - "domain": "SV", - "purpose": "Tabulation", - "structure": "One record per actual or planned visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VISITNUM" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SV.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISITNUM", - "mandatory": true, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Topic", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISIT", - "mandatory": false, - "name": "VISIT", - "description": "Visit Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.SVPRESP", - "mandatory": false, - "name": "SVPRESP", - "description": "Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVOCCUR", - "mandatory": false, - "name": "SVOCCUR", - "description": "Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVCNTMOD", - "mandatory": false, - "name": "SVCNTMOD", - "description": "Contact Mode", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.CNTMODE" - }, - { - "OID": "IT.SV.SVSTDTC", - "mandatory": false, - "name": "SVSTDTC", - "description": "Start Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SV.SVENDTC", - "mandatory": false, - "name": "SVENDTC", - "description": "End Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - }, - { - "OID": "IG.SE", - "name": "SE", - "description": "Subject Elements", - "domain": "SE", - "purpose": "Tabulation", - "structure": "One record per actual Element per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SESTDTC" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.SESEQ", - "mandatory": true, - "name": "SESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.SE.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.SE.EPOCH", - "mandatory": false, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - }, - { - "OID": "IT.SE.SESTDTC", - "mandatory": true, - "name": "SESTDTC", - "description": "Start Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SE.SEENDTC", - "mandatory": false, - "name": "SEENDTC", - "description": "End Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - } - ], - "conditions": [ - { - "OID": "COND.TS.TSPARMCD.4b2c750e", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "COMPTRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.82dcbb4a", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INDIC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.de0404c1", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INTTYPE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.1d8ed13f", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "NARMS" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.cccc9db0", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJPRIM" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.863c5858", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.69b92c86", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSPRI" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.df99032e", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.5b1e67a5", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "SPONSOR" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.90f47ac3", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TITLE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.e2190e21", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - } - ], - "whereClauses": [ - { - "OID": "WC.TS.8c559472", - "conditions": [ - "COND.TS.TSPARMCD.4b2c750e" - ] - }, - { - "OID": "WC.TS.e5769859", - "conditions": [ - "COND.TS.TSPARMCD.82dcbb4a" - ] - }, - { - "OID": "WC.TS.d3e89d3f", - "conditions": [ - "COND.TS.TSPARMCD.de0404c1" - ] - }, - { - "OID": "WC.TS.efd2a465", - "conditions": [ - "COND.TS.TSPARMCD.1d8ed13f" - ] - }, - { - "OID": "WC.TS.fe255586", - "conditions": [ - "COND.TS.TSPARMCD.cccc9db0" - ] - }, - { - "OID": "WC.TS.62794b6c", - "conditions": [ - "COND.TS.TSPARMCD.863c5858" - ] - }, - { - "OID": "WC.TS.4266ae9d", - "conditions": [ - "COND.TS.TSPARMCD.69b92c86" - ] - }, - { - "OID": "WC.TS.1d6311e2", - "conditions": [ - "COND.TS.TSPARMCD.df99032e" - ] - }, - { - "OID": "WC.TS.e06f8db5", - "conditions": [ - "COND.TS.TSPARMCD.5b1e67a5" - ] - }, - { - "OID": "WC.TS.d94c6616", - "conditions": [ - "COND.TS.TSPARMCD.90f47ac3" - ] - }, - { - "OID": "WC.TS.d368cfb2", - "conditions": [ - "COND.TS.TSPARMCD.e2190e21" - ] - } - ], - "codeLists": [ - { - "OID": "CL.ARMCD", - "name": "ARM Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ARM A" - }, - { - "codedValue": "ARM B" - } - ] - }, - { - "OID": "CL.ARM", - "name": "ARM", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ARM A" - }, - { - "codedValue": "ARM B" - } - ] - }, - { - "OID": "CL.ELEMENT", - "name": "Description of Element", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Screening" - }, - { - "codedValue": "Induction: Fulvestrant + Everolimus" - }, - { - "codedValue": "Induction: Fulvestrant + Placebo" - }, - { - "codedValue": "Continuation: Fulvestrant + Everolimus" - }, - { - "codedValue": "Continuation: Fulvestrant alone" - }, - { - "codedValue": "Follow-Up Off-Therapy" - } - ] - }, - { - "OID": "CL.ETCD", - "name": "Element Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SCREENING_ELEMENT", - "decode": "Screening" - }, - { - "codedValue": "INDUCTION_EVE_FUL", - "decode": "Induction: Fulvestrant + Everolimus" - }, - { - "codedValue": "INDUCTION_PBO_FUL", - "decode": "Induction: Fulvestrant + Placebo" - }, - { - "codedValue": "CONTINUATION_EVE_FUL", - "decode": "Continuation: Fulvestrant + Everolimus" - }, - { - "codedValue": "CONTINUATION_FUL", - "decode": "Continuation: Fulvestrant alone" - }, - { - "codedValue": "FOLLOW_UP_ELEMENT", - "decode": "Follow-Up Off-Therapy" - } - ] - }, - { - "OID": "CL.EPOCH", - "name": "Epoch", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99079", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "Pre-Study Phase", - "coding": { - "code": "C202487", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Induction Phase", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Continuation Phase", - "coding": { - "code": "C123452", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Follow-up Off Therapy", - "coding": { - "code": "C202578", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.ad42d7e1", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "INFORMED CONSENT OBTAINED", - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED" - } - ] - } - ] - }, - { - "OID": "CL.65a3e8d0", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ELIGIBILITY CRITERIA MET", - "coding": [ - { - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ELIGIBILITY CRITERIA MET" - } - ] - } - ] - }, - { - "OID": "CL.7cfd6cc5", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "mmHg", - "coding": [ - { - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg" - } - ] - } - ] - }, - { - "OID": "CL.20024ecd", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "beats/min", - "coding": [ - { - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min" - } - ] - } - ] - }, - { - "OID": "CL.9e69169e", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SERUM OR PLASMA", - "coding": [ - { - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA" - } - ] - } - ] - }, - { - "OID": "CL.5183f82c", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "URINE", - "coding": [ - { - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE" - } - ] - } - ] - }, - { - "OID": "CL.b6e07c4c", - "name": "TSPARMCD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "RANDOM", - "coding": [ - { - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "RANDOM" - } - ] - } - ] - }, - { - "OID": "CL.3705a725", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "s", - "coding": [ - { - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s" - } - ] - } - ] - }, - { - "OID": "CL.af8f8a19", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "BLOOD", - "coding": [ - { - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD" - } - ] - } - ] - }, - { - "OID": "CL.dab673be", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "RATIO", - "coding": [ - { - "code": "C44256", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RATIO" - } - ] - } - ] - }, - { - "OID": "CL.0fe19c26", - "name": "TUORRES Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "TARGET", - "coding": [ - { - "code": "C94520", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "TARGET" - } - ] - } - ] - }, - { - "OID": "CL.NCOMPLT", - "name": "Completion/Reason for Non-Completion", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66727", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSCAT", - "name": "Category of Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74558", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSSCAT", - "name": "Subcategory for Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C170443", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRTSCD", - "name": "Oncology Response Assessment Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96782", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRTS", - "name": "Oncology Response Assessment Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96781", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRSCAT", - "name": "Category of Oncology Response Assessment", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C124298", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRSR", - "name": "Oncology Response Assessment Result", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96785", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EVAL", - "name": "Evaluator", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C78735", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MEDEVAL", - "name": "Medical Evaluator Identifier", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96777", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTESTCD", - "name": "Vital Signs Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66741", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTEST", - "name": "Vital Signs Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67153", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.POSITION", - "name": "Position", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71148", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSRESU", - "name": "Units for Vital Signs Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66770", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LOC", - "name": "Anatomical Location", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74456", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LAT", - "name": "Laterality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99073", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY", - "name": "No Yes Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTESTCD", - "name": "Laboratory Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C65047", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTEST", - "name": "Laboratory Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67154", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.UNIT", - "name": "Unit", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71620", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.URNSTSCD", - "name": "Urinary System Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129942", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.URNSTS", - "name": "Urinary System Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129941", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.METHOD", - "name": "Method", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C85492", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FRM", - "name": "Dosage Form", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66726", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FREQ", - "name": "Frequency", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71113", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ROUTE", - "name": "Route of Administration Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66729", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.STENRF", - "name": "Relation to Reference Period", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66728", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TSPARMCD", - "name": "Trial Summary Parameter Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66738", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "RANDOM", - "decode": "Trial is Randomized", - "coding": { - "code": "C25196", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.TSPARM", - "name": "Trial Summary Parameter Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67152", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "Trial is Randomized", - "decode": "Trial is Randomized", - "coding": { - "code": "C25196", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.DICTNAM", - "name": "Dictionary Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66788", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUTESTCD", - "name": "Tumor or Lesion Identification Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96784", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUTEST", - "name": "Tumor or Lesion Identification Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96783", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUIDRS", - "name": "Tumor or Lesion Identification Test Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C123650", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DIR", - "name": "Directionality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99074", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.CNTMODE", - "name": "Mode of Subject Contact", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C171445", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "IN PERSON", - "decode": "In-Person", - "coding": { - "code": "C175574", - "codeSystem": "nci:ExtCodeID" - } - } - ] - } - ], - "methods": [], - "comments": [], - "standards": [ - { - "OID": "STD.SDTMIG", - "name": "SDTMIG", - "type": "IG", - "version": "3.4", - "status": "FINAL" - }, - { - "OID": "STD.SDTMCT", - "name": "CDISC/NCI", - "type": "CT", - "version": "2026-03-27", - "status": "FINAL", - "publishingSet": "SDTM" - } - ], - "annotatedCRF": [], - "concepts": [ - { - "OID": "CONC.BiomedicalConcept_1", - "name": "Informed Consent", - "label": "Informed Consent", - "aliases": [ - "Informed Consent Obtained" - ], - "href": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_2", - "name": "Eligibility Criteria Met By Subject", - "label": "Eligibility Criteria Met By Subject", - "aliases": [ - "Eligibility Criteria Met" - ], - "href": "/mdr/bc/biomedicalconcepts/C132447", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.65a3e8d0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Eligibility Criteria Met By Subject" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_3", - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "aliases": [ - "MHYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C85522", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_4", - "name": "Medical History Reported Term [RETIRED]", - "label": "Medical History Reported Term [RETIRED]", - "aliases": [ - "Medical History", - "MHTERM" - ], - "href": "/mdr/bc/biomedicalconcepts/C83118", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "Medical History Dictionary Derived Term", - "label": "Medical History Dictionary Derived Term", - "mandatory": true, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "Medical History Occurrence", - "label": "Medical History Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C83067", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "Medical History Pre-specified", - "label": "Medical History Pre-specified", - "mandatory": true, - "coding": [ - { - "code": "C87897", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Pre-specified" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "Medical History Reported Term", - "label": "Medical History Reported Term", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "Medical History Category", - "label": "Medical History Category", - "mandatory": true, - "coding": [ - { - "code": "C83018", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "Medical History Subcategory", - "label": "Medical History Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C83143", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Subcategory" - } - ] - } - ], - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_5", - "name": "ECOG - Performance Status", - "label": "ECOG - Performance Status", - "aliases": [ - "ECOG1-Performance Status", - "ECOG101", - "ECOG - Performance Status" - ], - "href": "/mdr/bc/biomedicalconcepts/C102408", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C102408", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG - Performance Status" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_6", - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "coding": [ - { - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_7", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "aliases": [ - "SYSBP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_8", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "aliases": [ - "DIABP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_9", - "name": "Heart Rate", - "label": "Heart Rate", - "aliases": [ - "HR" - ], - "href": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_10", - "name": "Body Temperature", - "label": "Body Temperature", - "aliases": [ - "Temperature" - ], - "href": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Body Temperature" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_11", - "name": "Body Weight", - "label": "Body Weight", - "aliases": [ - "WEIGHT" - ], - "href": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_18", - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "aliases": [ - "ALT", - "SGPT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_19", - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "aliases": [ - "AST", - "SGOT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_20", - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "aliases": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "href": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_21", - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "aliases": [ - "Creatinine" - ], - "href": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_22", - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "aliases": [ - "Albumin" - ], - "href": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_26", - "name": "pH", - "label": "pH", - "aliases": [ - "PH", - "potential of Hydrogen" - ], - "href": "/mdr/bc/biomedicalconcepts/C45997", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_302", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_303", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_304", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_305", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C45997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "pH" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_27", - "name": "Color Assessment", - "label": "Color Assessment", - "aliases": [ - "COLOR", - "Color" - ], - "href": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_306", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_307", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_308", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_28", - "name": "Specific Gravity", - "label": "Specific Gravity", - "aliases": [ - "SPGRAV" - ], - "href": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_309", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_310", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_311", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_312", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_47", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "aliases": [ - "AEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_313", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_314", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_48", - "name": "Adverse Event", - "label": "Adverse Event", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "coding": [ - { - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_49", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "aliases": [ - "CMYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_315", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_316", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_50", - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "aliases": [ - "Concomitant Medication" - ], - "href": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_51", - "name": "Randomization", - "label": "Randomization", - "aliases": [ - "randomization", - "RANDOM", - "Randomized", - "Trial is Randomized", - "randomized" - ], - "href": "/mdr/bc/biomedicalconcepts/C25196", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.b6e07c4c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.b6e07c4c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ], - "coding": [ - { - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Randomization" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_52", - "name": "Prothrombin Time", - "label": "Prothrombin Time", - "aliases": [ - "PT" - ], - "href": "/mdr/bc/biomedicalconcepts/C62656", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_341", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_342", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.3705a725" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_343", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_344", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_345", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C62656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Prothrombin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_53", - "name": "International Normalized Ratio of Prothrombin Time", - "label": "International Normalized Ratio of Prothrombin Time", - "aliases": [ - "INR", - "Prothrombin Intl. Normalized Ratio" - ], - "href": "/mdr/bc/biomedicalconcepts/C64805", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.dab673be" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64805", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "International Normalized Ratio of Prothrombin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_54", - "name": "Activated Partial Thromboplastin Time", - "label": "Activated Partial Thromboplastin Time", - "aliases": [ - "APTT" - ], - "href": "/mdr/bc/biomedicalconcepts/C38462", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.3705a725" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38462", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Activated Partial Thromboplastin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_55", - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "aliases": [ - "Glucose" - ], - "href": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_354", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_355", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_356", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_358", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_359", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_56", - "name": "Triglyceride Measurement", - "label": "Triglyceride Measurement", - "aliases": [ - "TRIG", - "Triglycerides" - ], - "href": "/mdr/bc/biomedicalconcepts/C64812", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_360", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_361", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64812", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triglyceride Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_57", - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "aliases": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_365", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_366", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_367", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_368", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_369", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_58", - "name": "High Density Lipoprotein Cholesterol Measurement", - "label": "High Density Lipoprotein Cholesterol Measurement", - "aliases": [ - "HDL", - "HDL Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105587", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_370", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_371", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_372", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_373", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_374", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105587", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "High Density Lipoprotein Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_59", - "name": "Low Density Lipoprotein Cholesterol Measurement", - "label": "Low Density Lipoprotein Cholesterol Measurement", - "aliases": [ - "LDL", - "LDL Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105588", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_375", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_376", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_377", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_378", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_379", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105588", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Low Density Lipoprotein Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_60", - "name": "ECOG Clinical Classification Question", - "label": "ECOG Clinical Classification Question", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C101874", - "properties": [], - "coding": [ - { - "code": "C101874", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG Clinical Classification Question" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_61", - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "aliases": [ - "WBC", - "White Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_380", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_381", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_382", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_383", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_384", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_62", - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "aliases": [ - "RBC", - "Red Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_385", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_386", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_387", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_388", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_389", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_63", - "name": "Platelet Count", - "label": "Platelet Count", - "aliases": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_390", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_391", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_392", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_393", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_394", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_64", - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "aliases": [ - "Potassium", - "K" - ], - "href": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_395", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_396", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_397", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_398", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_399", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_65", - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "aliases": [ - "Sodium", - "NA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_400", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_401", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_402", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_403", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_404", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_66", - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "aliases": [ - "Chloride", - "CL" - ], - "href": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_405", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_406", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_407", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_408", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_409", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_67", - "name": "Carbon Dioxide Measurement", - "label": "Carbon Dioxide Measurement", - "aliases": [ - "Carbon Dioxide", - "CO2" - ], - "href": "/mdr/bc/biomedicalconcepts/C64545", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_410", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_411", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_412", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_413", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_414", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64545", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Carbon Dioxide Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_68", - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "aliases": [ - "Calcium", - "CA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_415", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_416", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_417", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_418", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_419", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_69", - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "aliases": [ - "Urea Nitrogen" - ], - "href": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_420", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_421", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_422", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_423", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_424", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_70", - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "aliases": [ - "Protein" - ], - "href": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_425", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_426", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_427", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_428", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_429", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_71", - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "aliases": [ - "Alkaline Phosphatase" - ], - "href": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_430", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_431", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_432", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_433", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_434", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_72", - "name": "Urate Measurement", - "label": "Urate Measurement", - "aliases": [ - "Urate", - "Uric Acid" - ], - "href": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_435", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_436", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_437", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_438", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_439", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_73", - "name": "Tumor Size Measurement", - "label": "Tumor Size Measurement", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C106303", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_440", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_441", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_442", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_443", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_444", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_445", - "name": "Specimen Anatomic Site", - "label": "Specimen Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C171435", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Specimen Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_446", - "name": "Biospecimen Type", - "label": "Biospecimen Type", - "mandatory": true, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_447", - "name": "Unit of Length", - "label": "Unit of Length", - "mandatory": true, - "coding": [ - { - "code": "C42578", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Unit of Length" - } - ] - } - ], - "coding": [ - { - "code": "C106303", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Tumor Size Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_74", - "name": "Tumor Identification", - "label": "Tumor Identification", - "aliases": [ - "TUMIDENT" - ], - "href": "/mdr/bc/biomedicalconcepts/C94523", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_448", - "name": "TUORRES", - "label": "TUORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.0fe19c26" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_449", - "name": "TULOC", - "label": "TULOC", - "mandatory": false, - "coding": [ - { - "code": "C170500", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_450", - "name": "TULAT", - "label": "TULAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_451", - "name": "TUDIR", - "label": "TUDIR", - "mandatory": false, - "coding": [ - { - "code": "C54215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_452", - "name": "TUMETHOD", - "label": "TUMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_453", - "name": "TUEVAL", - "label": "TUEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_454", - "name": "TUEVALID", - "label": "TUEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_455", - "name": "TUREFID", - "label": "TUREFID", - "mandatory": false, - "coding": [ - { - "code": "C117442", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_456", - "name": "TULNKID", - "label": "TULNKID", - "mandatory": false, - "coding": [ - { - "code": "C117436", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_457", - "name": "TUDTC", - "label": "TUDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C94523", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identification" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_75", - "name": "Response in Non-Target Lesion", - "label": "Response in Non-Target Lesion", - "aliases": [ - "NTRGRESP", - "Non-Target Response" - ], - "href": "/mdr/bc/biomedicalconcepts/C94535", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_458", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_459", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_460", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_461", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C94535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Non-Target Lesion" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_76", - "name": "Response in Target Lesion", - "label": "Response in Target Lesion", - "aliases": [ - "TRGRESP", - "Target Response" - ], - "href": "/mdr/bc/biomedicalconcepts/C94534", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_462", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_463", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_464", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_465", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C94534", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Target Lesion" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_77", - "name": "Overall Response", - "label": "Overall Response", - "aliases": [ - "OVRLRESP" - ], - "href": "/mdr/bc/biomedicalconcepts/C96613", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_466", - "name": "RSLNKGRP", - "label": "RSLNKGRP", - "mandatory": false, - "coding": [ - { - "code": "C117394", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Disease Response Link Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_467", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_468", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_469", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_470", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C96613", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Overall Response" - } - ] - } - ], - "conceptProperties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.65a3e8d0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "Medical History Dictionary Derived Term", - "label": "Medical History Dictionary Derived Term", - "mandatory": true, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "Medical History Occurrence", - "label": "Medical History Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C83067", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "Medical History Pre-specified", - "label": "Medical History Pre-specified", - "mandatory": true, - "coding": [ - { - "code": "C87897", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Pre-specified" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "Medical History Reported Term", - "label": "Medical History Reported Term", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "Medical History Category", - "label": "Medical History Category", - "mandatory": true, - "coding": [ - { - "code": "C83018", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "Medical History Subcategory", - "label": "Medical History Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C83143", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_302", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_303", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_304", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_305", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_306", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_307", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_308", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_309", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_310", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_311", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_312", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_313", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_314", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_315", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_316", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.b6e07c4c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.b6e07c4c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_341", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_342", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.3705a725" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_343", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_344", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_345", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.dab673be" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.3705a725" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_354", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_355", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_356", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_358", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_359", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_360", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_361", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_365", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_366", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_367", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_368", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_369", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_370", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_371", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_372", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_373", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_374", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_375", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_376", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_377", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_378", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_379", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_380", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_381", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_382", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_383", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_384", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_385", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_386", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_387", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_388", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_389", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_390", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_391", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_392", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_393", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_394", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_395", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_396", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_397", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_398", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_399", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_400", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_401", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_402", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_403", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_404", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_405", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_406", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_407", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_408", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_409", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_410", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_411", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_412", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_413", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_414", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_415", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_416", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_417", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_418", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_419", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_420", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_421", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_422", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_423", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_424", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_425", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_426", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_427", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_428", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_429", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_430", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_431", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_432", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_433", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_434", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_435", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_436", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_437", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_438", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_439", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_440", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_441", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_442", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_443", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_444", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_445", - "name": "Specimen Anatomic Site", - "label": "Specimen Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C171435", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Specimen Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_446", - "name": "Biospecimen Type", - "label": "Biospecimen Type", - "mandatory": true, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_447", - "name": "Unit of Length", - "label": "Unit of Length", - "mandatory": true, - "coding": [ - { - "code": "C42578", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Unit of Length" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_448", - "name": "TUORRES", - "label": "TUORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.0fe19c26" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_449", - "name": "TULOC", - "label": "TULOC", - "mandatory": false, - "coding": [ - { - "code": "C170500", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_450", - "name": "TULAT", - "label": "TULAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_451", - "name": "TUDIR", - "label": "TUDIR", - "mandatory": false, - "coding": [ - { - "code": "C54215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_452", - "name": "TUMETHOD", - "label": "TUMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_453", - "name": "TUEVAL", - "label": "TUEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_454", - "name": "TUEVALID", - "label": "TUEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_455", - "name": "TUREFID", - "label": "TUREFID", - "mandatory": false, - "coding": [ - { - "code": "C117442", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_456", - "name": "TULNKID", - "label": "TULNKID", - "mandatory": false, - "coding": [ - { - "code": "C117436", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_457", - "name": "TUDTC", - "label": "TUDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_458", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_459", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_460", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_461", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_462", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_463", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_464", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_465", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_466", - "name": "RSLNKGRP", - "label": "RSLNKGRP", - "mandatory": false, - "coding": [ - { - "code": "C117394", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Disease Response Link Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_467", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_468", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_469", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_470", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ] -} diff --git a/output/json/NCT01797120-define-latest.json b/output/json/NCT01797120-define-latest.json deleted file mode 100644 index 9d6955f..0000000 --- a/output/json/NCT01797120-define-latest.json +++ /dev/null @@ -1,11183 +0,0 @@ -{ - "OID": "MDV.None.Version1.Design1", - "name": "MDV None", - "description": "Data Definitions for None", - "fileOID": "ODM.DEFINE-JSON.None.Version1.Design1", - "creationDateTime": "2026-07-16T11:38:41.433296+00:00", - "odmVersion": "1.3.2", - "fileType": "Snapshot", - "originator": "Define-JSON Processor", - "context": "Other", - "defineVersion": "2.1.0", - "studyOID": "ODM.None.Version1.Design1", - "studyName": null, - "studyDescription": "Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", - "protocolName": null, - "itemGroups": [ - { - "OID": "IG.DS", - "name": "DS", - "description": "Disposition", - "domain": "DS", - "purpose": "Tabulation", - "structure": "One record per disposition status or protocol milestone per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "DSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.DS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSSEQ", - "mandatory": true, - "name": "DSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSTERM", - "mandatory": true, - "name": "DSTERM", - "description": "Reported Term for the Disposition Event", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_228", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSDECOD", - "mandatory": true, - "name": "DSDECOD", - "description": "Standardized Disposition Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_227", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NCOMPLT" - }, - { - "OID": "IT.DS.DSCAT", - "mandatory": false, - "name": "DSCAT", - "description": "Category for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSCAT" - }, - { - "OID": "IT.DS.DSSCAT", - "mandatory": false, - "name": "DSSCAT", - "description": "Subcategory for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSSCAT" - }, - { - "OID": "IT.DS.DSSTDTC", - "mandatory": false, - "name": "DSSTDTC", - "description": "Start Date/Time of Disposition Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_229", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSSTDY", - "mandatory": false, - "name": "DSSTDY", - "description": "Study Day of Start of Disposition Event", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_1" - }, - { - "OID": "IG.RS", - "name": "RS", - "description": "Disease Response and Clin Classification", - "domain": "RS", - "purpose": "Tabulation", - "structure": "One record per response assessment or clinical classification assessment per time point per visit per subject per assessor per medical evaluator", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "RSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.RS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSSEQ", - "mandatory": true, - "name": "RSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSLNKGRP", - "mandatory": false, - "name": "RSLNKGRP", - "description": "Link Group ID", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSTESTCD", - "mandatory": true, - "name": "RSTESTCD", - "description": "Assessment Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRTSCD" - }, - { - "OID": "IT.RS.RSTEST", - "mandatory": true, - "name": "RSTEST", - "description": "Assessment Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRTS" - }, - { - "OID": "IT.RS.RSCAT", - "mandatory": false, - "name": "RSCAT", - "description": "Category for Assessment", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ONCRSCAT" - }, - { - "OID": "IT.RS.RSORRES", - "mandatory": false, - "name": "RSORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_250", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.RS.RSSTRESC", - "mandatory": false, - "name": "RSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.ONCRSR" - }, - { - "OID": "IT.RS.RSSTRESN", - "mandatory": false, - "name": "RSSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.RS.RSEVAL", - "mandatory": false, - "name": "RSEVAL", - "description": "Evaluator", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EVAL" - }, - { - "OID": "IT.RS.RSEVALID", - "mandatory": false, - "name": "RSEVALID", - "description": "Evaluator Identifier", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Vendor" - }, - "codeList": "CL.MEDEVAL" - }, - { - "OID": "IT.RS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.RS.RSDTC", - "mandatory": false, - "name": "RSDTC", - "description": "Date/Time of Assessment", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_251", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_5" - }, - { - "OID": "IG.VS", - "name": "VS", - "description": "Vital Signs", - "domain": "VS", - "purpose": "Tabulation", - "structure": "One record per vital sign measurement per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.VS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSEQ", - "mandatory": true, - "name": "VSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSTESTCD", - "mandatory": true, - "name": "VSTESTCD", - "description": "Vital Signs Test Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTESTCD" - }, - { - "OID": "IT.VS.VSTEST", - "mandatory": true, - "name": "VSTEST", - "description": "Vital Signs Test Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTEST" - }, - { - "OID": "IT.VS.VSPOS", - "mandatory": false, - "name": "VSPOS", - "description": "Vital Signs Position of Subject", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_254", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.POSITION" - }, - { - "OID": "IT.VS.VSORRES", - "mandatory": false, - "name": "VSORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_252", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSORRESU", - "mandatory": false, - "name": "VSORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_253", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSSTRESC", - "mandatory": false, - "name": "VSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESN", - "mandatory": false, - "name": "VSSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESU", - "mandatory": false, - "name": "VSSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSLOC", - "mandatory": false, - "name": "VSLOC", - "description": "Location of Vital Signs Measurement", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_255", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.VS.VSLAT", - "mandatory": false, - "name": "VSLAT", - "description": "Laterality", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_256", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.VS.VSLOBXFL", - "mandatory": false, - "name": "VSLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.VS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSDTC", - "mandatory": false, - "name": "VSDTC", - "description": "Date/Time of Measurements", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_257", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_7" - }, - { - "OID": "IG.UR", - "name": "UR", - "description": "Urinary System Findings", - "domain": "UR", - "purpose": "Tabulation", - "structure": "One record per finding per location per per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "URSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.UR.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URSEQ", - "mandatory": true, - "name": "URSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URTESTCD", - "mandatory": true, - "name": "URTESTCD", - "description": "Short Name of Urinary Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTSCD" - }, - { - "OID": "IT.UR.URTEST", - "mandatory": true, - "name": "URTEST", - "description": "Name of Urinary Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTS" - }, - { - "OID": "IT.UR.URORRES", - "mandatory": false, - "name": "URORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URSTRESC", - "mandatory": false, - "name": "URSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URMETHOD", - "mandatory": false, - "name": "URMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.UR.URLOBXFL", - "mandatory": false, - "name": "URLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.UR.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URDTC", - "mandatory": false, - "name": "URDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_27" - }, - { - "OID": "IG.CM", - "name": "CM", - "description": "Concomitant/Prior Medications", - "domain": "CM", - "purpose": "Tabulation", - "structure": "One record per recorded intervention occurrence or constant-dosing interval per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "CMSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.CM.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSEQ", - "mandatory": true, - "name": "CMSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMTRT", - "mandatory": true, - "name": "CMTRT", - "description": "Reported Name of Drug, Med, or Therapy", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_317", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDECOD", - "mandatory": false, - "name": "CMDECOD", - "description": "Standardized Medication Name", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_318", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCAT", - "mandatory": false, - "name": "CMCAT", - "description": "Category for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSCAT", - "mandatory": false, - "name": "CMSCAT", - "description": "Subcategory for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMPRESP", - "mandatory": false, - "name": "CMPRESP", - "description": "CM Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMOCCUR", - "mandatory": false, - "name": "CMOCCUR", - "description": "CM Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMINDC", - "mandatory": false, - "name": "CMINDC", - "description": "Indication", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_320", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMCLAS", - "mandatory": false, - "name": "CMCLAS", - "description": "Medication Class", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_319", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCLASCD", - "mandatory": false, - "name": "CMCLASCD", - "description": "Medication Class Code", - "role": "Variable Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMDOSE", - "mandatory": false, - "name": "CMDOSE", - "description": "Dose per Administration", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_321", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSTXT", - "mandatory": false, - "name": "CMDOSTXT", - "description": "Dose Description", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_322", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSU", - "mandatory": false, - "name": "CMDOSU", - "description": "Dose Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_323", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.CM.CMDOSFRM", - "mandatory": false, - "name": "CMDOSFRM", - "description": "Dose Form", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_324", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FRM" - }, - { - "OID": "IT.CM.CMDOSFRQ", - "mandatory": false, - "name": "CMDOSFRQ", - "description": "Dosing Frequency per Interval", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_325", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.CM.CMROUTE", - "mandatory": false, - "name": "CMROUTE", - "description": "Route of Administration", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_326", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ROUTE" - }, - { - "OID": "IT.CM.CMSTDTC", - "mandatory": false, - "name": "CMSTDTC", - "description": "Start Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_327", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMENDTC", - "mandatory": false, - "name": "CMENDTC", - "description": "End Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_328", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMSTRF", - "mandatory": false, - "name": "CMSTRF", - "description": "Start Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_329", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENRF", - "mandatory": false, - "name": "CMENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_332", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTRTPT", - "mandatory": false, - "name": "CMSTRTPT", - "description": "Start Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_330", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTTPT", - "mandatory": false, - "name": "CMSTTPT", - "description": "Start Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_331", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMENRTPT", - "mandatory": false, - "name": "CMENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_333", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENTPT", - "mandatory": false, - "name": "CMENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_334", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_50" - }, - { - "OID": "IG.TS", - "name": "TS", - "description": "Trial Summary", - "domain": "TS", - "purpose": "Tabulation", - "structure": "One record per trial summary parameter value", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "TSPARMCD", - "TSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSSEQ", - "mandatory": true, - "name": "TSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSPARMCD", - "mandatory": true, - "name": "TSPARMCD", - "description": "Trial Summary Parameter Short Name", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_335", - "dataType": "text", - "length": null, - "codeList": "CL.TSPARMCD" - }, - { - "OID": "IT.TS.TSPARM", - "mandatory": true, - "name": "TSPARM", - "description": "Trial Summary Parameter", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_336", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TSPARM" - }, - { - "OID": "IT.TS.TSVAL", - "mandatory": false, - "name": "TSVAL", - "description": "Parameter Value", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_337", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVALCD", - "mandatory": false, - "name": "TSVALCD", - "description": "Parameter Value Code", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_338", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVCDREF", - "mandatory": false, - "name": "TSVCDREF", - "description": "Name of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_339", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DICTNAM" - }, - { - "OID": "IT.TS.TSVCDVER", - "mandatory": false, - "name": "TSVCDVER", - "description": "Version of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_340", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_51", - "slices": [ - { - "OID": "VL.TS.TSPARMCD", - "name": "VL_TS_TSPARMCD", - "type": "ValueList", - "wasDerivedFrom": "IT.TS.TSPARMCD", - "items": [ - { - "OID": "IT.TS.TSPARMCD.COMPTRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.8c559472" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INDIC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e5769859" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INTTYPE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d3e89d3f" - ] - }, - { - "OID": "IT.TS.TSPARMCD.NARMS", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.efd2a465" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJPRIM", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.fe255586" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.62794b6c" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSPRI", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.4266ae9d" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.1d6311e2" - ] - }, - { - "OID": "IT.TS.TSPARMCD.SPONSOR", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e06f8db5" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TITLE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d94c6616" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d368cfb2" - ] - } - ] - } - ] - }, - { - "OID": "IG.TU", - "name": "TU", - "description": "Tumor/Lesion Identification", - "domain": "TU", - "purpose": "Tabulation", - "structure": "One record per identified tumor per subject per assessor", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "TUSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.TU.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUSEQ", - "mandatory": true, - "name": "TUSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUREFID", - "mandatory": false, - "name": "TUREFID", - "description": "Reference ID", - "role": "Identifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_455", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TULNKID", - "mandatory": false, - "name": "TULNKID", - "description": "Link ID", - "role": "Identifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_456", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TU.TUTESTCD", - "mandatory": true, - "name": "TUTESTCD", - "description": "Tumor/Lesion ID Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TUTESTCD" - }, - { - "OID": "IT.TU.TUTEST", - "mandatory": true, - "name": "TUTEST", - "description": "Tumor/Lesion ID Test Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TUTEST" - }, - { - "OID": "IT.TU.TUORRES", - "mandatory": false, - "name": "TUORRES", - "description": "Tumor/Lesion ID Result", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_448", - "dataType": "text", - "length": 24, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TU.TUSTRESC", - "mandatory": false, - "name": "TUSTRESC", - "description": "Tumor/Lesion ID Result Std. Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 24, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.TUIDRS" - }, - { - "OID": "IT.TU.TULOC", - "mandatory": false, - "name": "TULOC", - "description": "Location of the Tumor/Lesion", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_449", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.TU.TULAT", - "mandatory": false, - "name": "TULAT", - "description": "Laterality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_450", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.TU.TUDIR", - "mandatory": false, - "name": "TUDIR", - "description": "Directionality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_451", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DIR" - }, - { - "OID": "IT.TU.TUMETHOD", - "mandatory": false, - "name": "TUMETHOD", - "description": "Method of Identification", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_452", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.TU.TULOBXFL", - "mandatory": false, - "name": "TULOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.TU.TUEVAL", - "mandatory": false, - "name": "TUEVAL", - "description": "Evaluator", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_453", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EVAL" - }, - { - "OID": "IT.TU.TUEVALID", - "mandatory": false, - "name": "TUEVALID", - "description": "Evaluator Identifier", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_454", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Vendor" - }, - "codeList": "CL.MEDEVAL" - }, - { - "OID": "IT.TU.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TU.TUDTC", - "mandatory": false, - "name": "TUDTC", - "description": "Date/Time of Tumor/Lesion Identification", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_457", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_74" - }, - { - "OID": "IG.TA", - "name": "TA", - "description": "Trial Arms", - "domain": "TA", - "purpose": "Tabulation", - "structure": "One record per planned Element per Arm", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ARMCD", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TA.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.ARMCD", - "mandatory": true, - "name": "ARMCD", - "description": "Planned Arm Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARMCD" - }, - { - "OID": "IT.TA.ARM", - "mandatory": true, - "name": "ARM", - "description": "Description of Planned Arm", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARM" - }, - { - "OID": "IT.TA.TAETORD", - "mandatory": true, - "name": "TAETORD", - "description": "Planned Order of Element within Arm", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TA.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TA.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TA.TABRANCH", - "mandatory": false, - "name": "TABRANCH", - "description": "Branch", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.TATRANS", - "mandatory": false, - "name": "TATRANS", - "description": "Transition Rule", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.EPOCH", - "mandatory": true, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - } - ] - }, - { - "OID": "IG.TE", - "name": "TE", - "description": "Trial Elements", - "domain": "TE", - "purpose": "Tabulation", - "structure": "One record per planned Element", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TE.ELEMENT", - "mandatory": true, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TE.TESTRL", - "mandatory": true, - "name": "TESTRL", - "description": "Rule for Start of Element", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ] - }, - { - "OID": "IG.SV", - "name": "SV", - "description": "Subject Visits", - "domain": "SV", - "purpose": "Tabulation", - "structure": "One record per actual or planned visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VISITNUM" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SV.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISITNUM", - "mandatory": true, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Topic", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISIT", - "mandatory": false, - "name": "VISIT", - "description": "Visit Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.SVPRESP", - "mandatory": false, - "name": "SVPRESP", - "description": "Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVOCCUR", - "mandatory": false, - "name": "SVOCCUR", - "description": "Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVCNTMOD", - "mandatory": false, - "name": "SVCNTMOD", - "description": "Contact Mode", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.CNTMODE" - }, - { - "OID": "IT.SV.SVSTDTC", - "mandatory": false, - "name": "SVSTDTC", - "description": "Start Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SV.SVENDTC", - "mandatory": false, - "name": "SVENDTC", - "description": "End Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - }, - { - "OID": "IG.SE", - "name": "SE", - "description": "Subject Elements", - "domain": "SE", - "purpose": "Tabulation", - "structure": "One record per actual Element per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SESTDTC" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.SESEQ", - "mandatory": true, - "name": "SESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.SE.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.SE.EPOCH", - "mandatory": false, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - }, - { - "OID": "IT.SE.SESTDTC", - "mandatory": true, - "name": "SESTDTC", - "description": "Start Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SE.SEENDTC", - "mandatory": false, - "name": "SEENDTC", - "description": "End Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - } - ], - "conditions": [ - { - "OID": "COND.TS.TSPARMCD.4b2c750e", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "COMPTRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.82dcbb4a", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INDIC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.de0404c1", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INTTYPE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.1d8ed13f", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "NARMS" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.cccc9db0", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJPRIM" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.863c5858", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.69b92c86", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSPRI" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.df99032e", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.5b1e67a5", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "SPONSOR" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.90f47ac3", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TITLE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.e2190e21", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - } - ], - "whereClauses": [ - { - "OID": "WC.TS.8c559472", - "conditions": [ - "COND.TS.TSPARMCD.4b2c750e" - ] - }, - { - "OID": "WC.TS.e5769859", - "conditions": [ - "COND.TS.TSPARMCD.82dcbb4a" - ] - }, - { - "OID": "WC.TS.d3e89d3f", - "conditions": [ - "COND.TS.TSPARMCD.de0404c1" - ] - }, - { - "OID": "WC.TS.efd2a465", - "conditions": [ - "COND.TS.TSPARMCD.1d8ed13f" - ] - }, - { - "OID": "WC.TS.fe255586", - "conditions": [ - "COND.TS.TSPARMCD.cccc9db0" - ] - }, - { - "OID": "WC.TS.62794b6c", - "conditions": [ - "COND.TS.TSPARMCD.863c5858" - ] - }, - { - "OID": "WC.TS.4266ae9d", - "conditions": [ - "COND.TS.TSPARMCD.69b92c86" - ] - }, - { - "OID": "WC.TS.1d6311e2", - "conditions": [ - "COND.TS.TSPARMCD.df99032e" - ] - }, - { - "OID": "WC.TS.e06f8db5", - "conditions": [ - "COND.TS.TSPARMCD.5b1e67a5" - ] - }, - { - "OID": "WC.TS.d94c6616", - "conditions": [ - "COND.TS.TSPARMCD.90f47ac3" - ] - }, - { - "OID": "WC.TS.d368cfb2", - "conditions": [ - "COND.TS.TSPARMCD.e2190e21" - ] - } - ], - "codeLists": [ - { - "OID": "CL.ARMCD", - "name": "ARM Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ARM A" - }, - { - "codedValue": "ARM B" - } - ] - }, - { - "OID": "CL.ARM", - "name": "ARM", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ARM A" - }, - { - "codedValue": "ARM B" - } - ] - }, - { - "OID": "CL.ELEMENT", - "name": "Description of Element", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Screening" - }, - { - "codedValue": "Induction: Fulvestrant + Everolimus" - }, - { - "codedValue": "Induction: Fulvestrant + Placebo" - }, - { - "codedValue": "Continuation: Fulvestrant + Everolimus" - }, - { - "codedValue": "Continuation: Fulvestrant alone" - }, - { - "codedValue": "Follow-Up Off-Therapy" - } - ] - }, - { - "OID": "CL.ETCD", - "name": "Element Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SCREENING_ELEMENT", - "decode": "Screening" - }, - { - "codedValue": "INDUCTION_EVE_FUL", - "decode": "Induction: Fulvestrant + Everolimus" - }, - { - "codedValue": "INDUCTION_PBO_FUL", - "decode": "Induction: Fulvestrant + Placebo" - }, - { - "codedValue": "CONTINUATION_EVE_FUL", - "decode": "Continuation: Fulvestrant + Everolimus" - }, - { - "codedValue": "CONTINUATION_FUL", - "decode": "Continuation: Fulvestrant alone" - }, - { - "codedValue": "FOLLOW_UP_ELEMENT", - "decode": "Follow-Up Off-Therapy" - } - ] - }, - { - "OID": "CL.EPOCH", - "name": "Epoch", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99079", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "Pre-Study Phase", - "coding": { - "code": "C202487", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Induction Phase", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Continuation Phase", - "coding": { - "code": "C123452", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Follow-up Off Therapy", - "coding": { - "code": "C202578", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.ad42d7e1", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "INFORMED CONSENT OBTAINED", - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED" - } - ] - } - ] - }, - { - "OID": "CL.65a3e8d0", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ELIGIBILITY CRITERIA MET", - "coding": [ - { - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ELIGIBILITY CRITERIA MET" - } - ] - } - ] - }, - { - "OID": "CL.7cfd6cc5", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "mmHg", - "coding": [ - { - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg" - } - ] - } - ] - }, - { - "OID": "CL.20024ecd", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "beats/min", - "coding": [ - { - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min" - } - ] - } - ] - }, - { - "OID": "CL.9e69169e", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SERUM OR PLASMA", - "coding": [ - { - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA" - } - ] - } - ] - }, - { - "OID": "CL.5183f82c", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "URINE", - "coding": [ - { - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE" - } - ] - } - ] - }, - { - "OID": "CL.b6e07c4c", - "name": "TSPARMCD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "RANDOM", - "coding": [ - { - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "RANDOM" - } - ] - } - ] - }, - { - "OID": "CL.3705a725", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "s", - "coding": [ - { - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s" - } - ] - } - ] - }, - { - "OID": "CL.af8f8a19", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "BLOOD", - "coding": [ - { - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD" - } - ] - } - ] - }, - { - "OID": "CL.dab673be", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "RATIO", - "coding": [ - { - "code": "C44256", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RATIO" - } - ] - } - ] - }, - { - "OID": "CL.0fe19c26", - "name": "TUORRES Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "TARGET", - "coding": [ - { - "code": "C94520", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "TARGET" - } - ] - } - ] - }, - { - "OID": "CL.NCOMPLT", - "name": "Completion/Reason for Non-Completion", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66727", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSCAT", - "name": "Category of Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74558", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSSCAT", - "name": "Subcategory for Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C170443", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRTSCD", - "name": "Oncology Response Assessment Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96782", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRTS", - "name": "Oncology Response Assessment Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96781", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRSCAT", - "name": "Category of Oncology Response Assessment", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C124298", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ONCRSR", - "name": "Oncology Response Assessment Result", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96785", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EVAL", - "name": "Evaluator", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C78735", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MEDEVAL", - "name": "Medical Evaluator Identifier", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96777", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTESTCD", - "name": "Vital Signs Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66741", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTEST", - "name": "Vital Signs Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67153", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.POSITION", - "name": "Position", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71148", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSRESU", - "name": "Units for Vital Signs Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66770", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LOC", - "name": "Anatomical Location", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74456", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LAT", - "name": "Laterality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99073", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY", - "name": "No Yes Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTESTCD", - "name": "Laboratory Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C65047", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTEST", - "name": "Laboratory Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67154", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.UNIT", - "name": "Unit", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71620", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.URNSTSCD", - "name": "Urinary System Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129942", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.URNSTS", - "name": "Urinary System Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129941", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.METHOD", - "name": "Method", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C85492", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FRM", - "name": "Dosage Form", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66726", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FREQ", - "name": "Frequency", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71113", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ROUTE", - "name": "Route of Administration Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66729", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.STENRF", - "name": "Relation to Reference Period", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66728", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TSPARMCD", - "name": "Trial Summary Parameter Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66738", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "RANDOM", - "decode": "Trial is Randomized", - "coding": { - "code": "C25196", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.TSPARM", - "name": "Trial Summary Parameter Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67152", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "Trial is Randomized", - "decode": "Trial is Randomized", - "coding": { - "code": "C25196", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.DICTNAM", - "name": "Dictionary Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66788", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUTESTCD", - "name": "Tumor or Lesion Identification Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96784", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUTEST", - "name": "Tumor or Lesion Identification Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C96783", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TUIDRS", - "name": "Tumor or Lesion Identification Test Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C123650", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DIR", - "name": "Directionality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99074", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.CNTMODE", - "name": "Mode of Subject Contact", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C171445", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "IN PERSON", - "decode": "In-Person", - "coding": { - "code": "C175574", - "codeSystem": "nci:ExtCodeID" - } - } - ] - } - ], - "methods": [], - "comments": [], - "standards": [ - { - "OID": "STD.SDTMIG", - "name": "SDTMIG", - "type": "IG", - "version": "3.4", - "status": "FINAL" - }, - { - "OID": "STD.SDTMCT", - "name": "CDISC/NCI", - "type": "CT", - "version": "2026-03-27", - "status": "FINAL", - "publishingSet": "SDTM" - } - ], - "annotatedCRF": [], - "concepts": [ - { - "OID": "CONC.BiomedicalConcept_1", - "name": "Informed Consent", - "label": "Informed Consent", - "aliases": [ - "Informed Consent Obtained" - ], - "href": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_2", - "name": "Eligibility Criteria Met By Subject", - "label": "Eligibility Criteria Met By Subject", - "aliases": [ - "Eligibility Criteria Met" - ], - "href": "/mdr/bc/biomedicalconcepts/C132447", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.65a3e8d0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Eligibility Criteria Met By Subject" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_3", - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "aliases": [ - "MHYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C85522", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_4", - "name": "Medical History Reported Term [RETIRED]", - "label": "Medical History Reported Term [RETIRED]", - "aliases": [ - "Medical History", - "MHTERM" - ], - "href": "/mdr/bc/biomedicalconcepts/C83118", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "Medical History Dictionary Derived Term", - "label": "Medical History Dictionary Derived Term", - "mandatory": true, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "Medical History Occurrence", - "label": "Medical History Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C83067", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "Medical History Pre-specified", - "label": "Medical History Pre-specified", - "mandatory": true, - "coding": [ - { - "code": "C87897", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Pre-specified" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "Medical History Reported Term", - "label": "Medical History Reported Term", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "Medical History Category", - "label": "Medical History Category", - "mandatory": true, - "coding": [ - { - "code": "C83018", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "Medical History Subcategory", - "label": "Medical History Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C83143", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Subcategory" - } - ] - } - ], - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_5", - "name": "ECOG - Performance Status", - "label": "ECOG - Performance Status", - "aliases": [ - "ECOG1-Performance Status", - "ECOG101", - "ECOG - Performance Status" - ], - "href": "/mdr/bc/biomedicalconcepts/C102408", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C102408", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG - Performance Status" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_6", - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "coding": [ - { - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_7", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "aliases": [ - "SYSBP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_8", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "aliases": [ - "DIABP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_9", - "name": "Heart Rate", - "label": "Heart Rate", - "aliases": [ - "HR" - ], - "href": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_10", - "name": "Body Temperature", - "label": "Body Temperature", - "aliases": [ - "Temperature" - ], - "href": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Body Temperature" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_11", - "name": "Body Weight", - "label": "Body Weight", - "aliases": [ - "WEIGHT" - ], - "href": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_18", - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "aliases": [ - "ALT", - "SGPT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_19", - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "aliases": [ - "AST", - "SGOT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_20", - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "aliases": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "href": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_21", - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "aliases": [ - "Creatinine" - ], - "href": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_22", - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "aliases": [ - "Albumin" - ], - "href": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_26", - "name": "pH", - "label": "pH", - "aliases": [ - "PH", - "potential of Hydrogen" - ], - "href": "/mdr/bc/biomedicalconcepts/C45997", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_302", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_303", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_304", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_305", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C45997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "pH" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_27", - "name": "Color Assessment", - "label": "Color Assessment", - "aliases": [ - "COLOR", - "Color" - ], - "href": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_306", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_307", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_308", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_28", - "name": "Specific Gravity", - "label": "Specific Gravity", - "aliases": [ - "SPGRAV" - ], - "href": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_309", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_310", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_311", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_312", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_47", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "aliases": [ - "AEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_313", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_314", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_48", - "name": "Adverse Event", - "label": "Adverse Event", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "coding": [ - { - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_49", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "aliases": [ - "CMYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_315", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_316", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_50", - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "aliases": [ - "Concomitant Medication" - ], - "href": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_51", - "name": "Randomization", - "label": "Randomization", - "aliases": [ - "randomization", - "RANDOM", - "Randomized", - "Trial is Randomized", - "randomized" - ], - "href": "/mdr/bc/biomedicalconcepts/C25196", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.b6e07c4c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.b6e07c4c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ], - "coding": [ - { - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Randomization" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_52", - "name": "Prothrombin Time", - "label": "Prothrombin Time", - "aliases": [ - "PT" - ], - "href": "/mdr/bc/biomedicalconcepts/C62656", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_341", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_342", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.3705a725" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_343", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_344", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_345", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C62656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Prothrombin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_53", - "name": "International Normalized Ratio of Prothrombin Time", - "label": "International Normalized Ratio of Prothrombin Time", - "aliases": [ - "INR", - "Prothrombin Intl. Normalized Ratio" - ], - "href": "/mdr/bc/biomedicalconcepts/C64805", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.dab673be" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64805", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "International Normalized Ratio of Prothrombin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_54", - "name": "Activated Partial Thromboplastin Time", - "label": "Activated Partial Thromboplastin Time", - "aliases": [ - "APTT" - ], - "href": "/mdr/bc/biomedicalconcepts/C38462", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.3705a725" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38462", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Activated Partial Thromboplastin Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_55", - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "aliases": [ - "Glucose" - ], - "href": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_354", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_355", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_356", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_358", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_359", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_56", - "name": "Triglyceride Measurement", - "label": "Triglyceride Measurement", - "aliases": [ - "TRIG", - "Triglycerides" - ], - "href": "/mdr/bc/biomedicalconcepts/C64812", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_360", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_361", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64812", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triglyceride Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_57", - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "aliases": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_365", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_366", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_367", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_368", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_369", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_58", - "name": "High Density Lipoprotein Cholesterol Measurement", - "label": "High Density Lipoprotein Cholesterol Measurement", - "aliases": [ - "HDL", - "HDL Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105587", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_370", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_371", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_372", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_373", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_374", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105587", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "High Density Lipoprotein Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_59", - "name": "Low Density Lipoprotein Cholesterol Measurement", - "label": "Low Density Lipoprotein Cholesterol Measurement", - "aliases": [ - "LDL", - "LDL Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105588", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_375", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_376", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_377", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_378", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_379", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105588", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Low Density Lipoprotein Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_60", - "name": "ECOG Clinical Classification Question", - "label": "ECOG Clinical Classification Question", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C101874", - "properties": [], - "coding": [ - { - "code": "C101874", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG Clinical Classification Question" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_61", - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "aliases": [ - "WBC", - "White Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_380", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_381", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_382", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_383", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_384", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_62", - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "aliases": [ - "RBC", - "Red Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_385", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_386", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_387", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_388", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_389", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_63", - "name": "Platelet Count", - "label": "Platelet Count", - "aliases": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_390", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_391", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_392", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_393", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_394", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_64", - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "aliases": [ - "Potassium", - "K" - ], - "href": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_395", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_396", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_397", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_398", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_399", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_65", - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "aliases": [ - "Sodium", - "NA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_400", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_401", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_402", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_403", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_404", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_66", - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "aliases": [ - "Chloride", - "CL" - ], - "href": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_405", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_406", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_407", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_408", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_409", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_67", - "name": "Carbon Dioxide Measurement", - "label": "Carbon Dioxide Measurement", - "aliases": [ - "Carbon Dioxide", - "CO2" - ], - "href": "/mdr/bc/biomedicalconcepts/C64545", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_410", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_411", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_412", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_413", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_414", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64545", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Carbon Dioxide Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_68", - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "aliases": [ - "Calcium", - "CA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_415", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_416", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_417", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_418", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_419", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_69", - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "aliases": [ - "Urea Nitrogen" - ], - "href": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_420", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_421", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_422", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_423", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_424", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_70", - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "aliases": [ - "Protein" - ], - "href": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_425", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_426", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_427", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_428", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_429", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_71", - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "aliases": [ - "Alkaline Phosphatase" - ], - "href": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_430", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_431", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_432", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_433", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_434", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_72", - "name": "Urate Measurement", - "label": "Urate Measurement", - "aliases": [ - "Urate", - "Uric Acid" - ], - "href": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_435", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_436", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_437", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_438", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_439", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_73", - "name": "Tumor Size Measurement", - "label": "Tumor Size Measurement", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C106303", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_440", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_441", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_442", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_443", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_444", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_445", - "name": "Specimen Anatomic Site", - "label": "Specimen Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C171435", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Specimen Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_446", - "name": "Biospecimen Type", - "label": "Biospecimen Type", - "mandatory": true, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_447", - "name": "Unit of Length", - "label": "Unit of Length", - "mandatory": true, - "coding": [ - { - "code": "C42578", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Unit of Length" - } - ] - } - ], - "coding": [ - { - "code": "C106303", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Tumor Size Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_74", - "name": "Tumor Identification", - "label": "Tumor Identification", - "aliases": [ - "TUMIDENT" - ], - "href": "/mdr/bc/biomedicalconcepts/C94523", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_448", - "name": "TUORRES", - "label": "TUORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.0fe19c26" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_449", - "name": "TULOC", - "label": "TULOC", - "mandatory": false, - "coding": [ - { - "code": "C170500", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_450", - "name": "TULAT", - "label": "TULAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_451", - "name": "TUDIR", - "label": "TUDIR", - "mandatory": false, - "coding": [ - { - "code": "C54215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_452", - "name": "TUMETHOD", - "label": "TUMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_453", - "name": "TUEVAL", - "label": "TUEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_454", - "name": "TUEVALID", - "label": "TUEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_455", - "name": "TUREFID", - "label": "TUREFID", - "mandatory": false, - "coding": [ - { - "code": "C117442", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_456", - "name": "TULNKID", - "label": "TULNKID", - "mandatory": false, - "coding": [ - { - "code": "C117436", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_457", - "name": "TUDTC", - "label": "TUDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C94523", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identification" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_75", - "name": "Response in Non-Target Lesion", - "label": "Response in Non-Target Lesion", - "aliases": [ - "NTRGRESP", - "Non-Target Response" - ], - "href": "/mdr/bc/biomedicalconcepts/C94535", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_458", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_459", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_460", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_461", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C94535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Non-Target Lesion" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_76", - "name": "Response in Target Lesion", - "label": "Response in Target Lesion", - "aliases": [ - "TRGRESP", - "Target Response" - ], - "href": "/mdr/bc/biomedicalconcepts/C94534", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_462", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_463", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_464", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_465", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C94534", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Target Lesion" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_77", - "name": "Overall Response", - "label": "Overall Response", - "aliases": [ - "OVRLRESP" - ], - "href": "/mdr/bc/biomedicalconcepts/C96613", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_466", - "name": "RSLNKGRP", - "label": "RSLNKGRP", - "mandatory": false, - "coding": [ - { - "code": "C117394", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Disease Response Link Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_467", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_468", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_469", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_470", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C96613", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Overall Response" - } - ] - } - ], - "conceptProperties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.65a3e8d0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "Medical History Dictionary Derived Term", - "label": "Medical History Dictionary Derived Term", - "mandatory": true, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "Medical History Occurrence", - "label": "Medical History Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C83067", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "Medical History Pre-specified", - "label": "Medical History Pre-specified", - "mandatory": true, - "coding": [ - { - "code": "C87897", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Pre-specified" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "Medical History Reported Term", - "label": "Medical History Reported Term", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "Medical History Category", - "label": "Medical History Category", - "mandatory": true, - "coding": [ - { - "code": "C83018", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "Medical History Subcategory", - "label": "Medical History Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C83143", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_302", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_303", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_304", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_305", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_306", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_307", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_308", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_309", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_310", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_311", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_312", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_313", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_314", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_315", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_316", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.b6e07c4c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.b6e07c4c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_341", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_342", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.3705a725" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_343", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_344", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_345", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.dab673be" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ], - "codeList": "CL.3705a725" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_354", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_355", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_356", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_358", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_359", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_360", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_361", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_365", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_366", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_367", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_368", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_369", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_370", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_371", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_372", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_373", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_374", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_375", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_376", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_377", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_378", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_379", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_380", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_381", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_382", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_383", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_384", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_385", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_386", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_387", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_388", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_389", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_390", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_391", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_392", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_393", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_394", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_395", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_396", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_397", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_398", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_399", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_400", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_401", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_402", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_403", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_404", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_405", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_406", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_407", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_408", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_409", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_410", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_411", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_412", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_413", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_414", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_415", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_416", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_417", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_418", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_419", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_420", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_421", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_422", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_423", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_424", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_425", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_426", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_427", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_428", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_429", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_430", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_431", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_432", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_433", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_434", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_435", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_436", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_437", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_438", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_439", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_440", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_441", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_442", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_443", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_444", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_445", - "name": "Specimen Anatomic Site", - "label": "Specimen Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C171435", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Specimen Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_446", - "name": "Biospecimen Type", - "label": "Biospecimen Type", - "mandatory": true, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_447", - "name": "Unit of Length", - "label": "Unit of Length", - "mandatory": true, - "coding": [ - { - "code": "C42578", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Unit of Length" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_448", - "name": "TUORRES", - "label": "TUORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ], - "codeList": "CL.0fe19c26" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_449", - "name": "TULOC", - "label": "TULOC", - "mandatory": false, - "coding": [ - { - "code": "C170500", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_450", - "name": "TULAT", - "label": "TULAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_451", - "name": "TUDIR", - "label": "TUDIR", - "mandatory": false, - "coding": [ - { - "code": "C54215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_452", - "name": "TUMETHOD", - "label": "TUMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_453", - "name": "TUEVAL", - "label": "TUEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_454", - "name": "TUEVALID", - "label": "TUEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_455", - "name": "TUREFID", - "label": "TUREFID", - "mandatory": false, - "coding": [ - { - "code": "C117442", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_456", - "name": "TULNKID", - "label": "TULNKID", - "mandatory": false, - "coding": [ - { - "code": "C117436", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_457", - "name": "TUDTC", - "label": "TUDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_458", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_459", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_460", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_461", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_462", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_463", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_464", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_465", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_466", - "name": "RSLNKGRP", - "label": "RSLNKGRP", - "mandatory": false, - "coding": [ - { - "code": "C117394", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Disease Response Link Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_467", - "name": "RSORRES", - "label": "RSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_468", - "name": "RSEVAL", - "label": "RSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_469", - "name": "RSEVALID", - "label": "RSEVALID", - "mandatory": false, - "coding": [ - { - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_470", - "name": "RSDTC", - "label": "RSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ] -} diff --git a/output/json/NCT01797120-latest.json b/output/json/NCT01797120-latest.json index 94da8b8..1a0b16e 100644 --- a/output/json/NCT01797120-latest.json +++ b/output/json/NCT01797120-latest.json @@ -25,13 +25,13 @@ { "id": "ExtensionAttribute_46", "url": "tool-version", - "valueString": "1.6.0", + "valueString": "master", "instanceType": "ExtensionAttribute" }, { "id": "ExtensionAttribute_47", "url": "usdm-creation-date", - "valueString": "20260806T13:12", + "valueString": "20260811T12:04", "instanceType": "ExtensionAttribute" } ], @@ -975,7 +975,7 @@ "childIds": [], "definedProcedures": [], "biomedicalConceptIds": [ - "BiomedicalConcept_6" + "BiomedicalConcept_124" ], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1017,7 +1017,8 @@ "BiomedicalConcept_8", "BiomedicalConcept_9", "BiomedicalConcept_10", - "BiomedicalConcept_11" + "BiomedicalConcept_11", + "BiomedicalConcept_128" ], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1036,8 +1037,7 @@ "childIds": [], "definedProcedures": [], "biomedicalConceptIds": [ - "BiomedicalConcept_5", - "BiomedicalConcept_60" + "BiomedicalConcept_5" ], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1056,8 +1056,8 @@ "childIds": [], "definedProcedures": [], "biomedicalConceptIds": [ - "BiomedicalConcept_79", - "BiomedicalConcept_81" + "BiomedicalConcept_81", + "BiomedicalConcept_127" ], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1245,12 +1245,11 @@ "BiomedicalConcept_70", "BiomedicalConcept_71", "BiomedicalConcept_72", - "BiomedicalConcept_118" + "BiomedicalConcept_118", + "BiomedicalConcept_125" ], "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_1" - ], + "bcSurrogateIds": [], "timelineId": null, "notes": [], "instanceType": "Activity" @@ -1363,16 +1362,11 @@ "nextId": "Activity_31", "childIds": [], "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_19", - "BiomedicalConceptSurrogate_20", - "BiomedicalConceptSurrogate_21", - "BiomedicalConceptSurrogate_22", - "BiomedicalConceptSurrogate_23", - "BiomedicalConceptSurrogate_24" + "biomedicalConceptIds": [ + "BiomedicalConcept_126" ], + "bcCategoryIds": [], + "bcSurrogateIds": [], "timelineId": null, "notes": [], "instanceType": "Activity" @@ -1397,13 +1391,10 @@ "BiomedicalConcept_114", "BiomedicalConcept_115", "BiomedicalConcept_116", - "BiomedicalConcept_117", - "BiomedicalConcept_123" + "BiomedicalConcept_129" ], "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_25" - ], + "bcSurrogateIds": [], "timelineId": null, "notes": [], "instanceType": "Activity" @@ -4347,32 +4338,6 @@ "notes": [], "instanceType": "BiomedicalConcept" }, - { - "id": "BiomedicalConcept_6", - "extensionAttributes": [], - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "code": { - "id": "AliasCode_21", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28", - "extensionAttributes": [], - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, { "id": "BiomedicalConcept_7", "extensionAttributes": [ @@ -8336,32 +8301,6 @@ "notes": [], "instanceType": "BiomedicalConcept" }, - { - "id": "BiomedicalConcept_60", - "extensionAttributes": [], - "name": "ECOG Clinical Classification Question", - "label": "ECOG Clinical Classification Question", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C101874", - "properties": [], - "code": { - "id": "AliasCode_9912", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10668", - "extensionAttributes": [], - "code": "C101874", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG Clinical Classification Question", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, { "id": "BiomedicalConcept_61", "extensionAttributes": [ @@ -10733,33 +10672,92 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_79", + "id": "BiomedicalConcept_80", + "extensionAttributes": [], + "name": "Physical Examination Finding", + "label": "Physical Examination Finding", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C83119", + "properties": [], + "code": { + "id": "AliasCode_9916", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10672", + "extensionAttributes": [], + "code": "C83119", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-04-02", + "decode": "Physical Examination Finding", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_81", "extensionAttributes": [], - "name": "Unsolicited Adverse Event", - "label": "Unsolicited Adverse Event", + "name": "Physical Examination Finding", + "label": "Physical Examination Finding", + "synonyms": [], + "reference": "/mdr/bc/biomedicalconcepts/C83119", + "properties": [], + "code": { + "id": "AliasCode_9917", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10673", + "extensionAttributes": [], + "code": "C83119", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-04-02", + "decode": "Physical Examination Finding", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_82", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_48", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEWLPROG", + "instanceType": "ExtensionAttribute" + } + ], + "name": "New Lesion Progression", + "label": "New Lesion Progression", "synonyms": [ - "Adverse Event" + "NEWLPROG" ], - "reference": "/mdr/bc/biomedicalconcepts/C179176", + "reference": "/mdr/bc/biomedicalconcepts/C103420", "properties": [ { - "id": "BiomedicalConceptProperty_559", + "id": "BiomedicalConceptProperty_440", "extensionAttributes": [], - "name": "Adverse Event Verbatim Description", - "label": "Adverse Event Verbatim Description", + "name": "Category", + "label": "Category", "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10082", + "id": "AliasCode_9932", "standardCode": { - "id": "Code_10838", + "id": "Code_10688", "extensionAttributes": [], - "code": "C78541", + "code": "C25372", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Verbatim Description", + "codeSystemVersion": "2024-06-27", + "decode": "Category", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10768,23 +10766,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_560", + "id": "BiomedicalConceptProperty_441", "extensionAttributes": [], - "name": "Adverse Event Dictionary Derived Term", - "label": "Adverse Event Dictionary Derived Term", + "name": "Observation Result", + "label": "Observation Result", "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10083", + "id": "AliasCode_9933", "standardCode": { - "id": "Code_10839", + "id": "Code_10689", "extensionAttributes": [], - "code": "C83344", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Dictionary Derived Term", + "codeSystemVersion": "2024-06-27", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10793,23 +10791,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_561", + "id": "BiomedicalConceptProperty_442", "extensionAttributes": [], - "name": "Adverse Event Category", - "label": "Adverse Event Category", + "name": "Evaluator", + "label": "Evaluator", "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10084", + "id": "AliasCode_9934", "standardCode": { - "id": "Code_10840", + "id": "Code_10690", "extensionAttributes": [], - "code": "C83198", + "code": "C51824", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Category", + "codeSystemVersion": "2024-06-27", + "decode": "Evaluator", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10818,23 +10816,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_562", + "id": "BiomedicalConceptProperty_443", "extensionAttributes": [], - "name": "Adverse Event Subcategory", - "label": "Adverse Event Subcategory", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10085", + "id": "AliasCode_9935", "standardCode": { - "id": "Code_10841", + "id": "Code_10691", "extensionAttributes": [], - "code": "C83212", + "code": "C117043", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Subcategory", + "codeSystemVersion": "2024-06-27", + "decode": "Evaluator Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10843,48 +10841,84 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_563", + "id": "BiomedicalConceptProperty_444", "extensionAttributes": [], - "name": "Adverse Event Location", - "label": "Adverse Event Location", + "name": "Collection Date Time", + "label": "Collection Date Time", "isRequired": true, "isEnabled": true, - "datatype": "string", + "datatype": "datetime", "responseCodes": [], "code": { - "id": "AliasCode_10086", + "id": "AliasCode_9936", "standardCode": { - "id": "Code_10842", + "id": "Code_10692", "extensionAttributes": [], - "code": "C83205", + "code": "C82515", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Location", + "codeSystemVersion": "2024-06-27", + "decode": "Collection Date Time", "instanceType": "Code" }, "instanceType": "AliasCode" }, "notes": [], "instanceType": "BiomedicalConceptProperty" + } + ], + "code": { + "id": "AliasCode_9918", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10674", + "extensionAttributes": [], + "code": "C103420", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2024-06-27", + "decode": "New Lesion Progression", + "instanceType": "Code" }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "notes": [], + "instanceType": "BiomedicalConcept" + }, + { + "id": "BiomedicalConcept_83", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_49", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/LNSTATE_RECIST1_1", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Lymph Node State", + "label": "Lymph Node State", + "synonyms": [ + "LNSTATE" + ], + "reference": "/mdr/bc/biomedicalconcepts/C124448", + "properties": [ { - "id": "BiomedicalConceptProperty_564", + "id": "BiomedicalConceptProperty_445", "extensionAttributes": [], - "name": "Severity of Adverse Event", - "label": "Severity of Adverse Event", + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10087", + "id": "AliasCode_9937", "standardCode": { - "id": "Code_10843", + "id": "Code_10693", "extensionAttributes": [], - "code": "C53253", + "code": "C117413", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Severity of Adverse Event", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Link Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10893,23 +10927,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_565", + "id": "BiomedicalConceptProperty_446", "extensionAttributes": [], - "name": "Seriousness of Adverse Event", - "label": "Seriousness of Adverse Event", + "name": "Evaluator", + "label": "Evaluator", "isRequired": true, "isEnabled": true, - "datatype": "boolean", + "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10088", + "id": "AliasCode_9938", "standardCode": { - "id": "Code_10844", + "id": "Code_10694", "extensionAttributes": [], - "code": "C53252", + "code": "C51824", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Seriousness of Adverse Event", + "codeSystemVersion": "2026-05-26", + "decode": "Evaluator", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10918,23 +10952,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_566", + "id": "BiomedicalConceptProperty_447", "extensionAttributes": [], - "name": "Adverse Event Toxicity Grade", - "label": "Adverse Event Toxicity Grade", + "name": "Test Method", + "label": "Test Method", "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10089", + "id": "AliasCode_9939", "standardCode": { - "id": "Code_10845", + "id": "Code_10695", "extensionAttributes": [], - "code": "C78605", + "code": "C82535", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Toxicity Grade", + "codeSystemVersion": "2026-05-26", + "decode": "Test Method", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10943,23 +10977,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_567", + "id": "BiomedicalConceptProperty_448", "extensionAttributes": [], - "name": "Adverse Event Action Taken with Study Treatment", - "label": "Adverse Event Action Taken with Study Treatment", + "name": "Observation Result", + "label": "Observation Result", "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10090", + "id": "AliasCode_9940", "standardCode": { - "id": "Code_10846", + "id": "Code_10696", "extensionAttributes": [], - "code": "C83013", + "code": "C70856", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Action Taken with Study Treatment", + "codeSystemVersion": "2026-05-26", + "decode": "Observation Result", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10968,23 +11002,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_568", + "id": "BiomedicalConceptProperty_449", "extensionAttributes": [], - "name": "Other Actions taken in Response to Adverse Event", - "label": "Other Actions taken in Response to Adverse Event", + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10091", + "id": "AliasCode_9941", "standardCode": { - "id": "Code_10847", + "id": "Code_10697", "extensionAttributes": [], - "code": "C83109", + "code": "C117419", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Other Actions taken in Response to Adverse Event", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Reference Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -10993,23 +11027,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_569", + "id": "BiomedicalConceptProperty_450", "extensionAttributes": [], - "name": "Adverse Event Attribution to Product or Procedure", - "label": "Adverse Event Attribution to Product or Procedure", + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10092", + "id": "AliasCode_9942", "standardCode": { - "id": "Code_10848", + "id": "Code_10698", "extensionAttributes": [], - "code": "C41358", + "code": "C117411", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Attribution to Product or Procedure", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Group Identifier", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11018,23 +11052,23 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_570", + "id": "BiomedicalConceptProperty_451", "extensionAttributes": [], - "name": "Adverse Event Relationship to Non Study Treatment", - "label": "Adverse Event Relationship to Non Study Treatment", + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10093", + "id": "AliasCode_9943", "standardCode": { - "id": "Code_10849", + "id": "Code_10699", "extensionAttributes": [], - "code": "C83210", + "code": "C117412", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Relationship to Non Study Treatment", + "codeSystemVersion": "2026-05-26", + "decode": "Tumor Results Link Group", "instanceType": "Code" }, "instanceType": "AliasCode" @@ -11043,769 +11077,20 @@ "instanceType": "BiomedicalConceptProperty" }, { - "id": "BiomedicalConceptProperty_571", + "id": "BiomedicalConceptProperty_452", "extensionAttributes": [], - "name": "Adverse Event Pattern", - "label": "Adverse Event Pattern", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", "isRequired": true, "isEnabled": true, "datatype": "string", "responseCodes": [], "code": { - "id": "AliasCode_10094", + "id": "AliasCode_9944", "standardCode": { - "id": "Code_10850", + "id": "Code_10700", "extensionAttributes": [], - "code": "C83208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Pattern", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_572", - "extensionAttributes": [], - "name": "Adverse Event Outcome", - "label": "Adverse Event Outcome", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_10095", - "standardCode": { - "id": "Code_10851", - "extensionAttributes": [], - "code": "C49489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Outcome", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_573", - "extensionAttributes": [], - "name": "Adverse Event Involves Cancer", - "label": "Adverse Event Involves Cancer", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_10096", - "standardCode": { - "id": "Code_10852", - "extensionAttributes": [], - "code": "C83211", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Involves Cancer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_574", - "extensionAttributes": [], - "name": "Adverse Event Seriousness Due to Congenital Anomaly", - "label": "Adverse Event Seriousness Due to Congenital Anomaly", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_10097", - "standardCode": { - "id": "Code_10853", - "extensionAttributes": [], - "code": "C83117", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_575", - "extensionAttributes": [], - "name": "Disabling Adverse Event", - "label": "Disabling Adverse Event", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_10098", - "standardCode": { - "id": "Code_10854", - "extensionAttributes": [], - "code": "C113380", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Disabling Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_576", - "extensionAttributes": [], - "name": "Death Related to Adverse Event", - "label": "Death Related to Adverse Event", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_10099", - "standardCode": { - "id": "Code_10855", - "extensionAttributes": [], - "code": "C48275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Death Related to Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_577", - "extensionAttributes": [], - "name": "Adverse Event associated with Hospitalization", - "label": "Adverse Event associated with Hospitalization", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_10100", - "standardCode": { - "id": "Code_10856", - "extensionAttributes": [], - "code": "C83052", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event associated with Hospitalization", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_578", - "extensionAttributes": [], - "name": "Life Threatening Adverse Event", - "label": "Life Threatening Adverse Event", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_10101", - "standardCode": { - "id": "Code_10857", - "extensionAttributes": [], - "code": "C84266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Life Threatening Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_579", - "extensionAttributes": [], - "name": "Adverse Event Occurred with Overdose", - "label": "Adverse Event Occurred with Overdose", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_10102", - "standardCode": { - "id": "Code_10858", - "extensionAttributes": [], - "code": "C83214", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Occurred with Overdose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_580", - "extensionAttributes": [], - "name": "Adverse Event Associated with Serious Medical Event", - "label": "Adverse Event Associated with Serious Medical Event", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_10103", - "standardCode": { - "id": "Code_10859", - "extensionAttributes": [], - "code": "C83053", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Associated with Serious Medical Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_581", - "extensionAttributes": [], - "name": "Adverse Event Concomitant Treatment", - "label": "Adverse Event Concomitant Treatment", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_10104", - "standardCode": { - "id": "Code_10860", - "extensionAttributes": [], - "code": "C83199", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Concomitant Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_582", - "extensionAttributes": [], - "name": "Adverse Event Start Date Time", - "label": "Adverse Event Start Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_10105", - "standardCode": { - "id": "Code_10861", - "extensionAttributes": [], - "code": "C83215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_583", - "extensionAttributes": [], - "name": "Adverse Event End Date Time", - "label": "Adverse Event End Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_10106", - "standardCode": { - "id": "Code_10862", - "extensionAttributes": [], - "code": "C83201", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Adverse Event End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9915", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10671", - "extensionAttributes": [], - "code": "C179176", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Unsolicited Adverse Event", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_80", - "extensionAttributes": [], - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "code": { - "id": "AliasCode_9916", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10672", - "extensionAttributes": [], - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_81", - "extensionAttributes": [], - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "code": { - "id": "AliasCode_9917", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10673", - "extensionAttributes": [], - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_82", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_48", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEWLPROG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "New Lesion Progression", - "label": "New Lesion Progression", - "synonyms": [ - "NEWLPROG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C103420", - "properties": [ - { - "id": "BiomedicalConceptProperty_440", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9932", - "standardCode": { - "id": "Code_10688", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_441", - "extensionAttributes": [], - "name": "Observation Result", - "label": "Observation Result", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9933", - "standardCode": { - "id": "Code_10689", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_442", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9934", - "standardCode": { - "id": "Code_10690", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_443", - "extensionAttributes": [], - "name": "Evaluator Identifier", - "label": "Evaluator Identifier", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9935", - "standardCode": { - "id": "Code_10691", - "extensionAttributes": [], - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Evaluator Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_444", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9936", - "standardCode": { - "id": "Code_10692", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9918", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10674", - "extensionAttributes": [], - "code": "C103420", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "New Lesion Progression", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_83", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_49", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/LNSTATE_RECIST1_1", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Lymph Node State", - "label": "Lymph Node State", - "synonyms": [ - "LNSTATE" - ], - "reference": "/mdr/bc/biomedicalconcepts/C124448", - "properties": [ - { - "id": "BiomedicalConceptProperty_445", - "extensionAttributes": [], - "name": "Tumor Results Link Identifier", - "label": "Tumor Results Link Identifier", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9937", - "standardCode": { - "id": "Code_10693", - "extensionAttributes": [], - "code": "C117413", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Link Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_446", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9938", - "standardCode": { - "id": "Code_10694", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_447", - "extensionAttributes": [], - "name": "Test Method", - "label": "Test Method", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9939", - "standardCode": { - "id": "Code_10695", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_448", - "extensionAttributes": [], - "name": "Observation Result", - "label": "Observation Result", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9940", - "standardCode": { - "id": "Code_10696", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_449", - "extensionAttributes": [], - "name": "Tumor Results Reference Identifier", - "label": "Tumor Results Reference Identifier", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9941", - "standardCode": { - "id": "Code_10697", - "extensionAttributes": [], - "code": "C117419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Reference Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_450", - "extensionAttributes": [], - "name": "Tumor Results Group Identifier", - "label": "Tumor Results Group Identifier", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9942", - "standardCode": { - "id": "Code_10698", - "extensionAttributes": [], - "code": "C117411", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Group Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_451", - "extensionAttributes": [], - "name": "Tumor Results Link Group", - "label": "Tumor Results Link Group", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9943", - "standardCode": { - "id": "Code_10699", - "extensionAttributes": [], - "code": "C117412", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Results Link Group", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_452", - "extensionAttributes": [], - "name": "Evaluator Identifier", - "label": "Evaluator Identifier", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9944", - "standardCode": { - "id": "Code_10700", - "extensionAttributes": [], - "code": "C117043", + "code": "C117043", "codeSystem": "http://www.cdisc.org", "codeSystemVersion": "2026-05-26", "decode": "Evaluator Identifier", @@ -13498,9 +12783,9 @@ "id": "BiomedicalConcept_92", "extensionAttributes": [ { - "id": "ExtensionAttribute_56", + "id": "ExtensionAttribute_96", "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BESTRESP", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/OVRLRESP", "instanceType": "ExtensionAttribute" } ], @@ -17579,118 +16864,6 @@ "notes": [], "instanceType": "BiomedicalConcept" }, - { - "id": "BiomedicalConcept_117", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_84", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DLCOVA_RE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Diffusion Capacity of the Lung for Carbon Monoxide/Alveolar Volume Ratio", - "label": "Diffusion Capacity of the Lung for Carbon Monoxide/Alveolar Volume Ratio", - "synonyms": [ - "DLCO/VA", - "DLCOVA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C120830", - "properties": [ - { - "id": "BiomedicalConceptProperty_656", - "extensionAttributes": [], - "name": "REORRES", - "label": "REORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_10190", - "standardCode": { - "id": "Code_10946", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_657", - "extensionAttributes": [], - "name": "REORRESU", - "label": "REORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_10191", - "standardCode": { - "id": "Code_10947", - "extensionAttributes": [], - "code": "C48570", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_658", - "extensionAttributes": [], - "name": "REDTC", - "label": "REDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_10192", - "standardCode": { - "id": "Code_10948", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_10069", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10825", - "extensionAttributes": [], - "code": "C120830", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Diffusion Capacity of the Lung for Carbon Monoxide/Alveolar Volume Ratio", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, { "id": "BiomedicalConcept_118", "extensionAttributes": [ @@ -18656,28 +17829,39 @@ "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConcept_123", - "extensionAttributes": [], - "name": "Pulmonary Function Test", - "label": "Pulmonary Function Test", + "id": "BiomedicalConcept_124", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_90", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MHBRCADIAG", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_91", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MHBRCARELAPSE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Solicited Medical History", + "label": "Solicited Medical History", "synonyms": [ - "Pulmonary Function Test", - "lung function test", - "PFT", - "Pulmonary Function Testing" + "Medical History", + "Medical History Collection" ], - "reference": "/mdr/bc/biomedicalconcepts/C38081", + "reference": "/mdr/bc/biomedicalconcepts/C200145", "properties": [], "code": { - "id": "AliasCode_10226", + "id": "AliasCode_10227", "extensionAttributes": [], "standardCode": { - "id": "Code_10982", + "id": "Code_10983", "extensionAttributes": [], - "code": "C38081", + "code": "C200145", "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Pulmonary Function Test", + "codeSystemVersion": "2026-07-14", + "decode": "Solicited Medical History", "instanceType": "Code" }, "standardCodeAliases": [], @@ -18685,90 +17869,204 @@ }, "notes": [], "instanceType": "BiomedicalConcept" - } - ], - "bcSurrogates": [ - { - "id": "BiomedicalConceptSurrogate_1", - "extensionAttributes": [], - "name": "Magnesium Measurement", - "label": "Magnesium Measurement (C64840)", - "description": "A quantitative measurement of the amount of magnesium present in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64840", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_19", - "extensionAttributes": [], - "name": "Adherence", - "label": "Adherence (C25729)", - "description": "The act of abiding by a stated treatment plan or protocol.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C25729", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_20", - "extensionAttributes": [], - "name": "Patient Compliance", - "label": "Patient Compliance (C39490)", - "description": "The extent to which a patient conforms to medical advice regarding prescribed regimen, lifestyle, dietary changes, follow-up schedule and other recommendations.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C39490", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" }, { - "id": "BiomedicalConceptSurrogate_21", - "extensionAttributes": [], - "name": "Compliance Monitoring", - "label": "Compliance Monitoring (C62737)", - "description": "The act of continuously assessing whether an individual is adhering to their treatment plan.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C62737", + "id": "BiomedicalConcept_125", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_92", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/MGSERPL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Magnesium Measurement", + "label": "Magnesium Measurement", + "synonyms": [ + "Magnesium", + "MG" + ], + "reference": "/mdr/bc/biomedicalconcepts/C64840", + "properties": [], + "code": { + "id": "AliasCode_10228", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10984", + "extensionAttributes": [], + "code": "C64840", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-07-14", + "decode": "Magnesium Measurement", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, "notes": [], - "instanceType": "BiomedicalConceptSurrogate" + "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConceptSurrogate_22", - "extensionAttributes": [], - "name": "Non-Compliance With Study Drug", - "label": "Non-Compliance With Study Drug (C49631)", - "description": "An indication that a subject has not agreed with or followed the instructions related to the study medication. (NCI)", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C49631", + "id": "BiomedicalConcept_126", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_93", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/EXPOSCOLL", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Exposure as Collected Domain", + "label": "Exposure as Collected Domain", + "synonyms": [ + "EC", + "Exposure as Collected" + ], + "reference": "/mdr/bc/biomedicalconcepts/C117466", + "properties": [], + "code": { + "id": "AliasCode_10229", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10985", + "extensionAttributes": [], + "code": "C117466", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2023-10-03", + "decode": "Exposure as Collected Domain", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, "notes": [], - "instanceType": "BiomedicalConceptSurrogate" + "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConceptSurrogate_23", - "extensionAttributes": [], - "name": "Non-Compliance with Study Product", - "label": "Non-Compliance with Study Product (C210354)", - "description": "An indication that a subject has not agreed with or followed the instructions related to the study product.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C210354", + "id": "BiomedicalConcept_127", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_94", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/AEPRESP", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_95", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/AE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Solicited Adverse Event", + "label": "Solicited Adverse Event", + "synonyms": [ + "Adverse Event" + ], + "reference": "/mdr/bc/biomedicalconcepts/C179175", + "properties": [], + "code": { + "id": "AliasCode_10230", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10986", + "extensionAttributes": [], + "code": "C179175", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-07-01", + "decode": "Solicited Adverse Event", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, "notes": [], - "instanceType": "BiomedicalConceptSurrogate" + "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConceptSurrogate_24", - "extensionAttributes": [], - "name": "Trial Compliance", - "label": "Trial Compliance (C142734)", - "description": "Adherence to clinical trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. (ICH)", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C142734", + "id": "BiomedicalConcept_128", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_97", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/HEIGHT", + "instanceType": "ExtensionAttribute" + }, + { + "id": "ExtensionAttribute_99", + "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", + "valueString": "/mdr/specializations/crf/specializations/HEIGHT_DENORMALIZED", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Body Height", + "label": "Body Height", + "synonyms": [ + "HEIGHT" + ], + "reference": "/mdr/bc/biomedicalconcepts/C164634", + "properties": [], + "code": { + "id": "AliasCode_10231", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10987", + "extensionAttributes": [], + "code": "C164634", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-11-18", + "decode": "Body Height", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, "notes": [], - "instanceType": "BiomedicalConceptSurrogate" + "instanceType": "BiomedicalConcept" }, { - "id": "BiomedicalConceptSurrogate_25", - "extensionAttributes": [], - "name": "DLCO", - "label": "DLCO (C38083)", - "description": "The volume of the carbon monoxide that is transferred from inspired air into the pulmonary capillary blood.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38083", + "id": "BiomedicalConcept_129", + "extensionAttributes": [ + { + "id": "ExtensionAttribute_98", + "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", + "valueString": "/mdr/specializations/sdtm/datasetspecializations/DLCO_RE", + "instanceType": "ExtensionAttribute" + } + ], + "name": "Carbon Monoxide Diffusing Capability Test", + "label": "Carbon Monoxide Diffusing Capability Test", + "synonyms": [ + "Diffusion Capacity of Lung for CO", + "DLCO", + "TLCO", + "Transfer Factor of Lung for CO", + "Diffusion Capacity of the Lung for Carbon Monoxide", + "PFT/DLCO", + "Pulmonary Function Test/Carbon Monoxide Diffusing Capability" + ], + "reference": "/mdr/bc/biomedicalconcepts/C38083", + "properties": [], + "code": { + "id": "AliasCode_10232", + "extensionAttributes": [], + "standardCode": { + "id": "Code_10988", + "extensionAttributes": [], + "code": "C38083", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2026-03-31", + "decode": "Carbon Monoxide Diffusing Capability Test", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, "notes": [], - "instanceType": "BiomedicalConceptSurrogate" + "instanceType": "BiomedicalConcept" } ], + "bcSurrogates": [], "bcCategories": [], "eligibilityCriterionItems": [], "narrativeContentItems": [ @@ -20772,5 +20070,5 @@ }, "usdmVersion": "4.0", "systemName": "SOA Workbench", - "systemVersion": "1.6.0" + "systemVersion": "master" } diff --git a/output/json/NCT01797120-usdm-20260716T1134.json b/output/json/NCT01797120-usdm-20260716T1134.json deleted file mode 100644 index ac0703c..0000000 --- a/output/json/NCT01797120-usdm-20260716T1134.json +++ /dev/null @@ -1,14385 +0,0 @@ -{ - "study": { - "id": "Study_60", - "extensionAttributes": [], - "name": "NCT01797120", - "description": "Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).\r\n\r\nFulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy.\r\n\r\nEverolimus is an orally administered drug that blocks a signaling pathway called \"mTOR\". \"mTOR\" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth.\r\n\r\nThe combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.", - "label": "Study of Fulvestrant +/\u200b- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI", - "versions": [ - { - "id": "StudyVersion_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_44", - "url": "http://www.cdisc.org/usdm/extensions/studyDesignSolution", - "valueExtensionClass": { - "id": "ExtensionClass_1", - "url": "http://www.cdisc.org/usdm/extensions/StudyDesignSolution", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_45", - "url": "tool-name", - "valueString": "SoA Workbench", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_46", - "url": "tool-version", - "valueString": "pi-fix-bc-props-specs-in-usdm", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_47", - "url": "usdm-creation-date", - "valueString": "20260716T11:34", - "instanceType": "ExtensionAttribute" - } - ], - "instanceType": "ExtensionClass" - }, - "instanceType": "ExtensionAttribute" - } - ], - "versionIdentifier": "1", - "rationale": "", - "studyIdentifiers": [ - { - "id": "StudyIdentifier_1", - "extensionAttributes": [], - "text": "PrE0102", - "scopeId": "Organization_1", - "instanceType": "StudyIdentifier" - } - ], - "referenceIdentifiers": [], - "studyDesigns": [ - { - "id": "InterventionalStudyDesign_1", - "extensionAttributes": [], - "name": "PrE0102", - "label": "Study of Fulvestrant +/\u200b- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI", - "description": "Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).\r\n\r\nFulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy.\r\n\r\nEverolimus is an orally administered drug that blocks a signaling pathway called \"mTOR\". \"mTOR\" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth.\r\n\r\nThe combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways.", - "studyType": null, - "studyPhase": null, - "therapeuticAreas": [], - "characteristics": [], - "encounters": [ - { - "id": "Encounter_1", - "extensionAttributes": [], - "name": "PRE-STUDY", - "label": "Pre-Study", - "description": "Occuring before Randomization and Treatment", - "type": { - "id": "Code_485", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "Encounter_2", - "scheduledAtId": "Timing_2", - "environmentalSettings": [ - { - "id": "Code_486", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_487", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": { - "id": "TransitionRule_1", - "extensionAttributes": [], - "name": "Screening Exit / Randomization", - "label": "Screening Exit / Randomization", - "description": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", - "text": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_2", - "extensionAttributes": [], - "name": "C1D1", - "label": "Cycle 1 Day 1", - "description": "First day fulvestrant is given with everolimus/placebo; start of Induction Phase. Treatment begins within 7 working days of randomization.", - "type": { - "id": "Code_488", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_1", - "nextId": "Encounter_3", - "scheduledAtId": "Timing_1", - "environmentalSettings": [ - { - "id": "Code_489", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_490", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_2", - "extensionAttributes": [], - "name": "Induction Phase Entry", - "label": "Induction Phase Entry", - "description": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "text": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_3", - "extensionAttributes": [], - "name": "C1D15", - "label": "Cycle 1 Day 15", - "description": "Second fulvestrant dose (Cycle 1 only) plus safety assessments.", - "type": { - "id": "Code_491", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_2", - "nextId": "Encounter_4", - "scheduledAtId": "Timing_3", - "environmentalSettings": [ - { - "id": "Code_492", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_493", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_4", - "extensionAttributes": [], - "name": "C2D1", - "label": "Cycle 2 Day 1", - "description": "Day 1 of Cycle 2 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10038", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_3", - "nextId": "Encounter_5", - "scheduledAtId": "Timing_4", - "environmentalSettings": [ - { - "id": "Code_10039", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10040", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_5", - "extensionAttributes": [], - "name": "C3D1", - "label": "Cycle 3 Day 1", - "description": "Day 1 of Cycle 3 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10041", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_4", - "nextId": "Encounter_6", - "scheduledAtId": "Timing_5", - "environmentalSettings": [ - { - "id": "Code_10042", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10043", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_6", - "extensionAttributes": [], - "name": "C4D1", - "label": "Cycle 4 Day 1", - "description": "Day 1 of Cycle 4 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10044", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_5", - "nextId": "Encounter_7", - "scheduledAtId": "Timing_6", - "environmentalSettings": [ - { - "id": "Code_10045", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10046", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_7", - "extensionAttributes": [], - "name": "C5D1", - "label": "Cycle 5 Day 1", - "description": "Day 1 of Cycle 5 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10047", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_6", - "nextId": "Encounter_8", - "scheduledAtId": "Timing_7", - "environmentalSettings": [ - { - "id": "Code_10048", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10049", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_8", - "extensionAttributes": [], - "name": "C6D1", - "label": "Cycle 6 Day 1", - "description": "Day 1 of Cycle 6 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10050", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_7", - "nextId": "Encounter_9", - "scheduledAtId": "Timing_8", - "environmentalSettings": [ - { - "id": "Code_10051", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10052", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_9", - "extensionAttributes": [], - "name": "C7D1", - "label": "Cycle 7 Day 1", - "description": "Day 1 of Cycle 7 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10053", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_8", - "nextId": "Encounter_10", - "scheduledAtId": "Timing_9", - "environmentalSettings": [ - { - "id": "Code_10054", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10055", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_10", - "extensionAttributes": [], - "name": "C8D1", - "label": "Cycle 8 Day 1", - "description": "Day 1 of Cycle 8 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10056", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_9", - "nextId": "Encounter_11", - "scheduledAtId": "Timing_10", - "environmentalSettings": [ - { - "id": "Code_10057", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10058", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_11", - "extensionAttributes": [], - "name": "C9D1", - "label": "Cycle 9 Day 1", - "description": "Day 1 of Cycle 9 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10059", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_10", - "nextId": "Encounter_12", - "scheduledAtId": "Timing_11", - "environmentalSettings": [ - { - "id": "Code_10060", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10061", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_12", - "extensionAttributes": [], - "name": "C10D1", - "label": "Cycle 10 Day 1", - "description": "Day 1 of Cycle 10 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10062", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_11", - "nextId": "Encounter_13", - "scheduledAtId": "Timing_12", - "environmentalSettings": [ - { - "id": "Code_10063", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10064", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_13", - "extensionAttributes": [], - "name": "C11D1", - "label": "Cycle 11 Day 1", - "description": "Day 1 of Cycle 11 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10065", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_12", - "nextId": "Encounter_14", - "scheduledAtId": "Timing_13", - "environmentalSettings": [ - { - "id": "Code_10069", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10070", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_14", - "extensionAttributes": [], - "name": "C12D1", - "label": "Cycle 12 Day 1", - "description": "Day 1 of Cycle 12 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", - "type": { - "id": "Code_10066", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_13", - "nextId": "Encounter_15", - "scheduledAtId": "Timing_14", - "environmentalSettings": [ - { - "id": "Code_10067", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10068", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_15", - "extensionAttributes": [], - "name": "EOI_EOT", - "label": "End of Induction / End of Treatment", - "description": "Performed within 30 days of last fulvestrant dose, before moving to the Continuation Phase or directly to Follow-Up.", - "type": { - "id": "Code_10071", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_14", - "nextId": "Encounter_16", - "scheduledAtId": "Timing_15", - "environmentalSettings": [ - { - "id": "Code_10072", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10073", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_3", - "extensionAttributes": [], - "name": "Induction Phase Exit", - "label": "Induction Phase Exit", - "description": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_16", - "extensionAttributes": [], - "name": "CONT_CXD1", - "label": "Continuation Phase Cycle Day 1", - "description": "Day 1 of each 28-day cycle in the Continuation Phase (begins D29 after last Cycle 12 fulvestrant dose); fulvestrant +/- everolimus until progression or unacceptable toxicity. This visit repeats indefinitely - the protocol defines no fixed cycle count for the Continuation Phase, so it cannot be enumerated and is modeled as a single repeating visit.", - "type": { - "id": "Code_10074", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_15", - "nextId": "Encounter_17", - "scheduledAtId": "Timing_16", - "environmentalSettings": [ - { - "id": "Code_10075", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10076", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_4", - "extensionAttributes": [], - "name": "Continuation Phase Entry", - "label": "Continuation Phase Entry", - "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_5", - "extensionAttributes": [], - "name": "Continuation Phase Exit", - "label": "Continuation Phase Exit", - "description": "Documented disease progression or unacceptable toxicity.", - "text": "Documented disease progression or unacceptable toxicity.", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_17", - "extensionAttributes": [], - "name": "FU_OFF_THERAPY", - "label": "Follow-Up Off-Therapy", - "description": "Every 3 months for 3 years from randomization; disease progression, survival and new systemic therapy documented.", - "type": { - "id": "Code_10077", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_16", - "nextId": null, - "scheduledAtId": "Timing_17", - "environmentalSettings": [ - { - "id": "Code_10078", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_10079", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2026-03-27", - "codeSystemVersion": "2026-03-27", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_6", - "extensionAttributes": [], - "name": "Follow-Up Off-Therapy Entry", - "label": "Follow-Up Off-Therapy Entry", - "description": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", - "text": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_7", - "extensionAttributes": [], - "name": "Follow-Up Off-Therapy Exit", - "label": "Follow-Up Off-Therapy Exit", - "description": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", - "text": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - } - ], - "activities": [ - { - "id": "Activity_2", - "extensionAttributes": [], - "name": "ELIGIBILITY ASSESSMENT", - "label": "Eligibility Assessment", - "description": "Determine subject meets eligibility requirements", - "previousId": null, - "nextId": "Activity_1", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_2" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_1", - "extensionAttributes": [], - "name": "INFORMED CONSENT", - "label": "Informed Consent", - "description": "Informed Consent collected", - "previousId": "Activity_2", - "nextId": "Activity_19", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_1" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_19", - "extensionAttributes": [], - "name": "RANDOMIZATION", - "label": "Randomization", - "description": "Randomization", - "previousId": "Activity_1", - "nextId": "Activity_3", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_51" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_3", - "extensionAttributes": [], - "name": "MEDICAL HISTORY", - "label": "Medical History", - "description": "Medical History & Assessment of Baseline Signs and Symptoms", - "previousId": "Activity_19", - "nextId": "Activity_5", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_3", - "BiomedicalConcept_4" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_5", - "extensionAttributes": [], - "name": "PHYSICAL EXAM", - "label": "Physical Examination", - "description": "Physical Examination", - "previousId": "Activity_3", - "nextId": "Activity_18", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_6" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_18", - "extensionAttributes": [], - "name": "CONCOMITANT MEDS", - "label": "Concomitant Medications", - "description": "Concomitant Medications", - "previousId": "Activity_5", - "nextId": "Activity_6", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_49", - "BiomedicalConcept_50" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_6", - "extensionAttributes": [], - "name": "VITAL SIGNS", - "label": "Vital Signs", - "description": "Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight", - "previousId": "Activity_18", - "nextId": "Activity_4", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_7", - "BiomedicalConcept_8", - "BiomedicalConcept_9", - "BiomedicalConcept_10", - "BiomedicalConcept_11" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_4", - "extensionAttributes": [], - "name": "ECOG PERFORMANCE STATUS", - "label": "ECOG Performance Status", - "description": "ECOG performance status", - "previousId": "Activity_6", - "nextId": "Activity_17", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_5", - "BiomedicalConcept_60" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_17", - "extensionAttributes": [], - "name": "ADVERSE EVENTS ASSESSMENTS", - "label": "Adverse Event Assessment", - "description": "Adverse Event Assessment", - "previousId": "Activity_4", - "nextId": "Activity_22", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_47", - "BiomedicalConcept_48" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_22", - "extensionAttributes": [], - "name": "IMAGING SCANS", - "label": "Imaging Scans", - "description": "Tumor imaging scans", - "previousId": "Activity_17", - "nextId": "Activity_23", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_73", - "BiomedicalConcept_74", - "BiomedicalConcept_75", - "BiomedicalConcept_76", - "BiomedicalConcept_77" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_23", - "extensionAttributes": [], - "name": "PT/INR", - "label": "PT with INR", - "description": "prothrombin time and international normalized ratio", - "previousId": "Activity_22", - "nextId": "Activity_10", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_52", - "BiomedicalConcept_53", - "BiomedicalConcept_54" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_10", - "extensionAttributes": [], - "name": "URINALYSIS", - "label": "Urinalysis Labs", - "description": "Urinalysis Labs", - "previousId": "Activity_23", - "nextId": "Activity_24", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_26", - "BiomedicalConcept_27", - "BiomedicalConcept_28" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_24", - "extensionAttributes": [], - "name": "CBC", - "label": "CBC with differentials, Platelets", - "description": "CBC with differentials, Platelets", - "previousId": "Activity_10", - "nextId": "Activity_8", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_61", - "BiomedicalConcept_62", - "BiomedicalConcept_63" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_8", - "extensionAttributes": [], - "name": "CHEMISTRY LABS", - "label": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", - "description": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", - "previousId": "Activity_24", - "nextId": "Activity_25", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_18", - "BiomedicalConcept_19", - "BiomedicalConcept_20", - "BiomedicalConcept_21", - "BiomedicalConcept_22", - "BiomedicalConcept_64", - "BiomedicalConcept_65", - "BiomedicalConcept_66", - "BiomedicalConcept_67", - "BiomedicalConcept_68", - "BiomedicalConcept_69", - "BiomedicalConcept_70", - "BiomedicalConcept_71", - "BiomedicalConcept_72" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_1", - "BiomedicalConceptSurrogate_8" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_25", - "extensionAttributes": [], - "name": "GLUCOSE", - "label": "Fasting Glucose", - "description": "Fasting Glucose", - "previousId": "Activity_8", - "nextId": "Activity_26", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_55" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_26", - "extensionAttributes": [], - "name": "LIPID PROFILE", - "label": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", - "description": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", - "previousId": "Activity_25", - "nextId": "Activity_27", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_56", - "BiomedicalConcept_57", - "BiomedicalConcept_58", - "BiomedicalConcept_59" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_27", - "extensionAttributes": [], - "name": "HBV-DNA-1", - "label": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV- RNA-PCR", - "description": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV- RNA-PCR", - "previousId": "Activity_26", - "nextId": "Activity_28", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_2", - "BiomedicalConceptSurrogate_3", - "BiomedicalConceptSurrogate_4", - "BiomedicalConceptSurrogate_5", - "BiomedicalConceptSurrogate_6" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_28", - "extensionAttributes": [], - "name": "HBV-DNA-2", - "label": "HBV DNA", - "description": "HBV DNA", - "previousId": "Activity_27", - "nextId": "Activity_29", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_2" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_29", - "extensionAttributes": [], - "name": "HCV", - "label": "HCV RNA-PCR", - "description": "HCV RNA-PCR", - "previousId": "Activity_28", - "nextId": "Activity_30", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_6" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_30", - "extensionAttributes": [], - "name": "COMPLIANCE", - "label": "Study Drug Compliance (Pill Diary)", - "description": "Study Drug Compliance (Pill Diary)", - "previousId": "Activity_29", - "nextId": "Activity_31", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_19", - "BiomedicalConceptSurrogate_20", - "BiomedicalConceptSurrogate_21", - "BiomedicalConceptSurrogate_22", - "BiomedicalConceptSurrogate_23", - "BiomedicalConceptSurrogate_24" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_31", - "extensionAttributes": [], - "name": "PFTS", - "label": "PFTs with DLCO as medically indicatedn", - "description": "PFTs with DLCO as medically indicatedn", - "previousId": "Activity_30", - "nextId": null, - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_7" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - } - ], - "arms": [ - { - "id": "StudyArm_1", - "extensionAttributes": [], - "name": "ARM A", - "label": "Fulvestrant + Everolimus", - "description": "Fulvestrant 500mg IM Q28D (loading D1/D15) + Everolimus 10mg PO QD", - "type": { - "id": "Code_4", - "extensionAttributes": [], - "code": "C174266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Experimental Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_5", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - }, - { - "id": "StudyArm_2", - "extensionAttributes": [], - "name": "ARM B", - "label": "Fulvestrant + Placebo", - "description": "Fulvestrant 500mg IM Q28D (loading D1/D15) + Placebo PO QD", - "type": { - "id": "Code_6", - "extensionAttributes": [], - "code": "C174268", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Placebo Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_7", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - } - ], - "studyCells": [ - { - "id": "StudyCell_1", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_2", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_7", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_4" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_8", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_6" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_9", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_10", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_11", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_5" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_12", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_6" - ], - "instanceType": "StudyCell" - } - ], - "rationale": "", - "epochs": [ - { - "id": "StudyEpoch_1", - "extensionAttributes": [], - "name": "Pre-Study Phase", - "label": "Pre-Study Phase", - "description": "Eligibility assessment, up to 28 days prior to C1D1", - "type": { - "id": "Code_1", - "extensionAttributes": [], - "code": "C202487", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "SCREENING", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "StudyEpoch_2", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_2", - "extensionAttributes": [], - "name": "Induction Phase", - "label": "Induction Phase", - "description": "From C1D1 until disease progression or discontinuation", - "type": { - "id": "Code_2", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_1", - "nextId": "StudyEpoch_4", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_4", - "extensionAttributes": [], - "name": "Continuation Phase", - "label": "Continuation Phase", - "description": "Continuation Phase (until progression or unacceptable toxicity", - "type": { - "id": "Code_813", - "extensionAttributes": [], - "code": "C123452", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "CONTINUATION TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_2", - "nextId": "StudyEpoch_3", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_3", - "extensionAttributes": [], - "name": "Follow-up Off Therapy", - "label": "Follow-up, off therapy", - "description": "Post-EOT survival and safety follow-up", - "type": { - "id": "Code_3", - "extensionAttributes": [], - "code": "C202578", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "FOLLOW-UP", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_4", - "nextId": null, - "notes": [], - "instanceType": "StudyEpoch" - } - ], - "elements": [ - { - "id": "StudyElement_1", - "extensionAttributes": [], - "name": "SCREENING_ELEMENT", - "label": "Screening", - "description": "Pre-study eligibility and baseline assessment period (within 4 weeks of randomization).", - "transitionStartRule": null, - "transitionEndRule": { - "id": "TransitionRule_1", - "extensionAttributes": [], - "name": "Screening Exit / Randomization", - "label": "Screening Exit / Randomization", - "description": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", - "text": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_2", - "extensionAttributes": [], - "name": "INDUCTION_EVE_FUL", - "label": "Induction: Fulvestrant + Everolimus", - "description": "Induction treatment for Arm A: fulvestrant 500 mg IM (D1 & D15 of Cycle 1, then D1 each cycle) plus everolimus 10 mg PO daily, 28-day cycles, max 12 cycles.", - "transitionStartRule": { - "id": "TransitionRule_2", - "extensionAttributes": [], - "name": "Induction Phase Entry", - "label": "Induction Phase Entry", - "description": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "text": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_3", - "extensionAttributes": [], - "name": "Induction Phase Exit", - "label": "Induction Phase Exit", - "description": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [ - "StudyIntervention_3" - ], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_3", - "extensionAttributes": [], - "name": "INDUCTION_PBO_FUL", - "label": "Induction: Fulvestrant + Placebo", - "description": "Induction treatment for Arm B: fulvestrant 500 mg IM (D1 & D15 of Cycle 1, then D1 each cycle) plus placebo PO daily, 28-day cycles, max 12 cycles.", - "transitionStartRule": { - "id": "TransitionRule_2", - "extensionAttributes": [], - "name": "Induction Phase Entry", - "label": "Induction Phase Entry", - "description": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "text": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_3", - "extensionAttributes": [], - "name": "Induction Phase Exit", - "label": "Induction Phase Exit", - "description": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [ - "StudyIntervention_4" - ], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_4", - "extensionAttributes": [], - "name": "CONTINUATION_EVE_FUL", - "label": "Continuation: Fulvestrant + Everolimus", - "description": "Continuation treatment for patients originally randomized to everolimus: fulvestrant 500 mg IM D1 every 28-day cycle plus everolimus, until progression or unacceptable toxicity.", - "transitionStartRule": { - "id": "TransitionRule_4", - "extensionAttributes": [], - "name": "Continuation Phase Entry", - "label": "Continuation Phase Entry", - "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_5", - "extensionAttributes": [], - "name": "Continuation Phase Exit", - "label": "Continuation Phase Exit", - "description": "Documented disease progression or unacceptable toxicity.", - "text": "Documented disease progression or unacceptable toxicity.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [ - "StudyIntervention_3" - ], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_5", - "extensionAttributes": [], - "name": "CONTINUATION_FUL", - "label": "Continuation: Fulvestrant alone", - "description": "Continuation treatment for patients originally randomized to placebo: fulvestrant 500 mg IM D1 every 28-day cycle alone, until progression or unacceptable toxicity.", - "transitionStartRule": { - "id": "TransitionRule_4", - "extensionAttributes": [], - "name": "Continuation Phase Entry", - "label": "Continuation Phase Entry", - "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_5", - "extensionAttributes": [], - "name": "Continuation Phase Exit", - "label": "Continuation Phase Exit", - "description": "Documented disease progression or unacceptable toxicity.", - "text": "Documented disease progression or unacceptable toxicity.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [ - "StudyIntervention_5" - ], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_6", - "extensionAttributes": [], - "name": "FOLLOW_UP_ELEMENT", - "label": "Follow-Up Off-Therapy", - "description": "Off-therapy follow-up for disease progression and survival, every 3 months for 3 years from randomization.", - "transitionStartRule": { - "id": "TransitionRule_6", - "extensionAttributes": [], - "name": "Follow-Up Off-Therapy Entry", - "label": "Follow-Up Off-Therapy Entry", - "description": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", - "text": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_7", - "extensionAttributes": [], - "name": "Follow-Up Off-Therapy Exit", - "label": "Follow-Up Off-Therapy Exit", - "description": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", - "text": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - } - ], - "estimands": [ - { - "id": "Estimand_1", - "extensionAttributes": [], - "name": "Estimand for Progression-Free Survival (PFS)", - "label": "Primary Estimand", - "description": "Comparison of PFS between fulvestrant plus everolimus versus fulvestrant plus placebo in AI-resistant HR+ metastatic breast cancer. Constructed retrospectively per ICH E9(R1); this protocol predates the 2019 addendum.", - "populationSummary": "Post-menopausal women with HR+ (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy; ECOG PS 0-1; no prior mTOR inhibitor; up to one prior systemic chemotherapy for metastatic disease. Randomized 1:1; approximately 120 eligible patients.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_1", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_1", - "extensionAttributes": [], - "name": "Death before documented progression", - "label": "Death before documented progression", - "description": null, - "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", - "strategy": "Composite: death is included as a PFS event (composite endpoint definition per \u00a76.1.6). The time-to-event variable captures whichever occurs first: progression or death.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_2", - "extensionAttributes": [], - "name": "Discontinuation of everolimus due to toxicity", - "label": "Discontinuation of everolimus due to toxicity", - "description": null, - "text": "Patient permanently discontinues everolimus or placebo due to an adverse event but continues on fulvestrant monotherapy.", - "strategy": "Treatment-policy: patient remains on study and continues fulvestrant alone per \u00a75.5. Follow-up for progression and survival continues. PFS events occurring after everolimus discontinuation are included in the primary analysis regardless of treatment status.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_3", - "extensionAttributes": [], - "name": "Withdrawal of consent or loss to follow-up", - "label": "Withdrawal of consent or loss to follow-up", - "description": null, - "text": "Patient withdraws consent or is lost to follow-up before a PFS event is documented.", - "strategy": "Hypothetical (censoring): patient is censored at the date of last tumor assessment. The estimand implicitly assumes non-informative censoring \u2014 that censored patients would have experienced events at the same rate as those who remained in follow-up.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_4", - "extensionAttributes": [], - "name": "Initiation of prohibited anti-cancer therapy before progression", - "label": "Initiation of prohibited anti-cancer therapy before progression", - "description": null, - "text": "Patient receives a prohibited anti-cancer agent before disease progression is documented.", - "strategy": "Treatment-policy: protocol prohibits new anti-cancer agents before progression (\u00a75.3.4). If such a violation occurred, the patient would remain in the analysis with events counted as observed. No censoring at time of prohibited therapy initiation is specified.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_2", - "extensionAttributes": [], - "name": "Estimand for Overall Survival (OS)", - "label": "Secondary Estimand \u2014 OS", - "description": "Comparison of overall survival between treatment arms. Descriptive; no pre-specified alpha or power.", - "populationSummary": "All randomized eligible patients (same as PFS estimand population).", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_2", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_5", - "extensionAttributes": [], - "name": "Discontinuation of study treatment (any reason)", - "label": "Discontinuation of study treatment (any reason)", - "description": null, - "text": "Patient permanently discontinues all study treatment due to disease progression, toxicity, or other reasons.", - "strategy": "Treatment-policy: all patients who discontinue treatment are followed for survival per \u00a75.5. Deaths after treatment cessation are counted as OS events regardless of reason for discontinuation.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_6", - "extensionAttributes": [], - "name": "Initiation of subsequent anti-cancer therapy after progression", - "label": "Initiation of subsequent anti-cancer therapy after progression", - "description": null, - "text": "Patient initiates a new anti-cancer regimen after disease progression on study treatment.", - "strategy": "Treatment-policy: OS reflects real-world outcome including the effect of any subsequent therapies. No censoring or adjustment for post-progression treatment is specified.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_7", - "extensionAttributes": [], - "name": "Withdrawal of consent or loss to follow-up", - "label": "Withdrawal of consent or loss to follow-up", - "description": null, - "text": "Patient withdraws consent or cannot be contacted for survival follow-up.", - "strategy": "Hypothetical (censoring): patient is censored at date of last known alive contact. Non-informative censoring assumed.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_3", - "extensionAttributes": [], - "name": "Estimand for Time to Progression (TTP)", - "label": "Secondary Estimand \u2014 TTP", - "description": "Comparison of time to disease progression, excluding deaths as events. Descriptive.", - "populationSummary": "All randomized eligible patients (same as PFS estimand population).", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_3", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_8", - "extensionAttributes": [], - "name": "Death before documented progression", - "label": "Death before documented progression", - "description": null, - "text": "Patient dies from any cause before radiological disease progression has been documented per RECIST v1.1.", - "strategy": "Hypothetical (censoring): death without prior progression results in censoring at time of death. This reflects the hypothetical question 'what would the time to progression have been if the patient had not died?' \u2014 the key mechanistic distinction from the PFS estimand.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_9", - "extensionAttributes": [], - "name": "Discontinuation of study treatment", - "label": "Discontinuation of study treatment (any reason)", - "description": null, - "text": "Patient permanently discontinues study treatment before disease progression.", - "strategy": "Treatment-policy: follow-up for progression continues after treatment discontinuation per \u00a75.5. TTP events occurring after treatment cessation are included.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_4", - "extensionAttributes": [], - "name": "Estimand for Objective Response Rate (ORR)", - "label": "Secondary Estimand \u2014 ORR", - "description": "Between-arm comparison of the proportion of patients achieving confirmed CR or PR in patients with measurable disease. Descriptive.", - "populationSummary": "Subset of randomized eligible patients with at least one measurable lesion at baseline per RECIST v1.1.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_4", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_10", - "extensionAttributes": [], - "name": "Death or progression before first response assessment", - "label": "Death or progression before first response assessment", - "description": null, - "text": "Patient dies or has documented progression before achieving CR or PR at any post-baseline tumor assessment.", - "strategy": "Composite: patients who die or progress without ever achieving a confirmed CR or PR are counted as non-responders in the ORR denominator.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_11", - "extensionAttributes": [], - "name": "Treatment discontinuation before response assessment", - "label": "Treatment discontinuation before response assessment", - "description": null, - "text": "Patient discontinues all study treatment before a post-baseline tumor assessment confirming CR or PR.", - "strategy": "Treatment-policy: patients who discontinue without a prior confirmed response are counted as non-responders. No censoring at time of treatment discontinuation.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_5", - "extensionAttributes": [], - "name": "Estimand for Clinical Benefit Rate (CBR)", - "label": "Secondary Estimand \u2014 CBR", - "description": "Between-arm comparison of the proportion of patients with CR, PR, or SD maintained for at least 6 months. Descriptive.", - "populationSummary": "All randomized eligible patients including those with measurable and non-measurable disease.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_5", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_12", - "extensionAttributes": [], - "name": "Death or progression before 6-month stable disease threshold", - "label": "Death or progression before 6-month stable disease threshold", - "description": null, - "text": "Patient dies or has documented progression before 6 months of confirmed stable disease, partial response, or complete response.", - "strategy": "Composite: patients who do not achieve and maintain CR, PR, or SD for at least 6 months are counted as not deriving clinical benefit, regardless of cause.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_13", - "extensionAttributes": [], - "name": "Treatment discontinuation before 6-month landmark", - "label": "Treatment discontinuation before 6-month landmark", - "description": null, - "text": "Patient discontinues study treatment before the 6-month landmark required for SD to qualify as clinical benefit.", - "strategy": "Treatment-policy: patients who discontinue and lack tumor assessment confirming \u22656 months of SD are counted as non-responders for CBR.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - }, - { - "id": "Estimand_6", - "extensionAttributes": [], - "name": "Estimand for Safety and Tolerability", - "label": "Secondary Estimand \u2014 Safety", - "description": "Descriptive characterization of the incidence and severity of adverse events in the safety-evaluable population. No formal hypothesis test.", - "populationSummary": "All patients who received at least one dose of any study treatment. Approximately 65 patients per arm.", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_6", - "interventionIds": [ - "StudyIntervention_1", - "StudyIntervention_2" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_14", - "extensionAttributes": [], - "name": "Treatment discontinuation", - "label": "Treatment discontinuation", - "description": null, - "text": "Patient permanently discontinues study treatment. AE collection continues for 30 days after last dose of any study drug per \u00a75.5.", - "strategy": "While-on-treatment: TEAEs are collected only during the treatment period and the 30-day post-treatment follow-up window. Adverse events occurring beyond this window are not captured as TEAEs in the primary safety analysis.", - "notes": [], - "instanceType": "IntercurrentEvent" - }, - { - "id": "IntercurrentEvent_15", - "extensionAttributes": [], - "name": "Dose reduction or interruption of everolimus", - "label": "Dose reduction or interruption of everolimus", - "description": null, - "text": "Patient undergoes dose modification (reduction or temporary interruption) of everolimus or placebo per protocol dose-modification rules.", - "strategy": "Treatment-policy: AEs that prompt dose modification are recorded regardless of the modification. Events are attributed to the randomized treatment arm and included in the safety summary as observed.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - } - ], - "indications": [ - { - "id": "Indication_1", - "extensionAttributes": [], - "name": "Hormone Receptor-Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", - "label": "HR+ AI-Resistant Metastatic Breast Cancer", - "description": "Post-menopausal women with hormone-receptor positive (ER/PR+, HER2-negative) stage IV or inoperable locally advanced breast cancer that is resistant to aromatase inhibitor therapy, defined as relapse while receiving adjuvant AI or progressive disease while receiving an AI for metastatic disease.", - "isRareDisease": false, - "codes": [ - { - "id": "Code_7947", - "extensionAttributes": [], - "code": "C9246", - "codeSystem": "http://ncithesaurus.nci.nih.gov", - "codeSystemVersion": "24.04e", - "decode": "Hormone Receptor-Positive Breast Carcinoma", - "instanceType": "Code" - }, - { - "id": "Code_7948", - "extensionAttributes": [], - "code": "C7771", - "codeSystem": "http://ncithesaurus.nci.nih.gov", - "codeSystemVersion": "24.04e", - "decode": "Metastatic Breast Carcinoma", - "instanceType": "Code" - } - ], - "notes": [], - "instanceType": "Indication" - } - ], - "studyInterventionIds": [ - "StudyIntervention_3", - "StudyIntervention_4", - "StudyIntervention_5" - ], - "objectives": [ - { - "id": "Objective_1", - "extensionAttributes": [], - "name": "Primary Objective", - "label": "Primary Objective", - "description": "To assess progression-free survival in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone.", - "text": "", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2355", - "extensionAttributes": [], - "code": "C85826", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C85826", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_1", - "extensionAttributes": [], - "name": "Progression-Free Survival (PFS)", - "label": "Progression-Free Survival (PFS)", - "description": "Time from randomization to documented disease progression or death, whichever occurs first. Subjects who have neither progressed nor died are censored at the date of last tumor assessment. Disease progression assessed per RECIST v1.1.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To demonstrate that the addition of everolimus to fulvestrant improves PFS compared to fulvestrant plus placebo (hypothesized median PFS improvement from 5.4 to 9.2 months; HR \u2248 0.59).", - "level": { - "id": "Code_2356", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_2", - "extensionAttributes": [], - "name": "Secondary Objective", - "label": "Secondary Objective", - "description": "To describe the safety profile, objective response rate, time to progression, and overall survival in this patient population.", - "text": "", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2357", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_2", - "extensionAttributes": [], - "name": "Overall Survival (OS)", - "label": "Overall Survival (OS)", - "description": "Time from randomization until death from any cause. Subjects alive at the time of analysis are censored at the date of last follow-up.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To characterize overall survival in the two treatment arms.", - "level": { - "id": "Code_2358", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_3", - "extensionAttributes": [], - "name": "Time to Progression (TTP)", - "label": "Time to Progression (TTP)", - "description": "Time from randomization until objective disease progression per RECIST v1.1. Unlike PFS, deaths without prior progression are not counted as events (subjects are censored at time of death).", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To estimate and compare median time to disease progression between treatment arms.", - "level": { - "id": "Code_2359", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_4", - "extensionAttributes": [], - "name": "Objective Response Rate (ORR)", - "label": "Objective Response Rate (ORR)", - "description": "Proportion of patients with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1. Assessed in patients with measurable disease at baseline.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To compare the proportion of patients achieving an objective tumor response between treatment arms.", - "level": { - "id": "Code_2360", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_5", - "extensionAttributes": [], - "name": "Clinical Benefit Rate (CBR)", - "label": "Clinical Benefit Rate (CBR)", - "description": "Proportion of patients with stable disease (SD) for \u22656 months, partial response (PR), or complete response (CR) \u2014 i.e., CR + PR + SD \u2265 6 months \u2014 per RECIST v1.1.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To compare the proportion of patients deriving clinical benefit (response or prolonged stable disease) between treatment arms.", - "level": { - "id": "Code_2361", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_6", - "extensionAttributes": [], - "name": "Safety and Tolerability", - "label": "Safety and Tolerability", - "description": "Incidence, severity (CTCAE v4.0 grade), and type of adverse events, including overall toxicity, grade 3\u20134 toxicities, serious adverse events (SAEs), and second primary cancers. Assessed in all patients who received at least one dose of study treatment.", - "text": "", - "dictionaryId": null, - "notes": [], - "purpose": "To characterize and compare the safety profile of fulvestrant plus everolimus versus fulvestrant plus placebo.", - "level": { - "id": "Code_2362", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - } - ], - "population": { - "id": "StudyDesignPopulation_1", - "extensionAttributes": [], - "name": "Population_1", - "label": null, - "description": null, - "includesHealthySubjects": false, - "plannedEnrollmentNumber": null, - "plannedCompletionNumber": null, - "plannedSex": [], - "criterionIds": [], - "plannedAge": null, - "notes": [], - "cohorts": [], - "instanceType": "StudyDesignPopulation" - }, - "scheduleTimelines": [ - { - "id": "ScheduleTimeline_1", - "extensionAttributes": [], - "name": "MAIN_TIMELINE", - "label": "PrE0102 Main Schedule of Activities Timeline", - "description": "Main timeline spanning Screening, Induction (max 12 x 28-day cycles), Continuation and Follow-Up.", - "mainTimeline": true, - "entryCondition": "Patient randomized 1:1 to Arm A (fulvestrant + everolimus) or Arm B (fulvestrant + placebo).", - "entryId": "ScheduledActivityInstance_1", - "exits": [], - "timings": [ - { - "id": "Timing_1", - "extensionAttributes": [], - "name": "C1D1_ANCHOR", - "label": "Cycle 1 Day 1 (anchor)", - "description": "Cycle 1 Day 1 (anchor)", - "type": { - "id": "Code_10080", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "P0D", - "valueLabel": "Day 1", - "relativeToFrom": { - "id": "Code_10081", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_2", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_2", - "extensionAttributes": [], - "name": "SCREEN_WINDOW", - "label": "Within 4 weeks before C1D1", - "description": "Within 4 weeks before C1D1", - "type": { - "id": "Code_10082", - "extensionAttributes": [], - "code": "C201357", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Before", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "Up to 28 days before", - "relativeToFrom": { - "id": "Code_10083", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_1", - "windowLower": "P0D", - "windowUpper": "P28D", - "windowLabel": "<= 4 weeks before C1D1", - "instanceType": "Timing" - }, - { - "id": "Timing_3", - "extensionAttributes": [], - "name": "C1D15_OFFSET", - "label": "14 days after C1D1", - "description": "14 days after C1D1", - "type": { - "id": "Code_10084", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P14D", - "valueLabel": "Day 15", - "relativeToFrom": { - "id": "Code_10085", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_4", - "extensionAttributes": [], - "name": "C2D1_OFFSET", - "label": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", - "description": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", - "type": { - "id": "Code_10086", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10087", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_4", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_5", - "extensionAttributes": [], - "name": "C3D1_OFFSET", - "label": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", - "description": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", - "type": { - "id": "Code_10088", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10089", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_4", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_5", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_6", - "extensionAttributes": [], - "name": "C4D1_OFFSET", - "label": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", - "description": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", - "type": { - "id": "Code_10090", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10091", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_5", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_6", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_7", - "extensionAttributes": [], - "name": "C5D1_OFFSET", - "label": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", - "description": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", - "type": { - "id": "Code_10092", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10093", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_6", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_7", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_8", - "extensionAttributes": [], - "name": "C6D1_OFFSET", - "label": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", - "description": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", - "type": null, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10094", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_7", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_8", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_9", - "extensionAttributes": [], - "name": "C7D1_OFFSET", - "label": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", - "description": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", - "type": null, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10095", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_8", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_9", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_10", - "extensionAttributes": [], - "name": "C8D1_OFFSET", - "label": "Cycle 8 Day 1 (28 days after Cycle 7 Day 1)", - "description": "Cycle 8 Day 1 (28 days after Cycle 7 Day 1)", - "type": { - "id": "Code_10096", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10097", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_9", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_10", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_11", - "extensionAttributes": [], - "name": "C9D1_OFFSET", - "label": "Cycle 9 Day 1 (28 days after Cycle 8 Day 1)", - "description": "Cycle 9 Day 1 (28 days after Cycle 8 Day 1)", - "type": { - "id": "Code_10098", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10099", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_10", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_11", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_12", - "extensionAttributes": [], - "name": "C10D1_OFFSET", - "label": "Cycle 10 Day 1 (28 days after Cycle 9 Day 1)", - "description": "Cycle 10 Day 1 (28 days after Cycle 9 Day 1)", - "type": { - "id": "Code_10100", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10101", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_11", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_12", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_13", - "extensionAttributes": [], - "name": "C11D1_OFFSET", - "label": "Cycle 11 Day 1 (28 days after Cycle 10 Day 1)", - "description": "Cycle 11 Day 1 (28 days after Cycle 10 Day 1)", - "type": { - "id": "Code_10102", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10103", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_12", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_13", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_14", - "extensionAttributes": [], - "name": "C12D1_OFFSET", - "label": "Cycle 12 Day 1 (28 days after Cycle 11 Day 1)", - "description": "Cycle 12 Day 1 (28 days after Cycle 11 Day 1)", - "type": { - "id": "Code_10104", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "28 Days", - "relativeToFrom": { - "id": "Code_10105", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_13", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_14", - "windowLower": "-PT72H", - "windowUpper": "PT72H", - "windowLabel": "+/- 72 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_15", - "extensionAttributes": [], - "name": "EOI_OFFSET", - "label": "End of Induction", - "description": "End of Induction", - "type": { - "id": "Code_10106", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P30D", - "valueLabel": "within 30 days of last dose", - "relativeToFrom": { - "id": "Code_10107", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_14", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_15", - "windowLower": "P0D", - "windowUpper": "P30D", - "windowLabel": "within 30 days of last fulvestrant dose", - "instanceType": "Timing" - }, - { - "id": "Timing_16", - "extensionAttributes": [], - "name": "CONT_OFFSET", - "label": "Continuation Day 1", - "description": "Continuation Day 1", - "type": { - "id": "Code_10108", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P28D", - "valueLabel": "D29 after last Cycle 12 dose", - "relativeToFrom": { - "id": "Code_10109", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_14", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_16", - "windowLower": "-P7D", - "windowUpper": "P7D", - "windowLabel": "+/- 1 week", - "instanceType": "Timing" - }, - { - "id": "Timing_17", - "extensionAttributes": [], - "name": "FU_OFFSET", - "label": "Every 3 months follow-up", - "description": "Every 3 months follow-up", - "type": { - "id": "Code_10110", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P84D", - "valueLabel": "Every 3 months (12 weeks)", - "relativeToFrom": { - "id": "Code_10111", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_16", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_17", - "windowLower": "-P7D", - "windowUpper": "P7D", - "windowLabel": "+/- 1 week", - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_1", - "extensionAttributes": [], - "name": "SAI_PRESTUDY", - "label": "Pre-Study", - "description": "Pre-Study", - "defaultConditionId": "ScheduledActivityInstance_2", - "epochId": "StudyEpoch_1", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_1" - }, - { - "id": "ScheduledActivityInstance_2", - "extensionAttributes": [], - "name": "SAI_C1D1", - "label": "Cycle 1 Day 1", - "description": "Cycle 1 Day 1", - "defaultConditionId": "ScheduledActivityInstance_3", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_2" - }, - { - "id": "ScheduledActivityInstance_3", - "extensionAttributes": [], - "name": "SAI_C1D15", - "label": "Cycle 1 Day 15", - "description": "Cycle 1 Day 15", - "defaultConditionId": "ScheduledActivityInstance_4", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_3" - }, - { - "id": "ScheduledActivityInstance_4", - "extensionAttributes": [], - "name": "SAI_C2D1", - "label": "Cycle 2 Day 1", - "description": "Cycle 2 Day 1", - "defaultConditionId": "ScheduledActivityInstance_5", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_4" - }, - { - "id": "ScheduledActivityInstance_5", - "extensionAttributes": [], - "name": "SAI_C3D1", - "label": "Cycle 3 Day 1", - "description": "Cycle 3 Day 1", - "defaultConditionId": "ScheduledActivityInstance_6", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_5" - }, - { - "id": "ScheduledActivityInstance_6", - "extensionAttributes": [], - "name": "SAI_C4D1", - "label": "Cycle 4 Day 1", - "description": "Cycle 4 Day 1", - "defaultConditionId": "ScheduledActivityInstance_7", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_6" - }, - { - "id": "ScheduledActivityInstance_7", - "extensionAttributes": [], - "name": "SAI_C5D1", - "label": "Cycle 5 Day 1", - "description": "Cycle 5 Day 1", - "defaultConditionId": "ScheduledActivityInstance_8", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_7" - }, - { - "id": "ScheduledActivityInstance_8", - "extensionAttributes": [], - "name": "SAI_C6D1", - "label": "Cycle 6 Day 1", - "description": "Cycle 6 Day 1", - "defaultConditionId": "ScheduledActivityInstance_9", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_8" - }, - { - "id": "ScheduledActivityInstance_9", - "extensionAttributes": [], - "name": "SAI_C7D1", - "label": "Cycle 7 Day 1", - "description": "Cycle 7 Day 1", - "defaultConditionId": "ScheduledActivityInstance_10", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_9" - }, - { - "id": "ScheduledActivityInstance_10", - "extensionAttributes": [], - "name": "SAI_C8D1", - "label": "Cycle 8 Day 1", - "description": "Cycle 8 Day 1", - "defaultConditionId": "ScheduledActivityInstance_11", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_10" - }, - { - "id": "ScheduledActivityInstance_11", - "extensionAttributes": [], - "name": "SAI_C9D1", - "label": "Cycle 9 Day 1", - "description": "Cycle 9 Day 1", - "defaultConditionId": "ScheduledActivityInstance_12", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_11" - }, - { - "id": "ScheduledActivityInstance_12", - "extensionAttributes": [], - "name": "SAI_C10D1", - "label": "Cycle 10 Day 1", - "description": "Cycle 10 Day 1", - "defaultConditionId": "ScheduledActivityInstance_13", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_12" - }, - { - "id": "ScheduledActivityInstance_13", - "extensionAttributes": [], - "name": "SAI_C11D1", - "label": "Cycle 11 Day 1", - "description": "Cycle 11 Day 1", - "defaultConditionId": "ScheduledActivityInstance_14", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_13" - }, - { - "id": "ScheduledActivityInstance_14", - "extensionAttributes": [], - "name": "SAI_C12D1", - "label": "Cycle 12 Day 1", - "description": "Cycle 12 Day 1", - "defaultConditionId": "ScheduledActivityInstance_15", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_14" - }, - { - "id": "ScheduledActivityInstance_15", - "extensionAttributes": [], - "name": "SAI_EOI", - "label": "End of Induction / End of Treatment", - "description": "End of Induction / End of Treatment", - "defaultConditionId": "ScheduledDecisionInstance_1", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_15" - }, - { - "id": "ScheduledActivityInstance_16", - "extensionAttributes": [], - "name": "SAI_CONT", - "label": "Continuation Phase Cycle Day 1", - "description": "Continuation Phase Cycle Day 1", - "defaultConditionId": "ScheduledDecisionInstance_2", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_16" - }, - { - "id": "ScheduledActivityInstance_17", - "extensionAttributes": [], - "name": "SAI_FU", - "label": "Follow-Up Off-Therapy", - "description": "Follow-Up Off-Therapy", - "defaultConditionId": null, - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": "Encounter_17" - }, - { - "id": "ScheduledDecisionInstance_1", - "extensionAttributes": [], - "name": "SDI_END_INDUCTION", - "label": "Decision: End of Induction (unblinding)", - "description": "Decision: End of Induction (unblinding)", - "defaultConditionId": "ScheduledActivityInstance_17", - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [ - { - "id": "Condition_1", - "extensionAttributes": [], - "condition": "No evidence of disease progression after 12 cycles of Induction: patient is unblinded and proceeds to the Continuation Phase.", - "conditionTargetId": "ScheduledActivityInstance_16", - "instanceType": "Condition" - }, - { - "id": "Condition_2", - "extensionAttributes": [], - "condition": "Disease progression or unacceptable toxicity (or other discontinuation per Sections 5.5/5.6): patient moves to Follow-Up Off-Therapy.", - "conditionTargetId": "ScheduledActivityInstance_17", - "instanceType": "Condition" - } - ] - }, - { - "id": "ScheduledDecisionInstance_2", - "extensionAttributes": [], - "name": "SDI_CONTINUATION", - "label": "Decision: Continuation Phase progression check", - "description": "Decision: Continuation Phase progression check", - "defaultConditionId": "ScheduledActivityInstance_16", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [ - { - "id": "Condition_3", - "extensionAttributes": [], - "condition": "No documented progression and no unacceptable toxicity: continue treatment with the next Continuation cycle (this visit repeats; the protocol sets no fixed Continuation cycle count).", - "conditionTargetId": "ScheduledActivityInstance_16", - "instanceType": "Condition" - }, - { - "id": "Condition_4", - "extensionAttributes": [], - "condition": "Documented disease progression or unacceptable toxicity: patient moves to Follow-Up Off-Therapy.", - "conditionTargetId": "ScheduledActivityInstance_17", - "instanceType": "Condition" - } - ] - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - } - ], - "biospecimenRetentions": [], - "documentVersionIds": [], - "eligibilityCriteria": [], - "analysisPopulations": [], - "notes": [], - "subTypes": [], - "model": { - "id": "Code_StudyDesignModel", - "extensionAttributes": [], - "code": "", - "codeSystem": "", - "codeSystemVersion": "", - "decode": "", - "instanceType": "Code" - }, - "intentTypes": [], - "blindingSchema": null, - "instanceType": "InterventionalStudyDesign" - } - ], - "titles": [ - { - "id": "StudyTitle_1", - "extensionAttributes": [], - "text": "Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", - "type": { - "id": "Code_8497", - "extensionAttributes": [], - "code": "C207616", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Official Study Title", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - } - ], - "documentVersionIds": [ - "StudyDefinitionDocumentVersion_1" - ], - "dateValues": [], - "amendments": [], - "organizations": [ - { - "id": "Organization_1", - "extensionAttributes": [], - "name": "PrECOG, LLC", - "label": "PrECOG", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_7949", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_1", - "extensionAttributes": [], - "text": "PrECOG, LLC, 1818 Market Street, Suite 1100, Philadelphia, PA 19103", - "lines": [ - "1818 Market Street", - "Suite 1100" - ], - "city": "Philadelphia", - "district": null, - "state": "PA", - "postalCode": "19103", - "country": { - "id": "Code_7950", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_2", - "extensionAttributes": [], - "name": "Novartis Pharmaceuticals Corporation", - "label": "Novartis", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_7951", - "extensionAttributes": [], - "code": "C25392", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Manufacturer", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_2", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_7952", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_3", - "extensionAttributes": [], - "name": "clinicaltrials.gov", - "label": "clinicaltrials.gov", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_9956", - "extensionAttributes": [], - "code": "C188863", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Regulatory Agency", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_3", - "extensionAttributes": [], - "text": "National Library of Medicine\n8600 Rockville Pike, Bethesda, MD 20894", - "lines": [ - "National Library of Medicine", - "8600 Rockville Pike" - ], - "city": "Bethesda", - "district": null, - "state": "MD", - "postalCode": "20894", - "country": { - "id": "Code_9957", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_4", - "extensionAttributes": [], - "name": "VendorLab1", - "label": "Vendor1", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_9958", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_4", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_9959", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_5", - "extensionAttributes": [], - "name": "VendorLab2", - "label": "Vendor2", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_9961", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_5", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_9962", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - } - ], - "roles": [ - { - "id": "StudyRole_1", - "extensionAttributes": [], - "name": "Clinical Study Sponsor", - "label": "Clinical Study Sponsor", - "description": "PrECOG, LLC serves as the clinical study sponsor and coordinating group for this investigator-initiated trial.", - "code": { - "id": "Code_8489", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_2", - "extensionAttributes": [], - "name": "Study Chair", - "label": "Study Chair", - "description": null, - "code": { - "id": "Code_9716", - "extensionAttributes": [], - "code": "C19924", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Principal Investigator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_1", - "extensionAttributes": [], - "name": "Noah Kornblum", - "label": null, - "description": null, - "personName": { - "id": "PersonName_1", - "extensionAttributes": [], - "text": null, - "familyName": "Kornblum", - "givenNames": [ - "Noah" - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "MD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Study Chair", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_3", - "extensionAttributes": [], - "name": "Study Co-Chair", - "label": "Study Co-Chair", - "description": null, - "code": { - "id": "Code_9717", - "extensionAttributes": [], - "code": "C25936", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Investigator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_2", - "extensionAttributes": [], - "name": "Joseph A. Sparano", - "label": null, - "description": null, - "personName": { - "id": "PersonName_2", - "extensionAttributes": [], - "text": null, - "familyName": "Sparano", - "givenNames": [ - "Joseph", - "A." - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "MD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Study Co-Chair", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_4", - "extensionAttributes": [], - "name": "Medical Monitor", - "label": "Medical Monitor", - "description": null, - "code": { - "id": "Code_9718", - "extensionAttributes": [], - "code": "C51876", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Sponsor Medical Expert", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_3", - "extensionAttributes": [], - "name": "Katherine M. Smith", - "label": null, - "description": null, - "personName": { - "id": "PersonName_3", - "extensionAttributes": [], - "text": null, - "familyName": "Smith", - "givenNames": [ - "Katherine", - "M." - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "MD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Medical Monitor", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_5", - "extensionAttributes": [], - "name": "Study Statistician", - "label": "Study Statistician", - "description": null, - "code": { - "id": "Code_9719", - "extensionAttributes": [], - "code": "C51877", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Statistician", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_4", - "extensionAttributes": [], - "name": "Judi Manola", - "label": null, - "description": null, - "personName": { - "id": "PersonName_4", - "extensionAttributes": [], - "text": null, - "familyName": "Manola", - "givenNames": [ - "Judi" - ], - "prefixes": [], - "suffixes": [ - "MS" - ], - "instanceType": "PersonName" - }, - "jobTitle": "Study Statistician", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_6", - "extensionAttributes": [], - "name": "Study Contact", - "label": "Study Contact", - "description": null, - "code": { - "id": "Code_9720", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_5", - "extensionAttributes": [], - "name": "Carolyn Andrews", - "label": null, - "description": null, - "personName": { - "id": "PersonName_5", - "extensionAttributes": [], - "text": null, - "familyName": "Andrews", - "givenNames": [ - "Carolyn" - ], - "prefixes": [], - "suffixes": [ - "RN" - ], - "instanceType": "PersonName" - }, - "jobTitle": "PrECOG Study Contact", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_7", - "extensionAttributes": [], - "name": "Investigational Product Manufacturer", - "label": "Investigational Product Manufacturer", - "description": "Novartis Pharmaceuticals Corporation supplies everolimus and matching placebo for the study.", - "code": { - "id": "Code_9714", - "extensionAttributes": [], - "code": "C25392", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Manufacturer", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_2" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_8", - "extensionAttributes": [], - "name": "Pharmacovigilance Group", - "label": "Pharmacovigilance Group", - "description": "Novartis Pharmaceuticals Drug Safety and Epidemiology Department (DS&E). Receives SAE notifications from PrECOG within 24 hours of awareness date.", - "code": { - "id": "Code_9715", - "extensionAttributes": [], - "code": "C215673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Pharmacovigilance Group", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_2" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_9", - "extensionAttributes": [], - "name": "Primary Data Manager", - "label": "Primary Data Manager", - "description": null, - "code": { - "id": "Code_9963", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_6", - "extensionAttributes": [], - "name": "Valerie S", - "label": null, - "description": null, - "personName": { - "id": "PersonName_6", - "extensionAttributes": [], - "text": null, - "familyName": "G", - "givenNames": [ - "Valerie" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Primary Data Manager", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_10", - "extensionAttributes": [], - "name": "Secondary Data Manager", - "label": "Secondary Data Manager", - "description": null, - "code": { - "id": "Code_9964", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_7", - "extensionAttributes": [], - "name": "Patrick G", - "label": null, - "description": null, - "personName": { - "id": "PersonName_7", - "extensionAttributes": [], - "text": null, - "familyName": "G", - "givenNames": [ - "Patrick" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Secondary Data Manager", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_11", - "extensionAttributes": [], - "name": "Data Acquisition Lead", - "label": "Data Acquisition Lead", - "description": null, - "code": { - "id": "Code_9965", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_4" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_8", - "extensionAttributes": [], - "name": "Eva J", - "label": null, - "description": null, - "personName": { - "id": "PersonName_8", - "extensionAttributes": [], - "text": null, - "familyName": "J", - "givenNames": [ - "Eva" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Data Acquisition Lead", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_12", - "extensionAttributes": [], - "name": "Data Acquisition Lead", - "label": "Data Acquisition Lead", - "description": null, - "code": { - "id": "Code_9966", - "extensionAttributes": [], - "code": "C51851", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Project Coordinator", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_5" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_9", - "extensionAttributes": [], - "name": "Melissa T", - "label": null, - "description": null, - "personName": { - "id": "PersonName_9", - "extensionAttributes": [], - "text": null, - "familyName": "T", - "givenNames": [ - "Melissa" - ], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Data Acquisition Lead", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - } - ], - "studyInterventions": [ - { - "id": "StudyIntervention_3", - "extensionAttributes": [], - "name": "Fulvestrant + Everolimus (Arm A)", - "label": "Fulvestrant + Everolimus", - "description": "Fulvestrant 500 mg IM on Day 1 of each 28-day cycle (Day 1 and 15 of Cycle 1 only) plus Everolimus 10 mg orally once daily.", - "role": { - "id": "Code_10033", - "extensionAttributes": [], - "code": "C41161", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Experimental Intervention", - "instanceType": "Code" - }, - "type": { - "id": "Code_10034", - "extensionAttributes": [], - "code": "C54696", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Combination Product", - "instanceType": "Code" - }, - "minimumResponseDuration": null, - "codes": [], - "administrations": [], - "notes": [], - "instanceType": "StudyIntervention" - }, - { - "id": "StudyIntervention_4", - "extensionAttributes": [], - "name": "Fulvestrant + Placebo (Arm B)", - "label": "Fulvestrant + Placebo", - "description": "Fulvestrant 500 mg IM on Day 1 of each 28-day cycle (Day 1 and 15 of Cycle 1 only) plus matching oral placebo once daily.", - "role": { - "id": "Code_10036", - "extensionAttributes": [], - "code": "C68609", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Active Comparator", - "instanceType": "Code" - }, - "type": { - "id": "Code_10037", - "extensionAttributes": [], - "code": "C54696", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Combination Product", - "instanceType": "Code" - }, - "minimumResponseDuration": null, - "codes": [], - "administrations": [], - "notes": [], - "instanceType": "StudyIntervention" - }, - { - "id": "StudyIntervention_5", - "extensionAttributes": [], - "name": "Fulvestrant", - "label": "Fulvestrant", - "description": "Fulvestrant administered on its own in Continuation Phase minus the placebo. Indicates subject PFS while on Fulvestrant + Placebo treatment arm (ARM B).", - "role": { - "id": "Code_10112", - "extensionAttributes": [], - "code": "C41161", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Experimental Intervention", - "instanceType": "Code" - }, - "type": { - "id": "Code_10113", - "extensionAttributes": [], - "code": "C1909", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Pharmacologic Substance", - "instanceType": "Code" - }, - "minimumResponseDuration": null, - "codes": [], - "administrations": [], - "notes": [], - "instanceType": "StudyIntervention" - } - ], - "businessTherapeuticAreas": [], - "biomedicalConcepts": [ - { - "id": "BiomedicalConcept_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_1", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Informed Consent", - "label": "Informed Consent", - "synonyms": [ - "Informed Consent Obtained" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "id": "BiomedicalConceptProperty_227", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_40", - "instanceType": "ResponseCode", - "name": "INFORMED CONSENT OBTAINED", - "label": "INFORMED CONSENT OBTAINED", - "isEnabled": true, - "code": { - "id": "Code_10380", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9623", - "standardCode": { - "id": "Code_10379", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_228", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9625", - "standardCode": { - "id": "Code_10381", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_229", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9626", - "standardCode": { - "id": "Code_10382", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1", - "extensionAttributes": [], - "standardCode": { - "id": "Code_8", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_2", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_2", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ELIGMET", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Eligibility Criteria Met By Subject", - "label": "Eligibility Criteria Met By Subject", - "synonyms": [ - "Eligibility Criteria Met" - ], - "reference": "/mdr/bc/biomedicalconcepts/C132447", - "properties": [ - { - "id": "BiomedicalConceptProperty_239", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_41", - "instanceType": "ResponseCode", - "name": "ELIGIBILITY CRITERIA MET", - "label": "ELIGIBILITY CRITERIA MET", - "isEnabled": true, - "code": { - "id": "Code_10393", - "extensionAttributes": [], - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ELIGIBILITY CRITERIA MET", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9636", - "standardCode": { - "id": "Code_10392", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_240", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9638", - "standardCode": { - "id": "Code_10394", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_241", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9639", - "standardCode": { - "id": "Code_10395", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_6", - "extensionAttributes": [], - "standardCode": { - "id": "Code_13", - "extensionAttributes": [], - "code": "C132447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Eligibility Criteria Met By Subject", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_3", - "extensionAttributes": [], - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "synonyms": [ - "MHYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C85522", - "properties": [ - { - "id": "BiomedicalConceptProperty_242", - "extensionAttributes": [], - "name": "Medical History Yes No Indicator", - "label": "Medical History Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9640", - "standardCode": { - "id": "Code_10396", - "extensionAttributes": [], - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_243", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9641", - "standardCode": { - "id": "Code_10397", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_11", - "extensionAttributes": [], - "standardCode": { - "id": "Code_18", - "extensionAttributes": [], - "code": "C85522", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Medical History Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_4", - "extensionAttributes": [], - "name": "Medical History Reported Term [RETIRED]", - "label": "Medical History Reported Term [RETIRED]", - "synonyms": [ - "Medical History", - "MHTERM" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83118", - "properties": [ - { - "id": "BiomedicalConceptProperty_244", - "extensionAttributes": [], - "name": "Medical History Dictionary Derived Term", - "label": "Medical History Dictionary Derived Term", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9642", - "standardCode": { - "id": "Code_10398", - "extensionAttributes": [], - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_245", - "extensionAttributes": [], - "name": "Medical History Occurrence", - "label": "Medical History Occurrence", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9643", - "standardCode": { - "id": "Code_10399", - "extensionAttributes": [], - "code": "C83067", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Occurrence", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_246", - "extensionAttributes": [], - "name": "Medical History Pre-specified", - "label": "Medical History Pre-specified", - "isRequired": true, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9644", - "standardCode": { - "id": "Code_10400", - "extensionAttributes": [], - "code": "C87897", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Pre-specified", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_247", - "extensionAttributes": [], - "name": "Medical History Reported Term", - "label": "Medical History Reported Term", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9645", - "standardCode": { - "id": "Code_10401", - "extensionAttributes": [], - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_248", - "extensionAttributes": [], - "name": "Medical History Category", - "label": "Medical History Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9646", - "standardCode": { - "id": "Code_10402", - "extensionAttributes": [], - "code": "C83018", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_249", - "extensionAttributes": [], - "name": "Medical History Subcategory", - "label": "Medical History Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9647", - "standardCode": { - "id": "Code_10403", - "extensionAttributes": [], - "code": "C83143", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_12", - "extensionAttributes": [], - "standardCode": { - "id": "Code_19", - "extensionAttributes": [], - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_5", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_3", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ECOG101", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECOG - Performance Status", - "label": "ECOG - Performance Status", - "synonyms": [ - "ECOG1-Performance Status", - "ECOG101", - "ECOG - Performance Status" - ], - "reference": "/mdr/bc/biomedicalconcepts/C102408", - "properties": [ - { - "id": "BiomedicalConceptProperty_250", - "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9648", - "standardCode": { - "id": "Code_10404", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_251", - "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9649", - "standardCode": { - "id": "Code_10405", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_13", - "extensionAttributes": [], - "standardCode": { - "id": "Code_20", - "extensionAttributes": [], - "code": "C102408", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG - Performance Status", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_6", - "extensionAttributes": [], - "name": "Physical Examination Finding", - "label": "Physical Examination Finding", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C83119", - "properties": [], - "code": { - "id": "AliasCode_21", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28", - "extensionAttributes": [], - "code": "C83119", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-04-02", - "decode": "Physical Examination Finding", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_7", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_4", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "synonyms": [ - "SYSBP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "id": "BiomedicalConceptProperty_252", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_9650", - "standardCode": { - "id": "Code_10406", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_253", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_42", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_10408", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9651", - "standardCode": { - "id": "Code_10407", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_254", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9653", - "standardCode": { - "id": "Code_10409", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_255", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9654", - "standardCode": { - "id": "Code_10410", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_256", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9655", - "standardCode": { - "id": "Code_10411", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_257", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9656", - "standardCode": { - "id": "Code_10412", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_22", - "extensionAttributes": [], - "standardCode": { - "id": "Code_29", - "extensionAttributes": [], - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_8", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_5", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "synonyms": [ - "DIABP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "id": "BiomedicalConceptProperty_258", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_9657", - "standardCode": { - "id": "Code_10413", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_259", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_43", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_10415", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9658", - "standardCode": { - "id": "Code_10414", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_260", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9660", - "standardCode": { - "id": "Code_10416", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_261", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9661", - "standardCode": { - "id": "Code_10417", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_262", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9662", - "standardCode": { - "id": "Code_10418", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_263", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9663", - "standardCode": { - "id": "Code_10419", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_34", - "extensionAttributes": [], - "standardCode": { - "id": "Code_41", - "extensionAttributes": [], - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_9", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_6", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Heart Rate", - "label": "Heart Rate", - "synonyms": [ - "HR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "id": "BiomedicalConceptProperty_264", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_9664", - "standardCode": { - "id": "Code_10420", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_265", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_44", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_10422", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9665", - "standardCode": { - "id": "Code_10421", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_266", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9667", - "standardCode": { - "id": "Code_10423", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_267", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9668", - "standardCode": { - "id": "Code_10424", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_268", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9669", - "standardCode": { - "id": "Code_10425", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_269", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9670", - "standardCode": { - "id": "Code_10426", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_46", - "extensionAttributes": [], - "standardCode": { - "id": "Code_53", - "extensionAttributes": [], - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_10", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_7", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TEMP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Temperature", - "label": "Body Temperature", - "synonyms": [ - "Temperature" - ], - "reference": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ - { - "id": "BiomedicalConceptProperty_270", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9671", - "standardCode": { - "id": "Code_10427", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_271", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9672", - "standardCode": { - "id": "Code_10428", - "extensionAttributes": [], - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_272", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9673", - "standardCode": { - "id": "Code_10429", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_273", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9674", - "standardCode": { - "id": "Code_10430", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5688", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5767", - "extensionAttributes": [], - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Body Temperature", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_11", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_8", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WEIGHT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Weight", - "label": "Body Weight", - "synonyms": [ - "WEIGHT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ - { - "id": "BiomedicalConceptProperty_274", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9675", - "standardCode": { - "id": "Code_10431", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_275", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9676", - "standardCode": { - "id": "Code_10432", - "extensionAttributes": [], - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_276", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9677", - "standardCode": { - "id": "Code_10433", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9354", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10029", - "extensionAttributes": [], - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_18", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_9", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "synonyms": [ - "ALT", - "SGPT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ - { - "id": "BiomedicalConceptProperty_277", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9678", - "standardCode": { - "id": "Code_10434", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_278", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9679", - "standardCode": { - "id": "Code_10435", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_279", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_45", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10437", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9680", - "standardCode": { - "id": "Code_10436", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_280", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9682", - "standardCode": { - "id": "Code_10438", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_281", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9683", - "standardCode": { - "id": "Code_10439", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9355", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10030", - "extensionAttributes": [], - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_19", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_10", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "synonyms": [ - "AST", - "SGOT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ - { - "id": "BiomedicalConceptProperty_282", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9684", - "standardCode": { - "id": "Code_10440", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_283", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9685", - "standardCode": { - "id": "Code_10441", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_284", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_46", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10443", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9686", - "standardCode": { - "id": "Code_10442", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_285", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9688", - "standardCode": { - "id": "Code_10444", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_286", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9689", - "standardCode": { - "id": "Code_10445", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_767", - "extensionAttributes": [], - "standardCode": { - "id": "Code_807", - "extensionAttributes": [], - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_20", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_11", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "synonyms": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "id": "BiomedicalConceptProperty_287", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9690", - "standardCode": { - "id": "Code_10446", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_288", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9691", - "standardCode": { - "id": "Code_10447", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_289", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_47", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10449", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9692", - "standardCode": { - "id": "Code_10448", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_290", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9694", - "standardCode": { - "id": "Code_10450", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_291", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9695", - "standardCode": { - "id": "Code_10451", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9906", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10662", - "extensionAttributes": [], - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_21", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_12", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "synonyms": [ - "Creatinine" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ - { - "id": "BiomedicalConceptProperty_292", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9696", - "standardCode": { - "id": "Code_10452", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_293", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9697", - "standardCode": { - "id": "Code_10453", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_294", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_48", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10455", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9698", - "standardCode": { - "id": "Code_10454", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_295", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9700", - "standardCode": { - "id": "Code_10456", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_296", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9701", - "standardCode": { - "id": "Code_10457", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5689", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5768", - "extensionAttributes": [], - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_22", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_13", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "synonyms": [ - "Albumin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ - { - "id": "BiomedicalConceptProperty_297", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9702", - "standardCode": { - "id": "Code_10458", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_298", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9703", - "standardCode": { - "id": "Code_10459", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_299", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_49", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10461", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9704", - "standardCode": { - "id": "Code_10460", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_300", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9706", - "standardCode": { - "id": "Code_10462", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_301", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9707", - "standardCode": { - "id": "Code_10463", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5690", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5769", - "extensionAttributes": [], - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_26", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_14", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "pH", - "label": "pH", - "synonyms": [ - "PH", - "potential of Hydrogen" - ], - "reference": "/mdr/bc/biomedicalconcepts/C45997", - "properties": [ - { - "id": "BiomedicalConceptProperty_302", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9708", - "standardCode": { - "id": "Code_10464", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_303", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_50", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_10466", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9709", - "standardCode": { - "id": "Code_10465", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_304", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9711", - "standardCode": { - "id": "Code_10467", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_305", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9712", - "standardCode": { - "id": "Code_10468", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5691", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5770", - "extensionAttributes": [], - "code": "C45997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "pH", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_27", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_15", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/COLORURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Color Assessment", - "label": "Color Assessment", - "synonyms": [ - "COLOR", - "Color" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [ - { - "id": "BiomedicalConceptProperty_306", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9713", - "standardCode": { - "id": "Code_10469", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_307", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_51", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_10471", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9714", - "standardCode": { - "id": "Code_10470", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_308", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9716", - "standardCode": { - "id": "Code_10472", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9356", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10031", - "extensionAttributes": [], - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_28", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_16", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Specific Gravity", - "label": "Specific Gravity", - "synonyms": [ - "SPGRAV" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ - { - "id": "BiomedicalConceptProperty_309", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9717", - "standardCode": { - "id": "Code_10473", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_310", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_52", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_10475", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9718", - "standardCode": { - "id": "Code_10474", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_311", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9720", - "standardCode": { - "id": "Code_10476", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_312", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9721", - "standardCode": { - "id": "Code_10477", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5692", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5771", - "extensionAttributes": [], - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_47", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "synonyms": [ - "AEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "id": "BiomedicalConceptProperty_313", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9722", - "standardCode": { - "id": "Code_10478", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_314", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9723", - "standardCode": { - "id": "Code_10479", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5693", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5772", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_48", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_17", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Adverse Event", - "label": "Adverse Event", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "code": { - "id": "AliasCode_9907", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10663", - "extensionAttributes": [], - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_49", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "synonyms": [ - "CMYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [ - { - "id": "BiomedicalConceptProperty_315", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9724", - "standardCode": { - "id": "Code_10480", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_316", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9725", - "standardCode": { - "id": "Code_10481", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5694", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5773", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_50", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_18", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMFREE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "synonyms": [ - "Concomitant Medication" - ], - "reference": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ - { - "id": "BiomedicalConceptProperty_317", - "extensionAttributes": [], - "name": "CMTRT", - "label": "CMTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9726", - "standardCode": { - "id": "Code_10482", - "extensionAttributes": [], - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_318", - "extensionAttributes": [], - "name": "CMDECOD", - "label": "CMDECOD", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9727", - "standardCode": { - "id": "Code_10483", - "extensionAttributes": [], - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_319", - "extensionAttributes": [], - "name": "CMCLAS", - "label": "CMCLAS", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9728", - "standardCode": { - "id": "Code_10484", - "extensionAttributes": [], - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_320", - "extensionAttributes": [], - "name": "CMINDC", - "label": "CMINDC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9729", - "standardCode": { - "id": "Code_10485", - "extensionAttributes": [], - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_321", - "extensionAttributes": [], - "name": "CMDOSE", - "label": "CMDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9730", - "standardCode": { - "id": "Code_10486", - "extensionAttributes": [], - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_322", - "extensionAttributes": [], - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9731", - "standardCode": { - "id": "Code_10487", - "extensionAttributes": [], - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_323", - "extensionAttributes": [], - "name": "CMDOSU", - "label": "CMDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9732", - "standardCode": { - "id": "Code_10488", - "extensionAttributes": [], - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_324", - "extensionAttributes": [], - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9733", - "standardCode": { - "id": "Code_10489", - "extensionAttributes": [], - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_325", - "extensionAttributes": [], - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9734", - "standardCode": { - "id": "Code_10490", - "extensionAttributes": [], - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_326", - "extensionAttributes": [], - "name": "CMROUTE", - "label": "CMROUTE", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9735", - "standardCode": { - "id": "Code_10491", - "extensionAttributes": [], - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_327", - "extensionAttributes": [], - "name": "CMSTDTC", - "label": "CMSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9736", - "standardCode": { - "id": "Code_10492", - "extensionAttributes": [], - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_328", - "extensionAttributes": [], - "name": "CMENDTC", - "label": "CMENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9737", - "standardCode": { - "id": "Code_10493", - "extensionAttributes": [], - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_329", - "extensionAttributes": [], - "name": "CMSTRF", - "label": "CMSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9738", - "standardCode": { - "id": "Code_10494", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_330", - "extensionAttributes": [], - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9739", - "standardCode": { - "id": "Code_10495", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_331", - "extensionAttributes": [], - "name": "CMSTTPT", - "label": "CMSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9740", - "standardCode": { - "id": "Code_10496", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_332", - "extensionAttributes": [], - "name": "CMENRF", - "label": "CMENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9741", - "standardCode": { - "id": "Code_10497", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_333", - "extensionAttributes": [], - "name": "CMENRTPT", - "label": "CMENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9742", - "standardCode": { - "id": "Code_10498", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_334", - "extensionAttributes": [], - "name": "CMENTPT", - "label": "CMENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9743", - "standardCode": { - "id": "Code_10499", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9908", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10664", - "extensionAttributes": [], - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_51", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_19", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RANDOM", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Randomization", - "label": "Randomization", - "synonyms": [ - "randomization", - "RANDOM", - "Randomized", - "Trial is Randomized", - "randomized" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25196", - "properties": [ - { - "id": "BiomedicalConceptProperty_335", - "extensionAttributes": [], - "name": "TSPARMCD", - "label": "TSPARMCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_53", - "instanceType": "ResponseCode", - "name": "RANDOM", - "label": "RANDOM", - "isEnabled": true, - "code": { - "id": "Code_10501", - "extensionAttributes": [], - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "RANDOM", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9744", - "standardCode": { - "id": "Code_10500", - "extensionAttributes": [], - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_336", - "extensionAttributes": [], - "name": "TSPARM", - "label": "TSPARM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_54", - "instanceType": "ResponseCode", - "name": "Trial is Randomized", - "label": "Trial is Randomized", - "isEnabled": true, - "code": { - "id": "Code_10503", - "extensionAttributes": [], - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial is Randomized", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9746", - "standardCode": { - "id": "Code_10502", - "extensionAttributes": [], - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_337", - "extensionAttributes": [], - "name": "TSVAL", - "label": "TSVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9748", - "standardCode": { - "id": "Code_10504", - "extensionAttributes": [], - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_338", - "extensionAttributes": [], - "name": "TSVALCD", - "label": "TSVALCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9749", - "standardCode": { - "id": "Code_10505", - "extensionAttributes": [], - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_339", - "extensionAttributes": [], - "name": "TSVCDREF", - "label": "TSVCDREF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9750", - "standardCode": { - "id": "Code_10506", - "extensionAttributes": [], - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_340", - "extensionAttributes": [], - "name": "TSVCDVER", - "label": "TSVCDVER", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9751", - "standardCode": { - "id": "Code_10507", - "extensionAttributes": [], - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9357", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10032", - "extensionAttributes": [], - "code": "C25196", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Randomization", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_52", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_20", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Prothrombin Time", - "label": "Prothrombin Time", - "synonyms": [ - "PT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C62656", - "properties": [ - { - "id": "BiomedicalConceptProperty_341", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9752", - "standardCode": { - "id": "Code_10508", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_342", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_55", - "instanceType": "ResponseCode", - "name": "s", - "label": "s", - "isEnabled": true, - "code": { - "id": "Code_10510", - "extensionAttributes": [], - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9753", - "standardCode": { - "id": "Code_10509", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_343", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_56", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10512", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9755", - "standardCode": { - "id": "Code_10511", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_344", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9757", - "standardCode": { - "id": "Code_10513", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_345", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9758", - "standardCode": { - "id": "Code_10514", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5695", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5774", - "extensionAttributes": [], - "code": "C62656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Prothrombin Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_53", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_21", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/INRBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "International Normalized Ratio of Prothrombin Time", - "label": "International Normalized Ratio of Prothrombin Time", - "synonyms": [ - "INR", - "Prothrombin Intl. Normalized Ratio" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64805", - "properties": [ - { - "id": "BiomedicalConceptProperty_346", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_9759", - "standardCode": { - "id": "Code_10515", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_347", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_57", - "instanceType": "ResponseCode", - "name": "RATIO", - "label": "RATIO", - "isEnabled": true, - "code": { - "id": "Code_10517", - "extensionAttributes": [], - "code": "C44256", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RATIO", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9760", - "standardCode": { - "id": "Code_10516", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_348", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_58", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10519", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9762", - "standardCode": { - "id": "Code_10518", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_349", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9764", - "standardCode": { - "id": "Code_10520", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5696", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5775", - "extensionAttributes": [], - "code": "C64805", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "International Normalized Ratio of Prothrombin Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_54", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_22", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/APTTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Activated Partial Thromboplastin Time", - "label": "Activated Partial Thromboplastin Time", - "synonyms": [ - "APTT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38462", - "properties": [ - { - "id": "BiomedicalConceptProperty_350", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_9765", - "standardCode": { - "id": "Code_10521", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_351", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_59", - "instanceType": "ResponseCode", - "name": "s", - "label": "s", - "isEnabled": true, - "code": { - "id": "Code_10523", - "extensionAttributes": [], - "code": "C42535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "s", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9766", - "standardCode": { - "id": "Code_10522", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_352", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_60", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10525", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9768", - "standardCode": { - "id": "Code_10524", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_353", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9770", - "standardCode": { - "id": "Code_10526", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9909", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10665", - "extensionAttributes": [], - "code": "C38462", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Activated Partial Thromboplastin Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_55", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_23", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "synonyms": [ - "Glucose" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "id": "BiomedicalConceptProperty_354", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9771", - "standardCode": { - "id": "Code_10527", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_355", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9772", - "standardCode": { - "id": "Code_10528", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_356", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_61", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10530", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9773", - "standardCode": { - "id": "Code_10529", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_357", - "extensionAttributes": [], - "name": "LBMETHOD", - "label": "LBMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9775", - "standardCode": { - "id": "Code_10531", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_358", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9776", - "standardCode": { - "id": "Code_10532", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_359", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9777", - "standardCode": { - "id": "Code_10533", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9910", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10666", - "extensionAttributes": [], - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_56", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_24", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TRIGSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Triglyceride Measurement", - "label": "Triglyceride Measurement", - "synonyms": [ - "TRIG", - "Triglycerides" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64812", - "properties": [ - { - "id": "BiomedicalConceptProperty_360", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9778", - "standardCode": { - "id": "Code_10534", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_361", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9779", - "standardCode": { - "id": "Code_10535", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_362", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_62", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10537", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9780", - "standardCode": { - "id": "Code_10536", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_363", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9782", - "standardCode": { - "id": "Code_10538", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_364", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9783", - "standardCode": { - "id": "Code_10539", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9911", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10667", - "extensionAttributes": [], - "code": "C64812", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triglyceride Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_57", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_25", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "synonyms": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [ - { - "id": "BiomedicalConceptProperty_365", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9784", - "standardCode": { - "id": "Code_10540", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_366", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9785", - "standardCode": { - "id": "Code_10541", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_367", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_63", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10543", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9786", - "standardCode": { - "id": "Code_10542", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_368", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9788", - "standardCode": { - "id": "Code_10544", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_369", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9789", - "standardCode": { - "id": "Code_10545", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_534", - "extensionAttributes": [], - "standardCode": { - "id": "Code_574", - "extensionAttributes": [], - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_58", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_26", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HDLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "High Density Lipoprotein Cholesterol Measurement", - "label": "High Density Lipoprotein Cholesterol Measurement", - "synonyms": [ - "HDL", - "HDL Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105587", - "properties": [ - { - "id": "BiomedicalConceptProperty_370", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9790", - "standardCode": { - "id": "Code_10546", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_371", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9791", - "standardCode": { - "id": "Code_10547", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_372", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_64", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10549", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9792", - "standardCode": { - "id": "Code_10548", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_373", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9794", - "standardCode": { - "id": "Code_10550", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_374", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9795", - "standardCode": { - "id": "Code_10551", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5697", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5776", - "extensionAttributes": [], - "code": "C105587", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "High Density Lipoprotein Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_59", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_27", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/LDLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Low Density Lipoprotein Cholesterol Measurement", - "label": "Low Density Lipoprotein Cholesterol Measurement", - "synonyms": [ - "LDL", - "LDL Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105588", - "properties": [ - { - "id": "BiomedicalConceptProperty_375", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9796", - "standardCode": { - "id": "Code_10552", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_376", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9797", - "standardCode": { - "id": "Code_10553", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_377", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_65", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10555", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9798", - "standardCode": { - "id": "Code_10554", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_378", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9800", - "standardCode": { - "id": "Code_10556", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_379", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9801", - "standardCode": { - "id": "Code_10557", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_7397", - "extensionAttributes": [], - "standardCode": { - "id": "Code_7476", - "extensionAttributes": [], - "code": "C105588", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Low Density Lipoprotein Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_60", - "extensionAttributes": [], - "name": "ECOG Clinical Classification Question", - "label": "ECOG Clinical Classification Question", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C101874", - "properties": [], - "code": { - "id": "AliasCode_9912", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10668", - "extensionAttributes": [], - "code": "C101874", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "ECOG Clinical Classification Question", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_61", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_28", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "synonyms": [ - "WBC", - "White Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [ - { - "id": "BiomedicalConceptProperty_380", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9802", - "standardCode": { - "id": "Code_10558", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_381", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9803", - "standardCode": { - "id": "Code_10559", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_382", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_66", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10561", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9804", - "standardCode": { - "id": "Code_10560", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_383", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9806", - "standardCode": { - "id": "Code_10562", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_384", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9807", - "standardCode": { - "id": "Code_10563", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5698", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5777", - "extensionAttributes": [], - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_62", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_29", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "synonyms": [ - "RBC", - "Red Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ - { - "id": "BiomedicalConceptProperty_385", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9808", - "standardCode": { - "id": "Code_10564", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_386", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9809", - "standardCode": { - "id": "Code_10565", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_387", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_67", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10567", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9810", - "standardCode": { - "id": "Code_10566", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_388", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9812", - "standardCode": { - "id": "Code_10568", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_389", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9813", - "standardCode": { - "id": "Code_10569", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_9913", - "extensionAttributes": [], - "standardCode": { - "id": "Code_10669", - "extensionAttributes": [], - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_63", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_30", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PLATBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Platelet Count", - "label": "Platelet Count", - "synonyms": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ - { - "id": "BiomedicalConceptProperty_390", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9814", - "standardCode": { - "id": "Code_10570", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_391", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9815", - "standardCode": { - "id": "Code_10571", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_392", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_68", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10573", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9816", - "standardCode": { - "id": "Code_10572", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_393", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9818", - "standardCode": { - "id": "Code_10574", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_394", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9819", - "standardCode": { - "id": "Code_10575", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5699", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5778", - "extensionAttributes": [], - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_64", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_31", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/KBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "synonyms": [ - "Potassium", - "K" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [ - { - "id": "BiomedicalConceptProperty_395", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9820", - "standardCode": { - "id": "Code_10576", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_396", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9821", - "standardCode": { - "id": "Code_10577", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_397", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_69", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10579", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9822", - "standardCode": { - "id": "Code_10578", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_398", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9824", - "standardCode": { - "id": "Code_10580", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_399", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9825", - "standardCode": { - "id": "Code_10581", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5700", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5779", - "extensionAttributes": [], - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_65", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_32", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "synonyms": [ - "Sodium", - "NA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [ - { - "id": "BiomedicalConceptProperty_400", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9826", - "standardCode": { - "id": "Code_10582", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_401", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9827", - "standardCode": { - "id": "Code_10583", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_402", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_70", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10585", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9828", - "standardCode": { - "id": "Code_10584", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_403", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9830", - "standardCode": { - "id": "Code_10586", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_404", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9831", - "standardCode": { - "id": "Code_10587", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5701", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5780", - "extensionAttributes": [], - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_66", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_33", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CLBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "synonyms": [ - "Chloride", - "CL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [ - { - "id": "BiomedicalConceptProperty_405", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9832", - "standardCode": { - "id": "Code_10588", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_406", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9833", - "standardCode": { - "id": "Code_10589", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_407", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_71", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10591", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9834", - "standardCode": { - "id": "Code_10590", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_408", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9836", - "standardCode": { - "id": "Code_10592", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_409", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9837", - "standardCode": { - "id": "Code_10593", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5702", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5781", - "extensionAttributes": [], - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_67", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_34", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CO2BLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Carbon Dioxide Measurement", - "label": "Carbon Dioxide Measurement", - "synonyms": [ - "Carbon Dioxide", - "CO2" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64545", - "properties": [ - { - "id": "BiomedicalConceptProperty_410", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9838", - "standardCode": { - "id": "Code_10594", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_411", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9839", - "standardCode": { - "id": "Code_10595", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_412", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_72", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10597", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9840", - "standardCode": { - "id": "Code_10596", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_413", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9842", - "standardCode": { - "id": "Code_10598", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_414", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9843", - "standardCode": { - "id": "Code_10599", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5703", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5782", - "extensionAttributes": [], - "code": "C64545", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Carbon Dioxide Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_68", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_35", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CABLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "synonyms": [ - "Calcium", - "CA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [ - { - "id": "BiomedicalConceptProperty_415", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9844", - "standardCode": { - "id": "Code_10600", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_416", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9845", - "standardCode": { - "id": "Code_10601", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_417", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_73", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_10603", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9846", - "standardCode": { - "id": "Code_10602", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_418", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9848", - "standardCode": { - "id": "Code_10604", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_419", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9849", - "standardCode": { - "id": "Code_10605", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5704", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5783", - "extensionAttributes": [], - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_69", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_36", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "synonyms": [ - "Urea Nitrogen" - ], - "reference": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [ - { - "id": "BiomedicalConceptProperty_420", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9850", - "standardCode": { - "id": "Code_10606", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_421", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9851", - "standardCode": { - "id": "Code_10607", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_422", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_74", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10609", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9852", - "standardCode": { - "id": "Code_10608", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_423", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9854", - "standardCode": { - "id": "Code_10610", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_424", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9855", - "standardCode": { - "id": "Code_10611", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5705", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5784", - "extensionAttributes": [], - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_70", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_37", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "synonyms": [ - "Protein" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "id": "BiomedicalConceptProperty_425", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9856", - "standardCode": { - "id": "Code_10612", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_426", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9857", - "standardCode": { - "id": "Code_10613", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_427", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_75", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10615", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9858", - "standardCode": { - "id": "Code_10614", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_428", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9860", - "standardCode": { - "id": "Code_10616", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_429", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9861", - "standardCode": { - "id": "Code_10617", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5706", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5785", - "extensionAttributes": [], - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_71", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_38", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "synonyms": [ - "Alkaline Phosphatase" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [ - { - "id": "BiomedicalConceptProperty_430", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9862", - "standardCode": { - "id": "Code_10618", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_431", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9863", - "standardCode": { - "id": "Code_10619", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_432", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_76", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10621", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9864", - "standardCode": { - "id": "Code_10620", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_433", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9866", - "standardCode": { - "id": "Code_10622", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_434", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9867", - "standardCode": { - "id": "Code_10623", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5707", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5786", - "extensionAttributes": [], - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_72", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_39", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/URATESERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urate Measurement", - "label": "Urate Measurement", - "synonyms": [ - "Urate", - "Uric Acid" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [ - { - "id": "BiomedicalConceptProperty_435", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_9868", - "standardCode": { - "id": "Code_10624", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_436", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9869", - "standardCode": { - "id": "Code_10625", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_437", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_77", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_10627", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9870", - "standardCode": { - "id": "Code_10626", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_438", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_9872", - "standardCode": { - "id": "Code_10628", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_439", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9873", - "standardCode": { - "id": "Code_10629", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_717", - "extensionAttributes": [], - "standardCode": { - "id": "Code_757", - "extensionAttributes": [], - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_73", - "extensionAttributes": [], - "name": "Tumor Size Measurement", - "label": "Tumor Size Measurement", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C106303", - "properties": [ - { - "id": "BiomedicalConceptProperty_440", - "extensionAttributes": [], - "name": "Anatomic Site", - "label": "Anatomic Site", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9874", - "standardCode": { - "id": "Code_10630", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_441", - "extensionAttributes": [], - "name": "Observation Result", - "label": "Observation Result", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_9875", - "standardCode": { - "id": "Code_10631", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_442", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9876", - "standardCode": { - "id": "Code_10632", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_443", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9877", - "standardCode": { - "id": "Code_10633", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_444", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9878", - "standardCode": { - "id": "Code_10634", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_445", - "extensionAttributes": [], - "name": "Specimen Anatomic Site", - "label": "Specimen Anatomic Site", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9879", - "standardCode": { - "id": "Code_10635", - "extensionAttributes": [], - "code": "C171435", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Specimen Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_446", - "extensionAttributes": [], - "name": "Biospecimen Type", - "label": "Biospecimen Type", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9880", - "standardCode": { - "id": "Code_10636", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_447", - "extensionAttributes": [], - "name": "Unit of Length", - "label": "Unit of Length", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9881", - "standardCode": { - "id": "Code_10637", - "extensionAttributes": [], - "code": "C42578", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Unit of Length", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5708", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5787", - "extensionAttributes": [], - "code": "C106303", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Tumor Size Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_74", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_40", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TUMERGE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Tumor Identification", - "label": "Tumor Identification", - "synonyms": [ - "TUMIDENT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C94523", - "properties": [ - { - "id": "BiomedicalConceptProperty_448", - "extensionAttributes": [], - "name": "TUORRES", - "label": "TUORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_78", - "instanceType": "ResponseCode", - "name": "TARGET", - "label": "TARGET", - "isEnabled": true, - "code": { - "id": "Code_10639", - "extensionAttributes": [], - "code": "C94520", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "TARGET", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_9882", - "standardCode": { - "id": "Code_10638", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_449", - "extensionAttributes": [], - "name": "TULOC", - "label": "TULOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9884", - "standardCode": { - "id": "Code_10640", - "extensionAttributes": [], - "code": "C170500", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Result Anatomical Location", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_450", - "extensionAttributes": [], - "name": "TULAT", - "label": "TULAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9885", - "standardCode": { - "id": "Code_10641", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_451", - "extensionAttributes": [], - "name": "TUDIR", - "label": "TUDIR", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9886", - "standardCode": { - "id": "Code_10642", - "extensionAttributes": [], - "code": "C54215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Directionality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_452", - "extensionAttributes": [], - "name": "TUMETHOD", - "label": "TUMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9887", - "standardCode": { - "id": "Code_10643", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_453", - "extensionAttributes": [], - "name": "TUEVAL", - "label": "TUEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9888", - "standardCode": { - "id": "Code_10644", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_454", - "extensionAttributes": [], - "name": "TUEVALID", - "label": "TUEVALID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9889", - "standardCode": { - "id": "Code_10645", - "extensionAttributes": [], - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_455", - "extensionAttributes": [], - "name": "TUREFID", - "label": "TUREFID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9890", - "standardCode": { - "id": "Code_10646", - "extensionAttributes": [], - "code": "C117442", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Reference Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_456", - "extensionAttributes": [], - "name": "TULNKID", - "label": "TULNKID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9891", - "standardCode": { - "id": "Code_10647", - "extensionAttributes": [], - "code": "C117436", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identifier Link Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_457", - "extensionAttributes": [], - "name": "TUDTC", - "label": "TUDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9892", - "standardCode": { - "id": "Code_10648", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5709", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5788", - "extensionAttributes": [], - "code": "C94523", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Tumor Identification", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_75", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_41", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NTRGRESP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Response in Non-Target Lesion", - "label": "Response in Non-Target Lesion", - "synonyms": [ - "NTRGRESP", - "Non-Target Response" - ], - "reference": "/mdr/bc/biomedicalconcepts/C94535", - "properties": [ - { - "id": "BiomedicalConceptProperty_458", - "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9893", - "standardCode": { - "id": "Code_10649", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_459", - "extensionAttributes": [], - "name": "RSEVAL", - "label": "RSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9894", - "standardCode": { - "id": "Code_10650", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_460", - "extensionAttributes": [], - "name": "RSEVALID", - "label": "RSEVALID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9895", - "standardCode": { - "id": "Code_10651", - "extensionAttributes": [], - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_461", - "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9896", - "standardCode": { - "id": "Code_10652", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5710", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5789", - "extensionAttributes": [], - "code": "C94535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Non-Target Lesion", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_76", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_42", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TRGRESP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Response in Target Lesion", - "label": "Response in Target Lesion", - "synonyms": [ - "TRGRESP", - "Target Response" - ], - "reference": "/mdr/bc/biomedicalconcepts/C94534", - "properties": [ - { - "id": "BiomedicalConceptProperty_462", - "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9897", - "standardCode": { - "id": "Code_10653", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_463", - "extensionAttributes": [], - "name": "RSEVAL", - "label": "RSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9898", - "standardCode": { - "id": "Code_10654", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_464", - "extensionAttributes": [], - "name": "RSEVALID", - "label": "RSEVALID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9899", - "standardCode": { - "id": "Code_10655", - "extensionAttributes": [], - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_465", - "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9900", - "standardCode": { - "id": "Code_10656", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_5711", - "extensionAttributes": [], - "standardCode": { - "id": "Code_5790", - "extensionAttributes": [], - "code": "C94534", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Response in Target Lesion", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_77", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_43", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/OVRLRESP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Overall Response", - "label": "Overall Response", - "synonyms": [ - "OVRLRESP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C96613", - "properties": [ - { - "id": "BiomedicalConceptProperty_466", - "extensionAttributes": [], - "name": "RSLNKGRP", - "label": "RSLNKGRP", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9901", - "standardCode": { - "id": "Code_10657", - "extensionAttributes": [], - "code": "C117394", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Disease Response Link Group", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_467", - "extensionAttributes": [], - "name": "RSORRES", - "label": "RSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_9902", - "standardCode": { - "id": "Code_10658", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_468", - "extensionAttributes": [], - "name": "RSEVAL", - "label": "RSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9903", - "standardCode": { - "id": "Code_10659", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_469", - "extensionAttributes": [], - "name": "RSEVALID", - "label": "RSEVALID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_9904", - "standardCode": { - "id": "Code_10660", - "extensionAttributes": [], - "code": "C117043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_470", - "extensionAttributes": [], - "name": "RSDTC", - "label": "RSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_9905", - "standardCode": { - "id": "Code_10661", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_763", - "extensionAttributes": [], - "standardCode": { - "id": "Code_803", - "extensionAttributes": [], - "code": "C96613", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-06-27", - "decode": "Overall Response", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - } - ], - "bcSurrogates": [ - { - "id": "BiomedicalConceptSurrogate_1", - "extensionAttributes": [], - "name": "Magnesium Measurement", - "label": "Magnesium Measurement (C64840)", - "description": "A quantitative measurement of the amount of magnesium present in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64840", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_2", - "extensionAttributes": [], - "name": "Hepatitis B DNA Measurement", - "label": "Hepatitis B DNA Measurement (C103404)", - "description": "A measurement of the Hepatitis B virus DNA in a biological specimen", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103404", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_3", - "extensionAttributes": [], - "name": "Hepatitis B Surface Antigen", - "label": "Hepatitis B Virus Surface Antigen Measurement (C64850)", - "description": "A measurement of the surface antigen reaction of a biological specimen to the Hepatitis B virus.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64850", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_4", - "extensionAttributes": [], - "name": "HBsAb+", - "label": "Hepatitis B Surface Antibody Positive (C153243)", - "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153243", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_5", - "extensionAttributes": [], - "name": "HBsAb-", - "label": "Hepatitis B Surface Antibody Negative (C153244)", - "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have not been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153244", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_6", - "extensionAttributes": [], - "name": "HCV RNA Positive", - "label": "HCV RNA Positive (C162042)", - "description": "An indication that hepatitis C RNA has been detected in a sample.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C162042", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_7", - "extensionAttributes": [], - "name": "PFTs with DLCO", - "label": "Pulmonary function tests (PFTs) that include DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) (C38081)", - "description": "A broad range of tests that are performed to assess how well lungs inhale and exhale air and how efficiently they transfer oxygen into the blood.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38081", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_8", - "extensionAttributes": [], - "name": "Dietary Phosphorus Measurement", - "label": "Dietary Phosphorus Measurement (C184481)", - "description": "A determination of the phosphorus in a nutritional product or meal, or a portion thereof.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C184481", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_19", - "extensionAttributes": [], - "name": "Adherence", - "label": "Adherence (C25729)", - "description": "The act of abiding by a stated treatment plan or protocol.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C25729", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_20", - "extensionAttributes": [], - "name": "Patient Compliance", - "label": "Patient Compliance (C39490)", - "description": "The extent to which a patient conforms to medical advice regarding prescribed regimen, lifestyle, dietary changes, follow-up schedule and other recommendations.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C39490", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_21", - "extensionAttributes": [], - "name": "Compliance Monitoring", - "label": "Compliance Monitoring (C62737)", - "description": "The act of continuously assessing whether an individual is adhering to their treatment plan.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C62737", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_22", - "extensionAttributes": [], - "name": "Non-Compliance With Study Drug", - "label": "Non-Compliance With Study Drug (C49631)", - "description": "An indication that a subject has not agreed with or followed the instructions related to the study medication. (NCI)", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C49631", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_23", - "extensionAttributes": [], - "name": "Non-Compliance with Study Product", - "label": "Non-Compliance with Study Product (C210354)", - "description": "An indication that a subject has not agreed with or followed the instructions related to the study product.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C210354", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_24", - "extensionAttributes": [], - "name": "Trial Compliance", - "label": "Trial Compliance (C142734)", - "description": "Adherence to clinical trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. (ICH)", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C142734", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - } - ], - "bcCategories": [], - "eligibilityCriterionItems": [], - "narrativeContentItems": [ - { - "id": "NarrativeContentItem_1", - "extensionAttributes": [], - "name": "NCI_1", - "text": "

See section 1 Introduction.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_2", - "extensionAttributes": [], - "name": "NCI_1_1", - "text": "
\n

Endocrine therapy represents the foundation of treatment for hormone-receptor\npositive metastatic and locally advanced breast cancer. Multiple compounds in\nvarying classes exist, and those most widely used include the selective estrogen\nreceptor modulators (SERMs), aromatase inhibitors (AIs), and the selective estrogen\nreceptor down-regulators (SERDs). Although the utility of these drugs is well\nestablished, as many as 50% of women with hormone-receptor positive breast cancer\nwill fail to respond to endocrine treatment (de novo resistance). Moreover, those who\ndo respond will inevitably develop acquired resistance.1 Resistance to endocrine\ntherapy remains a serious clinical challenge.\nBasic scientific research into the mechanisms surrounding endocrine therapy\nresistance has been particularly intense in recent years. Advances in this area of\ninvestigation are driving the development of novel treatments and therapeutic\nstrategies. For example, various signal transduction pathways, when activated, have\nbeen demonstrated to allow breast cancer cells to escape the effect of endocrine\ntherapy. The Protein Kinase B (Akt/PKB), a downstream target in the PI3 kinase\nsignaling pathway appears to play a vital role in drug resistance.2 Several studies\nidentify a close association between aberrant Akt signaling and tamoxifen resistance.3\nHigh levels of Akt activity confer resistance to the aromatase inhibitor letrozole and\nthe selective estrogen receptor down-regulator fulvestrant.4 This Akt-induced\nresistance does not appear to be secondary to failure of these agents to inhibit the\nestrogen receptor \u03b1 activity, but instead may lead to altered cell cycle and apoptotic\nresponse.5 Clinically, Akt/PKB activation in breast cancer appears to predict an\ninferior outcome among patients treated with endocrine therapy.6\nmTOR, mammalian target of rapamycin, is a cytoplasmic protein kinase that acts as a\ncentral regulator of many biological processes involved in cellular proliferation,\nangiogenesis and metabolism. mTOR is a key protein involved in control and\nregulation of the cell\u2019s translational machinery through multiple mechanisms including\nby directly activating or inhibiting ribosomal activity.7 mTOR is a key intracellular point\nof convergence for a number of cellular signaling pathways, including Akt/PKB.8\nmTOR lies downstream to Akt/PKB, and targeted inhibition of this protein has\nemerged as an important therapeutic strategy in clinical oncology. Inhibition of mTOR\nactivity has been shown to restore tamoxifen response in breast cancer cells with\naberrant Akt activity.9\nEverolimus is an orally bioavailable inhibitor of the mTOR pathway. Combination\ntreatment with everolimus and either letrozole or fulvestrant has been shown to\nreverse Akt-mediated endocrine therapy resistance and restore responsiveness to\nanti-estrogens in preclinical studies.5 These observations formed the rationale leading\nto the Phase I clinical trial evaluating the combination of everolimus and letrozole in\nwomen previously treated with letrozole \u2265 4 months without objective response (e.g.,\nstable or progressive disease). Eighteen postmenopausal female patients with\nadvanced HR+ breast cancer were treated with letrozole 2.5 mg/day and everolimus\nat 5 mg/day (cohort 1) or 10 mg/day (cohort 2).10 Overall the combination was well\ntolerated and toxicities were manageable and consistent with that expected for

\n

everolimus monotherapy. The results suggest antitumor activity for this combination\nwithout Pharmacokinetic (PK) interactions.\nThis study will examine the efficacy and tolerability of the combination of fulvestrant\nand everolimus for the treatment of postmenopausal metastatic breast cancer\nresistant to an aromatase inhibitor.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_3", - "extensionAttributes": [], - "name": "NCI_1_2", - "text": "
\n

Breast cancer is the most commonly diagnosed malignancy in women worldwide. In\nthe United States, an estimated 230,480 new cases of invasive breast cancer were\ndiagnosed in 2011, with 39,520 breast cancer deaths.11 Despite the recent advances\nin breast cancer therapy, 40-80% of women with node-positive disease and up to\n30% of women with node-negative disease at diagnosis will relapse. When distant\nmetastases occur, the prognosis remains poor with a median survival of 18 to 36\nmonths from time of recurrence. Among the 60-70% of women with hormone-receptor\npositive breast cancer, 40-60% of them will benefit from endocrine therapy. Endocrine\ntherapy has shown to yield similar survival rates in hormone-sensitive disease as\ncompared to chemotherapy; although response rates are lower and responses\ndevelop more slowly. Endocrine therapy is considerably less toxic than\nchemotherapy, and is therefore the preferred treatment option for patients with\nhormone-receptor (HR)-positive disease.12,13 Chemotherapy is generally indicated in\nHR-negative disease, in cases unresponsive to endocrine therapy, or when extensive\nmetastases require rapid tumor response.14

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_4", - "extensionAttributes": [], - "name": "NCI_1_3", - "text": "
\n

Several endocrine therapies are available for the treatment of metastatic breast\ncancer in postmenopausal women, including selective estrogen-receptor modulators\n(SERMs), aromatase inhibitors (AIs), progestins, androgens, and most recently the\nselective estrogen receptor downregulators (SERDs- e.g., fulvestrant). Tamoxifen\nwas generally regarded as a standard option in HR-positive disease for adjuvant\ntherapy, and for first-line therapy of metastatic disease in postmenopausal women.\nWithin the past decade, however, the AIs (letrozole, anastrozole, exemestane) have\nsupplanted tamoxifen as the preferred choice for adjuvant therapy and metastatic\ndisease in postmenopausal women.15,16 There is therefore a need to develop more\neffective endocrine therapies for patients with AI-resistant disease, and to enhance\nthe effectiveness of existing endocrine therapies that have demonstrated efficacy in\nAI-resistant disease.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_5", - "extensionAttributes": [], - "name": "NCI_1_3_1", - "text": "
\n

Fulvestrant (Faslodex\u00ae, AstraZeneca Pharmaceuticals LP, Wilmington, DE) has\nseveral unique characteristics. It is the first drug which acts as a pure estrogen\nreceptor (ER) antagonist without known agonist effects. It competitively binds to the\nERs with an approximately 100 times greater affinity than that of tamoxifen.\nFulvestrant promotes the degradation of ERs and subsequently prevents ERmediated gene transcription. Two studies that led to the approval of fulvestrant were\nperformed in postmenopausal women with HR-positive metastatic breast cancer who\nhad progressive disease after tamoxifen therapy. These trials compared fulvestrant

\n

(250 mg IM injection monthly) with anastrozole (1 mg PO daily) (Table 1-0).17,18 The\nprimary endpoint for both studies was time to disease progression (TTP), which was\nsimilar between the two treatment arms (5.4 versus 3.4 months in the North American\ntrial, and 5.5 versus 5.1 months in the European trial). Secondary endpoints were\nalso comparable. The response rate for fulvestrant was 17-20% (versus 15.7-17.5%\nfor anastrozole), Clinical Benefit Rate (CBR) was 42-45% (versus 36-45% for\nanastrozole), median duration of response was 15-19 months (versus 11-15 months\nfor anastrozole), and median time to disease progression (TTP) was 5.5 months\n(versus 3.4-5.1 months for anastrozole). Further subgroups analyses confirm the\nclinical activity of fulvestrant in both visceral and non-visceral metastatic disease as\ncompared with anastrozole.19 These trials led to the approval of Faslodex\u00ae\n(fulvestrant) Injection for \u201c\u2026the treatment of hormone-receptor positive metastatic\nbreast cancer in postmenopausal women with disease progression following\nantiestrogen therapy\u201d.\nTable 1-0\nPhase III Studies Comparing Fulvestrant and Anastrozole after TamoxifenFailure in Postmenopausal Women with HR-Positive Metastatic Breast Cancer\nNorth American Trial

\n

European Trial

\n

Treatment Group:

\n

Fulvestrant

\n

Anastrozole

\n

Fulvestrant

\n

Anastrozole

\n

No. of Patients:

\n

Overall RR (%):

\n

17.5

\n

17.5

\n

20.7

\n

15.7

\n

CR (%):

\n

4.9

\n

3.6

\n

4.5

\n

1.7

\n

PR (%):

\n

12.6

\n

13.9

\n

16.2

\n

14.0

\n

42.2

\n

36.1

\n

44.6

\n

45.0

\n

24.8

\n

18.6

\n

23.9

\n

29.3

\n

Median TTP (months):

\n

5.4

\n

3.4

\n

5.5

\n

5.1

\n

Median Duration of Response\n(months):

\n

19.0

\n

10.8

\n

15.0

\n

14.5

\n

Withdrawal Rate (%):

\n

2.5

\n

2.6

\n

3.2

\n

1.3

\n

Clinical Benefit Rate (%):\nSD for more than 24 weeks (%):

\n

Fulvestrant has also been compared with tamoxifen as first line therapy in a Phase III\ntrial that included 587 postmenopausal women with HR-positive metastatic breast\ncancer, but proved to be no more effective than tamoxifen in this setting.20 When\ncomparing fulvestrant with tamoxifen, the objective response rate (34% versus 32%)\nand clinical benefit rate (57% versus 62%) were similar.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_6", - "extensionAttributes": [], - "name": "NCI_1_3_2", - "text": "
\n

Several trials have evaluated the role of fulvestrant in AI-resistant disease, as\nsummarized in Table 1-1.

\n

Table 1-1\nPhase II or III Trial of Fulvestrant in AI-Resistant Disease\nReference\nIngle, 2006

\n

Treatment

\n

No.

\n

RR

\n

CBR

\n

Median TTP

\n

Fulvestrant

\n

14%

\n

25%

\n

3.0 mo.

\n

Fulvestrant

\n

5%

\n

37%

\n

3.5 mo.

\n

Fulvestrant

\n

7%

\n

23%

\n

3.7 mo.

\n

Exemestane

\n

7%

\n

19%

\n

3.7 mo.

\n

Perey, 2007

\n

Chia, 2008

\n

The Clinical Benefit Rate (CBR) for patients with AI-resistant disease is approximately\n20-30%, and median TTP is approximately 3.5 months. In the EFECT trial reported by\nChia et al, patients who had progressive disease after treatment with a non-steroidal\nAI (anastrozole, letrozole) were randomized to fulvestrant or the steroidal aromatase\ninhibitor exemestane. In contrast to most other trials that utilized a single 250 mg\nmonthly dose based upon the original pharmacokinetic studies,23 patients in the\nEFECT trial received a 500 mg loading dose on day 1, then 250 mg on day 15 and 28\n(then every 4 weeks thereafter) based upon recent evidence that this dose/schedule\nmay more rapidly achieve therapeutic blood levels. There was no significant\ndifference in CBR between the two treatment arms. Nevertheless, the EFECT trial\nconfirmed the effectiveness of fulvestrant previously reported in other smaller trials of\nfulvestrant in AI-resistant disease.\nPrevious trials had demonstrated that a dose of 125 mg was less effective than the\n250 mg monthly dose.16,20 Based upon evidence that dosing schedules higher than\nthe 250 mg monthly dose may produce greater clinical benefit, several trials\nevaluated alternative dosing schedules (similar to that used in the EFECT trial),\nincluding FINDER I (NCT00305448), FINDER II (NCT00313170), and CONFIRM\n(NCT00099437).

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_7", - "extensionAttributes": [], - "name": "NCI_1_3_3", - "text": "
\n

Fulvestrant has demonstrated activity when used as first, second, or third line\nendocrine therapy, making it an attractive therapy for combination with other agents.\nIn addition, it is commonly reserved for use following disease progression on AI\ntherapy. The loading dose schedule employed in the EFECT trial will be used in this\nstudy taking advantage of the known dose-response effect observed for fulvestrant,\nthe more rapid achievement of therapeutic blood levels, the extensive efficacy and\nsafety experience with this schedule, and because it appears to be emerging as the\npreferred schedule for fulvestrant based upon the results of ongoing and recently\ncompleted clinical trials.\nThe recently reported CONFIRM trial compared fulvestrant dosing of 250 mg every\n28 days (the previously FDA-approved dose) with 500 mg on days 1, 14, 28 and\nevery 28 days thereafter (the current FDA-approved dose).24 The study demonstrated\nthat the higher dose was more effective. Median time to progression (TTP) was 6.5\nmonths with the higher dose compared with 5.5 months with the lower dose (HR 0.8,\np=0.006). The CBR was 45%, with the high dose as compared to 39.6% with the low\ndose arm (odds ratio 1.28, p= 0.10). In the subgroup of patients who had

\n

relapsed/progressed on an aromatase inhibitor (the population targeted in this study),\nmedian TTP was 5.4 months with the high-dose arm, and 4.1 months on the standard\narm (with CBRs of 36% and 32% respectively). We will therefore use the high-dose\nregimen as utilized in the CONFIRM trial.24

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_8", - "extensionAttributes": [], - "name": "NCI_1_4", - "text": "
\n

Everolimus (RAD001) is a novel oral derivative of rapamycin that is an m-TOR\ninhibitor.\nEverolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation. Everolimus is approved in Europe and other global\nmarkets (trade name: Certican\u00ae) for cardiac and renal transplantation, and in the\nUnited States (trade name: Zortress\u00ae) for the prevention of organ rejection of kidney\ntransplantation.\nEverolimus was developed in oncology as Afinitor\u00ae and was approved for advanced\nrenal cell carcinoma (RCC) in 2009. In 2010, Afinitor\u00ae received United States (US)\napproval for patients with subependymal giant cell astrocytoma (SEGA) associated\nwith tuberous sclerosis (TS). Everolimus is also available as Votubia\u00ae in the\nEuropean Union (EU) for patients with SEGA associated with TS. Afinitor\u00ae was\napproved for \u201cprogressive pancreatic neuroendocrine tumor (PNET) in patients with\nunresectable, locally advanced, or metastatic disease\u201d in 2011 in various countries,\nincluding the US and Europe.\nIn 2012 Afinitor\u00ae received approval for the treatment of postmenopausal women with\nadvanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+\nBC) in combination with exemestane, after failure of treatment with letrozole or\nanastrozole. Furthermore in 2012, Afinitor\u00ae received approval for the treatment of\npatients with Tuberous Sclerosis Complex (TSC) who have renal angiomyolipoma not\nrequiring immediate surgery.\nEverolimus is being investigated as an anticancer agent based on its potential to act:\n\u2022

\n

Directly on the tumor cells by inhibiting tumor cell growth and proliferation.

\n

\u2022

\n

Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via\npotent inhibition of tumor cell HIF-1 activity, VEGF production and VEGF-induced\nproliferation of endothelial cells). The role of angiogenesis in the maintenance of\nsolid tumor growth is well established, and the mTOR pathway has been\nimplicated in the regulation of tumor production of proangiogenic factors as well\nas modulation of VEGFR signaling in endothelial cells.

\n

At weekly and daily schedules and at various doses explored, everolimus is generally\nwell tolerated. The most frequent adverse events (rash, mucositis, fatigue and\nheadache) associated with everolimus therapy are manageable. Non-infectious\npneumonitis has been reported with mTOR inhibitors but is commonly low-grade and\nreversible.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_9", - "extensionAttributes": [], - "name": "NCI_1_4_1", - "text": "
\n

At cellular and molecular levels, everolimus acts as a signal transduction inhibitor.\nEverolimus selectively inhibits mTOR (mammalian target of rapamycin), specifically

\n

targeting the mTOR-raptor signal transduction complex. mTOR is a key and highly\nconserved serine-threonine kinase which is present in all cells and is a central\nregulator of protein synthesis and ultimately cell growth, cell proliferation,\nangiogenesis and cell survival. mTOR is the only currently known target of\neverolimus.25\nmTOR is downstream of PI3K/AKT pathway, a pathway known to be dysregulated in\na wide spectrum of human cancers (e.g. through loss/mutation of the PTEN negative\nregulator; through PI3K mutation/amplification; through AKT/PKB overexpression/\noveractivation; through modulation of TSC1/TSC2 tumor suppressors). In addition,\nactivation of the PI3K/AKT/mTOR pathway is associated with worsening prognosis\nthrough increased aggressiveness, resistance to treatment and progression.\nThe main known functions of mTOR include the following:7,25\n\u2022\n\u2022\n\u2022

\n

\u2022\n\u2022

\n

mTOR functions as a sensor of mitogens, growth factors and energy, and nutrient\nlevels, facilitating cell-cycle progression from G1 to S phase in appropriate growth\nconditions.\nThe PI3K-mTOR pathway itself is frequently activated in many human cancers,\nand oncogenic transformation may sensitize tumor cells to mTOR inhibitors.\nThrough inactivating eukaryotic initiation factor 4E binding proteins (4E-BP1) and\nactivating the 40S ribosomal S6 kinases (e.g., p70S6K1), mTOR regulates protein\ntranslation, including the HIF-1 proteins. Inhibition of mTOR is expected to lead to\ndecreased expression of HIF-1.\nThe activation of mTOR pathway is involved in the production of pro-angiogenic\nfactors (i.e., VEGF) and inhibition of endothelial cell growth and proliferation.\nThe regulation of mTOR signaling is complex and involves positive regulators,\nsuch as AKT that phosphorylate and inactivate negative regulators such as the\nTuberous Sclerosis Complex (TSC1/TSC2).

\n

mTOR is represented by two structurally and functionally distinct multiprotein\nsignaling complexes, mTORC1 (mTOR complex 1, rapamycin sensitive) and\nmTORC2 (mTOR complex 2, rapamycin insensitive).26\nmTORC1 is mainly activated via the PI3 kinase pathway through AKT (also known as\nPKB, protein kinase B) and the tuberous sclerosis complex (TSC1/TSC2).7 Activated\nAKT phosphorylates TSC2, which leads to the dissociation of TSC1/TSC2 complex,\nthus inhibiting the ability of TSC2 to act as a GTPase activating protein. This allows\nRheb, a small G-protein, to remain in a GTP bound state and to activate mTORC1.\nAKT can also activate mTORC1 by PRAS40 phosphorylation, thereby relieving the\nPRAS40-mediated inhibition of mTORC1.27,28\nmTORC2 (mTOR complex 2) is activated through a currently unknown mechanism,\npossibly by receptor tyrosine kinase (RTK) signaling.27 It has been suggested that\nmTORC2 phosphorylates and activates a different pool of AKT that is not upstream of\nmTORC1. PHLPP phosphatase plays a role of a negative regulator. mTORC2 is\nrapamycin insensitive and is required for the organization of the actin cytoskeleton.26\nmTORC1-mediated signaling is subject to modulation by the macrocyclic lactone\nrapamycin and its derivatives, such as everolimus. Once these agents bind to the 12\nkDa cytosolic FK506-binding protein immunophilin FKBP12, the resulting rapamycinFKBP12 complexes bind to a specific site near the catalytic domain of mTORC1 and

\n

inhibit phosphorylation of mTOR substrates. As a consequence, downstream\nsignaling events involved in regulation of the G1 to S-phase transition are inhibited.\nThis mechanism is thought to be responsible for the immunosuppressive effects of\nrapamycin as well as its putative antineoplastic activity.29 As many cancers are\ncharacterized by dysregulation of G1 transit (for example, overexpression of cyclin or\ncyclin-dependent kinases), inhibition of mTOR becomes an intriguing target for\ninducing cytostasis.7\n1.4.1.1

\n

Preclinical Studies

\n

Everolimus acts as an inhibitor of cytokine and growth-factor-dependent proliferation\nof cells. The only currently known target of everolimus is mTOR, a key regulatory\nprotein affecting cell growth.25 Everolimus exerts its activity through high affinity\ninteraction with an intracellular receptor protein, the immunophilin FKBP12. The\nFKBP12/everolimus complex subsequently interacts with the mTOR protein kinase,\ninhibiting downstream signaling events involved in regulation of the G1 to S-phase\ntransition.\nThe main known functions of mTOR include:\n\u2022

\n

Function as a sensor of mitogens, growth factors, energy and nutrient levels,\nfacilitating cell-cycle progression from G1 - S phase in appropriate growth\nconditions.

\n

\u2022

\n

Regulation of protein synthesis important for tumor cell proliferation and\nangiogenesis through inactivating eukaryotic initiation factor 4E binding proteins\nand activating the 40S ribosomal S6 kinases (e.g. p70S6K1). For example,\nactivation of the mTOR pathway leads to a) increased production of proangiogenic factors (e.g. VEGF) in tumors b) tumor, endothelial and smooth\nmuscle cell growth and proliferation.

\n

The PI3K-mTOR pathway itself is frequently activated in many human cancers, and\noncogenic transformation may sensitize tumor cells to mTOR inhibitors. The\nregulation of mTOR signaling is complex and involves positive regulators such as\nAKT that phosphorylate and inactivate negative regulators such as the Tuberous\nSclerosis Complex (TSC1/TSC2). In summary, mTOR has pleiotropic functions;\nhence, the activities of everolimus may vary depending upon cell type.\nThe mTOR inhibitory activities presumably contribute to the anti-proliferative activity\nof everolimus against tumor cell lines. However, everolimus may also exert an\nantitumor effect through the inhibition of angiogenesis. Indeed, both rapamycin and\neverolimus potently inhibit proliferation of endothelial cells and have antiangiogenic\nactivity in vivo.30,31 Exactly which molecular determinants predict responsiveness of\ntumor cells to everolimus is still unclear. Currently, the activation status of the\nPI3K/AKT/mTOR/p70 S6K pathway may be indicative of responsiveness to\nrapamycins. For example, pre-clinically, loss of PTEN or constitutive/hyper-activation\nof AKT has been suggested to sensitize tumors to the effects of inhibition of\nmTOR.25,31 Also, clinically, it has been suggested that high p70S6K activation in\nbaseline Glioblastoma Multiforme (GBM) tumor samples may predict a patient\npopulation more likely to derive benefit from mTOR inhibition.32

\n

Everolimus is a highly specific inhibitor of mTOR, which is afforded by high-affinity\nbinding to the protein FKBP-12 (IC50 of 5.3 nM) similar to that of rapamycin. Similar\npotency of rapamycin and everolimus was also demonstrated at forming the mTOR/\nFKBP-12 tertiary complex in vitro. Specificity was demonstrated by a lack of inhibitory\nactivity against 10 other protein kinases at concentrations up to 10 \u03bcM.\nThe anti-proliferative effects of everolimus were investigated in a mixed panel of 48\ndifferent tumor cell lines (including breast, colon, epidermoid, glioblastoma, lung,\nmelanoma, prostate and renal). The majority of tumor cell lines were highly sensitive\nto the anti-proliferative effects of everolimus while a few others appeared intrinsically\ninsensitive, or \u2018resistant\u2019 (IC50 range 0.2 to 4125 nM).33 The median IC50 value of the\n48 cell lines was 0.5 nM. Similar findings have been observed for rapamycin.34\nEverolimus was also shown to have activity in human pancreatic neuroendocrine\ncells, where induction of apoptosis was reported,35 as well as in acute myeloid\nleukemia cells,36 mantle cell lymphoma cells37, adult T-cell leukemia cells38, diffuse\nlarge B cell lymphoma cells,39 pancreatic tumor cells,40 ovarian cancer cells,31,41 and\nhepatocellular carcinoma cells.42\nEverolimus was also evaluated in a clonogenic assay using cells derived from 81\npatient derived tumor xenografts never cultured in vitro (11 human tumor types with 3\nto 24 tumors each: bladder, colon, gastric, Non-Small Cell Lung Cancer (NSCLC),\nSmall Cell Lung Cancer (SCLC), breast, ovary, pancreatic, renal, melanoma, and\npleuramesothelioma). Everolimus inhibited colony formation in a concentrationdependent manner (mean IC50: 175 nM). In addition, normal hematopoetic stem cells\nwere found to be relatively insensitive to everolimus, with an IC50 about 15 fold higher\nthan the tumor lines.\nEverolimus was effective and well tolerated against subcutaneous (s.c.) tumors\nestablished from a variety of tumor cell lines of diverse histotypes (NSCLC,\npancreatic, colon, melanoma, epidermoid), including a PgP170-overexpressing, multidrug resistant tumor line. Typically, the antitumor activity of everolimus was that of\nreduction of tumor growth rates rather than producing regressions or stable disease\nalthough, in the case of A549 and NCI-H596 lung and ARJ42 pancreatic tumors,\nregressions could be obtained. These effects occurred within the dose range of 2.5 to\n10 mg/kg, P.O., once per day. The change in tumor volume of the treated mice\ndivided by the change in tumor volume of control mice (T/C) typically ranged from\napproximately 15 to 50% at optimal doses. A marked loss of antitumor activity\noccurred when tumor-bearing mice were treated with everolimus once per week, but\nimproved moderately with twice per week dosing. Antitumor activity of everolimus has\nalso been demonstrated in mouse models of ovarian,31 breast,43,44 and\ngastrointestinal stromal tumors.45

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_10", - "extensionAttributes": [], - "name": "NCI_1_4_2", - "text": "
\n

In safety pharmacology studies, everolimus was devoid of relevant effects on vital\norgan functions including the cardiovascular, respiratory and nervous systems.\nEverolimus had no effects on QT interval. Furthermore, everolimus showed no\nantigenic potential. Although everolimus passes the blood-brain barrier, there was no\nindication of relevant changes in the behavior of rodents, even after single oral doses\nup to 2000 mg/kg or after repeated administration at up to 40 mg/kg/day.

\n

The preclinical safety profile of everolimus was assessed in mice, rats, minipigs,\nmonkeys, and rabbits. The major target organs were male and female reproductive\nsystems (testicular tubular degeneration, reduced sperm content in epididymides and\nuterine atrophy) in several species; lungs (increased alveolar macrophages) in rats\nand mice; and eyes (lenticular anterior suture line opacities) in rats only. Minor kidney\nchanges were seen in the rat (exacerbation of age-related lipofuscin in tubular\nepithelium, increases in hydronephrosis) and mouse (exacerbation of background\nlesions). There was no indication of kidney toxicity in monkeys or minipigs.\nGenotoxicity studies covering relevant genotoxicity endpoints showed no evidence of\nclastogenic or mutagenic activity. Administration of everolimus for up to 2 years did\nnot indicate any oncogenic potential in mice and rats up to the highest doses,\ncorresponding respectively to 4.2 and 0.2 times the estimated clinical exposure. In\nreproduction studies, everolimus was toxic to the conceptus in rats and rabbits, and\nwas considered potentially teratogenic in rats. It is therefore recommended that\nwomen of childbearing potential should use effective contraceptive measures during\nthe entire treatment period and for 8 weeks thereafter.\nMore pre-clinical information is provided in the Investigator\u2019s Brochure.

\n

1.4.3\n1.4.3.1

\n

Clinical Experience

\n

Everolimus Pharmacokinetics

\n

Everolimus is rapidly absorbed with a median tmax of 1-2 hours. The steady-state\nAUC0-\u03c4 is dose-proportional over the dose range between 5 to 70 mg in the weekly\nregimen and 5 and 10 mg in the daily regimen. Steady-state was achieved within two\nweeks with the daily dosing regimen. Cmax is dose-proportional between 5 and 10 mg\nfor both the weekly and daily regimens. At doses of 20 mg/week and higher, the\nincrease in Cmax is less than dose proportional. In healthy subjects, high fat meals\nreduced systemic exposure to everolimus 10 mg (as measured by Area Under the\nConcentration Time-Curve (AUC)) by 22% and the peak plasma concentration Cmax\nby 54%. Light fat meals reduced AUC by 32% and Cmax by 42%. Food, however, had\nno apparent effect on the post absorption phase concentration-time profile.\nThe blood-to-plasma ratio of everolimus, which is concentration-dependent over the\nrange of 5 to 5,000 ng/mL, is 17% to 73%. The amount of everolimus confined to the\nplasma is approximately 20% at blood concentrations observed in cancer patients\ngiven everolimus 10 mg/day. Plasma protein binding is approximately 74% both in\nhealthy subjects and in patients with moderate hepatic impairment.\nEverolimus is a substrate of CYP3A4 and a substrate and moderate inhibitor of PgP.\nFollowing oral administration, everolimus is the main circulating component in human\nblood and is considered to contribute the majority of the overall pharmacologic\nactivity. No specific excretion studies have been undertaken in cancer patients;\nhowever, data available from the transplantation setting found the drug to be mainly\neliminated through the feces. There was a significant correlation between AUC0-\u03c4 and\npre-dose trough concentration at steady-state on the daily regimen. The mean\nelimination half-life of everolimus is approximately 30 hours.\nAppendix C lists examples of clinically relevant CYP3A4 inhibitors and inducers.

\n

Please refer to Section 5.3.5 for more information on the concomitant use of CYP3A4\ninhibitors/inducers and other medications.\nMore information on everolimus pharmacokinetics is provided in the Investigator\u2019s\nBrochure.\n1.4.3.2

\n

Everolimus Pharmacodynamic Studies

\n

Pharmacokinetic/pharmacodynamic modeling based on inhibition of the biomarker\np70S6 kinase 1 [S6K1] in peripheral blood mononuclear cells [PBMC]) suggests that\n5-10 mg daily should be an adequate dose to produce a high-degree of sustained\ntarget inhibition ([Study C2101]/[Study 2102]).46 Molecular changes in tumor were\nevaluated through serial biopsy before and during treatment. Biopsy on treatment\ntook place in week 4 (pharmacokinetic steady-state). All patients underwent a 24hour post-dose biopsy. Patients following the weekly regimen had a further biopsy on\nDay 4 or 5 of the same week. Molecular activity was measured by\nimmunohistochemistry. In the absence of a reliable technique for measuring mTOR\nphosphorylation, the phosphorylation status of downstream markers S6 and eIF4G,\nfor which reliable antibodies exist, was selected as reflecting the immediate\npharmacodynamic effect of everolimus. Also measured were changes in the\nphosphorylation status of upstream AKT and the proliferation index Ki67. Fifty-five\npatients were treated and the results revealed a dose and schedule dependent\ninhibition of the mTOR pathway with a near complete inhibition of pS6 and pelF-4G at\nthe 10 mg/day and 50 mg/wk schedules. In addition, pAKT was upregulated in 50% of\nthe treated tumors. In the daily schedule, there was a correlation between everolimus\nplasma trough concentrations and inhibition of peIF4G and p4E-BP1. There was\ngood concordance of mTOR pathway inhibition between skin and tumor. [Study\nC2107].47\nMore information on everolimus pharmacodynamics is provided in the Investigator\u2019s\nBrochure (IB).\n1.4.3.3

\n

Clinical Experience with Everolimus

\n

Everolimus has been in clinical development since 1996 as an immunosuppressant in\nsolid organ transplantation and was approved in Europe in 2003 under the trade\nname Certican\u00ae, for the prevention of organ rejection in patients with renal and\ncardiac transplantation. It is also approved in the United States (trade name:\nZortress\u00ae) for the prevention of organ rejection of kidney transplantation. Additional\nnon-oncologic indications currently being explored are wet age-related macular\ndegeneration (AMD) and autosomal dominant polycystic kidney disease (ADPKD).\nClinical experience of everolimus in the transplant indication is summarized in a\nseparate Investigator\u2019s Brochure.\nIn oncology, everolimus has been in clinical development since 2002 for patients with\nvarious hematologic and non-hematologic malignancies as a single agent or in\ncombination with antitumor agents. Please note that safety pharmacology and\ntoxicology studies as well as some human pharmacology studies which have been\nconducted in support of the transplant indication, are described in the oncology IB\ndue to the relevance of these data for the oncology indication. Malignancies that are\ncurrently being evaluated in Novartis sponsored studies include the following:

\n

metastatic renal cell carcinoma (mRCC), breast cancer, gastroenteropancreatic\nneuroendocrine tumors (GEP-NET), mantle cell lymphoma and diffuse large B cell\nlymphoma (DLBCL), hepatocellular cancer (HCC), gastric cancer, and lung cancer. In\naddition, treatment of patients with Tuberous Sclerosis Complex (TSC) associated\nsubependymal giant cell astrocytoma (SEGA) and Angiomyolypoma is also being\nevaluated. Colorectal cancer (CRC) is no longer being evaluated.\nEverolimus 2.5 mg, 5 mg and 10 mg tablets were approved under the trade name\nAfinitor\u00ae for patients with advanced renal cell carcinoma in the US, EU and several\nother countries and is undergoing registration in other regions worldwide. Recent\napproval was granted in the US for the treatment of patients with subependymal giant\ncell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require\ntherapeutic intervention but are not candidates for curative surgical resection.\nPhase I dose escalating studies, exploratory Phase I/II studies with everolimus as\nsingle agent or in combination with other anti-cancer agents, Phase II/III studies of\neverolimus in indications, and Phase III double-blind studies are contributing to the\nextensive database.\nApproximately 18,730 cancer patients have been treated with everolimus as of 30Sep-2011:\n\u2022\n\u2022\n\u2022\n\u2022

\n

9,528 patients in Novartis-sponsored clinical trials\n2,559 patients in the individual patient supply program\n6,638 in investigator-sponsored studies.\nIn addition, healthy volunteer subjects have participated in the clinical\npharmacology studies as described in Section 1.4.3.1.

\n

As of 30-Sep-2011, there are a total of 11 Phase III trials ongoing in the indications\nmRCC (1), advanced NET (2), breast cancer (3), TSC (2), DLBCL (1), gastric cancer\n(1) and HCC (1).\nRecent approvals of everolimus (Afinitor\u00ae) were based upon a Phase III, international,\nmulticenter randomized, double-blind, placebo-controlled study [C2240] in patients\nwith metastatic renal cell carcinoma (mRCC) whose disease had progressed despite\nprior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine\nkinase inhibitor) therapy. Progression-free survival (PFS) assessed via a blinded,\nindependent central review, was the primary endpoint. Secondary endpoints included\nsafety and objective tumor response.\nIn the pivotal, Phase III study [C2240], which included patients with advanced renal\ncell carcinoma, the most common adverse reactions (incidence \u2265 10%) were\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, pneumonitis, cough, peripheral edema, infections, dry skin, epistaxis,\npruritus, and dyspnea. The most common grade 3-4 adverse reactions (incidence \u2265\n2%) were infections, stomatitis, fatigue, and pneumonitis. Non-infectious pneumonitis\nis a class effect of rapamycin derivatives, including everolimus and some of these\ncases have been severe and on rare occasions, fatal outcomes have been observed.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral

\n

infections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.\nThe most common laboratory abnormalities (incidence \u2265 50%) were anemia,\nhypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and\nincreased creatinine. The most common grade 3/4 laboratory abnormalities\n(incidence \u2265 3%) were lymphopenia, hyperglycemia, anemia, hypophosphatemia, and\nhypercholesterolemia. Deaths due to acute respiratory failure (0.7%), infection\n(0.7%), and acute renal failure (0.4%) were observed on the everolimus arm. The\nrates of treatment-emergent adverse reactions resulting in permanent discontinuation\nwere 7% and 0% for the everolimus and placebo treatment groups, respectively.\nSafety data from study [C2240] are described in detail in Section 1.4.3.3.\nOverall, safety data available from completed, controlled and uncontrolled studies are\nconsistent with the aforementioned findings of the Phase III trial. Everolimus is\ngenerally well tolerated at weekly and daily dose schedules. The safety profile is\ncharacterized by manageable adverse events (AEs). These AEs are generally\nreversible and non-cumulative.\nFurther detailed information regarding everolimus clinical development, safety and\nefficacy is provided in the Investigator\u2019s Brochure.\n1.4.3.4

\n

Clinical Experience with Everolimus in Metastatic Breast Cancer\nResistant to Non-Steroidal Aromatase Inhibitors

\n

Based on data indicating that resistance to endocrine therapy in breast cancer is\nassociated with activation of the mammalian target of rapamycin (mTOR) intracellular\nsignaling pathway, a Phase 3, randomized trial (BOLERO2) compared the steroidal\naromatase inhibitor exemestane (25 mg PO daily) plus either everolimus (10 mg PO\ndaily) or a placebo (randomly assigned in a 2:1 ratio) in 724 patients with HR-positive\nadvanced breast cancer who had recurrence or progression while receiving previous\ntherapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat\nadvanced disease (or both). The primary end point was progression-free survival.\nSecondary end points included survival, response rate, and safety. A preplanned\ninterim analysis was performed by an independent data and safety monitoring\ncommittee after 359 progression-free survival events were observed. Baseline\ncharacteristics were well balanced between the two study groups. The median age\nwas 62 years, 56% had visceral involvement, and 84% had hormone-sensitive\ndisease. Previous therapy included letrozole or anastrozole (100%), tamoxifen (48%),\nfulvestrant (16%), and chemotherapy (68%). The most common grade 3 or 4 adverse\nevents were stomatitis (8% in the everolimus-plus-exemestane group vs. 1% in the\nplacebo-plus-exemestane group), anemia (6% vs. <1%), dyspnea (4% vs. 1%),\nhyperglycemia (4% vs. <1%), fatigue (4% vs. 1%), and pneumonitis (3% vs. 0%). At\nthe interim analysis, median progression-free survival was 6.9 months with\neverolimus plus exemestane and 2.8 months with placebo plus exemestane,\naccording to assessments by local investigators (hazard ratio for progression or\ndeath, 0.43; 95% confidence interval [CI], 0.35 to 0.54; P<0.001). Median\nprogression-free survival was 10.6 months and 4.1 months, respectively, according to\ncentral assessment (hazard ratio, 0.36; 95% CI, 0.27 to 0.47; P<0.001). The study\nmet its pre-specified endpoint, which led to FDA approval of everolimus in

\n

combination with exemestane for this indication in the U.S. on July 20, 2012.48\nOverall survival results were immature at the time of the interim analysis, with a total\nof 83 deaths: 10.7% of patients in the combination-therapy group and 13.0% of those\nin the exemestane-alone group died. Patients and investigators continue to be\nunaware of study assignments and will remain so until survival results are mature for\nanalysis.49

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_11", - "extensionAttributes": [], - "name": "NCI_1_4_3", - "text": "

See section 1.4.3 Clinical Experience.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_12", - "extensionAttributes": [], - "name": "NCI_1_5", - "text": "
\n

We hypothesize more complete blockade of the ER-signaling pathway may be\nachieved with selective estrogen receptor downregulator fulvestrant (given at a high\ndose) than may be achieved with the steroidal AI exemestane, and that this will result\nin either comparable or greater effectiveness for the fulvestrant-everolimus\ncombination than the exemestane-everolimus combination. This is supported by\npreclinical data demonstrating that fulvestrant is particularly effective when combined\nwith agents targeting the PI3K-AKT-m-TOR pathway in tumors that have undergone\nlong-term estrogen deprivation, as is the case for patients who have acquired\nresistance to AI therapy.50\nWe therefore propose to study the efficacy of fulvestrant in combination with\neverolimus for the treatment of post-menopausal HR-positive metastatic breast\ncancer in women who have progressed after treatment with an aromatase inhibitor.\nThe combination of a novel class of agents (mTOR inhibitors) and an established\nstandard treatment for metastatic HR-positive breast cancer may potentially increase\nthe clinical benefit by targeting multiple different biological pathways.\nThis is a randomized, double-blind, placebo controlled Phase II study. It is expected\nthat 130 patients will be accrued at 25 centers within the US. Patients will be\nrandomized (1:1) to receive everolimus or placebo after consideration of stratification\nfactors of performance status (0 vs.1), measurable disease (with or without nonmeasurable) vs. non-measurable disease, and prior chemotherapy for metastatic\ndisease vs. no prior chemotherapy.\nInduction Phase:\nTreatment during the Induction Phase includes:\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus everolimus 10 mg (two- 5 mg tablets) PO daily\nOR\nFulvestrant 500 mg IM (two-250 mg injections per dose) on day 1 & 15 of Cycle 1,\nthen 500 mg IM (two-250 mg injections) on day 1 of all subsequent cycles (every 28\ndays) plus placebo two tablets PO daily\nPatients will be evaluated for disease response every 12 weeks (every 3 treatment\ncycles), +/- 1 week, and treated until disease progression, unacceptable toxicity or for\na total of up to 12 cycles.

\n

Continuation Phase:\nPatients with no evidence of progressive disease who remain on study after\ncompleting Cycle 12 will be unblinded and proceed to the Continuation Phase.\nPatients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule. Patients will continue to\nbe evaluated for disease response every 12 weeks (every 3 treatment cycles), +/- 1\nweek, and may continue treatment until disease progression or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).

\n

Objectives

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_13", - "extensionAttributes": [], - "name": "NCI_2", - "text": "

See section 2 Objectives.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_14", - "extensionAttributes": [], - "name": "NCI_2_1", - "text": "
\n

To assess progression-free survival in post-menopausal patients with hormonereceptor positive metastatic breast cancer that is resistant to aromatase inhibitor\ntherapy treated with fulvestrant and everolimus compared to fulvestrant alone.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_15", - "extensionAttributes": [], - "name": "NCI_2_2", - "text": "
\n

To describe the safety profile, objective response rate, time to progression and\noverall survival in this patient population.

\n

Selection of Patients

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_16", - "extensionAttributes": [], - "name": "NCI_3", - "text": "

See section 3 Selection of Patients.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_17", - "extensionAttributes": [], - "name": "NCI_3_1", - "text": "
\n

Each of the criteria in the following section must be met in order for a patient to be\nconsidered eligible for this study.\nPrECOG will not grant any exceptions or waivers to protocol eligibility criteria.\nIn calculating pre-treatment days of tests and measurements, the day a test or\nmeasurement is done is considered Day 0. Therefore, if a test is done on a\nMonday, the Monday four weeks later would be considered Day 28.\nNote: All questions regarding eligibility should be directed to the PrECOG Study\nContact in study materials. Questions will be further discussed with the medical leads\nfor the trial as deemed appropriate (e.g., medical monitor, study chair).\nInvestigator sites may use the eligibility checklist (see Appendix A: Eligibility\nChecklist) which will be provided as a separate study document, as documentation\nthat eligibility criteria were verified. If used, it should be reviewed, signed, and dated\nprior to patient randomization by the treating physician, and all required elements of\nsource documentation must be found in the patient record (e.g. scans, consent,\npathology).\nInclusion Criteria:\n1. Must be willing to sign a protocol-specific informed consent.\n2. Patients must be 18 years of age or older.\n3. Patients must have an ECOG Performance Status 0 or 1 (see Appendix B:\nECOG Performance Status Scale).\n4. Patients must have histologically or cytologically confirmed adenocarcinoma\nof the breast.\n5. Patients must have stage IV disease or inoperable locally advanced disease.\n6. Patients must have ER and/or PR-positive disease as determined by their\nlocal pathology or reference laboratory by ASCO-CAP criteria.51 Tumors must\nbe HER-2/neu negative or equivocal by standard ICH/FISH or ICH/CISH\nmethodologies by ASCO-CAP criteria.52\n7. Patients must be Aromatase Inhibitor (AI) resistant, defined as:\n\u2022\n\u2022

\n

relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or,\nprogressive disease while receiving an aromatase inhibitor for metastatic\ndisease.

\n

Note: Patients may have received an endocrine agent (e.g., Tamoxifen)\nbetween the time of progression on an AI and registration.

\n

8. Patients who have received one prior cycle (dose on day 1 and day 15) of\nfulvestrant within 28 days of randomization are eligible so long as they meet\nother eligibility criteria.\n\u2022

\n

patients previously treated with two or more prior cycles of fulvestrant are\nnot eligible.

\n

9. Patients must be female and postmenopausal, defined as:\n\u2022\n\u2022\n\u2022\n\u2022

\n

\u2022

\n

a history of at least 12 months without spontaneous menstrual bleeding or,\nprior bilateral salpingo-oophorectomy, with or without hysterectomy or,\nage \u2265 55 years with a prior hysterectomy with or without oophorectomy or,\nage <55 years with a prior hysterectomy without oophorectomy or\nunknown status, with a documented FSH level in postmenopausal range\nwithin 4 weeks of randomization or,\nreceiving a gonadotropin releasing hormone analog (GnRH) to suppress\novarian function (e.g., goserelin 3.6 mg q 4 weeks).

\n

10. Patients may have received up to one prior systemic chemotherapy regimen\nfor metastatic disease.\n11. Adequate organ function, as evidenced by ALL the following obtained within 4\nweeks of randomization*:\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022

\n

\u2022

\n

total white blood cell count (leukocytes, WBC) \u2265 3.0 x 109/L, absolute\nneutrophil count (ANC) \u2265 1.5 x 109/L and platelet count \u2265 100 x 109/L\nhemoglobin \u2265 9 g/dL\nserum bilirubin \u2264 1.5 x ULN\nAST or ALT \u2264 2.5 x ULN (\u2264 5 x ULN in patients with liver metastases)\nserum creatinine \u2264 1.5 x ULN\nserum albumin \u2265 3 g/dL\nfasting serum cholesterol \u2264 300 mg/dL OR \u2264 7.75 mmol/L AND fasting\ntriglycerides \u2264 2.5 x ULN. Note: In case one or both of these thresholds\nare exceeded, the patient can only be included after initiation of\nappropriate lipid lowering medication.\nPT with INR \u2264 1.5 (Anticoagulation is allowed if target INR \u2264 1.5 on a\nstable dose of warfarin or on a stable dose of LMW heparin for >2 weeks\nat time of randomization.)

\n

*Please see study table in Section 7.0 for labs that may need to be repeated\nwithin \u2264 7 days of Cycle 1 Day 1 (C1D1).\n12. Patients may have measurable disease, non-measurable disease (e.g., bone\nonly metastases), or both per RECIST Version 1.1 Criteria. Measurable\nlesions are defined as those that can be accurately measured in at least one\ndimension (longest diameter to be recorded) as \u2265 20 mm by chest x-ray, as \u2265\n10 mm with CT scan, or \u2265 10 mm with calipers by clinical exam. All tumor\nmeasurements must be recorded in millimeters (or decimal fractions of\ncentimeters). Note: Tumor lesions that are situated in a previously irradiated\narea are not considered measurable.

\n

13. Patients with basal cell or squamous cell carcinoma of the skin or carcinoma\nin situ of the cervix within the past five years must have been treated with\ncurative intent. Patients with a history of prior malignancy are eligible provided\nthey were treated with curative intent and have been free of disease for >3\nyears.\nExclusion Criteria:\n1. Patients who have had any major surgery or significant traumatic injury within\n4 weeks of randomization, or have not recovered from the side effects of any\nmajor surgery (defined as requiring general anesthesia) or patients that may\nrequire major surgery during the course of the study are not eligible.\n(Placement of vascular access device will not be considered major surgery.)\n2. Patients may not be receiving any other investigational agents or have\nreceived any investigational agent within 4 weeks of randomization.\n3. Patients must not be receiving any concomitant anticancer treatment or have\nreceived anticancer treatment within 4 weeks of randomization (including\nchemotherapy, radiation therapy, antibody based therapy, etc.), with the\nfollowing exceptions:\n\u2022

\n

Bisphosphonates, Zometa or Xgeva for bone metastases

\n

\u2022

\n

Hormonal therapy (e.g., AI, Tamoxifen)

\n

\u2022

\n

a GnRH analog is permitted if the patient had progressive disease on a\nGnRH analog plus a SERM or an AI; the GnRH analog may continue but\nthe SERM or AI must be discontinued.

\n

4. Patients must not have received prior treatment with an mTOR inhibitor\n(sirolimus, temsirolimus, everolimus).\n5. Patients must not be receiving chronic, systemic treatment with corticosteroids\nor another immunosuppressive agent greater than or equal to 5 mg\nprednisone or its equivalent daily. Topical or inhaled corticosteroids are\nallowed.\n6. Patients must not receive immunization with attenuated live vaccines within\none week of randomization or during the study period. Close contact with\nthose who have received attenuated live vaccines should be avoided during\ntreatment with everolimus. Examples of live vaccines include intranasal\ninfluenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\n7. Patients must not have current or a prior history of brain metastases or\nleptomeningeal disease. Patients must not have rapidly progressive, lifethreatening metastases. This includes patients with extensive hepatic\ninvolvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\n8. Patients must not have a known hypersensitivity/history of allergic reactions\nattributed to compounds of similar chemical or biologic composition to\neverolimus (or other rapamycins such as sirolimus, temsirolimus) or\nfulvestrant.

\n

9. Since everolimus may cause bone marrow suppression, patients with\ncongenital or acquired immune deficiency at increased risk of infection are not\neligible. This includes patients being treated with chronic immunosuppressive\nagents (including greater than or equal to 5 mg prednisone or its equivalent\ndaily), and patients with known HIV seropositivity.\n10. Patients must not have any impairment of gastrointestinal function or\ngastrointestinal disease that may significantly alter the absorption of\neverolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea,\nmalabsorption syndrome or small bowel resection).\n11. Patients must not have an active, bleeding diathesis.\n12. Patients must not have a history of any condition or uncontrolled intercurrent\nillness including, but not limited to, ongoing or active infection or psychiatric\nillness/social situations that in the opinion of the local investigator might\ninterfere with or limit the patient\u2019s ability to comply with the protocol or pose\nadditional or unacceptable risk to the patient.\n13. Patients must not have any severe and/or uncontrolled medical conditions or\nother conditions that could affect their participation in the study such as:\n\u2022

\n

Symptomatic congestive heart failure of New York Heart Association Class\nIII or IV (see Appendix D)

\n

\u2022

\n

Unstable angina pectoris, myocardial infarction within 6 months of\nrandomization, serious uncontrolled cardiac arrhythmia or any other\nclinically significant cardiac disease

\n

\u2022

\n

History of symptomatic pulmonary disease or non-malignant pulmonary\ndisease (e.g. COPD) requiring treatment. Such patients would be eligible if\nPFTs performed within 8 weeks of treatment noted a DLCO greater than\n50%.

\n

\u2022

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN\n(Note: Optimal glycemic control should be achieved before starting trial\ntherapy.)

\n

\u2022

\n

Active (acute or chronic) or uncontrolled severe infections

\n

\u2022

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh\nClass C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors\nmust be done at screening for all patients. HBV DNA and HCV RNA PCR\ntesting are required at screening for all patients with a positive medical history\nbased on risk factors and/or confirmation of prior HBV/HCV infection. (see\nSection 7.1.1 for additional details).

\n

Randomization Procedures

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_18", - "extensionAttributes": [], - "name": "NCI_4", - "text": "

See section 4 Randomization Procedures.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_19", - "extensionAttributes": [], - "name": "NCI_4_1", - "text": "
\n

This study will be conducted in accordance with the ethical principles that have their\norigin in the current Declaration of Helsinki and will be consistent with applicable US\nregulatory requirements and International Conference on Harmonization Good\nClinical Practice (ICH GCP).\nThe study will be conducted in compliance with the protocol. The protocol and any\namendments and the patient informed consent will receive Institutional Review Board\n(IRB) approval prior to initiation of the study.\nFreely given written informed consent must be obtained from every patient or their\nlegally acceptable representative prior to clinical trial participation, including informed\nconsent for any screening procedures conducted to establish patient eligibility for the\ntrial.\nStudy personnel involved in conducting this trial will be qualified by education,\ntraining, and experience to perform their respective task(s). This trial will not use the\nservices of investigators or study personnel where sanctions have been invoked or\nwhere there has been scientific misconduct or fraud (e.g., loss of medical licensure,\ndebarment). Investigators are responsible for the conduct of the study at their study\nsite.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_20", - "extensionAttributes": [], - "name": "NCI_4_2", - "text": "
\n

Before a site may enter patients, protocol-specific regulatory and other documents\nmust be submitted to PrECOG as noted in study materials. Detailed information\nregarding document submission and control is provided to each site in separate study\nmaterials.\nOnce all required documents are received, reviewed and approved by PrECOG or\ntheir representative, a Study Reference Manual (SRM) will be forwarded to the site.\nAny changes to site regulatory documents must be submitted by the investigator to\nthe responsible party in a timely manner. Initial study drug shipment will not occur\nuntil the regulatory packet is complete. No patients will begin protocol therapy without\nformal randomization as per the process below.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_21", - "extensionAttributes": [], - "name": "NCI_4_3", - "text": "
\n

Patients must meet all of the eligibility requirements listed in Section 3 prior to\nrandomization. Treatment must begin \u2264 7 working days from randomization.\nAn eligibility checklist has been appended as an example to the protocol and a usable\nversion is available in separate study materials provided to the site. A confirmation of\neligibility assessment by the investigator/site will be performed during the\nrandomization process.\nInformation regarding stratification factors (performance status, measurable disease\nand prior chemotherapy) must be available at the time of randomization.

\n

Once it is determined that a patient meets all eligibility requirements, the patient will\nbe randomized to the study by site personnel using an electronic interactive web\nregistration (IWR) system. Full information regarding registration and randomization\nprocedures and guidelines can be found in the SRM provided to your site. All\ncorrespondence regarding patient randomization must be kept in the study records.

\n

Treatment Plan

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_22", - "extensionAttributes": [], - "name": "NCI_5", - "text": "

See section 5 Treatment Plan.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_23", - "extensionAttributes": [], - "name": "NCI_5_1", - "text": "
\n

Note: 1 cycle = 28 days.\nPatients must begin treatment within 7 working days of randomization.\nDisease evaluations will occur after every 12 weeks, +/- 1 week (which corresponds\nto every 3 treatment cycles) and patients will be treated until disease progression,\nunacceptable toxicity or for a total duration of 12 cycles (Induction Phase). Patients\nwith no evidence of progressive disease who remain on study after completing 12\ncycles will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule. Disease evaluations will continue to\noccur after every 12 weeks (every 3 treatment cycles), +/- 1 week, and patients may\ncontinue treatment until disease progression is documented or unacceptable toxicity.\nAll patients will be followed for 30 days for toxicity after the last dose of study therapy\n(fulvestrant and/or everolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1)\nattributed to study therapy, whichever is longer (or if >grade 1, event must be\npermanent and stable).\nSee Sections 8.1 and 8.2 for information on study drug procurement, storage,\npreparation, handling and destruction information.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_24", - "extensionAttributes": [], - "name": "NCI_5_2", - "text": "

See section 5.2 Dosing and Administration.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_25", - "extensionAttributes": [], - "name": "NCI_5_2_1", - "text": "
\n

Induction Phase:\nCycle 1 (28 day cycle)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections each dose)\non day 1 and 15.\nNote: Cycle 1 is the only time fulvestrant is given on day 15. If patient\npreviously received one cycle of fulvestrant (day 1 and day 15) prior to study\nentry as permitted in Inclusion Criteria #8, patient should receive fulvestrant 500\nmg on day 1 only.\nCycle 2, and thereafter (28 day cycles)\nPatients will receive fulvestrant 500 mg IM (two-250 mg injections) on day 1 of\nall subsequent cycles for a maximum of 12 cycles.\nContinuation Phase:\nPatients with no evidence of disease progression after completing 12 cycles are\nunblinded and continue fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until progression of disease or unacceptable toxicity.

\n

Fulvestrant will be obtained from commercial pharmacy stock.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_26", - "extensionAttributes": [], - "name": "NCI_5_2_2", - "text": "
\n

\u2022

\n

The study drug everolimus/placebo will be self-administered (by the patients\nthemselves). The local investigator will instruct the patient to take the study drug\nexactly as specified in the protocol. Everolimus/placebo should be administered\norally once daily, preferably in the morning, at the same time every day with or\nwithout food. Everolimus/placebo tablets should be swallowed whole with a glass\nof water. The tablets must not be chewed or crushed. In cases where tablets\ncannot be swallowed, the tablets should be disintegrated in water just prior to\nbeing taken. Approximately 30 mL (2 tablespoons) of water should be put into a\nglass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should\nthen be drunk. If the patient vomits after taking the study drug, they should not\ntake another tablet that day. If the patient forgets to take the medication and\nremembers by 10 PM, they may take the dose. Otherwise, skip that dose and\nbegin as usual the next day.

\n

\u2022

\n

Everolimus/placebo will be administered orally as once daily dose of 10 mg (two5 mg tablets) continuously from study day 1 until progression of disease or\nunacceptable toxicity for 12 cycles. See Section 5.5 regarding duration of therapy\n(including guidelines for treatment beyond Cycle 12).

\n

\u2022

\n

If vomiting occurs, no attempt should be made to replace the vomited dose.

\n

\u2022

\n

All dosages prescribed and dispensed to the patient and all dose changes during\nthe study must be recorded.

\n

\u2022

\n

PrECOG, or their designee, will be responsible for blinding, drug randomization,\nand management of the electronic interactive web registration (IWR) system. Both\ntablets will be blinded and identified by kit number only. The IWR system will\nassign the proper kit to the patient based on the patient randomization. Conditions\nfor study drug will be described on the medication label.

\n

\u2022

\n

Both everolimus and placebo will be provided by Novartis. Everolimus is\nformulated as tablets for oral administration of 5 mg strength. Both placebo and\neverolimus tablets are blister-packed under aluminum foil in units of 10 tablets per\nblister card, which should be opened only at the time of administration as drug is\nboth hygroscopic and light-sensitive.

\n

\u2022

\n

Dose modifications should be made prior to dose calculation at the beginning of\neach cycle and reasons recorded in source documents and on appropriate case\nreport forms.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_27", - "extensionAttributes": [], - "name": "NCI_5_3", - "text": "

See section 5.3 Dose Modifications and Toxicity Management.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_28", - "extensionAttributes": [], - "name": "NCI_5_3_1", - "text": "
\n

Placebo

\n

CTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE)\nVersion 4.0 will be utilized for AE reporting. All appropriate treatment areas should\nhave access to a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0\ncan be downloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0. (see Appendix E).\nDose modifications for all drugs will be made using the general guidelines below.\n\u2022

\n

All dose reductions are permanent. Fulvestrant will not be dose reduced.

\n

\u2022

\n

Regardless of the reason for holding any study drug treatment, the maximum\nallowable length of treatment interruption is \u2264 3 weeks. If the delivery of any study\ndrug due to toxicity is delayed for more than 3 weeks, that drug should be\npermanently discontinued.

\n

\u2022

\n

No more than 2 dose reductions for everolimus/placebo will be allowed. Further\nneed for dose reduction will result in discontinuation of that drug.

\n

\u2022

\n

If dose is delayed due to toxicity, labs/toxicity should be reevaluated at least\nweekly until recovery to treatment levels, or as indicated in the dose modification\ntables.

\n

\u2022

\n

Patients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression.

\n

\u2022

\n

In unusual circumstances where fulvestrant must be discontinued prior to disease\nprogression due to intolerable fulvestrant-associated toxicity, the Medical Monitor\nshould be contacted.

\n

Table 5-0\nEverolimus or Placebo Dose Level Modification Guidelines\nEverolimus/Placebo

\n

Fulvestrant

\n

Starting dose

\n

10 mg daily\n(two- 5 mg tablets)

\n

500 mg

\n

Dose Level -1

\n

5 mg daily

\n

No reduction

\n

Dose Level -2

\n

5 mg every other day

\n

No reduction

\n

Table 5-1\nNon-Hematological Criteria for Dose-Modification in Case of Suspected\nEverolimus or Placebo Related Adverse Events and Re-Initiation of Everolimus\nor Placebo Treatment\nAdverse Event

\n

Action

\n

Non Hematological\nReactivation of HBV or HCV flare

\n

Please refer to Table 5-4 and Table 5-5.

\n

Non-Infectious Pneumonitis

\n

Please refer to Table 5-6.

\n

AST or ALT elevation

\n

Maintain current dose level.

\n

Grade 1 (>ULN - 3.0x ULN)\nGrade 2 (>3.0 - 5.0x ULN)\nAST or ALT elevation\nGrade 3 (>5.0 - 20.0 ULN)*

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\n(or \u2264 grade 2 if baseline values were within the range of grade\n2). If resolution occurs \u2264 7 days, everolimus should be re-started\nat the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to \u2264 grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.

\n

AST or ALT elevation\nGrade 4 (>20x ULN)*

\n

Intolerable Grade 2 mucositis\n(see Section 5.3.2.5)

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\n(or \u2264 grade 2 if baseline values were within the range of grade\n2). If resolution occurs \u2264 7 days, everolimus should be re-started\nat one dose level lower. If resolution takes >7 days, discontinue\neverolimus.\nInterrupt everolimus administration until resolution to \u2264 grade 1\nor baseline grade/value.\nIf resolution occurs within \u2264 7 days, everolimus should be restarted at the dose level prior to interruption.\nIf resolution takes >7 days, or if event recurs within 28 days,\nhold everolimus until recovery to \u2264 grade 1 or baseline grade/\nvalue and reintroduce everolimus at one dose level lower, if\navailable.\nPatients will be withdrawn from the study if they fail to recover to\n\u2264 grade 1 or baseline grade/value within 21 days.

\n

Grade 3 AE, except:\nhyperglycemia or\nhypertriglyceridemia or\nhypercholesterolemia\n(see Section 5.3.2.7)

\n

Interrupt everolimus administration until resolution to \u2264 grade 1\nor baseline grade/value.\nReintroduce everolimus at one dose level lower, if available.\nPatients will be withdrawn from the study if they fail to recover to\n\u2264 grade 1 or baseline grade/value within 21 days.

\n

Any other Grade 4

\n

Hold everolimus until recovery to grade \u2264 1 or baseline value.\nReintroduce everolimus at one dose level lower, if available.

\n

Grade 3 or 4 clinical liver failure\n(asterixis or encephalopathy/\ncoma)

\n

Discontinue everolimus.

\n

Recurrence of intolerable Grade 2\nmucositis or Grade 3 event after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

Recurrence of Grade 4 after\ndose reduction

\n

Discontinue everolimus.

\n

Any non-hematologic toxicity\nrequiring\ninterruption\nof\neverolimus for >21 days

\n

Discontinue everolimus.

\n

* Should HCV flare be confirmed, the guidelines for flare must take precedence (Table 5-5).

\n

Table 5-2\nHematological Criteria for Dose-Modification in Case of Suspected Everolimus\nor Placebo Related Adverse Events and Re-Initiation of Everolimus or Placebo\nAdverse Event

\n

Action

\n

Hematological\nGrade 2 thrombocytopenia

\n

No action.

\n

(platelets <75, \u2265 50 x 10 /L)\nGrade 3 thrombocytopenia

\n

Interrupt everolimus until resolution to grade \u22641

\n

(platelets <50, \u2265 25 x 10 /L)

\n

If resolution occurs \u2264 7 days, reintroduce everolimus at the\ndose level prior to interruption.

\n

If resolution occurs >7 days, or event occurs within 28 days,\nreintroduce everolimus at one dose level lower, if available.\nGrade 4 thrombocytopenia

\n

(platelets <25 x 10 /L)\nGrade 3 neutropenia or anemia

\n

(neutrophil <1, \u2265 0.5 x 10 /L)

\n

Interrupt everolimus until recovery to grade \u2264 1. Then\nreintroduce everolimus at one dose level lower, if available.\nInterrupt everolimus until resolution to grade \u22641 or baseline\nvalue\nIf AE resolution occurs \u2264 7 days, reintroduce everolimus at\nthe same dose level.\nIf AE resolution occurs >7 days, or event occurs within 28\ndays, reintroduce everolimus at one dose level lower, if\navailable.

\n

Grade 4 neutropenia or anemia

\n

Interrupt everolimus until recovery to grade \u2264 1 or baseline\nvalue. Reintroduce everolimus at one dose level lower, if\navailable.*

\n

Febrile neutropenia

\n

Interrupt everolimus until resolution to grade \u2264 1 (or baseline\nvalue) and no fever. Reintroduce everolimus at one dose\nlevel lower, if available.*

\n

Recurrence of Grade 3 toxicity after\ndose reduction

\n

Reduce dose to the next lower dose level, if available. The\nlowest possible dose level of everolimus is 5 mg every other\nday. Below this level, everolimus must be discontinued.

\n

*Recurrence of Grade 4 toxicity\n(including febrile neutropenia) after\ndose reduction

\n

Discontinue everolimus.

\n

*Any hematologic toxicity requiring\neverolimus interruption for >21\ndays

\n

Discontinue everolimus.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_29", - "extensionAttributes": [], - "name": "NCI_5_3_2", - "text": "
\n

The data described below reflect exposure to everolimus (n= 274) and placebo\n(n= 137) in a randomized Phase III study for the treatment of metastatic renal cell\ncarcinoma. In total, 165 patients were exposed to everolimus 10 mg/day for \u2265 4\nmonths. The median age of patients was 61 years (range 27 to 85). The most\ncommon adverse reactions (incidence \u2265 10%) were stomatitis, rash, fatigue, asthenia,\ndiarrhea, anorexia, nausea, mucosal inflammation, vomiting, cough, peripheral\nedema, infections, dry skin, epistaxis, pruritus, and dyspnea. The most common\ngrade 3-4 adverse reactions (incidence \u2265 2%) were infections, stomatitis, fatigue, and\npneumonitis.\nThe median duration of blinded study treatment was 141 days (range 19 to 451) for\npatients receiving everolimus and 60 days (range 21 to 295) for those receiving\nplacebo. The rates of treatment-emergent adverse reactions resulting in permanent\ndiscontinuation were 7% and 0% for the everolimus and placebo treatment groups,\nrespectively. Most treatment-emergent adverse reactions were grade 1 or 2 in\nseverity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 39%\nversus 7% of patients receiving everolimus and placebo, respectively. Deaths due to\nacute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were\nobserved on the everolimus arm.\nEverolimus has immunosuppressive properties and may predispose patients to\nbacterial, fungal, viral or protozoan infections, including infections with opportunistic\npathogens. Localized and systemic infections, including pneumonia, other bacterial\ninfections, invasive fungal infections, such as aspergillosis or candidiasis and viral\ninfections including reactivation of hepatitis B virus, have been described in patients\ntaking everolimus. Some of these infections have been severe (e.g. leading to\nrespiratory or hepatic failure) and occasionally have had a fatal outcome.

\n

Physicians and patients should be aware of the increased risk of infection with\neverolimus. Treat pre-existing infections prior to starting treatment with everolimus.\nWhile taking everolimus, be vigilant for symptoms and signs of infection; if a diagnosis\nof infection is made, institute appropriate treatment promptly and consider interruption\nor discontinuation of everolimus. If a diagnosis of invasive systemic fungal infection is\nmade, discontinue everolimus and treat with appropriate antifungal therapy.\nReactivation of Hepatitis B (HBV) has been observed in patients with cancer\nreceiving chemotherapy.53 Sporadic cases of Hepatitis B reactivation have also been\nseen in this setting with everolimus. Use of antivirals during anti-cancer therapy has\nbeen shown to reduce the risk of Hepatitis B virus reactivation and associated\nmorbidity and mortality.54 A detailed assessment of Hepatitis B/C medical history and\nrisk factors must be done for all patients at screening, with testing performed prior to\nthe first dose of everolimus.\nHypersensitivity reactions manifested by symptoms including, but not limited to,\nanaphylaxis, dyspnea, flushing, chest pain or angioedema (e.g. swelling of the\nairways or tongue, with or without respiratory impairment) have been observed with\neverolimus.\nElevations of serum creatinine, usually mild, have been reported in clinical trials.\nMonitoring of renal function, including measurement of blood urea nitrogen (BUN) or\nserum creatinine, is recommended prior to the start of everolimus therapy and\nperiodically thereafter.\nDecreased hemoglobin, lymphocytes, platelets and neutrophils have been reported in\nclinical trials. Monitoring of complete blood count is recommended prior to the start of\neverolimus therapy and periodically thereafter.\nThe use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus.\nHypophosphatemia, hypomagnesaemia, hyponatremia and hypocalcaemia have\nbeen reported as serious adverse reactions. Electrolytes should be monitored in\npatients treated with everolimus.\nTable 5-1 and Table 5-2 provide general recommendations for the management of\npatients, with suspected drug toxicities while on treatment with everolimus as singleagent therapy.\nMore detailed information regarding everolimus reported suspected toxicities and\nindividual cases are provided in the Investigator\u2019s Brochure.\n5.3.2.1

\n

Management of Hepatitis Reactivation/Flare

\n

In cancer patients with hepatitis B, whether carriers or in chronic state, use of\nantivirals during anticancer therapy has been shown to reduce the risk of hepatitis B\nvirus (HBV) reactivation and associated HBV morbidity and mortality.54

\n

5.3.2.2

\n

Monitoring and\nReactivation

\n

Prophylactic

\n

Treatment

\n

for

\n

Hepatitis

\n

B

\n

Table 5-3 provides details of monitoring and prophylactic therapy according to the\nbaseline results of viral load and serologic markers testing.\nTable 5-3\nAction to be Taken for Positive Baseline Hepatitis B Results

\n

Test

\n

Result

\n

Result

\n

Result

\n

Result

\n

Result

\n

HBV-DNA

\n

+

\n

+ or -

\n

-

\n

-

\n

-

\n

HBsAg

\n

+ or -

\n

+

\n

-

\n

-

\n

-

\n

HBsAb

\n

+ or -

\n

+ or -

\n

+

\n

+ or -

\n

-

\n

and no prior HBV\nvaccination\nHBcAb

\n

+ or -

\n

Recommendation

\n

+ or -

\n

+ or -

\n

or + with prior\nHBV vaccination\n+

\n

No prophylaxis

\n

Prophylaxis treatment should be\nstarted 1-2 weeks prior to first dose of\nstudy drug

\n

Monitor HBV-DNA approximately\nevery 3-4 weeks

\n

No specific\naction

\n

Monitor HBV-DNA approximately\nevery 4-8 weeks

\n

Antiviral prophylaxis therapy should continue for at least 4 weeks after last dose of\nstudy drug.\nFor hepatitis B reactivation, definition and management guidelines see Table 5-4\nGuidelines for Management of Hepatitis B.

\n

Table 5-4\nGuidelines for Management of Hepatitis B\nHBV Reactivation (with or without clinical signs and symptoms)*\nFor patients with baseline\nresults:\nPositive HBV-DNA

\n

\u2264 baseline HBV-DNA levels

\n

Positive HBsAg\n-------------------------------------Reactivation is defined as:\nIncrease of 1 log in HBVDNA relative to baseline\nHBV-DNA value OR new\nappearance of measurable\nHBV-DNA\nFor patients with baseline\nresults:\nHBV-DNA

\n

AND\nInterrupt study drug administration until resolution:

\n

OR

\n

Negative\nHBsAg

\n

Treat: Start a second antiviral

\n

and

\n

If resolution occurs within \u2264 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Both antiviral\ntherapies should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue both antiviral therapies at least 4 weeks after last\ndose of study drug.\nTreat: Start first antiviral medication\nAND\nInterrupt study drug administration until resolution:\n\u2264 baseline HBV-DNA levels

\n

AND\nPositive HBsAb (with no\nprior history of vaccination\nagainst HBV), OR positive\nHBcAb\n------------------------------------Reactivation is defined as:\nNew\nappearance\nmeasurable HBV-DNA

\n

of

\n

If resolution occurs within \u2264 21 days, study drug should be restarted at one dose lower, if available. If the patient is already\nreceiving the lowest dose of study drug according to the protocol, the\npatient should restart at the same dose after resolution. Antiviral\ntherapy should continue at least 4 weeks after last dose of study\ndrug.\nIf resolution occurs >21 days, patients should discontinue study\ndrug but continue antiviral therapy at least 4 weeks after last dose of\nstudy drug.

\n

* All reactivations of hepatitis B are to be recorded as grade 3 (CTEP CTCAE Version\n4.0 Metabolic Laboratory/Other: Viral Reactivation), unless considered life threatening\nby the investigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Reactivation).

\n

5.3.2.3

\n

Monitoring for Hepatitis C Flare

\n

The following two categories of patients should be monitored every 4-8 weeks for\nHCV reactivation:\n\u2022

\n

Patients with detectable HCV RNA-PCR test at baseline.

\n

\u2022

\n

Patients known to have a history of HCV infection, despite a negative viral load\ntest at baseline (including those that were treated and are considered \u2018cured\u2019).

\n

For definition of hepatitis C flare and the management guidelines, see Table 5-5\nGuidelines for Management of Hepatitis C.\nTable 5-5\nGuidelines for Management of Hepatitis C\nHCV Flare*\nFor patients with baseline results:

\n

Discontinue study drug.

\n

Detectable HCV-RNA:\nHCV Flare is defined as:\n\u02c32 log10 IU/mL increase in HCV-RNA\nAND\nALT elevation \u02c35x ULN or 3x baseline level,\nwhichever is higher\nDiscontinue study drug.

\n

For patients with baseline results:\nKnowledge of past hepatitis C infection\nwith no detectable HCV-RNA:\nHCV Flare is defined as:\nNew appearance of detectable HCV-RNA\nAND\nALT elevation \u02c35x ULN or 3x baseline level,\nwhichever is higher

\n

* All flares of hepatitis C are to be recorded as grade 3 (CTEP CTCAE Version 4.0.\nMetabolic Laboratory/Other: Viral Flare), unless considered life threatening by the\ninvestigator; in which case they should be recorded as grade 4 (CTEP CTCAE\nVersion 4.0 Metabolic Laboratory/Other: Viral Flare).

\n

5.3.2.4

\n

Management of Skin Toxicity

\n

For patients with grade 1 toxicity, no specific supportive care is usually needed or\nindicated. Rash must be reported as an AE. Patients with grade 2 or higher toxicity\nmay be treated with the following suggested supportive measures at the discretion of\nthe investigator: oral minocycline, topical tetracycline, topical clindamycin, topical\nsilver sulfadiazine, diphenhydramine, oral prednisolone (short course), topical\ncorticosteroids, or pimecrolimus.

\n

5.3.2.5

\n

Management of Stomatitis/Oral Mucositis/Mouth Ulcers

\n

Patients with a clinical history of stomatitis/mucositis/mouth ulcers and those with\ngastrointestinal morbidity associated with mouth/dental infections, irritation of\nesophageal mucosa e.g. gastroesophageal reflux disease (GERD) and pre-existing\nstomatitis/mucositis must be monitored even more closely. Patients should be\ninstructed to report the first onset of buccal mucosa irritation/reddening to their study\nphysician immediately.\nSuggested prophylactic treatment for prevention of stomatitis/mucositis:\na) Use 15 mL baking soda/salt mouth rinse QID (swish and spit). Mix 1/3 teaspoon\nbaking soda and 1/3 teaspoon of salt in 1 quart of water (refrigeration is not\nneeded); do not eat or drink anything for 10 minutes after rinsing.\nb) Use 10 mL prescribed \u201cmiracle mouth wash\u2019\u2019 QID (swish and spit). For 16-ounce\nrecipe: 320 mL Benadryl solution, 2 g tetracycline powder, 80 mg hydrocortisone,\nand 40 mL nystatin suspension, quantity sufficient with water. Wait 10-15 minutes\nafter the baking soda/salt rinse before using \u201cmiracle mouthwash\u2019\u2019.55\nStomatitis/oral mucositis/mouth ulcers due to everolimus should be treated using local\nsupportive care. Please note that investigators in earlier trials have described the oral\ntoxicities associated with everolimus as mouth ulcers, rather than mucositis or\nstomatitis. If your examination reveals mouth ulcers rather than a more general\ninflammation of the mouth, please classify the adverse event as such. Please follow\nthe paradigm below for treatment of stomatitis/oral mucositis/mouth ulcers:\n1. For mild toxicity (Grade 1), use conservative measures as noted above, baking\nsoda/salt mouth rinse and \u201cmiracle mouth wash\u201d.\n2. For more severe toxicity (Grade 2 in which case patients have pain but are able to\nmaintain adequate oral alimentation, or Grade 3 in which case patients cannot\nmaintain adequate oral alimentation), the suggested treatments are:\nIn addition to baking soda/salt mouth rinse and \u201cmiracle mouth wash\u201d\nabove, topical analgesic mouth treatments (e.g., local anesthetics such as\nbenzocaine, butyl aminobenzoate, tetracaine hydrochloride, menthol, or phenol)\nwith or without topical corticosteroids, such as triamcinolone oral paste 0.1%\n(Kenalog in Orabase\u00ae) or Periogard\u00ae oral rinse.\n3. Agents containing hydrogen peroxide, iodine, and thyme derivatives may tend to\nworsen mouth ulcers. It is preferable to avoid these agents. Alcohol\u2013containing\nrinses and tooth paste with sodium lauryl sulfate should also be avoided. Avoid\nacidic, spicy, hard, or crunchy foods, and consume foods that are tepid rather\nthan hot.55\n4. Antifungal agents must be avoided unless a fungal infection is diagnosed. In\nparticular, systemic imidazole antifungal agents (ketoconazole, fluconazole,\nitraconazole, etc.) should be avoided in all patients due to their strong inhibition of\neverolimus metabolism, thereby leading to higher everolimus exposures.\nTherefore, topical antifungal agents are preferred if an infection is diagnosed.\nSimilarly, antiviral agents such as acyclovir should be avoided unless a viral\ninfection is diagnosed.\nNote: Stomatitis/oral mucositis should be appropriately graded using the functional\ngrading given on the CTEP CTCAE Version 4.0.

\n

5.3.2.6

\n

Management of Diarrhea

\n

Appearance of grade 1-2 diarrhea attributed to study drug toxicity may be treated with\nsupportive care such as loperamide, initiated at the earliest onset (for example 4 mg\norally followed by 2 mg orally every 2 hours until resolution of diarrhea).\n5.3.2.7

\n

Management of Hyperlipidemia and Hyperglycemia

\n

Treatment of hyperlipidemia should take into account the pre-treatment status and\ndietary habits. Grade 2 or higher hypercholesterolemia (>300 mg/dL or 7.75 mmol/L)\nor grade 2 hypertriglyceridemia or higher (>2.5x upper normal limit) should be treated\nwith a 3-hydroxy-3-methyl-glutaryl (HMG)-CoA reductase inhibitor (e.g. atorvastatin,\npravastatin, fluvastatin) or appropriate triglyceride-lowering medication, in addition to\ndiet.\nNote: Concomitant therapy with fibrates and an HMG-CoA reductase inhibitor is\nassociated with an increased risk of a rare but serious skeletal muscle toxicity\nmanifested by rhabdomyolysis, markedly elevated creatine phosphokinase (CPK)\nlevels and myoglobinuria, acute renal failure and sometimes death. The risk versus\nbenefit of using this therapy should be determined for individual patients based on\ntheir risk of cardiovascular complications of hyperlipidemia.\nHyperglycemia has been reported in clinical trials. Monitoring of fasting serum\nglucose is recommended prior to the start of everolimus therapy and periodically\nthereafter. Optimal glycemic control should be achieved before starting trial therapy.\n5.3.2.8

\n

Management of Non-Infectious Pneumonitis

\n

Non-infectious pneumonitis is a class effect of rapamycin derivatives. Cases of noninfectious pneumonitis (including interstitial lung disease) have also been described in\npatients taking everolimus. Some of these have been severe and on rare occasions,\na fatal outcome was observed.\nA diagnosis of non-infectious pneumonitis should be considered in patients\npresenting with non-specific respiratory signs and symptoms such as hypoxia, pleural\neffusion, cough or dyspnea, and in whom infectious, neoplastic and other nonmedicinal causes have been excluded by means of appropriate investigations.\nPatients should be advised to report promptly any new or worsening respiratory\nsymptoms.\nPatients who develop radiological changes suggestive of non-infectious pneumonitis\nand have few or no symptoms may continue everolimus therapy without dose\nalteration. If symptoms are moderate (Grade 2), consideration should be given to\ninterruption of therapy until symptoms improve. The use of corticosteroids may be\nindicated. Everolimus may be reintroduced at a reduced dose until recovery to Grade\n1 or better.\nFor cases where symptoms of non-infectious pneumonitis are severe (Grade 3),\neverolimus therapy should be discontinued and the use of corticosteroids may be\nindicated until clinical symptoms resolve. Therapy with everolimus may be re-initiated\nat a reduced dose depending on the individual clinical circumstances.

\n

For non-infectious pneumonitis definition and management guidelines, see Table 5-6\nManagement of Non-Infectious Pneumonitis.\nTable 5-6\nManagement of Non-Infectious Pneumonitis\nWorst Grade\nPneumonitis

\n

Management of\nPneumonitis

\n

Required Investigations

\n

therapy

\n

Everolimus Dose\nAdjustment

\n

Grade 1

\n

CT scans with lung windows.

\n

No specific\nrequired

\n

is

\n

No dose adjustment required.\nInitiate appropriate monitoring.

\n

Grade 2

\n

CT scan with lung windows.\nConsider pulmonary function\ntesting includes: spirometry,\nDLCO, and room air O2\nsaturation at rest. Consider a\nbronchoscopy\nwith\nbiopsy\nand/or BAL. Monitoring at each\nvisit until return to \u2264 grade 1.\nReturn to initial monitoring\nfrequency if no recurrence.

\n

Symptomatic only.\nConsider\ncorticosteroids\nand/or other supportive\ntherapy if symptoms are\ntroublesome.

\n

Rule out infection and consider\ninterruption of everolimus until\nsymptoms improve to Grade \u2264\n1.\nRe-initiate everolimus at one\ndose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within \u2264 21\ndays.

\n

Grade 3

\n

CT scan with lung windows and\npulmonary\nfunction\ntesting\nincludes: spirometry, DLCO,\nand room air O2 saturation at\nrest. Monitoring at each visit\nuntil return to \u2264 grade 1. Return\nto initial monitoring frequency if\nno recurrence. Bronchoscopy\nwith biopsy and/or BAL is\nrecommended.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule out infection and interrupt\neverolimus until symptoms\nimprove to Grade \u2264 1.\nConsider re-initiating everolimus at one dose level lower.\nDiscontinue\neverolimus\nif\nfailure to recover within \u2264 21\ndays.

\n

Grade 4

\n

CT scan with lung windows and\nrequired pulmonary function\ntesting, if possible, includes:\nspirometry, DLCO, and room air\nO2 saturation at rest. Monitoring\nat each visit until return to \u2264\ngrade 1. Return to initial\nmonitoring frequency if no\nrecurrence. Bronchoscopy with\nbiopsy\nand/or\nBAL\nis\nrecommended if possible.

\n

Consider corticosteroids if\ninfective origin is ruled out.\nTaper\nas\nmedically\nindicated.

\n

Rule\nout\ninfection\ndiscontinue everolimus.

\n

All interruptions or changes to study drug administration must be recorded.\nIt will be documented whether or not each patient completed the clinical study. If for\nany patient either study treatment or observations were discontinued the reason will\nbe recorded.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_30", - "extensionAttributes": [], - "name": "NCI_5_3_3", - "text": "
\n

Patients will be instructed not to take any additional medications (including over-thecounter products) during the course of the study without prior consultation with the\nlocal investigator. At each visit, the investigator will ask the patient about any new\nmedications he/she is or has taken after the start of the study drug.

\n

and

\n

Concomitant medications/significant non-drug therapies taken \u2264 28 days prior\nto start and after start of study drug, including physical therapy and blood\ntransfusions, should be reviewed.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_31", - "extensionAttributes": [], - "name": "NCI_5_3_4", - "text": "
\n

The following restrictions apply during the entire duration of the study:\n\u2022

\n

No other investigational therapy should be given to patients.

\n

\u2022

\n

No anticancer agents other than the study medication should be given to patients,\nwith the following exceptions:\no\no

\n

Bisphosphonates, Zometa, or Xgeva for bone metastases\na GnRH analog is permitted if the patient had progressive disease on a GnRH\nanalog plus a SERM or an AI; the GnRH analog may continue but the SERM\nor AI must be discontinued.

\n

\u2022

\n

If any other anticancer agents are required for a patient then the patient must first\nbe withdrawn from the study.

\n

\u2022

\n

Concurrent radiation therapy is prohibited, however palliative radiotherapy may be\nconsidered on a case by case basis after discussion with the Study Chair.

\n

\u2022

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or\nanother immunosuppressive agent greater than or equal to 5 mg prednisone or its\nequivalent daily. Topical or inhaled corticosteroids are allowed.

\n

\u2022

\n

The use of live vaccines and close contact with those who have received live\nvaccines should be avoided during treatment with everolimus. Examples of live\nvaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG,\nyellow fever, varicella and TY21a typhoid vaccines.

\n

\u2022

\n

It is highly recommended that patients with positive HBV-DNA or HBsAg are\ntreated prophylactically with an antiviral for 1-2 weeks prior to receiving study drug\n(see Table 5-3).

\n

\u2022

\n

The antiviral treatment should continue throughout the entire study period and for\nat least 4 weeks after the last dose of study drug.

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA according to study visit schedule.

\n

\u2022

\n

Oral contraceptives in preclinical and clinical data have shown everolimus to have\nCYP3A4 inhibitory activity rather than induction activity, induction of metabolism\nof contraceptive hormones by everolimus is unlikely. Consequently, administration\nof everolimus should not reduce the efficacy of oral contraceptives.

\n

\u2022

\n

Grapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.

\n

5.3.5\n5.3.5.1

\n

Administration of Everolimus and CYP3A4 Inhibitors/\nInducers

\n

Inhibitors of CYP3A4 and/or PgP

\n

Everolimus is metabolized by CYP3A4 in the liver and to some extent in the intestinal\nwall.\nTherefore, the following are recommended:\nCo-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole,\nritonavir) or P-glycoprotein (PgP) should be avoided.\nCo-administration with moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole)\nor PgP inhibitors should be used with caution. If a patient requires co-administration\nof moderate CYP3A4 inhibitors or PgP inhibitors, reduce the dose of everolimus to 5\nmg every other day. Additional dose reductions to every other day may be required to\nmanage toxicities. If the inhibitor is discontinued, the everolimus dose should be\nreturned to the dose used prior to initiation of the moderate CYP3A4/PgP inhibitor\nafter a washout period of 2-3 days.\nGrapefruit and other citrus juices affect P450 and PgP activity. Concomitant use\nshould be avoided.\nRefer to Appendix C Table 15-0 for list of medications known to induce/inhibit\nCYP3A4 and Table 15-1 for a list of medications known to inhibit PgP.\n5.3.5.2

\n

Inducers of CYP3A4 and/or PgP

\n

Avoid the use of strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin,\nrifabutin, phenobarbital, St. John\u2019s Wort). If a patient requires co-administration of\nstrong CYP3A4 inducers, an increase in the dose of everolimus up to twice the\ncurrently used daily dose should be considered, 5 mg increments. Enzyme induction\nusually occurs within 7-10 days; therefore everolimus dose should be increased by\none increment 7 days after the start of the inducer therapy. If no safety concerns are\nseen within the next 7 days, the dose can be increased again one additional\nincrement up to a maximum of twice the daily dose used prior to initiation of the\nstrong CYP3A4 inducer. The choice to adjust the dose of everolimus in a patient\nrequiring co-administration of strong CYP3A4 inducers will be done at the discretion\nof the treating investigator.\nThis dose adjustment of everolimus is intended to achieve similar AUC to the range\nobserved without inducers. However, there are no clinical data with this dose\nadjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is\ndiscontinued the everolimus dose should be returned to the dose used prior to\ninitiation of the strong CYP3A4/PgP inducer. Refer to Appendix C Table 15-0 for list\nof medications known to induce CYP3A4 and Table 15-1 for a list of medications\nknown to induce PgP.\nOral anticoagulants such as warfarin are CYP2C9 substrates and, as such, no\ninteraction with everolimus is expected. However, drug-drug interaction studies\nbetween macrolide antibiotics and warfarin have produced mixed outcomes and the\ndisparity in these findings has led to the conclusion that multiple factors may alter the

\n

clearance of warfarin. The co-administration of everolimus and oral anticoagulants is\npossible but should be subject to verification of coagulation (INR) once steady state is\nreached (after one week\u2019s treatment).\nA comprehensive list of cytochrome P450 isoenzymes and CYP3A4 inhibitors,\ninducers, and substrates can be found at:\nhttp://medicine.iupui.edu/clinpharm/ddis/table.aspx. This\nrevised and should be checked frequently for updates.

\n

5.4

\n

website

\n

is

\n

continually

\n

Supportive Care

\n

All supportive measures consistent with optimal patient care will be given throughout\nthe study.\nThe clinical tolerance of the patient, the overall tumor response, and the medical\njudgment of the investigator will determine if it is in the patient\u2019s best interest to\ncontinue or discontinue treatment. If treatment is discontinued due to any toxicity, the\npatient must be followed to monitor duration of toxicity, response and time to\nprogression or survival and initiation of any new systemic therapy.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_32", - "extensionAttributes": [], - "name": "NCI_5_3_5", - "text": "

See section 5.3.5 Administration of Everolimus and CYP3A4 Inhibitors/Inducers.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_33", - "extensionAttributes": [], - "name": "NCI_5_4", - "text": "

See section 5.4 Supportive Care.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_34", - "extensionAttributes": [], - "name": "NCI_5_5", - "text": "
\n

CR, PR, or SD patients will continue therapy per their induction arm randomized\nassignments until evidence of progressive disease, unacceptable toxicity occurs, or\nfor a total of 12 cycles (Induction Phase). Patients with no evidence of progressive\ndisease who remain on study after completing 12 cycles will be unblinded and\nproceed to the Continuation Phase. Patients in the Continuation Phase should\ncontinue to receive fulvestrant alone (if originally randomized to placebo) or in\ncombination with everolimus (if originally randomized to everolimus) at the same dose\nand schedule until disease progression or unacceptable toxicity.\nProtocol therapy will be discontinued for progressive disease at any time. Patients are\nfree to halt therapy at their request. Treatment may be discontinued if intercurrent comorbidities occur, which, in the opinion of the treating physician, would preclude safe\nadministration of study drugs.\nPatients who discontinue everolimus/placebo because of suspected everolimusassociated toxicity should continue treatment with fulvestrant alone until disease\nprogression. In unusual circumstances where fulvestrant must be discontinued prior\nto disease progression due to intolerable fulvestrant-associated toxicity, the medical\nmonitor should be contacted. All patients who have discontinued protocol therapy will\nbe followed for survival and for progression if protocol therapy was discontinued\nbecause of toxicity or for other reasons. All surviving patients who have discontinued\ninduction protocol therapy (fulvestrant and everolimus/placebo) for any reason will be\nfollowed for 30 days for study drug related (fulvestrant and/or everolimus/placebo)\ntoxicities to \u2264 grade 1 (or if >grade 1, event must be permanent and stable).

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_35", - "extensionAttributes": [], - "name": "NCI_5_6", - "text": "
\n

Patients MUST be discontinued from study therapy AND be withdrawn from the study\nfor the following reasons:\n\u2022

\n

Withdrawal of the patient\u2019s consent (patient\u2019s decision to withdraw for any reason)

\n

\u2022

\n

Termination of the study by PrECOG

\n

\u2022

\n

Any clinical adverse event, laboratory abnormality or intercurrent illness which, in\nthe opinion of the investigator, indicates that continued participation in the study is\nnot in the best interest of the subject

\n

\u2022

\n

Inability to comply with protocol

\n

\u2022

\n

Discretion of the investigator

\n

\u2022

\n

Disease progression (patient will continued to be followed for survival)

\n

All subjects who discontinue treatment should comply with protocol specified followup procedures as outlined in Section 7.1.5.\nIf a subject is withdrawn before completing the study, the reason for withdrawal must\nbe entered on the appropriate case report form.

\n

Measurement of Effect

\n

6.1

\n

Antitumor Effect- Solid Tumors

\n

For the purposes of this study, patients should be re-evaluated for response every 12\nweeks, +/- 1 week. All baseline evaluations should be performed as closely as\npossible to the beginning of treatment and never more than four weeks before\nrandomization.\nResponse and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors\n(RECIST) guideline (Version 1.1).56 Changes in the largest diameter (unidimensional\nmeasurement) of the tumor lesions and the shortest diameter in the case of malignant\nlymph nodes are used in the RECIST criteria.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_36", - "extensionAttributes": [], - "name": "NCI_6", - "text": "

See section 6 Measurement of Effect.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_37", - "extensionAttributes": [], - "name": "NCI_6_1", - "text": "

See section 6.1 Antitumor Effect - Solid Tumors.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_38", - "extensionAttributes": [], - "name": "NCI_6_1_1", - "text": "
\n

Evaluable for toxicity: All patients will be evaluable for toxicity from the time of their\nfirst treatment with fulvestrant and everolimus/placebo. All patients will be followed for\n30 days for toxicity after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until recovery from all toxicity (to \u2264 grade 1) attributed to study\ntherapy, whichever is longer (or if >grade 1, event must be permanent and stable).\nEvaluable for objective response: Only those patients who have measurable disease\npresent at baseline, have received at least one cycle of therapy, and have had their\ndisease re-evaluated will be considered evaluable for response. These patients will\nhave their response classified according to the definitions stated below. (Note:\nPatients who exhibit objective disease progression prior to the end of Cycle 1 will also\nbe considered evaluable.)\nEvaluable non-target disease response: Patients who have lesions present at\nbaseline that are evaluable but do not meet the definitions of measurable disease,\nhave received at least one cycle of therapy, and have had their disease re-evaluated\nwill be considered evaluable for non-target disease. The response assessment is\nbased on the presence, absence, or unequivocal progression of the lesions.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_39", - "extensionAttributes": [], - "name": "NCI_6_1_2", - "text": "
\n

Measurable lesions: are defined as those that can be accurately measured in at least\none dimension (longest diameter in the plane of measurement) is to be recorded with\na minimum size of:\n\u2022

\n

\u2265 20 mm by chest x-ray (if clearly defined and surrounded by aerated lung)

\n

\u2022

\n

\u2265 10 mm with CT scan (irrespective of scanner type) and MRI (no less than\ndouble the slice thickness and a minimum of 10 mm)

\n

\u2022

\n

\u2265 10 mm with calipers by clinical exam when superficial

\n

All tumor measurements must be recorded in millimeters (or decimal fractions of\ncentimeters).

\n

Note: Tumor lesions that are situated in a previously irradiated area, or in an area\nsubjected to other loco-regional therapy, are usually not considered measurable\nunless there has been demonstrated progression in the lesion.\nMalignant lymph nodes: to be considered pathologically enlarged and measurable, a\nlymph node must be \u2265 15 mm in short axis (perpendicular to longest diameter) when\nassessed by CT scan (CT scan slice thickness recommended to be no greater than 5\nmm). At baseline and in follow-up, only the short axis will be measured and followed.\nNon-measurable lesions: all other lesions (or sites of disease), including small lesions\n(longest diameter <10 mm or pathological lymph nodes with \u2265 10 to <15 mm short\naxis), are considered non-measurable disease. Leptomeningeal disease, ascites,\npleural/pericardial effusions, lymphangitis cutis/pulmonitis, inflammatory breast\ndisease, and abdominal masses/organomegaly (not followed by CT or MRI), are\nconsidered as non-measurable.\nNote: Cystic lesions that meet the criteria for radiographically defined simple cysts\nshould not be considered as malignant lesions (neither measurable nor nonmeasurable) since they are, by definition, simple cysts.\n\u2018Cystic lesions\u2019 thought to represent cystic metastases can be considered as\nmeasurable lesions, if they meet the definition of measurability described above.\nHowever, if non-cystic lesions are present in the same patient, these are preferred for\nselection as target lesions.\nLytic bone lesions, with an identifiable soft tissue component, evaluated by CT or\nMRI, can be considered as measurable lesions if the soft tissue component otherwise\nmeets the definition of measurability noted above. Blastic bone lesions are nonmeasurable.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_40", - "extensionAttributes": [], - "name": "NCI_6_1_3", - "text": "
\n

All measurements should be taken and recorded in metric notation using a ruler or\ncalipers. All baseline evaluations should be performed as closely as possible to the\nbeginning of treatment and never more than 4 weeks before randomization.\nThe same method of assessment and the same technique should be used to\ncharacterize each identified and reported lesion at baseline and during follow-up.\nImaging-based evaluation is preferred to evaluation by clinical examination unless the\nlesion(s) being followed cannot be imaged but are assessable by clinical exam.\nClinical lesions: Clinical lesions will only be considered measurable when they are\nsuperficial (e.g., skin nodules and palpable lymph nodes) and \u2265 10 mm diameter as\nassessed using calipers (e.g., skin nodules). In the case of skin lesions,\ndocumentation by color photography, including a ruler to estimate the size of the\nlesion, is recommended.\nChest x-ray: Lesions on chest x-ray are acceptable as measurable lesions when they\nare clearly defined and surrounded by aerated lung. However, CT is preferable.

\n

Conventional CT and MRI: This guideline has defined measurability of lesions on CT\nscan based on the assumption that CT slice thickness is 5 mm or less. If CT scans\nhave slice thickness greater than 5 mm, the minimum size for a measurable lesion\nshould be twice the slice thickness. MRI is also acceptable in certain situations (e.g.\nfor body scans).\nUse of MRI remains a complex issue. MRI has excellent contrast, spatial, and\ntemporal resolution; however, there are many image acquisition variables involved in\nMRI, which greatly impact image quality, lesion conspicuity, and measurement.\nFurthermore, the availability of MRI is variable globally. As with CT, if an MRI is\nperformed, the technical specifications of the scanning sequences used should be\noptimized for the evaluation of the type and site of disease. Furthermore, as with CT,\nthe modality used at follow-up should be the same as was used at baseline and the\nlesions should be measured/assessed on the same pulse sequence. It is beyond the\nscope of the RECIST guidelines to prescribe specific MRI pulse sequence\nparameters for all scanners, body parts, and diseases. Ideally, the same type of\nscanner should be used and the image acquisition protocol should be followed as\nclosely as possible to prior scans. Body scans should be performed with breath-hold\nscanning techniques, if possible.\nPET-CT: At present, the low dose or attenuation correction CT portion of a combined\nPET-CT is not always of optimal diagnostic CT quality for use with RECIST\nmeasurements. However, if the site can document that the CT performed as part of a\nPET-CT is of identical diagnostic quality to a diagnostic CT (with IV and oral contrast),\nthen the CT portion of the PET-CT can be used for RECIST measurements and can\nbe used interchangeably with conventional CT in accurately measuring cancer\nlesions over time. Note, however, that the PET portion of the CT introduces additional\ndata which may bias an investigator if it is not routinely or serially performed.\nUltrasound: Ultrasound is not useful in assessment of lesion size and should not be\nused as a method of measurement. Ultrasound examinations cannot be reproduced\nin their entirety for independent review at a later date and, because they are operator\ndependent, it cannot be guaranteed that the same technique and measurements will\nbe taken from one assessment to the next. If new lesions are identified by ultrasound\nin the course of the study, confirmation by CT or MRI is advised. If there is concern\nabout radiation exposure at CT, MRI may be used instead of CT in selected\ninstances.\nEndoscopy, Laparoscopy: The utilization of these techniques for objective tumor\nevaluation is not advised. However, such techniques may be useful to confirm\ncomplete pathological response when biopsies are obtained or to determine relapse\nin trials where recurrence following complete response (CR) or surgical resection is\nan endpoint.\nTumor markers: Tumor markers alone cannot be used to assess response. If markers\nare initially above the upper normal limit, they must normalize for a patient to be\nconsidered in complete clinical response. Specific guidelines for both CA-125\nresponse (in recurrent ovarian cancer) and PSA response (in recurrent prostate\ncancer) have been published.57-59 In addition, the Gynecologic Cancer Intergroup has\ndeveloped CA-125 progression criteria which are to be integrated with objective\ntumor assessment for use in first-line trials in ovarian cancer.60

\n

Cytology, Histology: These techniques can be used to differentiate between partial\nresponses (PR) and complete responses (CR) in rare cases (e.g., residual lesions in\ntumor types, such as germ cell tumors, where known residual benign tumors can\nremain).\nThe cytological confirmation of the neoplastic origin of any effusion that appears or\nworsens during treatment when the measurable tumor has met criteria for response\nor stable disease is mandatory to differentiate between response or stable disease\n(an effusion may be a side effect of the treatment) and progressive disease.\nFDG-PET: While FDG-PET response assessments need additional study, it is\nsometimes reasonable to incorporate the use of FDG-PET scanning to complement\nCT scanning in assessment of progression (particularly possible 'new' disease). New\nlesions on the basis of FDG-PET imaging can be identified according to the following\nalgorithm:\n\u2022\n\u2022

\n

\u2022

\n

Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of\nPD based on a new lesion.\nNo FDG-PET at baseline and a positive FDG-PET at follow-up:\no If the positive FDG-PET at follow-up corresponds to a new site of disease\nconfirmed by CT, this is PD.\no If the positive FDG-PET at follow-up is not confirmed as a new site of disease\non CT, additional follow-up CT scans are needed to determine if there is truly\nprogression occurring at that site (if so, the date of PD will be the date of the\ninitial abnormal FDG-PET scan).\no If the positive FDG-PET at follow-up corresponds to a pre-existing site of\ndisease on CT that is not progressing on the basis of the anatomic images,\nthis is not PD.\nFDG-PET may be used to upgrade a response to a CR in a manner similar to a\nbiopsy in cases where a residual radiographic abnormality is thought to represent\nfibrosis or scarring. The use of FDG-PET in this circumstance should be\nprospectively described in the protocol and supported by disease-specific medical\nliterature for the indication. However, it must be acknowledged that both\napproaches may lead to false positive CR due to limitations of FDG-PET and\nbiopsy resolution/sensitivity.

\n

Note: A \u2018positive\u2019 FDG-PET scan lesion means one which is FDG avid with an uptake\ngreater than twice that of the surrounding tissue on the attenuation corrected image.

\n

6.1.4\n6.1.4.1

\n

Response Criteria

\n

Evaluation of Target Lesions

\n

All measurable lesions up to a maximum of 2 lesions per organ and five lesions in\ntotal, representative of all involved organs, should be identified as target lesions and\nrecorded and measured at baseline. Target lesions should be selected on the basis\nof their size (those with the longest diameters), be representative of all involved\norgans, but in addition should be those that lend themselves to reproducible repeated\nmeasurements. It may be the case that, on occasion, the largest lesion does not lend\nitself to reproducible measurement in which circumstance the next largest lesion\nwhich can be measured reproducibly should be selected.

\n

The sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions)\nfor all target lesions will be calculated and reported as the baseline sum diameters. If\nlymph nodes are to be included in the sum, then only the short axis is added into the\nsum. The baseline sum of the diameters will be used as reference to further\ncharacterize any objective tumor regression in the measurable dimension of the\ndisease.\nComplete Response (CR): Disappearance of all target lesions. Any pathological\nlymph nodes (whether target or non-target) must have reduction in short axis to <10\nmm.\nPartial Response (PR): At least a 30% decrease in the sum of the diameters of target\nlesions, taking as reference the baseline sum diameters.\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of\ntarget lesions, taking as reference the smallest sum on study (this includes the\nbaseline sum if that is the smallest on study). In addition to the relative increase of\n20%, the sum must also demonstrate an absolute increase of at least 5 mm over the\nnadir. (Note: the appearance of one or more new lesions is also considered\nprogression).\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient\nincrease to qualify for PD, taking as reference the smallest sum diameters while on\nstudy. (Note: a change of 20% or more that does not increase the sum of the\ndiameters by 5 mm or more is coded as stable disease).\n6.1.4.2

\n

Evaluation of Non-Target Lesions

\n

All other lesions or sites of disease including any measurable lesions over and above\nthe 5 target lesions should be identified as non-target lesions and should also be\nrecorded at baseline. Measurements of these lesions are not required, but the\npresence or absence of unequivocal progression of each should be noted throughout\nfollow-up.\nComplete Response (CR): Disappearance of all non-target lesions and normalization\nof tumor marker level. All lymph nodes must be non-pathological in size (<10 mm\nshort axis).\nNote: If tumor markers are initially above the upper normal limit, they must normalize\nfor a patient to be considered in complete clinical response.\nNon-CR/Non-PD: Persistence of one or more non-target\nmaintenance of tumor marker level above the normal limits.

\n

lesion(s)

\n

and/or

\n

Progressive Disease (PD): Appearance of one or more new lesions and/or\nunequivocal progression of existing non-target lesions. Unequivocal progression\nshould not normally trump target lesion status. It must be representative of overall\ndisease status change, not a single lesion increase.\nWhen the patient also has measurable disease, there must be an overall level of\nsubstantial worsening in non-target disease such that, even in the presence of SD or\nPR in target disease, the overall tumor burden has increased sufficiently to merit\ndiscontinuation of therapy. A modest \u201cincrease\u201d in the size of one or more non-target\nlesions is usually not sufficient to qualify for unequivocal progression status. The

\n

designation of overall progression solely on the basis of change in non-target disease\nin the face of SD or PR of target disease will therefore be extremely rare.\nWhen the patient only has non-measurable disease, the increase in overall disease\nburden should be comparable in magnitude to the increase that would be required to\ndeclare PD for measurable disease: i.e., an increase in tumor burden from \u201ctrace\u201d to\n\u201clarge\u201d, an increase in nodal disease from \u201clocalized\u201d to \u201cwidespread\u201d, or an increase\nsufficient to require a change in therapy.\nAlthough a clear progression of \u201cnon-target\u201d lesions only is exceptional, the opinion of\nthe treating physician should prevail in such circumstances, and the progression\nstatus should be confirmed at a later time by the review panel (or Principal\nInvestigator).\n6.1.4.3

\n

Evaluation of New Lesions

\n

The appearance of new lesions constitutes Progressive Disease (PD).\n6.1.4.4

\n

Evaluation of Patient\u2019s Best Overall Response

\n

The best overall response is the best response recorded from the start of the\ntreatment until disease progression/recurrence (taking as reference for progressive\ndisease the smallest measurements recorded since the treatment started). The\npatient's best response assignment will depend on the achievement of both\nmeasurement and confirmation criteria.

\n

Table 6-0\nPatients with Measurable Disease (e.g., Target Disease)\nTarget\nLesions

\n

Non-Target\nLesions

\n

New\nLesions

\n

Overall\nResponse

\n

Best Overall Response when\nConfirmation is Required*

\n

CR

\n

CR

\n

No

\n

CR

\n

Confirmation not required

\n

CR

\n

Non-CR/NonPD

\n

No

\n

PR

\n

CR

\n

Not Evaluated

\n

No

\n

PR

\n

PR

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

PR

\n

SD

\n

Non-CR/NonPD/Not\nEvaluated

\n

No

\n

SD

\n

PD

\n

Any

\n

Yes or No

\n

PD

\n

Any

\n

PD**

\n

Yes or No

\n

PD

\n

Any

\n

Any

\n

Yes

\n

PD

\n

Confirmation not required

\n

Confirmation not required

\n

No prior SD, PR or CR

\n

*See RECIST 1.1 manuscript for further details on what is evidence of a new lesion.\n**In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as\ndisease progression.\nNote:

\n

Patients with a global deterioration of health status requiring discontinuation of treatment\nwithout objective evidence of disease progression at that time should be reported as\n\u201csymptomatic deterioration\u201d. Every effort should be made to document the objective\nprogression even after discontinuation of treatment.

\n

Table 6-1\nPatients with Non-Measurable Disease (e.g., Non-Target Disease)\nNon-Target Lesions

\n

New Lesions

\n

Overall Response

\n

CR

\n

No

\n

CR

\n

Non-CR/Non-PD

\n

No

\n

Non-CR/Non-PD*

\n

Not all evaluated

\n

No

\n

Not Evaluated

\n

Unequivocal PD

\n

Yes or No

\n

PD

\n

Any

\n

Yes

\n

PD

\n

*\u2018Non-CR/Non-PD\u2019 is preferred over \u2018stable disease\u2019 for non-target disease since SD is increasingly\nused as an endpoint for assessment of efficacy in some trials so to assign this category when no\nlesions can be measured is not advised.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_41", - "extensionAttributes": [], - "name": "NCI_6_1_4", - "text": "

See section 6.1.4 Response Criteria.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_42", - "extensionAttributes": [], - "name": "NCI_6_1_5", - "text": "
\n

Duration of overall response: The duration of overall response is measured from the\ntime measurement criteria are met for CR or PR (whichever is first recorded) until the\nfirst date that recurrent or progressive disease is objectively documented (taking as\nreference for PD the smallest measurements recorded since the treatment started).\nThe duration of overall CR is measured from the time measurement criteria are first\nmet for CR until the first date that progressive disease is objectively documented.\nDuration of stable disease: Stable disease is measured from the start of the treatment\nuntil the criteria for progression are met, taking as reference the smallest\nmeasurements recorded since the treatment started, including the baseline\nmeasurements.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_43", - "extensionAttributes": [], - "name": "NCI_6_1_6", - "text": "
\n

PFS is defined as the duration of time from time of randomization to time of\nprogression or death, whichever occurs first. A subject who has neither progressed\nnor died will be censored on the date of last tumor assessment.

\n

Study Parameters

\n

TREATMENT MUST BEGIN \u2264 7 WORKING DAYS FROM RANDOMIZATION\nInduction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable

\n

Phase\n(until

\n

toxicity)

\n

Section 5.6^

\n

X

\n

Informed Consent

\n

X

\n

Medical History & Assessment of Baseline\nSigns and Symptoms

\n

X

\n

Physical Exam

\n

X

\n

a

\n

X

\n

a

\n

Vital Signs (Blood Pressure, Heart Rate,\nTemperature) and Weight\nECOG Performance Status

\n

Follow-Up Off\no\nTherapy\n(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a

\n

Eligibility Assessment

\n

Concomitant Meds (see Appendix C)

\n

\u00a3

\n

a

\n

X

\n

a

\n

X\n(includes Ht)\na

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

b

\n

X

\n

X

\n

c

\n

X

\n

X

\n

c

\n

X

\n

j

\n

X

\n

X

\n

i

\n

X

\n

X

\n

b

\n

Adverse Events Assessments

\n

X

\n

X

\n

a,i

\n

i

\n

Imaging Scans

\n

X

\n

X

\n

PT with INR

\n

X

\n

Urinalysis

\n

X

\n

CBC with differentials, Platelets

\n

X

\n

a

\n

X

\n

b

\n

X

\n

d

\n

X

\n

Serum Creatinine, Electrolytes (K, Na, Cl,\nCO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT),\nAlkaline Phosphatase, Total Bilirubin,\nMagnesium, Uric Acid.

\n

X

\n

a

\n

X

\n

b

\n

X

\n

X

\n

Fasting Glucose

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

Fasting serum Lipid Profile (triglycerides,\ntotal cholesterol, HDL and LDL)

\n

X

\n

a

\n

X

\n

b

\n

X

\n

e

\n

X

\n

e

\n

X

\n

j

\n

i

\n

a\na

\n

c,d

\n

X

\n

d

\n

X

\n

k

\n

c

\n

X

\n

X

\n

X

\n

e

\n

X

\n

e

\n

X

\n

k

\n

k\nk

\n

j

\n

X

\n

i,m,o

\n

X

\n

Induction Phase (fulvestrant + everolimus or placebo for a maximum of 12 cycles)\nProcedure

\n

Pre-Study

\n

Cycle 1

\n

Cycle 1

\n

Day 1*

\n

Day 15

\n

Day 1 Each\nSubsequent\nCycle*

\n

Every 12\nweeks

\n

End of\nInduction\nPhase

\n

Continuation\nPhase\n(until

\n

<OR>

\n

progression or

\n

End of\nTreatment

\n

unacceptable\ntoxicity)

\n

Section 5.6^

\n

HBV-DNA, HbsAg, HBsAb, HBcAb, HCVRNA-PCR

\n

(every 3\nmonths for total\nof 3 yrs from\ndate of\nrandomization)

\n

a,f\nf,g

\n

X

\n

f,h

\n

X

\n

X

\n

HCV RNA-PCR

\n

X

\n

PFTs with DLCO as medically indicated

\n

Follow-Up Off\no\nTherapy

\n

X

\n

HBV DNA\nStudy Drug Compliance (Pill Diary)

\n

\u00a3

\n

X

\n

f,g

\n

X

\n

f,h

\n

X

\n

X

\n

k\nk

\n

X

\n

l

\n

X

\n

n

\n

a: \u2264 4 weeks of randomization; if assessments required \u2264 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).\nb: \u2264 7 days prior to the start of C1D1.\nc: +/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends,\nbad weather or other unforeseen circumstances will be permitted.\nd: In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of\nhematologic recovery.\ne: +/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of\ntreatment.\nf: All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a\npositive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or\nHBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment\nshould continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.\ng: Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior\nto D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions.\nh: Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered \u2018cured\u2019) should have HCV RNAPCR testing performed on \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be\ndiscontinued if HCV flare is confirmed according to the guidance in Table 5-5.\ni: Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week\n(every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be\nrepeated once disease progression is documented.\nj: Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or\neverolimus/placebo) or until \u2264 grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last\ndose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.

\n

k: CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone.\nPatients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per\nlabeling guidelines.\nl: Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase.\nm: All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed\nduring the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented\nprogression.\nn: PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study).\no: Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented.\n* Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15\nof the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo.\n^ End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant.\n\u00a3 Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination\nwith everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to\nholidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_44", - "extensionAttributes": [], - "name": "NCI_7", - "text": "

See section 7 Study Parameters.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_45", - "extensionAttributes": [], - "name": "NCI_7_1", - "text": "
\n

Written informed consent must be obtained prior to any study required procedures that\nwould not have been performed as part of normal patient care at the site.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_46", - "extensionAttributes": [], - "name": "NCI_7_1_1", - "text": "
\n

Prior to randomization, patients will complete the informed consent process and have all\nrequired protocol assessments completed in order to assess eligibility requirements. All\nprocedures and an assessment of eligibility should be documented in the patient record.\nWithin \u2264 4 weeks of randomization to protocol therapy:\n\u2022

\n

Medical history

\n

\u2022

\n

Assessment of baseline signs and symptoms

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate and temperature, height and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Imaging scans for complete disease assessment. Care should be taken to continue\nto use the same evaluation method during the study as used for initial evaluation.\nSee Section 6 for additional details.

\n

\u2022

\n

PT with INR

\n

\u2022

\n

Urinalysis

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

A detailed assessment of hepatitis B/C medical history and risk factors must be done for\nall patients. Patients with positive hepatitis B and/or hepatitis C test results must begin a\ncourse of antivirals within 1-2 weeks prior to the first dose of everolimus (as outlined in\nSection 5.3.2.2 and 5.3.2.3).\nTesting for hepatitis B viral load and serologic markers: HBV-DNA, HBsAg, HBsAb,\nHBcAb and HCV RNA-PCR are required at screening for all patients in the following risk\ncategories:\no All patients who have lived in Asia, Africa, Central and South America, Eastern\nEurope, Spain, Portugal, and Greece.\n[http://wwwnc.cdc.gov/travel/yellowbook/2012/chapter-3-infectious-diseasesrelated-to-travel/hepatitis-b.htm]

\n

o Patients with any of the following risk factors:\n\u2022 known or suspected past hepatitis B infection\n\u2022 blood transfusion(s) prior to 1990\n\u2022 current or prior IV drug users\n\u2022 current or prior dialysis\n\u2022 household contact with hepatitis B infected patient(s)\n\u2022 current or prior high-risk sexual activity\n\u2022 body piercing or tattoos\n\u2022 mother known to have hepatitis B\n\u2022 history suggestive of hepatitis B infection, e.g., dark urine, jaundice, right\nupper quadrant pain.\no Additional patients at the discretion of the investigator

\n

Testing for hepatitis C should be performed using quantitative RNA-PCR at screening for\nall patients in the following risk categories:\no\no\no\no\no\no\no\no

\n

known or suspected past hepatitis C infection (including patients with past\ninterferon \u2018curative\u2019 treatment)\nblood transfusions prior to 1990\ncurrent or prior IV drug users\ncurrent or prior dialysis\nhousehold contact of hepatitis C infected patient(s)\ncurrent or prior high-risk sexual activity\nbody piercing or tattoos\nAt the discretion of the investigator, additional patients may also be tested for\nhepatitis C.

\n

Final determination of eligibility and randomization to therapy should be done only after\nall assessments are completed.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_47", - "extensionAttributes": [], - "name": "NCI_7_1_2", - "text": "
\n

Day 1 of each cycle is defined as the day in which fulvestrant is given, including the first\nfulvestrant dose, third fulvestrant dose, and every dose thereafter (the second fulvestrant\ndoses is given on day 15 of the first cycle only). Note: If patient previously received one\ncycle of fulvestrant (day 1 and day 15) prior to study entry as permitted in Inclusion\nCriteria #8, patient should receive fulvestrant 500 mg on day 1 only.\nPatients will be assessed continually for toxicity and study continuation. Protocol therapy\ndoses should be calculated and modified as per Section 5. Assessment of disease for\nresponse should be performed as per Section 6.\nOne cycle in the Induction Phase is equal to 28 days. Patients are treated for a\nmaximum of 12 cycles in the Induction Phase.\n7.1.2.1

\n

Within 7 Days of Cycle 1 Day 1

\n

Note: The following assessments do not have to be repeated if the pre-study\nassessments were performed within \u2264 7 days of Cycle 1 Day 1.

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). AE assessment should begin after the first dose of study\nmedication has been administered.

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered \u2018cured\u2019) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

7.1.2.2

\n

Cycle 1 Day 15

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature, and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously). (see Section 5.3 for dose modification guidelines)

\n

\u2022

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differentia and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.3

\n

Cycle 2 (and each subsequent cycle) Day 1

\n

\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment and dose modifications as necessary (AEs should be\nmonitored continuously, see Section 5.3 for dose modification guidelines).

\n

\u2022

\n

CBC with differential and platelets. In the event of grade 3 or 4 hematologic toxicity,\nCBC with differential and platelet count will be obtained every 1-3 days until there is\nevidence of hematologic recovery.

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose (Cycle 2 Day 1, then every 12 weeks during treatment, and more\nfrequently as clinically indicated)

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL) (Cycle 2\nDay 1, then every 12 weeks during treatment, and more frequently as clinically\nindicated)

\n

\u2022

\n

Patients on antiviral prophylaxis treatment or positive HBV antibodies should be\ntested for HBV-DNA on Cycle 1 Day 1 and Day 1 of all subsequent cycles (every 28\ndays) to monitor for re-activation. If re-activation is confirmed, everolimus must be\ninterrupted or discontinued according to the guidance in Table 5-4. Patients with\npositive HCV RNA-PCR results at screening and/or a history of past infection (even if\ntreated and considered \u2018cured\u2019) should have HCV RNA-PCR testing performed on\nCycle 1 Day 1 and Day 1 of all subsequent cycles (every 28 days) to monitor for\nflare. Everolimus must be discontinued if HCV reactivation is confirmed according to\nthe guidance in Table 5-5.

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

7.1.2.4

\n

Every 12 Weeks

\n

\u2022

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the Induction\nPhase. Scans should be repeated at the assigned intervals regardless of cycle or\ntreatment delays.

\n

\u2022

\n

Fasting Glucose and Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL\nand LDL) to be done every 12 weeks during Induction Phase (and more frequently\nas clinically indicated)

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_48", - "extensionAttributes": [], - "name": "NCI_7_1_3", - "text": "
\n

End of Induction Phase <OR> End of Treatment

\n

All patients will have the following assessments completed whether they are moving into\nthe Continuation Phase or no longer will be receiving treatment and are moving into\nFollow-Up Off-Therapy due to reasons noted in Sections 5.5 or 5.6. The assessments\nshould be completed within 30 days of last dose of fulvestrant and before moving from\nthe Induction Phase into the Continuation Phase or before moving directly into the\nFollow-Up Phase. (Note: Day 1 of the Continuation Phase should start on D29 of cycle\n12 if the assessments below are completed in order to maintain the 28 day fulvestrant\ndosing schedule).\n\u2022

\n

Physical examination

\n

\u2022

\n

Concomitant medication assessment (see Appendix C for list of excluded or\nmedications requiring monitoring on study)

\n

\u2022

\n

Vital signs, including blood pressure, heart rate, temperature and weight

\n

\u2022

\n

Assessment of ECOG performance status

\n

\u2022

\n

Adverse event assessment. All patients will be followed for toxicity assessment for\n30 days after the last dose of study therapy (fulvestrant and/or everolimus/placebo)\nor until resolution to \u2264 grade 1 attributed to study therapy (or if >grade 1, event must\nbe permanent and stable). Serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus/placebo are not reported unless the event may be\nrelated to everolimus/placebo.

\n

\u2022

\n

Tumor evaluation if due per every 12 weeks +/- 1 week (every 3 months) evaluation\nschedule.

\n

\u2022

\n

CBC with differential and platelets

\n

\u2022

\n

Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein,\nPhosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin,\nMagnesium and Uric Acid

\n

\u2022

\n

Fasting Glucose

\n

\u2022

\n

Fasting Serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for everolimus/placebo

\n

Patients in the Continuation Phase should continue to receive fulvestrant alone (if\noriginally randomized to placebo) or in combination with everolimus (if originally\nrandomized to everolimus) at the same dose and schedule until disease progression or\nunacceptable toxicity.\nPatients that are moving from the Induction Phase into Follow-Up Off Therapy should\nnot receive further investigational therapies for at least 30 days after the last dose of\nstudy drug, if possible, in order to eliminate overlapping toxicity.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_49", - "extensionAttributes": [], - "name": "NCI_7_1_4", - "text": "
\n

Patients with no evidence of disease progression after 12 cycles of treatment (Induction\nPhase) will be unblinded and proceed to the Continuation Phase. Patients in the\nContinuation Phase should continue to receive fulvestrant alone (if originally randomized\nto placebo) or in combination with everolimus (if originally randomized to everolimus) at\nthe same dose and schedule until disease progression is documented or unacceptable\ntoxicity. Once progression is documented, patients will move into Follow-Up Off Therapy.\nOne cycle in the Continuation Phase is equal to 28 days. Day 1 of the Continuation\nPhase should start 28 days (D29) after the last dose of fulvestrant was given during\nCycle 12 in the Induction Phase.\nAll adverse events that are related to fulvestrant and/or everolimus will be followed for 30\ndays after the last dose of study therapy (fulvestrant and/or everolimus) until \u2264 grade 1\nor if the grade is >1, the event must be permanent and stable.\n\u2022

\n

CBC and chemistry may be used to monitor any ongoing toxicities, but are not\nrequired for patients that receive fulvestrant alone.

\n

\u2022

\n

Patients who continue fulvestrant in combination with everolimus should periodically\nhave CBC, chemistries, fasting glucose, fasting serum lipids, HBV DNA, and HCV\nRNA-PCR per labeling guidelines.

\n

\u2022

\n

Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the\nContinuation Phase.

\n

After the Continuation Phase, serious adverse events >30 days after last dose of\nfulvestrant and/or everolimus are not reported unless the event may be related to\neverolimus.\n7.1.4.1\n\u2022

\n

Every 12 Weeks

\n

Tumor evaluation every 12 weeks, +/- 1 week (every 3 months) during the\nContinuation Phase until disease progression is documented.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_50", - "extensionAttributes": [], - "name": "NCI_7_1_5", - "text": "
\n

All patients, including those who discontinue protocol therapy, will be followed for 3\nyears from the time of randomization. Patients that did not progress during the Induction\nor Continuation Phase will continue to have imaging scans completed every 3 months\nuntil documented progression. Patients will then be followed for survival. Initiation of any\nnew systemic therapy will also be documented. Patients that have adverse events\nrelated to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last\ndose of study therapy (fulvestrant and/or everolimus/placebo) until \u2264 grade 1 or if the\ngrade is >1, the event must be permanent and stable. Serious adverse events >30 days\nafter last dose of fulvestrant and/or everolimus/placebo are not reported unless the event\nmay be related to everolimus/placebo.

\n

Drug Formulation and Procurement

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_51", - "extensionAttributes": [], - "name": "NCI_8", - "text": "

See section 8 Drug Formulation and Procurement.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_52", - "extensionAttributes": [], - "name": "NCI_8_1", - "text": "

See section 8.1 Everolimus.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_53", - "extensionAttributes": [], - "name": "NCI_8_1_1", - "text": "
\n

Full instructions for investigator sites and investigational pharmacies will be available in\nseparate protocol-specific documents. The supply of everolimus or placebo will be\nshipped directly to the local investigator. Drug ordering procedures will be provided in\nsupplemental study materials.\n8.1.1.1

\n

How Supplied

\n

Everolimus and an identically appearing placebo will be provided by Novartis.\nEverolimus is formulated as tablets for oral administration of 5 mg strength. Tablets are\nblister-packed under aluminum foil in units of 10 tablets per blister card, which should be\nopened only at the time of administration as drug is both hygroscopic and light-sensitive.\nEach tablet contains as inactive ingredients: butylhyroxytoluene/butylated\nhydroxytoluene (BHT), magnesium stearate, lactose monohydrate, hypromellose,\ncrospovidone and lactose anhydrous.\nMedication labels will comply with US legal requirements and be printed in English. They\nwill supply no information about the patient. The storage conditions for study drug will be\ndescribed on the medication label.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_54", - "extensionAttributes": [], - "name": "NCI_8_1_2", - "text": "
\n

Everolimus should be stored at room temperature between 20\u00b0C to 25\u00b0C (68\u00b0F to 77\u00b0F).\nAll investigational products must be kept in a secure place under appropriate storage\nconditions. A description of the appropriate storage and shipment conditions is specified\non the investigational product label and investigator brochure. The stored study drug\nsupplies must be accessible to authorized staff only. The storage area must also have\nadequate control of temperature in order to maintain stability and potency of study drug\nsupplies. The tablets should be stored in the original pack until use. For further\ninformation, investigators should refer to the current Investigators Brochure (IB).

\n

8.1.3\n8.1.3.1

\n

Handling, Dispensing and Administration

\n

Handling

\n

No special precautions are necessary when handling intact tablets. Avoid contact with\nskin and eyes. Wash hands after use. The risk to health in normal handling of tablets is\nvery low. Exposure to dust from crushed tablets may cause adverse health effects.\n8.1.3.2

\n

Dispensing

\n

Drug should be dispensed in original packaging. If other packaging is required by\ninstitutional policy, this procedure will need to be approved by PrECOG, or their\ndesignee, prior to proceeding. The PrECOG Site Contact should be contacted for further

\n

instruction. Investigational product records should be kept as per Section 8.1.5 and\ninstitutional policies.\n8.1.3.3

\n

Administration

\n

Patients should be instructed to take their assigned, once-a-day oral dose of\neverolimus/placebo at the same time each morning.\n\u2022

\n

Everolimus/placebo dose may be taken with or without food.

\n

\u2022

\n

Patients should be instructed to swallow the capsules whole and not chew them.

\n

\u2022

\n

Vomited doses should not be replaced.

\n

\u2022

\n

If the patient forgets to take the medication and remembers by 10 PM, they may take\nthe dose. Otherwise, skip that dose and begin as usual the next day.

\n

In cases where tablets cannot be swallowed, the tablets should be disintegrated in water\njust prior to being taken. Approximately 30 mL (2 tablespoons) of water should be put\ninto a glass. The tablets should then be added and the contents stirred gently (for a\nmaximum of 7 minutes) until the tablets are disintegrated. The contents should then be\ndrunk.\nPatients should be given instructions on correct dosing based on study requirements\nand toxicity management (dose modifications). All changes to recommended dosing\nregimen/schedule should be documented in the patient record. Documentation of patient\ninstructions for dosing changes should also be in source records.\nPatients should be instructed to record the reason for any missed doses and report to\nthe investigator at the next visit. If a dose is vomited, that dose should not be replaced,\n(and recorded as a vomited dose).\nCompliance with therapy will be assessed at the beginning of each cycle. Patients will be\ngiven a diary (see Appendix F for an Example Patient Pill Diary) for recording of doses of\nstudy drug as provided by each study site. A copy of the patient diary will be provided to\nsites in study materials.\n8.1.3.4

\n

Special Instructions for Unblinding

\n

Patients on study therapy and all site study staff will remain blinded as to the assignment\nof everolimus or placebo. Patients who have not had progressive disease and remain on\nstudy after 12 cycles are unblinded and continue fulvestrant alone (if originally\nrandomized to placebo) or in combination with everolimus (if originally randomized to\neverolimus) at the same dose and schedule in the Continuation Phase. If an emergency\nsituation arises and the patient must be unblinded during the Induction Phase (Cycles 112), the Medical Monitor for the study must be consulted.\nEmergency Unblinding for Patients during the Induction Phase (within Cycles 1-12):\nUnblinding is a serious action that should be restricted in order to limit potential study\nbias. The breaking of the blinding code in all cases will render the patient off-protocol.\nThe Medical Monitor for the study must be involved in the decision to unblind and must\ngrant approval for unblinding any individual. Requests for unblinding will only be\nconsidered in the event of an emergency or severe adverse reaction where identification

\n

of the medication is considered important for the welfare of the patient, and the rationale\nfor unblinding is applicable to the situation. All patients should be provided emergency\nmedical care by the treating physician and appropriate therapies for the medical\nemergency should be initiated prior to the request for unblinding.\nFor example, a Serious Adverse Event (SAE) possibly, probably or definitely related to\nthe study drug occurs during the trial and the treatment of the SAE would be influenced\nby whether he/she received everolimus or placebo. Unblinding is typically not necessary\nif the medical management of the patient would not be materially altered by knowledge\nof the treatment assignment. In the event that accidental unblinding occurs, the Principal\nInvestigator should report the occurrence promptly to the Medical Monitor and document\nthe incident in the patient records. All unblinding will be recorded as a protocol deviation.\nIf a participant is in a life-threatening situation in which knowledge of the treatment is\ncrucial to care AND the Medical Monitor cannot be reached immediately, the PM should\nbe contacted to facilitate the unblinding process. A report including the unblinding details\nwill be generated after the patient has been unblinded and will be sent to the site for\ndocumentation (refer to Study Reference Manual for Unblinding Process). Report\ninformation will include but is not limited to:\n\u2022\n\u2022\n\u2022\n\u2022\n\u2022

\n

ID number of the participant whose treatment assignment was unblinded\nDate of unblinding and reconciliation of study drug in site and patient records\nReason for unblinding, including initial SAE report\nPerson responsible for unblinding\nList of persons who are unblinded (e.g. study staff)

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_55", - "extensionAttributes": [], - "name": "NCI_8_1_3", - "text": "

See section 8.1.3 Handling, Dispensing and Administration.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_56", - "extensionAttributes": [], - "name": "NCI_8_1_4", - "text": "
\n

The most common adverse reactions (incidence \u2265 10%) reported for everolimus include\nstomatitis, rash, fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,\nvomiting, cough, peripheral edema, infections, dry skin, epistaxis, pruritus, and dyspnea.\nThe most commonly reported grade 3-4 adverse reactions (incidence \u2265 2%) reported for\neverolimus include infections, stomatitis, fatigue, and pneumonitis.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_57", - "extensionAttributes": [], - "name": "NCI_8_1_5", - "text": "
\n

Investigational product dispensing record/inventory logs and copies of signed packing\nlists must be maintained at the investigational site for everolimus. It is the responsibility\nof the Investigator to ensure that a current record of investigational product disposition is\nmaintained at each study site where investigational product is stored and/or dispensed.\nRecords must comply with applicable regulations and guidelines, and should include:\n\u2022

\n

Amount received and placed in storage area.

\n

\u2022

\n

Amount currently in storage area.

\n

\u2022

\n

Label ID number or batch number.

\n

\u2022

\n

Dates and initials of person responsible for each investigational product inventory\nentry/movement.

\n

\u2022

\n

Amount dispensed to and returned by each patient, including unique patient\nidentifiers.

\n

\u2022

\n

Amount transferred to another area for dispensing or storage.

\n

\u2022

\n

Non-study disposition (e.g., wasted, broken).

\n

\u2022

\n

Amount returned to manufacturer, if applicable

\n

\u2022

\n

Amount destroyed at study site, if applicable

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_58", - "extensionAttributes": [], - "name": "NCI_8_1_6", - "text": "
\n

Investigational product should be maintained at the site for accountability purposes.\nSites will be referred to the study pharmacy manual for instructions regarding the return\nor destruction of everolimus study drug supply (site\u2019s drug destruction policy must be\nreviewed and approved by PrECOG before any study drug can be destroyed at a site).\nPatients will be instructed to return all blister packs (empty or partially used) to the study\ncenter.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_59", - "extensionAttributes": [], - "name": "NCI_8_2", - "text": "
\n

8.2.1

\n

Packaging and Labeling

\n

Fulvestrant is commercially available and approved and is indicated for the treatment of\nHR-positive metastatic breast cancer in postmenopausal women whose disease has\nreturned or progressed following antiestrogen therapy.\nInvestigators should review the approved Package Insert (PI) (http://www.faslodex.com/\nfaslodex-prescribing-info/index.aspx) for full information on storage, handling,\npreparation and stability.\nFulvestrant is supplied as:\nOne clear neutral glass (Type 1) barrel containing 250 mg/5 mL (50 mg/mL) Injection for\nintramuscular injection and fitted with a tamper-evident closure. NDC 0310-0720-50.\n(Note: Patients will be receiving 500 mg doses IM therefore 2 injections of 250 mg will\nbe required for one dose.)\nThe syringes are presented in a tray with polystyrene plunger rod and safety needles\n(SafetyGlide\u2122) for connection to the barrel.\nEach injection contains as inactive ingredients: Alcohol, USP, Benzyl Alcohol, NF, and\nBenzyl Benzoate, USP as co-solvents, and Castor Oil, USP as a co-solvent and release\nrate modifier.

\n

8.2.2\n8.2.2.1

\n

Handling and Dispensing

\n

Storage Requirements/Stability

\n

Refrigerate 2\u00b0-8\u00b0C (36\u00b0-46\u00b0F). To protect from light, store in the original carton until time\nof use.\n8.2.2.2

\n

Preparation and Administration

\n

Fulvestrant should be disposed of or destroyed as per written institutional policies and\nper recommendations in the current approved Package Insert. To help avoid infectious\ndiseases due to accidental needle sticks, contaminated needles should not be recapped\nor removed, unless there is no alternative or that such action is required by a specific\nmedical procedure.\nWARNING: - Do not autoclave safety needle before use. Hands must remain\nbehind the needle at all times during use and disposal.\nDirections:\n(Source: Faslodex\u00ae Package Insert 1621903 Rev 12/11)\n\u2022 Remove the glass syringe barrel from tray and check that it is not damaged\n\u2022 Remove perforated patient record label from syringe\n\u2022 Peel open the safety needle outer packaging.\n\u2022 Break the seal of the white plastic cover on the syringe luer connector to remove the\ncover with the attached rubber tip cap (Figure 1).\n\u2022 Twist to lock the needle to the luer container.\n\u2022 Remove the needle sheath. Pull shield straight off needle to avoid damaging needle\npoint.\n\u2022 Remove excess gas from the syringe.\n\u2022 Administer intramuscularly slowly in the buttock. Administer injection following\npackage instruction. For user convenience, the needle \u2018bevel up\u2019 position is\norientated to the lever arm (Figure 3).\n\u2022 Immediately activate needle protection device upon withdrawal from patient by\npushing lever arm completely forward until the tip is fully covered (Figure 2).\n\u2022 Visually confirm that the lever arm has fully advanced and the needle tip is covered.\nIf unable to activate, discard immediately into an approved sharps collector.\nActivation of the protective mechanism may cause minimal splatter of fluid that may\nremain on the needle after injection. For greatest safety, use a one-handed\ntechnique and activate away from self and others.\n\u2022 If the 250 mg/5 mL formulation is used, repeat the above steps for the second\nsyringe. After single use, discard in an approved sharps collector in accordance with\napplicable regulations and institutional policy.\n\u2022 Review the official package insert for more information regarding the use of the\nSafetyGlide Needle.

\n

8.2.3

\n

Side Effects

\n

The most commonly reported adverse experiences in the Faslodex\u00ae treatment groups,\nregardless of the investigator\u2019s assessment of causality, were gastrointestinal symptoms\n(including nausea, vomiting, constipation, diarrhea and abdominal pain), headache, back\npain, vasodilatation (hot flushes), and pharyngitis.\nInjection site reactions with mild transient pain and inflammation were seen with\nFaslodex\u00ae and occurred in 7% of patients (1% of treatments) given the single 5 mL\ninjection (predominately European Trial) and in 27% of patients (4.6% of treatments)\ngiven the 2 x 2.5 mL injections (North American Trial).\nOther adverse events reported as drug-related and seen infrequently (<1%) include\nthromboembolic phenomena, myalgia, vertigo, leukopenia and hypersensitivity reactions\nincluding angioedema and urticaria. Vaginal bleeding has been reported infrequently\n(<1%), mainly in patients during the first 6 weeks after changing from existing hormonal\ntherapy to treatment with Faslodex\u00ae If bleeding persists, further evaluation should be\nconsidered.

\n

Statistical Considerations

\n

The efficacy endpoints will be assessed among all eligible patients who receive protocol\ntherapy. Safety endpoints will be assessed among all treated patients, regardless of\neligibility.

\n

9.1

\n

Primary Efficacy Endpoint

\n

The primary efficacy endpoint is progression-free survival (PFS). PFS is defined as the\ntime from randomization to documented disease progression or death. Based on results\nfrom the CONFIRM trial, median PFS among patients with AI-resistant disease on\nfulvestrant alone is 5.4 months. AI resistant disease is defined as: patients who have\neither relapsed while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane) or have progressive disease while receiving an\naromatase inhibitor for metastatic disease. (Patients previously treated with two or more\nprior cycles of fulvestrant are not eligible. Patients who have received one prior cycle\n(day 1 and day 15) of fulvestrant within 28 days of randomization are eligible so long as\nthey meet other eligibility criteria). Randomization will be 1:1, stratified for balancing\npurposes using ECOG performance status (0 vs. 1), presence of measurable disease\n(yes vs. no), and prior chemotherapy (yes vs. no).\nWe hypothesize that the addition of everolimus to fulvestrant will result in an\nimprovement in median PFS to 9.2 months. A one-sided stratified logrank test with a\ntype I error rate of 10% will be used to evaluate whether the addition of everolimus\nshows promising improvement in PFS relative to fulvestrant alone. To have 90% power\nto detect the hypothesized improvement, enrollment of approximately 120 eligible\npatients (60 per arm) and full information of 98 events (deaths or progressions) are\nrequired. Allowing up to 10 patients to be ineligible or to not start study treatment,\napproximately 130 patients will need to be enrolled. With accrual of approximately 130\npatients in 12 months, the required 98 events are expected to occur approximately 12\nmonths after accrual is completed. Other endpoints that will be evaluated include clinical\nbenefit rate (proportion stable or responding for at least 6 months), objective response\nrate (CR+PR), time to progression (TTP; defined as the time from randomization until\nprogression of the disease), and overall survival (OS; defined as the time from\nrandomization until death or censored at the date of last follow-up).\nPFS will be evaluated using the stratified log-rank test described above, as will TTP and\nOS. Kaplan-Meier plots will be used to graphically portray these time-to-event endpoints.\nClinical benefit rate and objective response rates will be compared between arms using\nFisher\u2019s exact tests. 90% exact binomial confidence intervals on the rates will be\nprovided.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_60", - "extensionAttributes": [], - "name": "NCI_9", - "text": "

See section 9 Statistical Considerations.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_61", - "extensionAttributes": [], - "name": "NCI_9_1", - "text": "

See section 9.1 Primary Endpoint Analysis.

", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_62", - "extensionAttributes": [], - "name": "NCI_9_2", - "text": "
\n

A descriptive comparison of overall toxicity and of grade 3-4 toxicity in the combination\narm and the fulvestrant arm will be provided. Assuming 65 patients are treated on each\narm, the exact binomial 90% confidence interval on the rate of severe toxicities will be no\nwider than 22% (+/- 11%). The probabilities of observing a rare toxicity (true rate of 5%)\nwill be 96% on each arm.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_63", - "extensionAttributes": [], - "name": "NCI_9_3", - "text": "
\n

Other endpoints that will be evaluated include overall survival, time to progression, and\nobjective response rate. Overall survival will be characterized using Kaplan-Meier plots\nand other descriptive metrics. The objective response rate will be provided for each arm,\nwith 90% exact binomial confidence intervals. Median time to progression will be\nestimated for each arm.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_64", - "extensionAttributes": [], - "name": "NCI_10", - "text": "
\n

10 Adverse Event Reporting

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_65", - "extensionAttributes": [], - "name": "NCI_10_1", - "text": "
\n

10.1 Collection of Safety Information\nAdverse Event (AE) is defined as any new untoward medical occurrence or worsening\nof a pre-existing medical condition in a patient administered a medicinal product in a\nclinical investigation and which does not necessarily have a causal relationship with this\ntreatment. An AE can therefore be any unfavorable and unintended sign (including an\nabnormal laboratory finding, for example), symptom, or disease temporally associated\nwith the use of a product (investigational or marketed), whether or not considered related\nto the product (investigational or marketed). Abnormal laboratory values or test results\nconstitute adverse events only if they induce clinical signs and symptoms, are\nconsidered clinically significant, or require therapy.\nFollowing written consent to participate in the study, all serious AEs should be collected\non a patient. The collection of non-serious AE information should begin at initiation of\ntherapy.\nAll identified AEs must be recorded and described on the appropriate page of the Case\nReport Form (CRF). If known, the diagnosis of the underlying illness or disorder should\nbe recorded, rather than individual symptoms. The following information should be\ndocumented for all AEs: date of onset and resolution, severity of the event; the\ninvestigator\u2019s opinion of the relationship to investigational product (see definitions\nbelow); treatment required for the AE; cause of the event (if known); and information\nregarding resolution/outcome.\nSeverity\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0 (see Appendix E).\nAttribution\nThe following categories and definitions of causal relationship or attribution to study drug\nshould be used to assess Adverse Events:\n\u2022

\n

Definite: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to withdrawal of study drug (dechallenge) and recurs with\nrechallenge, if clinically feasible.

\n

\u2022

\n

Probable: There is a reasonable causal relationship between the study drug and the\nevent. The event responds to dechallenge. Rechallenge is not required.

\n

\u2022

\n

Possible: There is a reasonable causal relationship between the study drug and the\nevent. Dechallenge information is lacking or unclear.

\n

\u2022

\n

Unlikely: There is doubtful causal relationship between the study drug and the event.

\n

\u2022

\n

Unrelated: There is clearly not a causal relationship between the study drug and the\nevent or there is a causal relationship between another drug, concurrent disease, or\ncircumstances and the event.

\n

Categories \u2018Definite\u2019, \u2018probable\u2019 and \u2018possible\u2019 are considered study drug related.\nCategories \u2018not likely\u2019 and \u2018not related\u2019 are considered not study drug-related.\nThe development of a new cancer should be regarded as an AE. New cancers are those\nthat are not the primary reason for administration of study treatment and have been\nidentified after inclusion of the patient into the clinical study.\nAEs related to fulvestrant and/or everolimus/placebo will be followed for 30 days\nafter the last dose of study therapy (fulvestrant and/or everolimus/placebo) until \u2264\ngrade 1 or stabilization, and reported as SAEs if they become serious. Serious\nadverse events >30 days after last dose of fulvestrant and/or everolimus/placebo\nare not reported unless the event may be related to everolimus/placebo.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_66", - "extensionAttributes": [], - "name": "NCI_10_2", - "text": "
\n

10.2 Handling of Serious Adverse Events (SAEs)

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_67", - "extensionAttributes": [], - "name": "NCI_10_2_1", - "text": "
\n

10.2.1 SAE Definitions\nA serious AE is any untoward medical occurrence occurring after informed consent is\ngranted or that at any dose:\n\u2022

\n

results in death,

\n

\u2022

\n

is life-threatening (defined as an event in which the study patient was at risk of death\nat the time of the event; it does not refer to an event which hypothetically might have\ncaused death if it were more severe),

\n

\u2022

\n

requires inpatient hospitalization or causes prolongation of existing hospitalization,

\n

\u2022

\n

results in persistent or significant disability/incapacity,

\n

\u2022

\n

is a congenital anomaly/birth defect,

\n

\u2022

\n

is an important medical event (defined as a medical event(s) that may not be\nimmediately life-threatening or result in death or hospitalization but, based upon\nappropriate medical and scientific judgment, may jeopardize the patient or may\nrequire intervention (e.g., medical, surgical) to prevent one of the other serious\noutcomes listed in the definition above.)\nExamples of such events include, but are not limited to, intensive treatment in an\nemergency room or at home for allergic bronchospasm; blood dyscrasias or\nconvulsions that do not result in hospitalization.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_68", - "extensionAttributes": [], - "name": "NCI_10_2_2", - "text": "
\n

10.2.2 SAE Reporting Requirements\nAll serious adverse events require expeditious handling and reporting to comply with\nregulatory requirements. The Principal Investigator has the obligation to report all\nserious adverse events to PrECOG, or their designee. A study specific SAE form to be\nutilized for SAE reporting will be provided with supplemental study materials.

\n

All serious adverse events that occur either during the study period (Induction and/or\nContinuation) or within 30 days of discontinuation of dosing regardless of event\nrelationship to the study medications (fulvestrant and/or everolimus/placebo) should be\nreported to PrECOG, or their designee within 24 hours of the investigator\u2019s knowledge of\nthe event or, when the event occurs on a weekend or national holiday, at the latest on\nthe following working day. All deaths during treatment or within 30 days following\ncompletion of active protocol therapy must be reported. Serious adverse events that\noccur >30 days from last dose of fulvestrant and/or everolimus/placebo and are judged\nrelated to the everolimus/placebo (definitely, probably or possibly) must be reported to\nPrECOG, or their designee using the 24 hour timeline noted above. If only limited\ninformation is initially available, follow-up reports are required. Serious adverse events\nthat occur >30 days from last dose of fulvestrant and are judged to be related to\nfulvestrant will follow normal reporting mechanisms for commercial drugs.\nSAE Hotline Phone Number:\n610-354-0404 during normal business hours (8:30 AM \u2013 5 PM EST)\n484-574-2367 after normal business hours (after 5 PM EST)\nSAE Fax Number:\n888-801-8795\nPrECOG will notify Novartis Pharmaceuticals Drug Safety and Epidemiology Department\n(DS&E) of all SAE\u2019s within 24 hours of the Awareness Date. Relevant follow-up\ninformation will be provided to Novartis DS&E as soon as it becomes available.\nIn addition, Investigators should also report event(s) to their IRB as required.\nCollection of complete information concerning SAEs is extremely important. Full\ndescriptions of each event will be followed. Thus, follow-up information which becomes\navailable as the SAE evolves, as well as supporting documentation (e.g., hospital\ndischarge summaries and autopsy reports), should be collected subsequently, if not\navailable at the time of the initial report, and immediately sent using the same procedure\nas the initial SAE report. The original and all follow-up SAEs form must be kept on file at\nthe study site.\nFor Comparator Drugs/Secondary Suspects (Concomitant Medications), all serious\nadverse experiences will be forwarded to the product manufacturer by PrECOG (or their\ndesignee), if applicable.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_69", - "extensionAttributes": [], - "name": "NCI_10_3", - "text": "
\n

10.3 Reporting of Second Primary Cancers\nNew cancers are those that are not the primary reason for administration of study\ntreatment and have been identified after inclusion of the patient into the clinical study.\nAll cases of new primary cancers that occur during or after protocol treatment must be\nreported to PrECOG within 30 days of diagnosis, regardless of relationship to protocol\ntreatment. Secondary primary malignancies should also be reported as a SAE. This form\nis not for use for reporting recurrence or development of metastatic disease. A copy of\nthe pathology report, if applicable, should be sent, if available.\nNote: Once data regarding survival and remission status are no longer required by the\nprotocol, no follow-up data should be submitted, including the PrECOG Second Primary\nForm.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_70", - "extensionAttributes": [], - "name": "NCI_11", - "text": "
\n

11 Administrative

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_71", - "extensionAttributes": [], - "name": "NCI_11_1", - "text": "
\n

11.1 Protocol Compliance\nThe study shall be conducted as described in this protocol. All revisions to the protocol\nmust be discussed with, and be prepared by PrECOG and/or representatives. The\nInvestigator should not implement any deviation or change to the protocol or consent\nwithout prior review and documented approval from PrECOG and/or representatives and\nthe IRB of an amendment, except where necessary to eliminate an immediate hazard(s)\nto study patients.\nIf a deviation or change to the approved protocol is implemented to eliminate an\nimmediate hazard(s) prior to obtaining IRB approval, notification will be submitted to the\nIRB for review and approval as soon as possible afterward. Documentation of approval\nsigned by the chairperson or designee of the IRB(s) should be in the study records. If\nPrECOG and/or representatives provides an amendment that substantially alters the\nstudy design or increases the potential risk to the patient; the consent form must be\nrevised and submitted to the IRB(s) for review and approval; the revised form must be\nused to obtain consent from patients currently enrolled in the study if they are affected\nby the amendment; and the new form must be used to obtain consent from new patients\nprior to study entry. Information as to who investigators should send correspondence will\nbe provided in additional study documents.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_72", - "extensionAttributes": [], - "name": "NCI_11_2", - "text": "
\n

11.2 Institutional Review Board\nBefore study initiation, the Investigator must have written and dated approval from their\nrespective IRB for the protocol, consent form, patient recruitment materials/process and\nany other written information to be provided to patients. The Investigator should also\nprovide the IRB with a copy of the Investigator Brochure or product labeling, and any\nupdates.\nThe Investigator should provide the IRB with reports, updates, and other information\n(e.g., Safety Updates, amendments, and administrative letters) according to regulatory\nrequirements, IRB or study site procedures.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_73", - "extensionAttributes": [], - "name": "NCI_11_3", - "text": "
\n

11.3 Informed Consent Procedures\nInvestigators must ensure that patients who volunteer for clinical trials or their legally\nacceptable representative are clearly and fully informed about the purpose, potential\nrisks and other information.\nA protocol specific informed consent form (ICF) template will be provided to sites.\nPreparation of the site-specific consent form is the responsibility of the site Investigator\nand must include all applicable regulatory and IRB requirements, and must adhere to\nGood Clinical Practice (GCP) and to the ethical principles that have their origin in the\nDeclaration of Helsinki. All changes to the ICF template will be approved by PrECOG\nand/or their representatives prior to implementation.\nIn accordance with the Health Information Portability and Accountability Act (HIPAA), the\nconsent process will also include written authorization by patients to release medical\ninformation to allow PrECOG and/or its agents, regulatory authorities, and the IRB of

\n

record at the study site for access to patient records and medical information relevant to\nthe study, including the medical history. This will be documented in the informed consent\nform or other approved form obtained at the time of informed consent per institutional\npolicies. This form should also be submitted to PrECOG and/or its agents for review\nprior to its implementation.\nThe Investigator must provide the patient or legally acceptable representative with a\ncopy of the consent form and written information about the study in the language in\nwhich the patient is most proficient. The language must be non-technical and easily\nunderstood. The Investigator should allow time necessary for patient or patient's legally\nacceptable representative to inquire about the details of the study, then informed\nconsent must be signed and personally dated by the patient or the patient's legally\nacceptable representative and by the person who conducted the informed consent\ndiscussion. The patient or legally acceptable representative should receive a copy of the\nsigned informed consent and any other written information provided to study patients\nprior to patient's participation in the trial. The investigator is responsible for assuring\nadequate documentation of this process and for storage and maintenance of the original\nsigned consent form for each patient/subject.\nThe informed consent and any other information provided to patients or the patient's\nlegally acceptable representative, should be revised whenever important new\ninformation becomes available that is relevant to the patient's consent, and should\nreceive IRB approval prior to use. The Investigator, or a person designated by the\nInvestigator should inform the patient or the patient's legally acceptable representative of\nall pertinent aspects of the study and of any new information relevant to the patient's\nwillingness to continue participation in the study. This communication should be\ndocumented in the patient record. During a patient's participation in the trial, any updates\nto the consent form and any updates to the written information will be provided to the\npatient.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_74", - "extensionAttributes": [], - "name": "NCI_11_4", - "text": "
\n

11.4 Safety Communication\nInvestigators will be notified of all AEs that are serious, unexpected, and definitely,\nprobably, or possibly related to the investigational product. Upon receiving such notices,\nthe Investigator must review and retain the notice with the Investigator Brochure and\nsubmit a copy of this information to the Institutional Review Board (IRB) according to\nlocal regulations. The Investigator and IRB will determine if the informed consent\nrequires revision. The Investigator should also comply with the IRB procedures for\nreporting any other safety information. All revisions should be submitted to PrECOG\nand/or agents for review.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_75", - "extensionAttributes": [], - "name": "NCI_11_5", - "text": "
\n

11.5 Monitoring\nRepresentatives and agents of PrECOG and, as applicable to the study, the\nmanufacturer of Investigational Product must be allowed to visit all study site locations\nperiodically to assess the data, quality and study integrity. The purpose of this visit is to\nreview study records and directly compare them with source documents and discuss the\nconduct of the study with the Investigator, and verify that the facilities remain acceptable.\nThe study may be evaluated by other auditors and government inspectors who must be\nallowed access to electronic Case Report Forms (eCRFs), source documents and other

\n

study files. The investigator must notify PrECOG of any scheduled visits by regulatory\nauthorities, and submit copies of all reports. Information as to who investigators should\nnotify of an audit or where to address questions will be provided in additional study\nmaterials. Monitoring of drug accountability will also occur.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_76", - "extensionAttributes": [], - "name": "NCI_11_6", - "text": "
\n

11.6 Study Records\nAn Investigator is required to maintain adequate regulatory files with corresponding\ncommunication and approvals, accurate histories, observations and other data on each\nindividual treated. Full details of required regulatory documents will be provided in\nadditional study materials. Data reported on the eCRF must be consistent with the\nsource documents as part of the patient record.\nThe confidentiality of records that could identify patients must be protected, respecting\nthe privacy and confidentiality rules in accordance with the applicable regulatory\nrequirement(s).\nA study specific signature record will be maintained to document signatures and initials\nof all persons at a study site who are authorized to make entries and/or corrections on\neCRFs as well as document other study-specific roles.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_77", - "extensionAttributes": [], - "name": "NCI_11_7", - "text": "
\n

11.7 Electronic Case Report Form (eCRF) Information\nAdditional information regarding eCRF instructions, timelines for data entry/submission\nand query completion can be found in supplemental materials provided to the site. Sites\nwill be expected to complete eCRFs as per the schedule provided and submit all\nrelevant data as per the specified timelines. All items recorded on eCRFs must be found\nin source documents.\nThe completed eCRF must be promptly reviewed, electronically signed, and dated by a\nqualified physician who is an Investigator or Sub-Investigator.\nInstructions for management of patients who do not receive any protocol therapy:\nIf a patient is randomized and does not receive any assigned protocol treatment,\nbaseline, Serious Adverse Event and follow-up data will still be entered and must be\nsubmitted according to the eCRF instructions. Document the reason for not starting\nprotocol treatment on the appropriate electronic off-treatment form.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_78", - "extensionAttributes": [], - "name": "NCI_11_8", - "text": "
\n

11.8 Records Retention\nFDA Regulations (21CFR 312.62) require clinical investigators to retain all trial-related\ndocumentation, including source documents for the periods described below for studies\nperformed under a US IND:\n\u2022\n\u2022\n\u2022

\n

two years after the FDA approves the marketing application, or\ntwo years after the FDA disapproves the application for the indication being studied,\nor\ntwo years after the FDA is notified by the sponsor of the discontinuation of trials and\nthat an application will not be submitted.

\n

The Investigator must retain investigational product disposition records, copies of eCRFs\n(or electronic files), and source documents for the maximum period required by

\n

applicable regulations and guidelines, or Institution procedures, whichever is longer but\nnot less than 5 years from the completion of the study. The Investigator must contact\nPrECOG and/or representatives prior to destroying any records associated with the\nstudy.\nInformation as to who investigators should contact for questions will be provided in\nadditional study documents. PrECOG and/or representatives will notify the Investigator\nwhen the trial records for this study are no longer needed.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_79", - "extensionAttributes": [], - "name": "NCI_12", - "text": "
\n

12 Glossary of Terms and List of Abbreviations\nTerm

\n

Definition

\n

4E-BP1

\n

4E-Binding Protein

\n

Ab\nADPKD

\n

Antibodies\nAutosomal Dominant Polycystic Kidney Disease

\n

ADR

\n

Adverse Drug Reaction

\n

AE(s)

\n

Adverse Events(s)

\n

Akt/PKB

\n

Protein Kinase B

\n

AI

\n

Aromatase Inhibitor

\n

Alk Phos

\n

Alkaline Phosphatase

\n

ALT/SGPT\nAMD

\n

Alanine Aminotransferase/Glutamic Pyruvic Transaminase/Serum GlutamicPyruvic Transaminase\nAge-Related Macular Degeneration

\n

ANC

\n

Absolute Neutrophil Count

\n

ASCO-CAP

\n

American Society of Clinical Oncology-College of American Pathologist

\n

AST/SGOT

\n

Aspartate\nAminotransferase/Glutamic\nGlutamic-Oxaloacetic Transaminase

\n

AUC\n\u00b0C

\n

Area Under the Concentration-Time Curve\ndegrees Celsius

\n

Ca

\n

Calcium

\n

CBC

\n

Complete Blood Count

\n

CBR

\n

Clinical Benefit Rate

\n

CI

\n

Confidence Interval

\n

CISH

\n

Chromogenic In Situ Hybridization

\n

Cl

\n

Chloride

\n

cm\nCmax

\n

centimeter\nMaximum plasma concentration

\n

CO2

\n

Carbon Dioxide

\n

CoA

\n

Coenzyme A

\n

COPD

\n

Chronic Obstructive Pulmonary Disease

\n

CPK

\n

Creatine Phosphokinase

\n

CR

\n

Complete Response

\n

CRC

\n

Colorectal Cancer

\n

Creat

\n

Creatinine

\n

CRF

\n

Case Report Form

\n

CRO

\n

Contract Research Organization

\n

CT

\n

Computer Tomography

\n

CTC

\n

Common Toxicity Criteria

\n

Oxaloacetic

\n

Transaminase/Serum

\n

Term

\n

Definition

\n

CTCAE

\n

The CTEP Common Terminology Criteria for Adverse Events (CTCAE)

\n

CTEP

\n

Cancer Therapy Evaluation Program

\n

CYP3A4

\n

CytochromeP450 3A4 Isoenzyme

\n

DLBCL

\n

Diffuse Large B Cell Lymphoma

\n

DLCO

\n

Diffusing Capacity of the Lung for Carbon Monoxide

\n

DLT

\n

Dose Limiting Toxicity

\n

DNA

\n

Deoxyribonucleic Acid

\n

DS&E

\n

Drug Safety and Epidemiology

\n

eCRF\ne.g.\nER

\n

Electronic Case Report Form\nexempli gratia (for example)\nEstrogen Receptor

\n

FSH\nEU\nFDA

\n

Follicle Stimulating Hormone\nEuropean Union\nFood and Drug Administration\nFluorine-18-2-fluoro-Deoxy-D-Glucose Positron Emission Tomography

\n

FDG-PET\nFISH\nFKBP-12\nFSH

\n

Fluorescence In Situ Hybridization\nFK506-Binding Protein 12\nFollicle Stimulating Hormone

\n

GBM

\n

Glioblastoma Multiforme

\n

GCP

\n

Good Clinical Practice

\n

GEP-NET

\n

Gastroenteropancreatic Neuroendocrine Tumor

\n

GERD

\n

Gastroesophageal Reflux Disease

\n

GF

\n

Growth Factor

\n

GI

\n

Gastrointestinal

\n

GnRH

\n

Gonadotropin-Releasing Hormone

\n

HBV

\n

Hepatitis B Virus

\n

HBcAb

\n

Hepatitis B core Antibodies

\n

HBsAb

\n

Hpatitis B surface Antibodies

\n

HbsAg

\n

Hepatitis B surface Antigen

\n

HCC

\n

Hepatocellular Cancer

\n

HCV

\n

Hepatitis C Virus

\n

HER-2

\n

Human Epidermal Growth Factor Receptor 2

\n

HIF-1

\n

Hypoxia-Inducible Factor-1

\n

HIPAA

\n

Health Information Portability and Accountability Act

\n

HIV

\n

Human Immunodeficiency Virus

\n

HMG

\n

3-hydroxy-3-methyl-glutaryl

\n

HR

\n

Hormone-Receptor

\n

HUVECS

\n

Human Umbilical Endothelial Cells

\n

IB

\n

Investigator Brochure (also called Investigator Drug Brochure, IDB)

\n

Term

\n

Definition

\n

ICF

\n

Informed Consent Form

\n

ICH

\n

International Conference on Harmonization

\n

IND\nINN

\n

Investigational New Drug\nInternational Non-Proprietary Name

\n

INR

\n

International Normal Ratio

\n

IRB\nIU

\n

Institutional Review Board\nInternational Unit

\n

IV

\n

Intravenous

\n

IWR

\n

Interactive Web Randomization

\n

K

\n

Potassium

\n

kg

\n

Kilogram

\n

L

\n

Liter

\n

LDH

\n

Lactate Dehydrogenase

\n

LDL

\n

Low-Density Lypoproteins

\n

LFTs

\n

Liver Function Tests

\n

LLN

\n

Lower Limit Normal

\n

LMW\nLog10

\n

Low Molecular Weight\nDecadic logarithm (common logarithm)

\n

M

\n

Meter

\n

mg\nMg

\n

Milligram\nMagnesium

\n

min

\n

minute

\n

mL

\n

Milliliter

\n

mRCC

\n

Metastatic Renal Cell Carcinoma

\n

MRI

\n

Magnetic Resonance Imaging

\n

mTOR

\n

mammalian Target of Rapamycin

\n

N\nNa

\n

Number of patients or observations\nSodium

\n

N/A

\n

Not Applicable

\n

NCI

\n

National Cancer Institute

\n

NSCLC

\n

Non-Small Cell Lung Cancer

\n

Ng

\n

Nanogram

\n

\u00b5M\nNm

\n

Nanometer

\n

nM

\n

Nanomolar

\n

OS

\n

Overall Survival

\n

PD

\n

Progressive Disease\nPhosphoinositide 3-kinase

\n

P13K

\n

Micromolar

\n

Term

\n

Definition

\n

PI

\n

Package Insert

\n

PBMC

\n

Peripheral Blood Mononuclear Cells

\n

PCR\nPET

\n

Polymerase Chain Reaction\nProton Emission Tomography

\n

PFS\nPgP

\n

Progression Free Survival\nP-glycoprotein

\n

PK

\n

Pharmacokinetic

\n

Plt

\n

Platelet

\n

PNET

\n

Pancreatic Neuroendocrine Tumor

\n

PO\nPR

\n

Per Oral (by mouth route of administration)\nPartial Response

\n

PR-positive

\n

Progesterone Receptor

\n

PSA

\n

Prostate-Specific Antigen

\n

PTEN

\n

Phosphatase and Tensin Homolog Deleted on Chromosome 10

\n

PT/PTT

\n

Prothrombin Time/Partial Thromboplastin Time

\n

QC\nQD

\n

Quality Control\nOnce Daily\nthe interval between the beginning of the Q-wave and the end of the T-wave on\nan electrocardiogram

\n

QT\nQTc

\n

corrected Q to T wave interval on electrocardiogram

\n

RCC\nRECIST\nRNA

\n

Renal Cell Carcinoma\nResponse Evaluation Criterion Solid Tumors\nRibonucleic Acid\nResponse Rate

\n

RR\nRTK\nS6K1\nSAE\nSC\nSCLC\nSD\nSEGA\nSERD

\n

Receptor Tyrosine Kinase\nS6 Kinase 1\nSerious Adverse Event\nSubcutaneous\nSmall Cell Lung Cancer\nStable Disease\nSubependymal Giant Cell Astrocytoma\nSelective Estrogen Receptor Down-Regulators

\n

SERM

\n

Selective Estrogen Receptor Modulator

\n

T Bili\nTKI

\n

Total Bilirubin\nTyrosine Kinase Inhibitor

\n

TS

\n

Tuberous Sclerosis

\n

TSC

\n

Tuberous Sclerosis Complex

\n

TTP

\n

Time to Progression

\n

Term

\n

Definition

\n

TUNNEL

\n

Terminal Deoxynucleotidyl Transferase (TdT)-Mediated dUTP-Biotin Nick End\nLabeling

\n

\u00b5g

\n

microgram

\n

ULN

\n

Upper Limit Normal

\n

US

\n

United States

\n

USP\nVEGF

\n

United States Pharmacopeia\nVascular Endothelial Growth Factor

\n

WBC

\n

White Blood Cell Count

\n

WHO

\n

World Health Organization

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_80", - "extensionAttributes": [], - "name": "NCI_13", - "text": "
\n

13 Appendix A: Eligibility Checklist\n\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

INCLUSION CRITERIA\nMust be willing to sign a protocol-specific informed consent.\nConsent Date: _____/_____/_____

\n

Consent in patient record

\n

Age > 18 and female.\nBirth Date: _____/_____/_____

\n

Documentation in patient record

\n

ECOG Performance Status 0 or 1.\nPS

\n

(must document in patient record)

\n

Patient must have histologically or cytologically confirmed adenocarcinoma of the breast.\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Must have stage IV disease or inoperable locally advanced disease.\nDocumentation in patient record (via imaging scans as per RECIST Section 6.0)\nPatients must have ER and/or PR-positive disease as determined by their local pathology or

\n

reference laboratory by ASCO-CAP criteria. Tumors must be HER-2/neu negative or equivocal

\n

by standard ICH/FISH or ICH/CISH methodologies by ASCO-CAP criteria.\nER+

\n

PR+

\n

ER+ and PR+

\n

Tumor is HER-2/neu negative by standard ICH/FISH or ICH/CISH methodologies\nPathology Date: _____/_____/______

\n

Pathology must be in patient record

\n

Patients must have had relapse while receiving adjuvant therapy with an aromatase inhibitor\n(anastrozole, letrozole, or exemestane), OR progressive disease while receiving an aromatase\ninhibitor for metastatic disease. Note: Patients may have received an endocrine agent (e.g.,\nTamoxifen) between the time of progression on an AI and registration.\nDocumentation in patient record\nPatients previously treated with two or more prior cycles of fulvestrant are not eligible. Patients\nwho have received one prior cycle (dose on day 1 and day 15) of fulvestrant within 28 days of\nrandomization are eligible as long as they meet other eligibility criteria.\nDocumentation in patient record\nPatients must be post menopausal. (see Section 3.1)\nDocumentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patient may have received up to one prior systemic chemotherapy regimen for metastatic\ndisease.\nno prior systemic chemotherapy\none prior systemic chemotherapy regimen\ndocumentation in patient record\nAdequate end organ function, as evidenced by the following obtained within 4 weeks of\nrandomization: all must be present (see Section 7.0 for labs that may need to be repeated within\n\u2264 7 days of Cycle 1, Day 1)

\n

Total White Blood Cell Count (leucocytes, WBC) \u2265 3.0 x 10 /L, absolute neutrophil count

\n

(ANC) \u2265 1.5 x 10 /L and platelet count \u2265 100 x 10 /L\n(Total WBC value:_________unit__________)\n(ANC value:_________unit__________)\n(Platelet Count value:_________unit__________)\nHemoglobin \u2265 9 g/dL\n(value:_________unit___________)\nSerum Bilirubin \u2264 1.5 x ULN\n(value:_________unit___________ULN_______)\nAST or ALT \u2264 2.5 x ULN (\u2264 5 x ULN in patients with liver metastases)\n(AST value:_________unit___________ULN_______)\n(ALT value:_________unit___________ULN_______)\nSerum Creatinine \u2264 1.5 x ULN (value:_________unit___________ULN_______)\nSerum Albumin \u2265 3 g/dL\n(value:_________unit__________)\nFasting Serum Cholesterol \u2264 300 mg/dL OR \u2264 7.75 mmol/L AND Fasting Triglycerides \u2264 2.5 x\nULN Note: In case one or both of these thresholds are exceeded, the patient can only be\nincluded after initiation of appropriate lipid lowering medication.\n(Fasting Serum Cholesterol value:_________unit__________)\n(Fasting Triglycerides value:_________unit___________ULN_______)\nPT with INR \u2264 1.5. (Anticoagulation is allowed if target INR \u2264 1.5 on a stable dose of warfarin\nor on a stable dose of low molecular weight heparin for >2 weeks at time of randomization.\n(INR value:_________unit___________)\n(PT value:_________unit___________)\nDocumentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients may have measurable disease, non-measurable disease (e.g., bone only metastases),\nor both. Response and progression will be evaluated in this study using the new international\ncriteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST)\nguideline (Version 1.1) [Eur J Ca 45:228-247, 2009]. Measurable lesions are defined as those\nthat can be accurately measured in at least one dimension (longest diameter to be recorded) as\n\u2265 20 mm by chest x-ray, as \u2265 10 mm with CT scan, or \u2265 10 mm with calipers by clinical exam. All\ntumor measurements must be recorded in millimeters (or decimal fractions of centimeters).\nMeasurable disease only\nNon-measurable disease only\nBoth measurable and non-measurable disease\nDocumentation in patient record\nNote: Tumor lesions in a previously irradiated field are not considered measurable.\nPatients with basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\nwithin the past five years must have been treated with curative intent. Patients with a history of\nprior malignancy are eligible provided they were treated with curative intent and have been free\nof disease for >3 years.\nN/A

\n

Date of treatment: _____/_____/_____

\n

Documentation in patient record

\n

EXCLUSION CRITERIA\nPatients who have had any major surgery or significant traumatic injury within 4 weeks of\nrandomization, or have not recovered from the side effects of any major surgery (defined as\nrequiring general anesthesia) or patients that may require major surgery during the course of the\nstudy are not eligible. (Placement of vascular access device will not be considered major\nsurgery.)\nDate of surgery: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients may not be receiving any other investigational agents or have received any\ninvestigational agent within 4 weeks of randomization.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

Patients must not be receiving any concomitant anticancer treatment or have received anticancer\ntreatment within 4 weeks of randomization (including chemotherapy, radiation therapy, antibody\nbased therapy, e.g.), with the following exceptions:\n\u2022 Bisphosphonates, Zometa or Xgeva for bone metastases\n\u2022 Hormonal therapy (e.g., AI, Tamoxifen)\n\u2022 a GnRH analog is permitted if the patient had progressive disease on a GnRH analog\nplus a SERM or an AI; the GnRH analog may continue but the SERM or AI must be\ndiscontinued.\nDate of last treatment: _____/_____/_____

\n

N/A

\n

Documentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus,\neverolimus).\nN/A

\n

Documentation in patient record

\n

Patients must not be receiving chronic, systemic treatment with corticosteroids or another\nimmunosuppressive agent greater than or equal to 5 mg prednisone or its equivalent daily.\nTopical or inhaled corticosteroids are allowed.\nN/A

\n

Documentation in patient record

\n

Patients must not receive immunization with attenuated live vaccines within one week of\nrandomization or during the study period. Close contact with those who have received attenuated\nlive vaccines should be avoided during treatment with everolimus. Examples of live vaccines\ninclude intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella\nand TY21a typhoid vaccines.\nN/A

\n

Documentation in patient record

\n

Patients must not have current or a prior history of brain metastases or leptomeningeal disease.\nPatients must not have rapidly progressive, life-threatening metastases. This includes patients\nwith extensive hepatic involvement (>50% of the liver involved) and symptomatic lymphangitic\nmetastases.\nN/A

\n

Documentation in patient record

\n

Patients must not have a known hypersensitivity/history of allergic reactions attributed to\ncompounds of similar chemical or biologic composition to everolimus (or other rapamycins such\nas sirolimus, temsirolimus) or fulvestrant.\nN/A

\n

Documentation in patient record

\n

Since everolimus may cause bone marrow suppression, patients with congenital or acquired\nimmune deficiency at increased risk of infection are not eligible. This includes patients being\ntreated with chronic immunosuppressive agents (including greater than or equal to 5 mg\nprednisone or its equivalent daily), and patients with known HIV seropositivity.\nN/A

\n

Documentation in patient record

\n

Patients must not have any impairment of gastrointestinal function or gastrointestinal disease\nthat may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled\nnausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).\nN/A

\n

Documentation in patient record

\n

Patients must not have an active, bleeding diathesis.\nN/A

\n

Documentation in patient record

\n

\uf0fc

\n

Pt Initials: ___ ___ ___\nF

\n

M

\n

L

\n

Study Personnel: ____________________________\nDate of Evaluation: ___/___/____

\n

Patients must not have a history of any condition or uncontrolled intercurrent illness including,\nbut not limited to, ongoing or active infection or psychiatric illness/social situations that in the\nopinion of the investigator might intefere with or limit the patient\u2019s ability to comply with the\nprotocol or pose additional or unacceptable risk to the patient.\nN/A

\n

Documentation in patient record

\n

Patients must not have any severe and/or uncontrolled medical conditions or other conditions\nthat could affect their participation in the study such as:\n\u2022

\n

Symptomatic congestive heart failure of New York Heart Association Class III or IV (see\nAppendix D)

\n

\u2022

\n

Unstable angina pectoris, myocardial infarction within 6 months of randomization, serious\nuncontrolled cardiac arrhythmia or any other clinically significant cardiac disease

\n

\u2022

\n

History of symptomatic pulmonary disease or non-malignant pulmonary disease (e.g.\nCOPD) requiring treatment. Such patients would be eligible if PFTs performed within 8\nweeks of treatment noted a DLCO greater than 50%.

\n

\u2022

\n

Uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN (Note: Optimal\nglycemic control should be achieved before starting trial therapy.)

\n

\u2022

\n

Active (acute or chronic) or uncontrolled severe infections

\n

\u2022

\n

Liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C).

\n

Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at\nscreening for all patients. HBV DNA and HCV RNA PCR testing are required at screening for all\npatients with a positive medical history based on risk factors and/or confirmation of prior\nHBV/HCV infection.\nN/A

\n

Documentation in patient record

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_81", - "extensionAttributes": [], - "name": "NCI_14", - "text": "
\n

14 Appendix B: ECOG Performance Status Scale\nGrade ECOG

\n

Fully active, able to carry on all pre-disease performance without restriction

\n

Restricted in physically strenuous activity but ambulatory and able to carry out\nwork of a light or sedentary nature, e.g., light house work, office work

\n

Ambulatory and capable of all self-care but unable to carry out any work\nactivities. Up and about more than 50% of waking hours

\n

Capable of only limited self-care, confined to bed or chair more than 50% of\nwaking hours

\n

Completely disabled. Cannot carry on any self-care. Totally confined to bed or\nchair

\n

Dead

\n

Source: Eastern Cooperative Oncology Group, Robert Comis M.D., Group Chair

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_82", - "extensionAttributes": [], - "name": "NCI_15", - "text": "
\n

15 Appendix C: Medications that can Inhibit/Induce CYP3A4\nand PgP\nSee Section 5.3.5.1 for guidelines on use of inhibitors and Section 5.3.5.2 for guidelines\non use of inducers. Table 15-0 shows clinically relevant drug interactions for inhibitors\nand inducers of isoenzyme CYP3A. Table 15-1 shows clinically relevant drug\ninteractions for substrates, inducers, and inhibitors of PgP and PgP/CYP3A.\nTable 15-0\nClinically Relevant Drug Interactions: Inhibitors and Inducers of Isoenzyme\nCYP3A\nINHIBITORS\nStrong Inhibitors:\nclarithromycin, conivaptan, elvitegravir, indinavir, itraconazole, ketoconazole, lopinavir,\nmibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin,\ntipranavir, troleandamycin, voriconazole\n(Krishna et al, 2009)\nModerate Inhibitors:\naprepitant, amprenavir, atazanavir, casopitant, cimetidine, ciprofloxacin, darunavir, diltiazem,\ndronedarone, erythromycin, fluconazole, fosamprenavir, grapefruit juice (citrus parasidi fruit\njuice), imatinib, tofisopam, verapamil\nINDUCERS\namprenavir, aprepitant, armodafinil (R-modafinil), avasimibe, bosentan, carbamazepine,\ndexamethasone, efavirenz, etravirine, glucocorticoids, modafinil, nafcillin, nevirapine,\noxcarbazepine, phenobarbital, phenytoin, pioglitazone, prednisone, rifabutin, rifampin,\nritonavir, rufinamide, St. John\u2019s wort, talviraline, tipranavir, topiramate, troglitazone

\n

Table 15-1\nClinically Relevant Drug Interactions: Substrates, Inducers, and Inhibitors of PgP\nand PgP/CYP3A\nSUBSTRATES\nColchicines, digoxin, fexofenadine, indinavir, paclitaxel, topotecan, vincristine\nINDUCERS\nRifampin, St. John\u2019s wort\nPgP INHIBITORS and PgP/CYP3A DUAL INHIBITORS\nAmiodarone, captopril, carvedilol, clarithromycin, conivaptan, diltiazem, dronedarone,\nelacridar, erythromycin, felodipine, fexofenadine, ginkgo (ginkgo biloba), indinavir,\nitraconazole, lopinavir, mibefradil, milk thistle (silybum marianum), nifedipine, nitrendipine,\nquercetin, quinidine, ranolazine, ritonavir, saquinavir, Schisandra chinensis, St John\u2019s wort\n(hypericum perforatum), talinolol, telmisartan, tipranavir, valspodar, verapamil\nReference: Internal Clinical Pharmacology Drug-drug interaction (DDI) memo, updated\nOct. 2, 2011, which summarizes DDI data from three sources including the FDA\u2019s\n\u201cGuidance for Industry, Drug Interaction Studies\u201d, the University of Washington\u2019s Drug\nInteraction Database, and Indiana University School of Medicine's Drug Interaction\nTable.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_83", - "extensionAttributes": [], - "name": "NCI_16", - "text": "
\n

16 Appendix D: New York Heart Association (NYHA) Cardiac\nClassification of Functional Capacity and Objective\nAssessment\nIn 1928 the New York Heart Association published a classification of patients with cardiac\ndisease based on clinical severity and prognosis. This classification has been updated in seven\nsubsequent editions of Nomenclature and Criteria for Diagnosis of Diseases of the Heart and\nGreat Vessels (Little, Brown & Co.). The ninth edition, revised by the Criteria Committee of the\nAmerican Heart Association, New York City Affiliate, was released March 4, 1994*. The new\nclassifications are summarized below.\nThe NYHA classification system relates symptoms to everyday activities and the patient\u2019s quality\nof life.

\n

Class

\n

Symptoms

\n

Class I

\n

Patients with cardiac disease but without resulting limitation of physical\nactivity. Ordinary physical activity does not cause undue fatigue,\npalpitation, dyspnea (shortness of breath), or anginal pain.

\n

Class II

\n

Patients with cardiac disease resulting in slight limitation of physical\nactivity. Comfortable at rest, but ordinary physical activity results in\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class III

\n

Patients with cardiac disease resulting in marked limitation of physical\nactivity. Comfortable at rest, but less than ordinary activity causes\nfatigue, palpitation, dyspnea or anginal pain.

\n

Class IV

\n

Patients with cardiac disease resulting in inability to carry out any\nphysical activity without discomfort. Symptoms of heart failure or anginal\nsyndrome may be present even at rest. If any physical activity is\nundertaken, discomfort increases.

\n

Objective Assessment\nI:

\n

No objective evidence of cardiovascular disease

\n

II:

\n

Objective evidence of minimal cardiovascular disease

\n

III:

\n

Objective evidence of moderately severe cardiovascular disease

\n

IV:

\n

Objective evidence of severe cardiovascular disease

\n

Accessed October 2009* http://www.americanheart.org/presenter.jhtml?identifier=1712\nThe Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of\nDiseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_84", - "extensionAttributes": [], - "name": "NCI_17", - "text": "
\n

17 Appendix E: CTEP Common Terminology Criteria for\nAdverse Events (CTCAE) Version 4.0\nCommon Terminology Criteria for Adverse Events (CTCAE)\nCTCAE term (AE description) and grade: The descriptions and grading scales found\nin the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) Version\n4.0 will be utilized for AE reporting. All appropriate treatment areas should have access\nto a copy of the CTCAE Version 4.0. A copy of the CTCAE Version 4.0 can be\ndownloaded from the CTEP web site (http://ctep.cancer.gov).\nAll appropriate treatment areas should have access to a copy of the CTEP CTCAE\nVersion 4.0.

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_85", - "extensionAttributes": [], - "name": "NCI_18", - "text": "
\n

18 Appendix F: Patient Pill Diary\nCopies of this form will be made available to study staff in study materials. This form is\nappended as an example only, and may be modified during the study.

\n

Site Instructions:\n1. If this or a similar diary is used this may be considered source documentation, if the\ndiary has been reviewed and signed by a member of the study staff. Patient\ncompliance with protocol therapy can be assessed using a pill record or by other\ndocumentation in the patient record.\n2. Patients should be instructed to begin Day 1 with the beginning of each cycle, with\neach cycle being 28 days.\n3. If a dose modification occurs, patients should be given instructions for dosing, and\nthe form can be modified as appropriate. Any dose changes should be recorded in\nthe patient chart with appropriate rationale as per protocol.\n4. A new form can be used at any time during a cycle; as long as the patient is made\naware of changes (e.g. study staff fills in dates and mark lines/dates not to be used).\n5. It is the responsibility of the investigator to appropriately dispense and monitor study\nmedications and to comply with the protocol.

\n

Patient Name: _____________________________

\n

Patient Study ID (filled in by Site Staff):\n______________________

\n

Patient Instructions:\n1. Complete each form as instructed by your physician or study nurse.\n2. You will take 2 pill(s) each day. You should take the pill(s) the same time each day, and in the\nmorning, if possible. If you forget to take a pill and remember by 10 PM, you may take the dose.\nOtherwise just skip that dose and begin as usual the next day. Please mark dates of any missed\npills on your record.\n3. .Each dose should be swallowed whole with a glass of water and may be taken with or without food.\nThe tablets must not be chewed or crushed. In cases where tablets cannot be swallowed, the tablets\nshould be disintegrated in water just prior to being taken. Approximately 30 mL (2 tablespoons) of\nwater should be put into a glass. The tablets should then be added and the contents stirred gently\n(for a maximum of 7 minutes) until the tablets are disintegrated. The contents should then be drunk.\nIf you vomit after taking the study drug, you should NOT take another tablet that day. If you forget to\ntake the medication and remembers by 10 PM, you may take the dose. Otherwise, skip that dose\nand begin as usual the next day.\n4. If you have any side effects or comments, please note in the comment section or on the back of the\npage. For questions or if you have any side effects that should be immediately reported to your\nstudy doctor, please call _______________________________at: (_____) _____ - _________.\n5. Please bring your pill(s) and this form to your study doctor when you go for each appointment. If\nyour dose changes, the study nurse or doctor will let you know. You should note this on the form.\nDate

\n

Day

\n

# Pills

\n

Comments

\n

Date

\n

Day

\n

Patient Signature: _________________________________

\n

# Pills

\n

Comments

\n

Date: ___________________

\n

Physician Office to complete this section:\nStudy Personnel Signature: __________________________

\n

Date: ____________________

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_86", - "extensionAttributes": [], - "name": "NCI_19", - "text": "
\n

19 References\n1.\nMoy B, Goss PE. Estrogen receptor pathway: resistance to endocrine therapy\nand new therapeutic approaches. Clin Cancer Res 2006;12:4790-3.\n2.\nNicholson KM, Anderson NG. The protein kinase B/Akt signalling pathway in\nhuman malignancy. Cell Signal 2002;14:381-95.\n3.\nDeGraffenried LA, Friedrichs WE, Fulcher L, et al. Eicosapentaenoic acid\nrestores tamoxifen sensitivity in breast cancer cells with high Akt activity. Ann Oncol\n2003;14:1051-6.\n4.\nTokunaga E, Kataoka A, Kimura Y, et al. The association between Akt\nactivation and resistance to hormone therapy in metastatic breast cancer. Eur J Cancer\n2006;42:629-35.\n5.\nBeeram M, Tan QT, Tekmal RR, Russell D, Middleton A, DeGraffenried LA.\nAkt-induced endocrine therapy resistance is reversed by inhibition of mTOR signaling.\nAnn Oncol 2007;18:1323-8.\n6.\nPerez-Tenorio G, Stal O. Activation of AKT/PKB in breast cancer predicts a\nworse outcome among endocrine treated patients. Br J Cancer 2002;86:540-5.\n7.\nBjornsti MA, Houghton PJ. The TOR pathway: A target for cancer therapy. Nat\nRev Cancer 2004;4:335-38.\n8.\nShaw RJ, Cantley LC. Ras, PI(3)K and mTOR signalling controls tumour cell\ngrowth. Nature 2006;441:424-30.\n9.\ndeGraffenried LA, Friedrichs WE, Russell DH, et al. Inhibition of mTOR activity\nrestores tamoxifen response in breast cancer cells with aberrant Akt Activity. Clin\nCancer Res 2004;10:8059-67.\n10.\nAwada A, Cardoso F, Fontaine C, et al. The oral mTOR inhibitor RAD001\n(everolimus) in combination with letrozole in patients with advanced breast cancer:\nresults of a phase I study with pharmacokinetics. Eur J Cancer 2008;44:84-91.\n11.\nAmerican Cancer Society. Breast Cancer Facts & Figures 2011-2012. Atlanta:\nAmerican\nCancer\nSociety\nInc.;\nhttp://www.cancer.org/acs/groups/content/@\nepidemiologysurveilance/documents/document/acspc-030975.pdf\n(accessed 7/11/2012)\n12.\nBuzdar AU. Endocrine therapy in the treatment of metastatic breast cancer.\nSemin Oncol 2001;28:291-304.\n13.\nCampos SM, Winer EP. Hormonal therapy in postmenopausal women with\nbreast cancer. Oncology 2003;64:289-99.\n14.\nSparano J, Pasqualini JR, eds. Breast cancer : prognosis, treatment, and\nprevention. New York: Marcel Dekker; 2002.\n15.\nWiner EP, Hudis C, Burstein HJ, et al. American Society of Clinical Oncology\ntechnology assessment on the use of aromatase inhibitors as adjuvant therapy for\npostmenopausal women with hormone receptor-positive breast cancer: status report\n2004. J Clin Oncol 2005;23:619-29.\n16.\nBerry J. Are all aromatase inhibitors the same? A review of controlled clinical\ntrials in breast cancer. Clin Ther 2005;27:1671-84.

\n

17.\nHowell A, Robertson JF, Quaresma Albano J, et al. Fulvestrant, formerly ICI\n182,780, is as effective as anastrozole in postmenopausal women with advanced\nbreast cancer progressing after prior endocrine treatment. J Clin Oncol 2002;20:3396403.\n18.\nOsborne CK, Pippen J, Jones SE, et al. Double-blind, randomized trial\ncomparing the efficacy and tolerability of fulvestrant versus anastrozole in\npostmenopausal women with advanced breast cancer progressing on prior endocrine\ntherapy: results of a North American trial. J Clin Oncol 2002;20:3386-95.\n19.\nMauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK.\nFulvestrant (Faslodex\u00ae) versus anastrozole for the second-line treatment of advanced\nbreast cancer in subgroups of postmenopausal women with visceral and non-visceral\nmetastases: combined results from two multicentre trials. Eur J Cancer 2003;39:122833.\n20.\nHowell A, Robertson JF, Abram P, et al. Comparison of fulvestrant versus\ntamoxifen for the treatment of advanced breast cancer in postmenopausal women\npreviously untreated with endocrine therapy: a multinational, double-blind, randomized\ntrial. J Clin Oncol 2004;22:1605-13.\n21.\nIngle JN, Suman VJ, Rowland KM, et al. Fulvestrant in women with advanced\nbreast cancer after progression on prior aromatase inhibitor therapy: North Central\nCancer Treatment Group Trial N0032. J Clin Oncol 2006;24:1052-6.\n22.\nPerey L, Paridaens R, Hawle H, et al. Clinical benefit of fulvestrant in\npostmenopausal women with advanced breast cancer and primary or acquired\nresistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical\nCancer Research Trial (SAKK 21/00). Ann Oncol 2007;18:64-9.\n23.\nChia S, Gradishar W, Mauriac L, et al. Double-blind, randomized placebo\ncontrolled trial of fulvestrant compared with exemestane after prior nonsteroidal\naromatase inhibitor therapy in postmenopausal women with hormone receptor-positive,\nadvanced breast cancer: results from EFECT. J Clin Oncol 2008;26:1664-70.\n24.\nDi Leo A, Jerusalem G, Petruzelka L, et al. CONFIRM: A Phase III,\nRandomized, Parallel-Group Trial Comparing Fulvestrant 250 mg vs Fulvestrant 500\nmg in Postmenopausal Women with Estrogen Receptor-Positive Advanced Breast\nCancer. J Clin Oncol. 2010 Oct 20; 28(30):4594-600.\n25.\nBoulay A, Lane HA. The mammalian target of rapamycin kinase and tumor\ngrowth inhibition. Recent Results Cancer Res 2007;172:99-124.\n26.\nWullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism.\nCell 2006;124(3):471-84.\n27.\nManning BD, Cantley LC. AKT/PKB signaling: navigating downstream. Cell\n2007;129(7):1261-74.\n28.\nWang L, Harris TE, Roth RA, Lawrence JC, Jr. PRAS40 regulates mTORC1\nkinase activity by functioning as a direct inhibitor of substrate binding. J Biol Chem\n2007;282(27):20036-44.\n29.\nWitzig TE, Geyer SM, Ghobrial I, et al. Phase II trial of single-agent\ntemsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol 2005;\n23(23):5347-56.

\n

30.\nLane HA, Wood JM, McSheehy PM, et al. mTOR inhibitor RAD001 (everolimus)\nhas antiangiogenic/vascular properties distinct from a VEGFR tyrosine kinase inhibitor.\nClin Cancer Res 2009;15(5):1612-22.\n31.\nMabuchi S, Altomare DA, Cheung M, et al. RAD001 inhibits human ovarian\ncancer cell proliferation, enhances cisplatin-induced apoptosis, and prolongs survival in\nan ovarian cancer model. Clin Cancer Res 2007;13(14):4261-70.\n32.\nGalanis E, Buckner JC, Maurer MJ, et al. Phase II trial of temsirolimus (CCI779) in recurrent glioblastoma multiforme: a North Central Cancer Treatment Group\nStudy. J Clin Oncol 2005;23:5294-304.\n33.\nO\u2019Reilly T, McSheehy PM. Biomarker Development for the Clinical Activity of\nthe mTOR Inhibitor everolimus (RAD001): Processes, Limitations, and Further\nProposals. Tran Oncol; 2010 Apr; 3(2):65-79.\n34.\nHuang S, Houghton PJ. Inhibitors of mammalian target of rapamycin as novel\nantitumor agents: from bench to clinic. Curr Opin Investig Drugs. 2002 Feb; 3(2):295304.\n35.\nZitzmann K, De Toni EN, Brand S, et al. The novel mTOR inhibitor RAD001\n(everolimus) induces antiproliferative effects in human pancreatic neuroendocrine\ntumor cells. Neuroendocrinology 2007;85(1):54-60.\n36.\nZeng Z, Sarbassov dos D, Samudio IJ, et al. Rapamycin derivatives reduce\nmTORC2 signaling and inhibit AKT activation in AML. Blood 2007;109(8):3509-12.\n37.\nHaritunians T, Mori A, O'Kelly J, Luong QT, Giles FJ, Koeffler HP.\nAntiproliferative activity of RAD001 (everolimus) as a single agent and combined with\nother agents in mantle cell lymphoma. Leukemia 2007;21(2):333-9.\n38.\nIkezoe T, Nishioka C, Bandobashi K, et al. Longitudinal inhibition of\nPI3K/Akt/mTOR signaling by LY294002 and rapamycin induces growth arrest of adult\nT-cell leukemia cells. Leuk Res 2007;31(5):673-82.\n39.\nWanner K, Hipp S, Oelsner M, et al. Mammalian target of rapamycin inhibition\ninduces cell cycle arrest in diffuse large B cell lymphoma (DLBCL) cells and sensitises\nDLBCL cells to rituximab. Br J Haematol 2006;134(5):475-84.\n40.\nTuncyurek P, Mayer JM, Klug F, et al. Everolimus and mycophenolate mofetil\nsensitize human pancreatic cancer cells to gemcitabine in vitro: a novel adjunct to\nstandard chemotherapy? Eur Surg Res 2007;39(6):380-7.\n41.\nTreeck O, Wackwitz B, Haus U, Ortmann O. Effects of a combined treatment\nwith mTOR inhibitor RAD001 and tamoxifen in vitro on growth and apoptosis of human\ncancer cells. Gynecol Oncol 2006;102(2):292-9.\n42.\nSieghart W, Fuereder T, Schmid K, et al. Mammalian target of rapamycin\npathway activity in hepatocellular carcinomas of patients undergoing liver\ntransplantation. Transplantation 2007;83(4):425-32.\n43.\nLu CH, Wyszomierski SL, Tseng LM, et al. Preclinical testing of clinically\napplicable strategies for overcoming trastuzumab resistance caused by PTEN\ndeficiency. Clin Cancer Res 2007;13(9):5883-8.\n44.\nTorres-Arzayus MI, Yuan J, DellaGatta JL, Lane H, Kung AL, Brown M.\nTargeting the AIB1 oncogene through mammalian target of rapamycin inhibition in the\nmammary gland. Cancer Res 2006;66(23):11381-8.

\n

45.\nRossi F, Ehlers I, Agosti V, et al. Oncogenic Kit signaling and therapeutic\nintervention in a mouse model of gastrointestinal stromal tumor. Proc Natl Acad Sci U\nS A 2006;103(34):12843-8.\n46.\nLane H, Tanaka C, Kovarik J, et al. Preclinical and clinical pharmacokinetic /\npharmacodynamic (PK/PD) modeling to help define an optimal biological dose for the\noral mTOR inhibitor, RAD001, in oncology [abstract]. J Clin Oncol; 2003; 22:237A.\n47.\nTabernero J, Rojo F, Calvo E, et al. Dose- and schedule-dependent inhibition of\nthe mammalian target of rapamycin pathway with everolimus: A phase I tumor\npharmacodynamic study in patients with advanced solid tumors. J Clin Oncol\n2008;28:10.\n48.\nhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312965\n.htm (accessed 8/1/2012)\n49.\nBaselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal\nhormone-receptor-positive advanced breast cancer. N Engl J Med 2012 Feb\n9;366(6):520-9. Epub 2011 Dec 7. PubMed PMID: 22149876\n50.\nSanchez CG, Ma CX, Crowder RJ, et al. Preclinical modeling of combined\nphosphatidylinositol-3-kinase inhibition with endocrine therapy for estrogen receptorpositive breast cancer. Breast Cancer Res 2011 Mar 1;13(2):R21.\n51.\nHammond ME, Hayes DF, Wolff AC, et al. American society of clinical\noncology/college of American pathologists guideline recommendations for\nimmunohistochemical testing of estrogen and progesterone receptors in breast cancer.\nOncol Pract. 2010 Jul;6(4):195-7. Epub 2010 Jun 23 PMCID: PMC2900870 PMID:\n21037871.\n52.\nWolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical\nOncology/College of American Pathologists guideline recommendations for human\nepidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan\n1;25(1):118-45. Epub 2006 Dec 11. American Society of Clinical Oncology; College of\nAmerican Pathologists. American Society of Clinical Oncology, Alexandria, VA, USA.)\nPMID: 17159189.\n53.\nYeo W, Lam KC, Zee B, et al. Hepatitis B reactivation in patients with\nhepatocellular carcinoma undergoing systemic chemotherapy. Ann Oncol\n2004;15:1661-6.\n54.\nLoomba R, Rowley A, Wesley R, et al. Systematic review: the effect of\npreventive lamivudine on hepatitis B reactivation during chemotherapy. Ann Intern Med\n2008;148(7):519-28.\n55.\nDivers J, RN BSN, Texas Oncology. Management of Stomatitis Associated with\nmTOR Inhibitors in Hormone Receptor-Positive HER2-Negative Advanced Breast\nCancer: Clinical Experiences from a Single Center. Presented at the 38th Annual\nOncology Nurses\u2019 Society Congress, April 25-28, 2013. Novartis Internal\nCommunication.\n56.\nEisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria\nin solid tumours: revised RECIST guideline (Version 1.1). Eur J Cancer 2009;45:22847.\n57.\nBubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for\nphase II clinical trials in androgen-independent prostate cancer: recommendations from\nthe Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461-7.

\n

58.\nScher HI, Halabi S, Tannock I, et al. Design and end points of clinical trials for\npatients with progressive prostate cancer and castrate levels of testosterone:\nrecommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol\n2008;26:1148-59.\n59.\nRustin GJ, Quinn M, Thigpen T, et al. Re: New guidelines to evaluate the\nresponse to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst\n2004;96:487-8.\n60.\nVergote I, Rustin GJ, Eisenhauer EA, et al. Re: new guidelines to evaluate the\nresponse to treatment in solid tumors [ovarian cancer]. Gynecologic Cancer Intergroup.\nJ Natl Cancer Inst 2000;92:1534-5.\n61.\nOken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the\nEastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55.

\n

20 Investigator\u2019s Statement\n1.

\n

I have carefully read this protocol entitled \u201cRandomized, Double-Blind,\nPlacebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus\nEverolimus in Post Menopausal Patients with Hormone-Receptor\nPositive Metastatic Breast Center Resistant to Aromatase Inhibitor\nTherapy, Version 2.0 dated 1/22/2014\u201d (Protocol number PrE0102)\nand agree that it contains all the necessary information required to\nconduct the study. I agree to conduct the study as outlined in the protocol.

\n

2.

\n

I agree to conduct this study according to the moral, ethical and scientific\nprinciples governing clinical research as set out in the Declaration of\nHelsinki, the principles of GCP as described in 21 CFR and any applicable\nlocal requirements.

\n

3.

\n

I understand that this trial and any subsequent changes to this trial will not\nbe initiated without approval of the appropriate Institutional Review Board,\nand that all administrative requirements of the governing body of the\ninstitution will be complied with fully.

\n

4.

\n

Informed written consent will be obtained from all participating patients in\naccordance with institutional and FDA requirements as specified in Title\n21, Code of Federal Regulations, Part 50.

\n

5.

\n

I understand that my signature on the Case Report Form indicates that I\nhave carefully reviewed each page and accept full responsibility for the\ncontents thereof.

\n

6.

\n

I understand that the information presented in this study protocol is\nconfidential, and I hereby assure that no information based on the conduct\nof the study will be released without prior consent from PrECOG, LLC\nunless this requirement is superseded by the Food and Drug\nAdministration.

\n

Principal Investigator:\nPI Name:\nSite Name:\nSignature of PI:\nDate of Signature:

\n

\\\nMMM

\n

\\\nDD

\n

YYYY

\n
", - "instanceType": "NarrativeContentItem" - }, - { - "id": "NarrativeContentItem_87", - "extensionAttributes": [], - "name": "NCI_20", - "text": "

See section 20 Investigator's Statement.

", - "instanceType": "NarrativeContentItem" - } - ], - "abbreviations": [], - "administrableProducts": [], - "medicalDevices": [], - "productOrganizationRoles": [], - "dictionaries": [], - "conditions": [], - "notes": [], - "instanceType": "StudyVersion" - } - ], - "documentedBy": [ - { - "id": "StudyDefinitionDocument_1", - "extensionAttributes": [], - "name": "NCT01797120_PROTOCOL", - "label": "PrE0102: Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant plus Everolimus", - "description": "Version 2.0, January 22 2014 protocol document for PrECOG study PrE0102 (NCT01797120).", - "language": { - "id": "Code_DocLang_1", - "extensionAttributes": [], - "code": "en", - "codeSystem": "ISO", - "codeSystemVersion": "1", - "decode": "English", - "instanceType": "Code" - }, - "type": { - "id": "Code_DocType_1", - "extensionAttributes": [], - "code": "C70817", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Protocol", - "instanceType": "Code" - }, - "templateName": "PrECOG Protocol Template", - "versions": [ - { - "id": "StudyDefinitionDocumentVersion_1", - "extensionAttributes": [], - "version": "2", - "status": { - "id": "Code_DocStatus_1", - "extensionAttributes": [], - "code": "C25508", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Final", - "instanceType": "Code" - }, - "dateValues": [ - { - "id": "GovernanceDate_DocVersion_1", - "extensionAttributes": [], - "name": "PROTOCOL_VERSION_DATE", - "label": "Protocol Version Date", - "description": "Date of the final protocol version", - "type": { - "id": "Code_DocDate_1", - "extensionAttributes": [], - "code": "C215663", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Effective Date", - "instanceType": "Code" - }, - "dateValue": "2014-01-22", - "geographicScopes": [], - "instanceType": "GovernanceDate" - } - ], - "contents": [ - { - "id": "NarrativeContent_1", - "extensionAttributes": [], - "name": "NC_1", - "sectionNumber": "1", - "sectionTitle": "Introduction", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_2", - "NarrativeContent_3", - "NarrativeContent_4", - "NarrativeContent_8", - "NarrativeContent_12" - ], - "previousId": null, - "nextId": "NarrativeContent_13", - "contentItemId": "NarrativeContentItem_1", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_2", - "extensionAttributes": [], - "name": "NC_1_1", - "sectionNumber": "1.1", - "sectionTitle": "Background and Rationale", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_3", - "contentItemId": "NarrativeContentItem_2", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_3", - "extensionAttributes": [], - "name": "NC_1_2", - "sectionNumber": "1.2", - "sectionTitle": "Breast Cancer", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_2", - "nextId": "NarrativeContent_4", - "contentItemId": "NarrativeContentItem_3", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_4", - "extensionAttributes": [], - "name": "NC_1_3", - "sectionNumber": "1.3", - "sectionTitle": "Endocrine Therapy for Breast Cancer", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_5", - "NarrativeContent_6", - "NarrativeContent_7" - ], - "previousId": "NarrativeContent_3", - "nextId": "NarrativeContent_8", - "contentItemId": "NarrativeContentItem_4", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_5", - "extensionAttributes": [], - "name": "NC_1_3_1", - "sectionNumber": "1.3.1", - "sectionTitle": "Fulvestrant for Post Menopausal Women with Breast Cancer", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_6", - "contentItemId": "NarrativeContentItem_5", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_6", - "extensionAttributes": [], - "name": "NC_1_3_2", - "sectionNumber": "1.3.2", - "sectionTitle": "Fulvestrant for Aromatase Inhibitor (AI) Resistant Disease", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_5", - "nextId": "NarrativeContent_7", - "contentItemId": "NarrativeContentItem_6", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_7", - "extensionAttributes": [], - "name": "NC_1_3_3", - "sectionNumber": "1.3.3", - "sectionTitle": "Rationale for Fulvestrant for this Trial", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_6", - "nextId": null, - "contentItemId": "NarrativeContentItem_7", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_8", - "extensionAttributes": [], - "name": "NC_1_4", - "sectionNumber": "1.4", - "sectionTitle": "Everolimus (RAD001)", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_9", - "NarrativeContent_10", - "NarrativeContent_11" - ], - "previousId": "NarrativeContent_4", - "nextId": "NarrativeContent_12", - "contentItemId": "NarrativeContentItem_8", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_9", - "extensionAttributes": [], - "name": "NC_1_4_1", - "sectionNumber": "1.4.1", - "sectionTitle": "mTOR Pathway and Mechanism of Action", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_10", - "contentItemId": "NarrativeContentItem_9", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_10", - "extensionAttributes": [], - "name": "NC_1_4_2", - "sectionNumber": "1.4.2", - "sectionTitle": "Pre-Clinical Safety", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_9", - "nextId": "NarrativeContent_11", - "contentItemId": "NarrativeContentItem_10", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_11", - "extensionAttributes": [], - "name": "NC_1_4_3", - "sectionNumber": "1.4.3", - "sectionTitle": "Clinical Experience", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_10", - "nextId": null, - "contentItemId": "NarrativeContentItem_11", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_12", - "extensionAttributes": [], - "name": "NC_1_5", - "sectionNumber": "1.5", - "sectionTitle": "Rationale and Study Design", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_8", - "nextId": null, - "contentItemId": "NarrativeContentItem_12", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_13", - "extensionAttributes": [], - "name": "NC_2", - "sectionNumber": "2", - "sectionTitle": "Objectives", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_14", - "NarrativeContent_15" - ], - "previousId": "NarrativeContent_1", - "nextId": "NarrativeContent_16", - "contentItemId": "NarrativeContentItem_13", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_14", - "extensionAttributes": [], - "name": "NC_2_1", - "sectionNumber": "2.1", - "sectionTitle": "Primary Objective", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_15", - "contentItemId": "NarrativeContentItem_14", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_15", - "extensionAttributes": [], - "name": "NC_2_2", - "sectionNumber": "2.2", - "sectionTitle": "Secondary Objectives", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_14", - "nextId": null, - "contentItemId": "NarrativeContentItem_15", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_16", - "extensionAttributes": [], - "name": "NC_3", - "sectionNumber": "3", - "sectionTitle": "Selection of Patients", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_17" - ], - "previousId": "NarrativeContent_13", - "nextId": "NarrativeContent_18", - "contentItemId": "NarrativeContentItem_16", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_17", - "extensionAttributes": [], - "name": "NC_3_1", - "sectionNumber": "3.1", - "sectionTitle": "Eligibility Criteria", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": null, - "contentItemId": "NarrativeContentItem_17", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_18", - "extensionAttributes": [], - "name": "NC_4", - "sectionNumber": "4", - "sectionTitle": "Randomization Procedures", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_19", - "NarrativeContent_20", - "NarrativeContent_21" - ], - "previousId": "NarrativeContent_16", - "nextId": "NarrativeContent_22", - "contentItemId": "NarrativeContentItem_18", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_19", - "extensionAttributes": [], - "name": "NC_4_1", - "sectionNumber": "4.1", - "sectionTitle": "Ethics", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_20", - "contentItemId": "NarrativeContentItem_19", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_20", - "extensionAttributes": [], - "name": "NC_4_2", - "sectionNumber": "4.2", - "sectionTitle": "Regulatory Requirements", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_19", - "nextId": "NarrativeContent_21", - "contentItemId": "NarrativeContentItem_20", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_21", - "extensionAttributes": [], - "name": "NC_4_3", - "sectionNumber": "4.3", - "sectionTitle": "Patient Randomization", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_20", - "nextId": null, - "contentItemId": "NarrativeContentItem_21", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_22", - "extensionAttributes": [], - "name": "NC_5", - "sectionNumber": "5", - "sectionTitle": "Treatment Plan", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_23", - "NarrativeContent_24", - "NarrativeContent_27", - "NarrativeContent_33", - "NarrativeContent_34", - "NarrativeContent_35" - ], - "previousId": "NarrativeContent_18", - "nextId": "NarrativeContent_36", - "contentItemId": "NarrativeContentItem_22", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_23", - "extensionAttributes": [], - "name": "NC_5_1", - "sectionNumber": "5.1", - "sectionTitle": "Administration Schedule", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_24", - "contentItemId": "NarrativeContentItem_23", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_24", - "extensionAttributes": [], - "name": "NC_5_2", - "sectionNumber": "5.2", - "sectionTitle": "Dosing and Administration", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_25", - "NarrativeContent_26" - ], - "previousId": "NarrativeContent_23", - "nextId": "NarrativeContent_27", - "contentItemId": "NarrativeContentItem_24", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_25", - "extensionAttributes": [], - "name": "NC_5_2_1", - "sectionNumber": "5.2.1", - "sectionTitle": "Fulvestrant (Arm A and Arm B)", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_26", - "contentItemId": "NarrativeContentItem_25", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_26", - "extensionAttributes": [], - "name": "NC_5_2_2", - "sectionNumber": "5.2.2", - "sectionTitle": "Everolimus or Placebo (Arm A and Arm B)", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_25", - "nextId": null, - "contentItemId": "NarrativeContentItem_26", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_27", - "extensionAttributes": [], - "name": "NC_5_3", - "sectionNumber": "5.3", - "sectionTitle": "Dose Modifications and Toxicity Management", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_28", - "NarrativeContent_29", - "NarrativeContent_30", - "NarrativeContent_31", - "NarrativeContent_32" - ], - "previousId": "NarrativeContent_24", - "nextId": "NarrativeContent_33", - "contentItemId": "NarrativeContentItem_27", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_28", - "extensionAttributes": [], - "name": "NC_5_3_1", - "sectionNumber": "5.3.1", - "sectionTitle": "Dose Modifications General Guidelines for Everolimus/Placebo", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_29", - "contentItemId": "NarrativeContentItem_28", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_29", - "extensionAttributes": [], - "name": "NC_5_3_2", - "sectionNumber": "5.3.2", - "sectionTitle": "Common Adverse Events Associated with Everolimus", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_28", - "nextId": "NarrativeContent_30", - "contentItemId": "NarrativeContentItem_29", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_30", - "extensionAttributes": [], - "name": "NC_5_3_3", - "sectionNumber": "5.3.3", - "sectionTitle": "Concomitant Therapies", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_29", - "nextId": "NarrativeContent_31", - "contentItemId": "NarrativeContentItem_30", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_31", - "extensionAttributes": [], - "name": "NC_5_3_4", - "sectionNumber": "5.3.4", - "sectionTitle": "Prohibited Therapies and Restrictions", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_30", - "nextId": "NarrativeContent_32", - "contentItemId": "NarrativeContentItem_31", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_32", - "extensionAttributes": [], - "name": "NC_5_3_5", - "sectionNumber": "5.3.5", - "sectionTitle": "Administration of Everolimus and CYP3A4 Inhibitors/Inducers", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_31", - "nextId": null, - "contentItemId": "NarrativeContentItem_32", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_33", - "extensionAttributes": [], - "name": "NC_5_4", - "sectionNumber": "5.4", - "sectionTitle": "Supportive Care", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_27", - "nextId": "NarrativeContent_34", - "contentItemId": "NarrativeContentItem_33", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_34", - "extensionAttributes": [], - "name": "NC_5_5", - "sectionNumber": "5.5", - "sectionTitle": "Duration of Therapy", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_33", - "nextId": "NarrativeContent_35", - "contentItemId": "NarrativeContentItem_34", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_35", - "extensionAttributes": [], - "name": "NC_5_6", - "sectionNumber": "5.6", - "sectionTitle": "Withdrawal of Patients from Study", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_34", - "nextId": null, - "contentItemId": "NarrativeContentItem_35", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_36", - "extensionAttributes": [], - "name": "NC_6", - "sectionNumber": "6", - "sectionTitle": "Measurement of Effect", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_37" - ], - "previousId": "NarrativeContent_22", - "nextId": "NarrativeContent_44", - "contentItemId": "NarrativeContentItem_36", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_37", - "extensionAttributes": [], - "name": "NC_6_1", - "sectionNumber": "6.1", - "sectionTitle": "Antitumor Effect - Solid Tumors", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_38", - "NarrativeContent_39", - "NarrativeContent_40", - "NarrativeContent_41", - "NarrativeContent_42", - "NarrativeContent_43" - ], - "previousId": null, - "nextId": null, - "contentItemId": "NarrativeContentItem_37", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_38", - "extensionAttributes": [], - "name": "NC_6_1_1", - "sectionNumber": "6.1.1", - "sectionTitle": "Definitions", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_39", - "contentItemId": "NarrativeContentItem_38", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_39", - "extensionAttributes": [], - "name": "NC_6_1_2", - "sectionNumber": "6.1.2", - "sectionTitle": "Disease Parameters", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_38", - "nextId": "NarrativeContent_40", - "contentItemId": "NarrativeContentItem_39", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_40", - "extensionAttributes": [], - "name": "NC_6_1_3", - "sectionNumber": "6.1.3", - "sectionTitle": "Methods for Evaluation of Measurable Disease", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_39", - "nextId": "NarrativeContent_41", - "contentItemId": "NarrativeContentItem_40", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_41", - "extensionAttributes": [], - "name": "NC_6_1_4", - "sectionNumber": "6.1.4", - "sectionTitle": "Response Criteria", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_40", - "nextId": "NarrativeContent_42", - "contentItemId": "NarrativeContentItem_41", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_42", - "extensionAttributes": [], - "name": "NC_6_1_5", - "sectionNumber": "6.1.5", - "sectionTitle": "Duration of Response", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_41", - "nextId": "NarrativeContent_43", - "contentItemId": "NarrativeContentItem_42", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_43", - "extensionAttributes": [], - "name": "NC_6_1_6", - "sectionNumber": "6.1.6", - "sectionTitle": "Progression-Free Survival", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_42", - "nextId": null, - "contentItemId": "NarrativeContentItem_43", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_44", - "extensionAttributes": [], - "name": "NC_7", - "sectionNumber": "7", - "sectionTitle": "Study Parameters", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_45" - ], - "previousId": "NarrativeContent_36", - "nextId": "NarrativeContent_51", - "contentItemId": "NarrativeContentItem_44", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_45", - "extensionAttributes": [], - "name": "NC_7_1", - "sectionNumber": "7.1", - "sectionTitle": "Procedures by Visit", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_46", - "NarrativeContent_47", - "NarrativeContent_48", - "NarrativeContent_49", - "NarrativeContent_50" - ], - "previousId": null, - "nextId": null, - "contentItemId": "NarrativeContentItem_45", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_46", - "extensionAttributes": [], - "name": "NC_7_1_1", - "sectionNumber": "7.1.1", - "sectionTitle": "Pre-Study", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_47", - "contentItemId": "NarrativeContentItem_46", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_47", - "extensionAttributes": [], - "name": "NC_7_1_2", - "sectionNumber": "7.1.2", - "sectionTitle": "Induction Phase", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_46", - "nextId": "NarrativeContent_48", - "contentItemId": "NarrativeContentItem_47", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_48", - "extensionAttributes": [], - "name": "NC_7_1_3", - "sectionNumber": "7.1.3", - "sectionTitle": "End of Induction Phase / End of Treatment", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_47", - "nextId": "NarrativeContent_49", - "contentItemId": "NarrativeContentItem_48", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_49", - "extensionAttributes": [], - "name": "NC_7_1_4", - "sectionNumber": "7.1.4", - "sectionTitle": "Continuation Phase", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_48", - "nextId": "NarrativeContent_50", - "contentItemId": "NarrativeContentItem_49", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_50", - "extensionAttributes": [], - "name": "NC_7_1_5", - "sectionNumber": "7.1.5", - "sectionTitle": "Follow-Up Off-Therapy", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_49", - "nextId": null, - "contentItemId": "NarrativeContentItem_50", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_51", - "extensionAttributes": [], - "name": "NC_8", - "sectionNumber": "8", - "sectionTitle": "Drug Formulation and Procurement", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_52", - "NarrativeContent_59" - ], - "previousId": "NarrativeContent_44", - "nextId": "NarrativeContent_60", - "contentItemId": "NarrativeContentItem_51", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_52", - "extensionAttributes": [], - "name": "NC_8_1", - "sectionNumber": "8.1", - "sectionTitle": "Everolimus", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_53", - "NarrativeContent_54", - "NarrativeContent_55", - "NarrativeContent_56", - "NarrativeContent_57", - "NarrativeContent_58" - ], - "previousId": null, - "nextId": "NarrativeContent_59", - "contentItemId": "NarrativeContentItem_52", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_53", - "extensionAttributes": [], - "name": "NC_8_1_1", - "sectionNumber": "8.1.1", - "sectionTitle": "Packaging and Labeling", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_54", - "contentItemId": "NarrativeContentItem_53", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_54", - "extensionAttributes": [], - "name": "NC_8_1_2", - "sectionNumber": "8.1.2", - "sectionTitle": "Storage Requirements/Stability", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_53", - "nextId": "NarrativeContent_55", - "contentItemId": "NarrativeContentItem_54", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_55", - "extensionAttributes": [], - "name": "NC_8_1_3", - "sectionNumber": "8.1.3", - "sectionTitle": "Handling, Dispensing and Administration", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_54", - "nextId": "NarrativeContent_56", - "contentItemId": "NarrativeContentItem_55", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_56", - "extensionAttributes": [], - "name": "NC_8_1_4", - "sectionNumber": "8.1.4", - "sectionTitle": "Side Effects", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_55", - "nextId": "NarrativeContent_57", - "contentItemId": "NarrativeContentItem_56", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_57", - "extensionAttributes": [], - "name": "NC_8_1_5", - "sectionNumber": "8.1.5", - "sectionTitle": "Investigational Product Records at Investigational Site(s)", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_56", - "nextId": "NarrativeContent_58", - "contentItemId": "NarrativeContentItem_57", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_58", - "extensionAttributes": [], - "name": "NC_8_1_6", - "sectionNumber": "8.1.6", - "sectionTitle": "Return and Destruction of Investigational Product", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_57", - "nextId": null, - "contentItemId": "NarrativeContentItem_58", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_59", - "extensionAttributes": [], - "name": "NC_8_2", - "sectionNumber": "8.2", - "sectionTitle": "Fulvestrant", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_52", - "nextId": null, - "contentItemId": "NarrativeContentItem_59", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_60", - "extensionAttributes": [], - "name": "NC_9", - "sectionNumber": "9", - "sectionTitle": "Statistical Considerations", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_61", - "NarrativeContent_62", - "NarrativeContent_63" - ], - "previousId": "NarrativeContent_51", - "nextId": "NarrativeContent_64", - "contentItemId": "NarrativeContentItem_60", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_61", - "extensionAttributes": [], - "name": "NC_9_1", - "sectionNumber": "9.1", - "sectionTitle": "Primary Endpoint Analysis", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_62", - "contentItemId": "NarrativeContentItem_61", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_62", - "extensionAttributes": [], - "name": "NC_9_2", - "sectionNumber": "9.2", - "sectionTitle": "Safety Analyses", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_61", - "nextId": "NarrativeContent_63", - "contentItemId": "NarrativeContentItem_62", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_63", - "extensionAttributes": [], - "name": "NC_9_3", - "sectionNumber": "9.3", - "sectionTitle": "Analyses of Other Secondary Endpoints", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_62", - "nextId": null, - "contentItemId": "NarrativeContentItem_63", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_64", - "extensionAttributes": [], - "name": "NC_10", - "sectionNumber": "10", - "sectionTitle": "Adverse Event Reporting", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_65", - "NarrativeContent_66", - "NarrativeContent_69" - ], - "previousId": "NarrativeContent_60", - "nextId": "NarrativeContent_70", - "contentItemId": "NarrativeContentItem_64", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_65", - "extensionAttributes": [], - "name": "NC_10_1", - "sectionNumber": "10.1", - "sectionTitle": "Collection of Safety Information", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_66", - "contentItemId": "NarrativeContentItem_65", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_66", - "extensionAttributes": [], - "name": "NC_10_2", - "sectionNumber": "10.2", - "sectionTitle": "Handling of Serious Adverse Events (SAEs)", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_67", - "NarrativeContent_68" - ], - "previousId": "NarrativeContent_65", - "nextId": "NarrativeContent_69", - "contentItemId": "NarrativeContentItem_66", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_67", - "extensionAttributes": [], - "name": "NC_10_2_1", - "sectionNumber": "10.2.1", - "sectionTitle": "SAE Definitions", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_68", - "contentItemId": "NarrativeContentItem_67", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_68", - "extensionAttributes": [], - "name": "NC_10_2_2", - "sectionNumber": "10.2.2", - "sectionTitle": "SAE Reporting Requirements", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_67", - "nextId": null, - "contentItemId": "NarrativeContentItem_68", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_69", - "extensionAttributes": [], - "name": "NC_10_3", - "sectionNumber": "10.3", - "sectionTitle": "Reporting of Second Primary Cancers", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_66", - "nextId": null, - "contentItemId": "NarrativeContentItem_69", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_70", - "extensionAttributes": [], - "name": "NC_11", - "sectionNumber": "11", - "sectionTitle": "Administrative", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [ - "NarrativeContent_71", - "NarrativeContent_72", - "NarrativeContent_73", - "NarrativeContent_74", - "NarrativeContent_75", - "NarrativeContent_76", - "NarrativeContent_77", - "NarrativeContent_78" - ], - "previousId": "NarrativeContent_64", - "nextId": "NarrativeContent_79", - "contentItemId": "NarrativeContentItem_70", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_71", - "extensionAttributes": [], - "name": "NC_11_1", - "sectionNumber": "11.1", - "sectionTitle": "Protocol Compliance", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": null, - "nextId": "NarrativeContent_72", - "contentItemId": "NarrativeContentItem_71", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_72", - "extensionAttributes": [], - "name": "NC_11_2", - "sectionNumber": "11.2", - "sectionTitle": "Institutional Review Board", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_71", - "nextId": "NarrativeContent_73", - "contentItemId": "NarrativeContentItem_72", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_73", - "extensionAttributes": [], - "name": "NC_11_3", - "sectionNumber": "11.3", - "sectionTitle": "Informed Consent Procedures", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_72", - "nextId": "NarrativeContent_74", - "contentItemId": "NarrativeContentItem_73", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_74", - "extensionAttributes": [], - "name": "NC_11_4", - "sectionNumber": "11.4", - "sectionTitle": "Safety Communication", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_73", - "nextId": "NarrativeContent_75", - "contentItemId": "NarrativeContentItem_74", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_75", - "extensionAttributes": [], - "name": "NC_11_5", - "sectionNumber": "11.5", - "sectionTitle": "Monitoring", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_74", - "nextId": "NarrativeContent_76", - "contentItemId": "NarrativeContentItem_75", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_76", - "extensionAttributes": [], - "name": "NC_11_6", - "sectionNumber": "11.6", - "sectionTitle": "Study Records", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_75", - "nextId": "NarrativeContent_77", - "contentItemId": "NarrativeContentItem_76", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_77", - "extensionAttributes": [], - "name": "NC_11_7", - "sectionNumber": "11.7", - "sectionTitle": "Electronic Case Report Form (eCRF) Information", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_76", - "nextId": "NarrativeContent_78", - "contentItemId": "NarrativeContentItem_77", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_78", - "extensionAttributes": [], - "name": "NC_11_8", - "sectionNumber": "11.8", - "sectionTitle": "Records Retention", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_77", - "nextId": null, - "contentItemId": "NarrativeContentItem_78", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_79", - "extensionAttributes": [], - "name": "NC_12", - "sectionNumber": "12", - "sectionTitle": "Glossary of Terms and List of Abbreviations", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_70", - "nextId": "NarrativeContent_80", - "contentItemId": "NarrativeContentItem_79", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_80", - "extensionAttributes": [], - "name": "NC_13", - "sectionNumber": "13", - "sectionTitle": "Appendix A: Eligibility Checklist", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_79", - "nextId": "NarrativeContent_81", - "contentItemId": "NarrativeContentItem_80", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_81", - "extensionAttributes": [], - "name": "NC_14", - "sectionNumber": "14", - "sectionTitle": "Appendix B: ECOG Performance Status Scale", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_80", - "nextId": "NarrativeContent_82", - "contentItemId": "NarrativeContentItem_81", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_82", - "extensionAttributes": [], - "name": "NC_15", - "sectionNumber": "15", - "sectionTitle": "Appendix C: Medications that can Inhibit/Induce CYP3A4 and PgP", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_81", - "nextId": "NarrativeContent_83", - "contentItemId": "NarrativeContentItem_82", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_83", - "extensionAttributes": [], - "name": "NC_16", - "sectionNumber": "16", - "sectionTitle": "Appendix D: New York Heart Association (NYHA) Cardiac Classification", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_82", - "nextId": "NarrativeContent_84", - "contentItemId": "NarrativeContentItem_83", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_84", - "extensionAttributes": [], - "name": "NC_17", - "sectionNumber": "17", - "sectionTitle": "Appendix E: CTEP Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_83", - "nextId": "NarrativeContent_85", - "contentItemId": "NarrativeContentItem_84", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_85", - "extensionAttributes": [], - "name": "NC_18", - "sectionNumber": "18", - "sectionTitle": "Appendix F: Patient Pill Diary", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_84", - "nextId": "NarrativeContent_86", - "contentItemId": "NarrativeContentItem_85", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_86", - "extensionAttributes": [], - "name": "NC_19", - "sectionNumber": "19", - "sectionTitle": "References", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_85", - "nextId": "NarrativeContent_87", - "contentItemId": "NarrativeContentItem_86", - "instanceType": "NarrativeContent" - }, - { - "id": "NarrativeContent_87", - "extensionAttributes": [], - "name": "NC_20", - "sectionNumber": "20", - "sectionTitle": "Investigator's Statement", - "displaySectionNumber": true, - "displaySectionTitle": true, - "childIds": [], - "previousId": "NarrativeContent_86", - "nextId": null, - "contentItemId": "NarrativeContentItem_87", - "instanceType": "NarrativeContent" - } - ], - "notes": [], - "instanceType": "StudyDefinitionDocumentVersion" - } - ], - "childIds": [], - "notes": [], - "instanceType": "StudyDefinitionDocument" - } - ], - "instanceType": "Study" - }, - "usdmVersion": "4.0", - "systemName": "SOA Workbench", - "systemVersion": "pi-fix-bc-props-specs-in-usdm" -} diff --git a/output/json/NCT12345678-define-20260716T1133.json b/output/json/NCT12345678-define-20260716T1133.json deleted file mode 100644 index ef4daa9..0000000 --- a/output/json/NCT12345678-define-20260716T1133.json +++ /dev/null @@ -1,33435 +0,0 @@ -{ - "OID": "MDV.LZZT - Pilot.Version1.Design1", - "name": "MDV LZZT - Pilot", - "description": "Data Definitions for LZZT - Pilot", - "fileOID": "ODM.DEFINE-JSON.LZZT - Pilot.Version1.Design1", - "creationDateTime": "2026-07-16T11:33:00.031383+00:00", - "odmVersion": "1.3.2", - "fileType": "Snapshot", - "originator": "Define-JSON Processor", - "context": "Other", - "defineVersion": "2.1.0", - "studyOID": "ODM.LZZT - Pilot.Version1.Design1", - "studyName": "LZZT - Pilot", - "studyDescription": "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease", - "protocolName": "LZZT - Pilot", - "itemGroups": [ - { - "OID": "IG.DS", - "name": "DS", - "description": "Disposition", - "domain": "DS", - "purpose": "Tabulation", - "structure": "One record per disposition status or protocol milestone per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "DSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.DS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSSEQ", - "mandatory": true, - "name": "DSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSTERM", - "mandatory": true, - "name": "DSTERM", - "description": "Reported Term for the Disposition Event", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_2", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSDECOD", - "mandatory": true, - "name": "DSDECOD", - "description": "Standardized Disposition Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_1", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NCOMPLT" - }, - { - "OID": "IT.DS.DSCAT", - "mandatory": false, - "name": "DSCAT", - "description": "Category for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSCAT" - }, - { - "OID": "IT.DS.DSSCAT", - "mandatory": false, - "name": "DSSCAT", - "description": "Subcategory for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSSCAT" - }, - { - "OID": "IT.DS.DSSTDTC", - "mandatory": false, - "name": "DSSTDTC", - "description": "Start Date/Time of Disposition Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_3", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSSTDY", - "mandatory": false, - "name": "DSSTDY", - "description": "Study Day of Start of Disposition Event", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_1" - }, - { - "OID": "IG.IE", - "name": "IE", - "description": "Inclusion/Exclusion Criteria Not Met", - "domain": "IE", - "purpose": "Tabulation", - "structure": "One record per inclusion/exclusion criterion not met per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "IESEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.IE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IESEQ", - "mandatory": true, - "name": "IESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IETESTCD", - "mandatory": true, - "name": "IETESTCD", - "description": "Inclusion/Exclusion Criterion Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IETEST", - "mandatory": true, - "name": "IETEST", - "description": "Inclusion/Exclusion Criterion", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IECAT", - "mandatory": true, - "name": "IECAT", - "description": "Inclusion/Exclusion Category", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.IECAT" - }, - { - "OID": "IT.IE.IEORRES", - "mandatory": true, - "name": "IEORRES", - "description": "I/E Criterion Original Result", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_5", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.IE.IESTRESC", - "mandatory": true, - "name": "IESTRESC", - "description": "I/E Criterion Result in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.IE.IEDTC", - "mandatory": false, - "name": "IEDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_6", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_2" - }, - { - "OID": "IG.SC", - "name": "SC", - "description": "Subject Characteristics", - "domain": "SC", - "purpose": "Tabulation", - "structure": "One record per characteristic per visit per subject.", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SCSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.SC.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCSEQ", - "mandatory": true, - "name": "SCSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCTESTCD", - "mandatory": true, - "name": "SCTESTCD", - "description": "Subject Characteristic Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.SCTESTCD" - }, - { - "OID": "IT.SC.SCTEST", - "mandatory": true, - "name": "SCTEST", - "description": "Subject Characteristic", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.SCTEST" - }, - { - "OID": "IT.SC.SCCAT", - "mandatory": false, - "name": "SCCAT", - "description": "Category for Subject Characteristic", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCORRES", - "mandatory": false, - "name": "SCORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_26", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SC.SCSTRESC", - "mandatory": false, - "name": "SCSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCSTRESN", - "mandatory": false, - "name": "SCSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCDTC", - "mandatory": false, - "name": "SCDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_27", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_11" - }, - { - "OID": "IG.MH", - "name": "MH", - "description": "Medical History", - "domain": "MH", - "purpose": "Tabulation", - "structure": "One record per medical history event per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "MHSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.MH.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHSEQ", - "mandatory": true, - "name": "MHSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHTERM", - "mandatory": true, - "name": "MHTERM", - "description": "Reported Term for the Medical History", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_30", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MH.MHDECOD", - "mandatory": false, - "name": "MHDECOD", - "description": "Dictionary-Derived Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_31", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHCAT", - "mandatory": false, - "name": "MHCAT", - "description": "Category for Medical History", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHSCAT", - "mandatory": false, - "name": "MHSCAT", - "description": "Subcategory for Medical History", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHPRESP", - "mandatory": false, - "name": "MHPRESP", - "description": "Medical History Event Pre-Specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.MH.MHOCCUR", - "mandatory": false, - "name": "MHOCCUR", - "description": "Medical History Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.MH.MHSTDTC", - "mandatory": false, - "name": "MHSTDTC", - "description": "Start Date/Time of Medical History Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_32", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MH.MHENDTC", - "mandatory": false, - "name": "MHENDTC", - "description": "End Date/Time of Medical History Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_33", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MH.MHENRF", - "mandatory": false, - "name": "MHENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_34", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.MH.MHENRTPT", - "mandatory": false, - "name": "MHENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_35", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.MH.MHENTPT", - "mandatory": false, - "name": "MHENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_36", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_14" - }, - { - "OID": "IG.SU", - "name": "SU", - "description": "Substance Use", - "domain": "SU", - "purpose": "Tabulation", - "structure": "One record per substance type per reported occurrence per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SUSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.SU.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUSEQ", - "mandatory": true, - "name": "SUSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUTRT", - "mandatory": true, - "name": "SUTRT", - "description": "Reported Name of Substance", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_37", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUCAT", - "mandatory": false, - "name": "SUCAT", - "description": "Category for Substance Use", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUSCAT", - "mandatory": false, - "name": "SUSCAT", - "description": "Subcategory for Substance Use", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUPRESP", - "mandatory": false, - "name": "SUPRESP", - "description": "SU Pre-Specified", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_38", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY_Y" - }, - { - "OID": "IT.SU.SUOCCUR", - "mandatory": false, - "name": "SUOCCUR", - "description": "SU Occurrence", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_39", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.SU.SUDOSE", - "mandatory": false, - "name": "SUDOSE", - "description": "Substance Use Consumption", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_40", - "dataType": "float", - "length": 12, - "displayFormat": "12.4", - "significantDigits": 4, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUDOSTXT", - "mandatory": false, - "name": "SUDOSTXT", - "description": "Substance Use Consumption Text", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_41", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUDOSU", - "mandatory": false, - "name": "SUDOSU", - "description": "Consumption Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_42", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.SU.SUDOSFRQ", - "mandatory": false, - "name": "SUDOSFRQ", - "description": "Use Frequency Per Interval", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_43", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.SU.SUSTDTC", - "mandatory": false, - "name": "SUSTDTC", - "description": "Start Date/Time of Substance Use", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_44", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUENDTC", - "mandatory": false, - "name": "SUENDTC", - "description": "End Date/Time of Substance Use", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_45", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUDUR", - "mandatory": false, - "name": "SUDUR", - "description": "Duration of Substance Use", - "role": "Timing", - "dataType": "durationDatetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUSTRF", - "mandatory": false, - "name": "SUSTRF", - "description": "Start Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_46", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUENRF", - "mandatory": false, - "name": "SUENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_49", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUSTRTPT", - "mandatory": false, - "name": "SUSTRTPT", - "description": "Start Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_47", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUSTTPT", - "mandatory": false, - "name": "SUSTTPT", - "description": "Start Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_48", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUENRTPT", - "mandatory": false, - "name": "SUENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_50", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUENTPT", - "mandatory": false, - "name": "SUENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_51", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_15" - }, - { - "OID": "IG.PR", - "name": "PR", - "description": "Procedures", - "domain": "PR", - "purpose": "Tabulation", - "structure": "One record per recorded procedure per occurrence per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "PRSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.PR.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRSEQ", - "mandatory": true, - "name": "PRSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRTRT", - "mandatory": true, - "name": "PRTRT", - "description": "Reported Name of Procedure", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_83", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.PR.PRDECOD", - "mandatory": false, - "name": "PRDECOD", - "description": "Standardized Procedure Name", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_84", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.PROCEDUR" - }, - { - "OID": "IT.PR.PRCAT", - "mandatory": false, - "name": "PRCAT", - "description": "Category", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRSCAT", - "mandatory": false, - "name": "PRSCAT", - "description": "Subcategory", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRPRESP", - "mandatory": false, - "name": "PRPRESP", - "description": "Pre-specified", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_85", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY_Y" - }, - { - "OID": "IT.PR.PROCCUR", - "mandatory": false, - "name": "PROCCUR", - "description": "Occurrence", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_86", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.PR.PRLOC", - "mandatory": false, - "name": "PRLOC", - "description": "Location of Procedure", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_87", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.PR.PRLAT", - "mandatory": false, - "name": "PRLAT", - "description": "Laterality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_88", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.PR.PRSTDTC", - "mandatory": false, - "name": "PRSTDTC", - "description": "Start Date/Time of Procedure", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_89", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.PR.PRENDTC", - "mandatory": false, - "name": "PRENDTC", - "description": "End Date/Time of Procedure", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_90", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_18" - }, - { - "OID": "IG.VS", - "name": "VS", - "description": "Vital Signs", - "domain": "VS", - "purpose": "Tabulation", - "structure": "One record per vital sign measurement per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.VS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSEQ", - "mandatory": true, - "name": "VSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSTESTCD", - "mandatory": true, - "name": "VSTESTCD", - "description": "Vital Signs Test Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTESTCD" - }, - { - "OID": "IT.VS.VSTEST", - "mandatory": true, - "name": "VSTEST", - "description": "Vital Signs Test Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTEST" - }, - { - "OID": "IT.VS.VSPOS", - "mandatory": false, - "name": "VSPOS", - "description": "Vital Signs Position of Subject", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.POSITION" - }, - { - "OID": "IT.VS.VSORRES", - "mandatory": false, - "name": "VSORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_94", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSORRESU", - "mandatory": false, - "name": "VSORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_95", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSSTRESC", - "mandatory": false, - "name": "VSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESN", - "mandatory": false, - "name": "VSSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESU", - "mandatory": false, - "name": "VSSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSLOC", - "mandatory": false, - "name": "VSLOC", - "description": "Location of Vital Signs Measurement", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_96", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.VS.VSLAT", - "mandatory": false, - "name": "VSLAT", - "description": "Laterality", - "role": "Result Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.VS.VSLOBXFL", - "mandatory": false, - "name": "VSLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.VS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSDTC", - "mandatory": false, - "name": "VSDTC", - "description": "Date/Time of Measurements", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_97", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_20" - }, - { - "OID": "IG.EG", - "name": "EG", - "description": "ECG Test Results", - "domain": "EG", - "purpose": "Tabulation", - "structure": "One record per ECG observation per replicate per time point or one record per ECG observation per beat per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "EGSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.EG.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.EGSEQ", - "mandatory": true, - "name": "EGSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.EGTESTCD", - "mandatory": true, - "name": "EGTESTCD", - "description": "ECG Test or Examination Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EGTESTCD" - }, - { - "OID": "IT.EG.EGTEST", - "mandatory": true, - "name": "EGTEST", - "description": "ECG Test or Examination Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EGTEST" - }, - { - "OID": "IT.EG.EGCAT", - "mandatory": false, - "name": "EGCAT", - "description": "Category for ECG", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.EGPOS", - "mandatory": false, - "name": "EGPOS", - "description": "ECG Position of Subject", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.POSITION" - }, - { - "OID": "IT.EG.EGORRES", - "mandatory": false, - "name": "EGORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_116", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Vendor" - } - }, - { - "OID": "IT.EG.EGORRESU", - "mandatory": false, - "name": "EGORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Vendor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.EG.EGSTRESC", - "mandatory": false, - "name": "EGSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Derived", - "source": "Vendor" - }, - "codeList": "CL.EGSTRESC" - }, - { - "OID": "IT.EG.EGSTRESN", - "mandatory": false, - "name": "EGSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Vendor" - } - }, - { - "OID": "IT.EG.EGSTRESU", - "mandatory": false, - "name": "EGSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Vendor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.EG.EGMETHOD", - "mandatory": false, - "name": "EGMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_117", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.EGMETHOD" - }, - { - "OID": "IT.EG.EGLOBXFL", - "mandatory": false, - "name": "EGLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.EG.EGEVAL", - "mandatory": false, - "name": "EGEVAL", - "description": "Evaluator", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_118", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.EVAL" - }, - { - "OID": "IT.EG.EGCLSIG", - "mandatory": false, - "name": "EGCLSIG", - "description": "Clinically Significant, Collected", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_119", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.EG.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EG.EGDTC", - "mandatory": false, - "name": "EGDTC", - "description": "Date/Time of ECG", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_120", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_27" - }, - { - "OID": "IG.CM", - "name": "CM", - "description": "Concomitant/Prior Medications", - "domain": "CM", - "purpose": "Tabulation", - "structure": "One record per recorded intervention occurrence or constant-dosing interval per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "CMSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.CM.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSEQ", - "mandatory": true, - "name": "CMSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMTRT", - "mandatory": true, - "name": "CMTRT", - "description": "Reported Name of Drug, Med, or Therapy", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_266", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDECOD", - "mandatory": false, - "name": "CMDECOD", - "description": "Standardized Medication Name", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_267", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCAT", - "mandatory": false, - "name": "CMCAT", - "description": "Category for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSCAT", - "mandatory": false, - "name": "CMSCAT", - "description": "Subcategory for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMPRESP", - "mandatory": false, - "name": "CMPRESP", - "description": "CM Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMOCCUR", - "mandatory": false, - "name": "CMOCCUR", - "description": "CM Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMINDC", - "mandatory": false, - "name": "CMINDC", - "description": "Indication", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_269", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMCLAS", - "mandatory": false, - "name": "CMCLAS", - "description": "Medication Class", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_268", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCLASCD", - "mandatory": false, - "name": "CMCLASCD", - "description": "Medication Class Code", - "role": "Variable Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMDOSE", - "mandatory": false, - "name": "CMDOSE", - "description": "Dose per Administration", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_270", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSTXT", - "mandatory": false, - "name": "CMDOSTXT", - "description": "Dose Description", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_271", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSU", - "mandatory": false, - "name": "CMDOSU", - "description": "Dose Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_272", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.CM.CMDOSFRM", - "mandatory": false, - "name": "CMDOSFRM", - "description": "Dose Form", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_273", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FRM" - }, - { - "OID": "IT.CM.CMDOSFRQ", - "mandatory": false, - "name": "CMDOSFRQ", - "description": "Dosing Frequency per Interval", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_274", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.CM.CMROUTE", - "mandatory": false, - "name": "CMROUTE", - "description": "Route of Administration", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_275", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ROUTE" - }, - { - "OID": "IT.CM.CMSTDTC", - "mandatory": false, - "name": "CMSTDTC", - "description": "Start Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_276", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMENDTC", - "mandatory": false, - "name": "CMENDTC", - "description": "End Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_277", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMSTRF", - "mandatory": false, - "name": "CMSTRF", - "description": "Start Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_278", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENRF", - "mandatory": false, - "name": "CMENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_281", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTRTPT", - "mandatory": false, - "name": "CMSTRTPT", - "description": "Start Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_279", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTTPT", - "mandatory": false, - "name": "CMSTTPT", - "description": "Start Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_280", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMENRTPT", - "mandatory": false, - "name": "CMENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_282", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENTPT", - "mandatory": false, - "name": "CMENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_283", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_55" - }, - { - "OID": "IG.MB", - "name": "MB", - "description": "Microbiology Specimen", - "domain": "MB", - "purpose": "Tabulation", - "structure": "One record per microbiology specimen finding per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "MBSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.MB.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.MBSEQ", - "mandatory": true, - "name": "MBSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.MBTESTCD", - "mandatory": true, - "name": "MBTESTCD", - "description": "Microbiology Test or Finding Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MBTESTCD" - }, - { - "OID": "IT.MB.MBTEST", - "mandatory": true, - "name": "MBTEST", - "description": "Microbiology Test or Finding Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MBTEST" - }, - { - "OID": "IT.MB.MBTSTDTL", - "mandatory": false, - "name": "MBTSTDTL", - "description": "Measurement, Test or Examination Detail", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_592", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MBFTSDTL" - }, - { - "OID": "IT.MB.MBORRES", - "mandatory": false, - "name": "MBORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_593", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Vendor" - } - }, - { - "OID": "IT.MB.MBSTRESC", - "mandatory": false, - "name": "MBSTRESC", - "description": "Result or Finding in Standard Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Derived", - "source": "Vendor" - } - }, - { - "OID": "IT.MB.MBSPEC", - "mandatory": false, - "name": "MBSPEC", - "description": "Specimen Material Type", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_594", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.SPECTYPE" - }, - { - "OID": "IT.MB.MBMETHOD", - "mandatory": false, - "name": "MBMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_595", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.MB.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MB.MBDTC", - "mandatory": false, - "name": "MBDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_596", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_99" - }, - { - "OID": "IG.UR", - "name": "UR", - "description": "Urinary System Findings", - "domain": "UR", - "purpose": "Tabulation", - "structure": "One record per finding per location per per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "URSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.UR.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URSEQ", - "mandatory": true, - "name": "URSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URTESTCD", - "mandatory": true, - "name": "URTESTCD", - "description": "Short Name of Urinary Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTSCD" - }, - { - "OID": "IT.UR.URTEST", - "mandatory": true, - "name": "URTEST", - "description": "Name of Urinary Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTS" - }, - { - "OID": "IT.UR.URORRES", - "mandatory": false, - "name": "URORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URSTRESC", - "mandatory": false, - "name": "URSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URMETHOD", - "mandatory": false, - "name": "URMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.UR.URLOBXFL", - "mandatory": false, - "name": "URLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.UR.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URDTC", - "mandatory": false, - "name": "URDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_101" - }, - { - "OID": "IG.EC", - "name": "EC", - "description": "Exposure as Collected", - "domain": "EC", - "purpose": "Tabulation", - "structure": "One record per protocol-specified study treatment, collected-dosing interval, per subject, per mood", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "ECSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.EC.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.ECSEQ", - "mandatory": true, - "name": "ECSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.ECREFID", - "mandatory": false, - "name": "ECREFID", - "description": "Reference ID", - "role": "Identifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_721", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECTRT", - "mandatory": true, - "name": "ECTRT", - "description": "Name of Treatment", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_720", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECDOSE", - "mandatory": false, - "name": "ECDOSE", - "description": "Dose", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_722", - "dataType": "integer", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECDOSTXT", - "mandatory": false, - "name": "ECDOSTXT", - "description": "Dose Description", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_723", - "dataType": "text", - "length": 100, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECDOSU", - "mandatory": false, - "name": "ECDOSU", - "description": "Dose Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_724", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.EC.ECDOSFRM", - "mandatory": false, - "name": "ECDOSFRM", - "description": "Dose Form", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_725", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FRM" - }, - { - "OID": "IT.EC.ECDOSFRQ", - "mandatory": false, - "name": "ECDOSFRQ", - "description": "Dosing Frequency per Interval", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_726", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.EC.ECDOSRGM", - "mandatory": false, - "name": "ECDOSRGM", - "description": "Intended Dose Regimen", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_727", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECROUTE", - "mandatory": false, - "name": "ECROUTE", - "description": "Route of Administration", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_728", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ROUTE" - }, - { - "OID": "IT.EC.ECLOC", - "mandatory": false, - "name": "ECLOC", - "description": "Location of Dose Administration", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_729", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.EC.ECLAT", - "mandatory": false, - "name": "ECLAT", - "description": "Laterality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_730", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.EC.ECDIR", - "mandatory": false, - "name": "ECDIR", - "description": "Directionality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_731", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DIR" - }, - { - "OID": "IT.EC.ECSTDTC", - "mandatory": false, - "name": "ECSTDTC", - "description": "Start Date/Time of Treatment", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_732", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECENDTC", - "mandatory": false, - "name": "ECENDTC", - "description": "End Date/Time of Treatment", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_733", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_112" - }, - { - "OID": "IG.QS", - "name": "QS", - "description": "Questionnaires", - "domain": "QS", - "purpose": "Tabulation", - "structure": "One record per questionnaire per question per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "QSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.QS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSSEQ", - "mandatory": true, - "name": "QSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSTESTCD", - "mandatory": true, - "name": "QSTESTCD", - "description": "Question Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSTEST", - "mandatory": true, - "name": "QSTEST", - "description": "Question Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSCAT", - "mandatory": true, - "name": "QSCAT", - "description": "Category of Question", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.QSCAT" - }, - { - "OID": "IT.QS.QSORRES", - "mandatory": false, - "name": "QSORRES", - "description": "Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_740", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.QS.QSSTRESC", - "mandatory": false, - "name": "QSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSSTRESN", - "mandatory": false, - "name": "QSSTRESN", - "description": "Numeric Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSLOBXFL", - "mandatory": false, - "name": "QSLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.QS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.QS.QSDTC", - "mandatory": false, - "name": "QSDTC", - "description": "Date/Time of Finding", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_741", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_114" - }, - { - "OID": "IG.AE", - "name": "AE", - "description": "Adverse Events", - "domain": "AE", - "purpose": "Tabulation", - "structure": "One record per adverse event per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "AESEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.AE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESEQ", - "mandatory": true, - "name": "AESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AETERM", - "mandatory": true, - "name": "AETERM", - "description": "Reported Term for the Adverse Event", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_785", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AELLT", - "mandatory": false, - "name": "AELLT", - "description": "Lowest Level Term", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AELLTCD", - "mandatory": false, - "name": "AELLTCD", - "description": "Lowest Level Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEDECOD", - "mandatory": true, - "name": "AEDECOD", - "description": "Dictionary-Derived Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_786", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEPTCD", - "mandatory": false, - "name": "AEPTCD", - "description": "Preferred Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLT", - "mandatory": false, - "name": "AEHLT", - "description": "High Level Term", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLTCD", - "mandatory": false, - "name": "AEHLTCD", - "description": "High Level Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLGT", - "mandatory": false, - "name": "AEHLGT", - "description": "High Level Group Term", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLGTCD", - "mandatory": false, - "name": "AEHLGTCD", - "description": "High Level Group Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AECAT", - "mandatory": false, - "name": "AECAT", - "description": "Category for Adverse Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESCAT", - "mandatory": false, - "name": "AESCAT", - "description": "Subcategory for Adverse Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEPRESP", - "mandatory": false, - "name": "AEPRESP", - "description": "Pre-Specified Adverse Event", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.AE.AEBODSYS", - "mandatory": false, - "name": "AEBODSYS", - "description": "Body System or Organ Class", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEBDSYCD", - "mandatory": false, - "name": "AEBDSYCD", - "description": "Body System or Organ Class Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESOC", - "mandatory": false, - "name": "AESOC", - "description": "Primary System Organ Class", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESOCCD", - "mandatory": false, - "name": "AESOCCD", - "description": "Primary System Organ Class Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AELOC", - "mandatory": false, - "name": "AELOC", - "description": "Location of Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_787", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.AE.AESEV", - "mandatory": false, - "name": "AESEV", - "description": "Severity/Intensity", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_788", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.AESEV" - }, - { - "OID": "IT.AE.AESER", - "mandatory": false, - "name": "AESER", - "description": "Serious Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_789", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AEACN", - "mandatory": false, - "name": "AEACN", - "description": "Action Taken with Study Treatment", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_790", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ACN" - }, - { - "OID": "IT.AE.AEACNOTH", - "mandatory": false, - "name": "AEACNOTH", - "description": "Other Action Taken", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_791", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEREL", - "mandatory": false, - "name": "AEREL", - "description": "Causality", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_792", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AERELNST", - "mandatory": false, - "name": "AERELNST", - "description": "Relationship to Non-Study Treatment", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_793", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEPATT", - "mandatory": false, - "name": "AEPATT", - "description": "Pattern of Adverse Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_794", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEOUT", - "mandatory": false, - "name": "AEOUT", - "description": "Outcome of Adverse Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_795", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.OUT" - }, - { - "OID": "IT.AE.AESCAN", - "mandatory": false, - "name": "AESCAN", - "description": "Involves Cancer", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_796", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESCONG", - "mandatory": false, - "name": "AESCONG", - "description": "Congenital Anomaly or Birth Defect", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_797", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESDISAB", - "mandatory": false, - "name": "AESDISAB", - "description": "Persist or Signif Disability/Incapacity", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_798", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESDTH", - "mandatory": false, - "name": "AESDTH", - "description": "Results in Death", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_799", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESHOSP", - "mandatory": false, - "name": "AESHOSP", - "description": "Requires or Prolongs Hospitalization", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_800", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESLIFE", - "mandatory": false, - "name": "AESLIFE", - "description": "Is Life Threatening", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_801", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESOD", - "mandatory": false, - "name": "AESOD", - "description": "Occurred with Overdose", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_802", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESMIE", - "mandatory": false, - "name": "AESMIE", - "description": "Other Medically Important Serious Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_803", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AECONTRT", - "mandatory": false, - "name": "AECONTRT", - "description": "Concomitant or Additional Trtmnt Given", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_804", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AETOXGR", - "mandatory": false, - "name": "AETOXGR", - "description": "Standard Toxicity Grade", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_805", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AESTDTC", - "mandatory": false, - "name": "AESTDTC", - "description": "Start Date/Time of Adverse Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_806", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEENDTC", - "mandatory": false, - "name": "AEENDTC", - "description": "End Date/Time of Adverse Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_807", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEENRF", - "mandatory": false, - "name": "AEENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_808", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.AE.AEENRTPT", - "mandatory": false, - "name": "AEENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_809", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.AE.AEENTPT", - "mandatory": false, - "name": "AEENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_810", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_135" - }, - { - "OID": "IG.MK", - "name": "MK", - "description": "Musculoskeletal System Findings", - "domain": "MK", - "purpose": "Tabulation", - "structure": "One record per assessment per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "MKSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.MK.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKSEQ", - "mandatory": true, - "name": "MKSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKTESTCD", - "mandatory": true, - "name": "MKTESTCD", - "description": "Short Name of Musculoskeletal Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MUSCTSCD" - }, - { - "OID": "IT.MK.MKTEST", - "mandatory": true, - "name": "MKTEST", - "description": "Name of Musculoskeletal Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MUSCTS" - }, - { - "OID": "IT.MK.MKORRES", - "mandatory": false, - "name": "MKORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_920", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MK.MKORRESU", - "mandatory": false, - "name": "MKORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_921", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.MK.MKSTRESC", - "mandatory": false, - "name": "MKSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKSTRESN", - "mandatory": false, - "name": "MKSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKSTRESU", - "mandatory": false, - "name": "MKSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.MK.MKLOC", - "mandatory": false, - "name": "MKLOC", - "description": "Location Used for the Measurement", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_922", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.MK.MKLAT", - "mandatory": false, - "name": "MKLAT", - "description": "Laterality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_923", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.MK.MKMETHOD", - "mandatory": false, - "name": "MKMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_924", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.MK.MKLOBXFL", - "mandatory": false, - "name": "MKLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.MK.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MK.MKDTC", - "mandatory": false, - "name": "MKDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_925", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_160" - }, - { - "OID": "IG.TS", - "name": "TS", - "description": "Trial Summary", - "domain": "TS", - "purpose": "Tabulation", - "structure": "One record per trial summary parameter value", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "TSPARMCD", - "TSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSSEQ", - "mandatory": true, - "name": "TSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSPARMCD", - "mandatory": true, - "name": "TSPARMCD", - "description": "Trial Summary Parameter Short Name", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_949", - "dataType": "text", - "length": null, - "codeList": "CL.TSPARMCD" - }, - { - "OID": "IT.TS.TSPARM", - "mandatory": true, - "name": "TSPARM", - "description": "Trial Summary Parameter", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_950", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TSPARM" - }, - { - "OID": "IT.TS.TSVAL", - "mandatory": false, - "name": "TSVAL", - "description": "Parameter Value", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_951", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVALCD", - "mandatory": false, - "name": "TSVALCD", - "description": "Parameter Value Code", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_952", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVCDREF", - "mandatory": false, - "name": "TSVCDREF", - "description": "Name of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_953", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DICTNAM" - }, - { - "OID": "IT.TS.TSVCDVER", - "mandatory": false, - "name": "TSVCDVER", - "description": "Version of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_954", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_162", - "slices": [ - { - "OID": "VL.TS.TSPARMCD", - "name": "VL_TS_TSPARMCD", - "type": "ValueList", - "wasDerivedFrom": "IT.TS.TSPARMCD", - "items": [ - { - "OID": "IT.TS.TSPARMCD.COMPTRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.8c559472" - ] - }, - { - "OID": "IT.TS.TSPARMCD.CRMDUR", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.bcc79825" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INDIC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e5769859" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INTTYPE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d3e89d3f" - ] - }, - { - "OID": "IT.TS.TSPARMCD.NARMS", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.efd2a465" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJPRIM", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.fe255586" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.62794b6c" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSPRI", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.4266ae9d" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.1d6311e2" - ] - }, - { - "OID": "IT.TS.TSPARMCD.SPONSOR", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e06f8db5" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TITLE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d94c6616" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d368cfb2" - ] - } - ] - } - ] - }, - { - "OID": "IG.FT", - "name": "FT", - "description": "Functional Tests", - "domain": "FT", - "purpose": "Tabulation", - "structure": "One record per Functional Test finding per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "FTSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.FT.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTSEQ", - "mandatory": true, - "name": "FTSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTTESTCD", - "mandatory": true, - "name": "FTTESTCD", - "description": "Short Name of Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTTEST", - "mandatory": true, - "name": "FTTEST", - "description": "Name of Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTCAT", - "mandatory": true, - "name": "FTCAT", - "description": "Category", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.FTCAT" - }, - { - "OID": "IT.FT.FTSCAT", - "mandatory": false, - "name": "FTSCAT", - "description": "Subcategory", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTORRES", - "mandatory": false, - "name": "FTORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 4, - "displayFormat": "5.2", - "significantDigits": 2, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.FT.FTORRESU", - "mandatory": false, - "name": "FTORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.FT.FTSTRESC", - "mandatory": false, - "name": "FTSTRESC", - "description": "Result or Finding in Standard Format", - "role": "Result Qualifier", - "dataType": "float", - "length": 4, - "displayFormat": "5.2", - "significantDigits": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTSTRESN", - "mandatory": false, - "name": "FTSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 4, - "displayFormat": "5.2", - "significantDigits": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTSTRESU", - "mandatory": false, - "name": "FTSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.FT.FTSTAT", - "mandatory": false, - "name": "FTSTAT", - "description": "Completion Status", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ND" - }, - { - "OID": "IT.FT.FTREASND", - "mandatory": false, - "name": "FTREASND", - "description": "Reason Not Done", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.FT.FTLOBXFL", - "mandatory": false, - "name": "FTLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.FT.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.FT.FTDTC", - "mandatory": false, - "name": "FTDTC", - "description": "Date/Time of Test", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_172" - }, - { - "OID": "IG.TA", - "name": "TA", - "description": "Trial Arms", - "domain": "TA", - "purpose": "Tabulation", - "structure": "One record per planned Element per Arm", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ARMCD", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TA.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.ARMCD", - "mandatory": true, - "name": "ARMCD", - "description": "Planned Arm Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARMCD" - }, - { - "OID": "IT.TA.ARM", - "mandatory": true, - "name": "ARM", - "description": "Description of Planned Arm", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARM" - }, - { - "OID": "IT.TA.TAETORD", - "mandatory": true, - "name": "TAETORD", - "description": "Planned Order of Element within Arm", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TA.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TA.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TA.TABRANCH", - "mandatory": false, - "name": "TABRANCH", - "description": "Branch", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.TATRANS", - "mandatory": false, - "name": "TATRANS", - "description": "Transition Rule", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.EPOCH", - "mandatory": true, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - } - ] - }, - { - "OID": "IG.TE", - "name": "TE", - "description": "Trial Elements", - "domain": "TE", - "purpose": "Tabulation", - "structure": "One record per planned Element", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TE.ELEMENT", - "mandatory": true, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TE.TESTRL", - "mandatory": true, - "name": "TESTRL", - "description": "Rule for Start of Element", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ] - }, - { - "OID": "IG.SV", - "name": "SV", - "description": "Subject Visits", - "domain": "SV", - "purpose": "Tabulation", - "structure": "One record per actual or planned visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VISITNUM" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SV.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISITNUM", - "mandatory": true, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Topic", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISIT", - "mandatory": false, - "name": "VISIT", - "description": "Visit Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.SVPRESP", - "mandatory": false, - "name": "SVPRESP", - "description": "Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVOCCUR", - "mandatory": false, - "name": "SVOCCUR", - "description": "Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVCNTMOD", - "mandatory": false, - "name": "SVCNTMOD", - "description": "Contact Mode", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.CNTMODE" - }, - { - "OID": "IT.SV.SVSTDTC", - "mandatory": false, - "name": "SVSTDTC", - "description": "Start Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SV.SVENDTC", - "mandatory": false, - "name": "SVENDTC", - "description": "End Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - }, - { - "OID": "IG.SE", - "name": "SE", - "description": "Subject Elements", - "domain": "SE", - "purpose": "Tabulation", - "structure": "One record per actual Element per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SESTDTC" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.SESEQ", - "mandatory": true, - "name": "SESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.SE.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.SE.EPOCH", - "mandatory": false, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - }, - { - "OID": "IT.SE.SESTDTC", - "mandatory": true, - "name": "SESTDTC", - "description": "Start Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SE.SEENDTC", - "mandatory": false, - "name": "SEENDTC", - "description": "End Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - } - ], - "conditions": [ - { - "OID": "COND.TS.TSPARMCD.4b2c750e", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "COMPTRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.745804cb", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "CRMDUR" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.82dcbb4a", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INDIC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.de0404c1", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INTTYPE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.1d8ed13f", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "NARMS" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.cccc9db0", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJPRIM" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.863c5858", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.69b92c86", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSPRI" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.df99032e", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.5b1e67a5", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "SPONSOR" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.90f47ac3", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TITLE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.e2190e21", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - } - ], - "whereClauses": [ - { - "OID": "WC.TS.8c559472", - "conditions": [ - "COND.TS.TSPARMCD.4b2c750e" - ] - }, - { - "OID": "WC.TS.bcc79825", - "conditions": [ - "COND.TS.TSPARMCD.745804cb" - ] - }, - { - "OID": "WC.TS.e5769859", - "conditions": [ - "COND.TS.TSPARMCD.82dcbb4a" - ] - }, - { - "OID": "WC.TS.d3e89d3f", - "conditions": [ - "COND.TS.TSPARMCD.de0404c1" - ] - }, - { - "OID": "WC.TS.efd2a465", - "conditions": [ - "COND.TS.TSPARMCD.1d8ed13f" - ] - }, - { - "OID": "WC.TS.fe255586", - "conditions": [ - "COND.TS.TSPARMCD.cccc9db0" - ] - }, - { - "OID": "WC.TS.62794b6c", - "conditions": [ - "COND.TS.TSPARMCD.863c5858" - ] - }, - { - "OID": "WC.TS.4266ae9d", - "conditions": [ - "COND.TS.TSPARMCD.69b92c86" - ] - }, - { - "OID": "WC.TS.1d6311e2", - "conditions": [ - "COND.TS.TSPARMCD.df99032e" - ] - }, - { - "OID": "WC.TS.e06f8db5", - "conditions": [ - "COND.TS.TSPARMCD.5b1e67a5" - ] - }, - { - "OID": "WC.TS.d94c6616", - "conditions": [ - "COND.TS.TSPARMCD.90f47ac3" - ] - }, - { - "OID": "WC.TS.d368cfb2", - "conditions": [ - "COND.TS.TSPARMCD.e2190e21" - ] - } - ], - "codeLists": [ - { - "OID": "CL.ARMCD", - "name": "ARM Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Placebo" - }, - { - "codedValue": "Xanomeline Low Dose" - }, - { - "codedValue": "Xanomeline High Dose" - } - ] - }, - { - "OID": "CL.ARM", - "name": "ARM", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Placebo" - }, - { - "codedValue": "Xanomeline Low Dose" - }, - { - "codedValue": "Xanomeline High Dose" - } - ] - }, - { - "OID": "CL.ELEMENT", - "name": "Description of Element", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Screening" - }, - { - "codedValue": "Placebo" - }, - { - "codedValue": "Low" - }, - { - "codedValue": "High - Start" - }, - { - "codedValue": "High - Middle" - }, - { - "codedValue": "High - End" - }, - { - "codedValue": "Follow up" - } - ] - }, - { - "OID": "CL.ETCD", - "name": "Element Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "EL1", - "decode": "Screening" - }, - { - "codedValue": "EL2", - "decode": "Placebo" - }, - { - "codedValue": "EL3", - "decode": "Low" - }, - { - "codedValue": "EL4", - "decode": "High - Start" - }, - { - "codedValue": "EL5", - "decode": "High - Middle" - }, - { - "codedValue": "EL6", - "decode": "High - End" - }, - { - "codedValue": "EL7", - "decode": "Follow up" - } - ] - }, - { - "OID": "CL.EPOCH", - "name": "Epoch", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99079", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "Screening", - "coding": { - "code": "C202487", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Treatment 1", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Treatment 2", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Treatment 3", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Follow-up", - "coding": { - "code": "C202578", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.ad42d7e1", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "INFORMED CONSENT OBTAINED", - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED" - } - ] - } - ] - }, - { - "OID": "CL.39e500d6", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "RANDOMIZED", - "coding": [ - { - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED" - } - ] - } - ] - }, - { - "OID": "CL.30a86bdd", - "name": "PRDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "X-RAY", - "coding": [ - { - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "X-RAY" - } - ] - } - ] - }, - { - "OID": "CL.20024ecd", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "beats/min", - "coding": [ - { - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min" - } - ] - } - ] - }, - { - "OID": "CL.da016f8d", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "breaths/min", - "coding": [ - { - "code": "C49674", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "breaths/min" - } - ] - } - ] - }, - { - "OID": "CL.798c8fb6", - "name": "EGORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "deg", - "coding": [ - { - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "deg" - } - ] - } - ] - }, - { - "OID": "CL.6751dc8e", - "name": "PRDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "CT SCAN", - "coding": [ - { - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "CT SCAN" - } - ] - } - ] - }, - { - "OID": "CL.5ae118a0", - "name": "PRLOC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "CHEST", - "coding": [ - { - "code": "C25389", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "CHEST" - } - ] - } - ] - }, - { - "OID": "CL.35f151cb", - "name": "PRDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "MRI", - "coding": [ - { - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI" - } - ] - } - ] - }, - { - "OID": "CL.bfc80e1f", - "name": "PRLOC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "BRAIN", - "coding": [ - { - "code": "C12439", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "BRAIN" - } - ] - } - ] - }, - { - "OID": "CL.af8f8a19", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "BLOOD", - "coding": [ - { - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD" - } - ] - } - ] - }, - { - "OID": "CL.1aeb2034", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ERYTHROCYTES", - "coding": [ - { - "code": "C12521", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ERYTHROCYTES" - } - ] - } - ] - }, - { - "OID": "CL.a00fe0a9", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "fL", - "coding": [ - { - "code": "C64780", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "fL" - } - ] - } - ] - }, - { - "OID": "CL.68e5ab5a", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "10^9/L", - "coding": [ - { - "code": "C67255", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^9/L" - } - ] - } - ] - }, - { - "OID": "CL.2c53325c", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "10^6/L", - "coding": [ - { - "code": "C67452", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^6/L" - } - ] - } - ] - }, - { - "OID": "CL.9e69169e", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SERUM OR PLASMA", - "coding": [ - { - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA" - } - ] - } - ] - }, - { - "OID": "CL.c75bb752", - "name": "MBTSTDTL Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "DETECTION", - "coding": [ - { - "code": "C174330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "DETECTION" - } - ] - } - ] - }, - { - "OID": "CL.bbc50609", - "name": "MBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SERUM", - "coding": [ - { - "code": "C13325", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM" - } - ] - } - ] - }, - { - "OID": "CL.bdb73f2b", - "name": "MBMETHOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "LINE PROBE ASSAY", - "coding": [ - { - "code": "C102656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "LINE PROBE ASSAY" - } - ] - } - ] - }, - { - "OID": "CL.5183f82c", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "URINE", - "coding": [ - { - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE" - } - ] - } - ] - }, - { - "OID": "CL.5fc938fc", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "STOOL", - "coding": [ - { - "code": "C13234", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "STOOL" - } - ] - } - ] - }, - { - "OID": "CL.b8dca4b6", - "name": "QSEVAL Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "CAREGIVER", - "coding": [ - { - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER" - } - ] - } - ] - }, - { - "OID": "CL.d8fccc32", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SITE TRANSFER", - "coding": [ - { - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SITE TRANSFER" - } - ] - } - ] - }, - { - "OID": "CL.a3e2e2db", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "coding": [ - { - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY" - } - ] - } - ] - }, - { - "OID": "CL.7cfd6cc5", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "mmHg", - "coding": [ - { - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg" - } - ] - } - ] - }, - { - "OID": "CL.1e00cfce", - "name": "TSPARMCD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "EGCTMON", - "coding": [ - { - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "EGCTMON" - } - ] - } - ] - }, - { - "OID": "CL.NCOMPLT", - "name": "Completion/Reason for Non-Completion", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66727", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSCAT", - "name": "Category of Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74558", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSSCAT", - "name": "Subcategory for Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C170443", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.IECAT", - "name": "Category of Inclusion/Exclusion", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66797", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY", - "name": "No Yes Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.AGEU", - "name": "Age Unit", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66781", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.SEX", - "name": "Sex", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66731", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.SCTESTCD", - "name": "Subject Characteristic Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74559", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.SCTEST", - "name": "Subject Characteristic Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C103330", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.STENRF", - "name": "Relation to Reference Period", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66728", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY_Y", - "name": "No Yes Response (Subset Y)", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY_NY", - "name": "No Yes Response (Subset NY)", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.UNIT", - "name": "Unit", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71620", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FREQ", - "name": "Frequency", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71113", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.PROCEDUR", - "name": "Procedure", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C101858", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "CT SCAN", - "decode": "CAT Scan", - "coding": { - "code": "C17204", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "MRI", - "decode": "Magnetic Resonance Imaging", - "coding": { - "code": "C16809", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "X-RAY", - "decode": "Static X-Ray", - "coding": { - "code": "C38101", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.LOC", - "name": "Anatomical Location", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74456", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "BRAIN", - "decode": "Nervous System, Brain", - "coding": { - "code": "C12439", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "CHEST", - "decode": "Chest", - "coding": { - "code": "C25389", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.LAT", - "name": "Laterality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99073", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTESTCD", - "name": "Vital Signs Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66741", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTEST", - "name": "Vital Signs Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67153", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.POSITION", - "name": "Position", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71148", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSRESU", - "name": "Units for Vital Signs Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66770", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGTESTCD", - "name": "ECG Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71153", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGTEST", - "name": "ECG Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71152", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGSTRESC", - "name": "ECG Result", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71150", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGMETHOD", - "name": "ECG Test Method", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71151", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EVAL", - "name": "Evaluator", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C78735", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "CAREGIVER", - "decode": "Caregiver", - "coding": { - "code": "C17445", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.FRM", - "name": "Dosage Form", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66726", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ROUTE", - "name": "Route of Administration Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66729", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTESTCD", - "name": "Laboratory Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C65047", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTEST", - "name": "Laboratory Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67154", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MBTESTCD", - "name": "Microbiology Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C120527", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MBTEST", - "name": "Microbiology Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C120528", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MBFTSDTL", - "name": "Microbiology Findings Test Details", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C174225", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "DETECTION", - "decode": "", - "coding": { - "code": "C174330", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.SPECTYPE", - "name": "Specimen Type", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C78734", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "SERUM", - "decode": "Sera", - "coding": { - "code": "C13325", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.METHOD", - "name": "Method", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C85492", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "LINE PROBE ASSAY", - "decode": "LiPA", - "coding": { - "code": "C102656", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.URNSTSCD", - "name": "Urinary System Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129942", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.URNSTS", - "name": "Urinary System Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129941", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DIR", - "name": "Directionality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99074", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.QSCAT", - "name": "Category of Questionnaire", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C100129", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.AESEV", - "name": "Severity/Intensity Scale for Adverse Events", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66769", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ACN", - "name": "Action Taken with Study Treatment", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66767", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.OUT", - "name": "Outcome of Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66768", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MUSCTSCD", - "name": "Musculoskeletal System Finding Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C127269", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MUSCTS", - "name": "Musculoskeletal System Finding Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C127270", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TSPARMCD", - "name": "Trial Summary Parameter Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66738", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "EGCTMON", - "decode": "ECG Continuous Monitoring", - "coding": { - "code": "C119561", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.TSPARM", - "name": "Trial Summary Parameter Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67152", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "ECG Continuous Monitoring", - "decode": "ECG Continuous Monitoring", - "coding": { - "code": "C119561", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.DICTNAM", - "name": "Dictionary Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66788", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FTCAT", - "name": "Category of Functional Test", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C115304", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ND", - "name": "Not Done", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66789", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.CNTMODE", - "name": "Mode of Subject Contact", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C171445", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "IN PERSON", - "decode": "In-Person", - "coding": { - "code": "C175574", - "codeSystem": "nci:ExtCodeID" - } - } - ] - } - ], - "methods": [], - "comments": [], - "standards": [ - { - "OID": "STD.SDTMIG", - "name": "SDTMIG", - "type": "IG", - "version": "3.4", - "status": "FINAL" - }, - { - "OID": "STD.SDTMCT", - "name": "CDISC/NCI", - "type": "CT", - "version": "2026-03-27", - "status": "FINAL", - "publishingSet": "SDTM" - } - ], - "annotatedCRF": [], - "concepts": [ - { - "OID": "CONC.BiomedicalConcept_1", - "name": "Informed Consent", - "label": null, - "aliases": [ - "Informed Consent Obtained" - ], - "href": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_2", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_3", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_2", - "name": "Inclusion Criteria", - "label": "Inclusion Criteria", - "aliases": [ - "Inclusion" - ], - "href": "/mdr/bc/biomedicalconcepts/C25532", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_4", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_5", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_6", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Inclusion Criteria" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_3", - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "aliases": [ - "Inclusion Exclusion Criteria Yes No Indicator", - "IEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83063", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_7", - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_8", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_4", - "name": "Exclusion Criteria", - "label": "Exclusion Criteria", - "aliases": [ - "Exclusion" - ], - "href": "/mdr/bc/biomedicalconcepts/C25370", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_9", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_10", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_11", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25370", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Exclusion Criteria" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_5", - "name": "Subject is Randomized", - "label": "Subject is Randomized", - "aliases": [ - "Randomized" - ], - "href": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_12", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.39e500d6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_13", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_14", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_6", - "name": "Race", - "label": "Race", - "aliases": [ - "Racial Group" - ], - "href": "/mdr/bc/biomedicalconcepts/C17049", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_15", - "name": "RACE", - "label": "RACE", - "mandatory": false, - "coding": [ - { - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Race" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_16", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Race" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_7", - "name": "Ethnic Group", - "label": "Ethnic Group", - "aliases": [ - "Ethnicity", - "Ethnic Origin" - ], - "href": "/mdr/bc/biomedicalconcepts/C16564", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_17", - "name": "ETHNIC", - "label": "ETHNIC", - "mandatory": false, - "coding": [ - { - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ethnic Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_18", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Ethnic Group" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_8", - "name": "Subject Age", - "label": "Subject Age", - "aliases": [ - "Age" - ], - "href": "/mdr/bc/biomedicalconcepts/C69260", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_19", - "name": "AGE", - "label": "AGE", - "mandatory": false, - "coding": [ - { - "code": "C170981", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Numeric Age for Data Tabulation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_20", - "name": "AGEU", - "label": "AGEU", - "mandatory": false, - "coding": [ - { - "code": "C50400", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Age Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_21", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C69260", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Subject Age" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_9", - "name": "Birth Date and Time", - "label": "Birth Date and Time", - "aliases": [ - "BRTHDTC", - "Date/Time of Birth" - ], - "href": "/mdr/bc/biomedicalconcepts/C83217", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_22", - "name": "BRTHDTC", - "label": "BRTHDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_23", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83217", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Birth Date and Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_10", - "name": "Sex", - "label": null, - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C28421", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_24", - "name": "SEX", - "label": "SEX", - "mandatory": false, - "coding": [ - { - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_25", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_11", - "name": "Education Level", - "label": "Education Level", - "aliases": [ - "EDULEVEL", - "Education", - "Education Level", - "Education Level Completed", - "education_level", - "Educational Attainment", - "Educational Level", - "Level of Education Attained" - ], - "href": "/mdr/bc/biomedicalconcepts/C17953", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_26", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_27", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C17953", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Education Level" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_12", - "name": "Number of Years of Education", - "label": "Number of Years of Education", - "aliases": [ - "EDUYRNUM", - "Number of Years of Education" - ], - "href": "/mdr/bc/biomedicalconcepts/C122393", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_28", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_29", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C122393", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Number of Years of Education" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_14", - "name": "Solicited Medical History", - "label": "Solicited Medical History", - "aliases": [ - "Medical History", - "Medical History Collection" - ], - "href": "/mdr/bc/biomedicalconcepts/C200145", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_30", - "name": "MHTERM", - "label": "MHTERM", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_31", - "name": "MHDECOD", - "label": "MHDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_32", - "name": "MHSTDTC", - "label": "MHSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83338", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_33", - "name": "MHENDTC", - "label": "MHENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_34", - "name": "MHENRF", - "label": "MHENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_35", - "name": "MHENRTPT", - "label": "MHENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_36", - "name": "MHENTPT", - "label": "MHENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C200145", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Medical History" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_15", - "name": "Alcohol Use History", - "label": "Alcohol Use History", - "aliases": [ - "Alcohol History", - "Alcohol Use" - ], - "href": "/mdr/bc/biomedicalconcepts/C81229", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_37", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_38", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_39", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_40", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_41", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_42", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_43", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_44", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_45", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_46", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_47", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_48", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_49", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_50", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_51", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C81229", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alcohol Use History" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_16", - "name": "Caffeine Use History", - "label": "Caffeine Use History", - "aliases": [ - "Caffeine History", - "Caffeine Use" - ], - "href": "/mdr/bc/biomedicalconcepts/C201990", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_52", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_53", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_54", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_55", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_56", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_57", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_58", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_59", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_60", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_61", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_62", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_63", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_64", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_65", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_66", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C201990", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Caffeine Use History" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_17", - "name": "History of Tobacco Use", - "label": "History of Tobacco Use", - "aliases": [ - "Tobacco Use", - "Tobacco Use History" - ], - "href": "/mdr/bc/biomedicalconcepts/C181760", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_67", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_68", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_69", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_70", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_71", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_72", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_73", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_74", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_75", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_76", - "name": "SUDUR", - "label": "SUDUR", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_77", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_78", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_79", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_80", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_81", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_82", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C181760", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "History of Tobacco Use" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_18", - "name": "X-Ray Imaging", - "label": "X-Ray Imaging", - "aliases": [ - "Conventional X-Ray", - "Medical Imaging", - "X-Ray", - "Static X-Ray" - ], - "href": "/mdr/bc/biomedicalconcepts/C38101", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_83", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_84", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.30a86bdd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_85", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_86", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_87", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_88", - "name": "PRLAT", - "label": "PRLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_89", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_90", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "X-Ray Imaging" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_19", - "name": "Subject is Randomized", - "label": null, - "aliases": [ - "Randomized" - ], - "href": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_91", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.39e500d6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_92", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_93", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_20", - "name": "Body Temperature", - "label": "Body Temperature", - "aliases": [ - "Temperature" - ], - "href": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_94", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_95", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_96", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_97", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_21", - "name": "Body Weight", - "label": "Body Weight", - "aliases": [ - "WEIGHT" - ], - "href": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_98", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_99", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_100", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_22", - "name": "Body Height", - "label": "Body Height", - "aliases": [ - "HEIGHT" - ], - "href": "/mdr/bc/biomedicalconcepts/C164634", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_101", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_102", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C168688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Height" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_103", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C164634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Height" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_23", - "name": "Pulse Rate", - "label": "Pulse Rate", - "aliases": [ - "Pulse" - ], - "href": "/mdr/bc/biomedicalconcepts/C49676", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_104", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_105", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_106", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_107", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_108", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_109", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_24", - "name": "Respiratory Rate", - "label": "Respiratory Rate", - "aliases": [ - "RESP", - "RESPRATE" - ], - "href": "/mdr/bc/biomedicalconcepts/C49678", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_110", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_111", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.da016f8d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_112", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49678", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_25", - "name": "Body Mass Index", - "label": "Body Mass Index", - "aliases": [ - "BMI", - "Quetelet Index" - ], - "href": "/mdr/bc/biomedicalconcepts/C16358", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_113", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_114", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Density" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_115", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Mass Index" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_26", - "name": "Blood Pressure", - "label": "Blood Pressure", - "aliases": [ - "BP" - ], - "href": "/mdr/bc/biomedicalconcepts/C54706", - "properties": [], - "coding": [ - { - "code": "C54706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_27", - "name": "Electrocardiogram Analysis", - "label": "Electrocardiogram Analysis", - "aliases": [ - "ECG Analysis", - "EKG Analysis", - "Electrocardiogram Interpretation", - "ECG Interpretation", - "EKG Interpretation" - ], - "href": "/mdr/bc/biomedicalconcepts/C181655", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_116", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C125009", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Interpretation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_117", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_118", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_119", - "name": "EGCLSIG", - "label": "EGCLSIG", - "mandatory": false, - "coding": [ - { - "code": "C93532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinically Significant Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_120", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C181655", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Electrocardiogram Analysis" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_28", - "name": "Atrioventricular Conduction ECG Assessment", - "label": "Atrioventricular Conduction ECG Assessment", - "aliases": [ - "AVCOND", - "Atrioventricular Conduction" - ], - "href": "/mdr/bc/biomedicalconcepts/C111131", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_121", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_122", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_123", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_124", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_125", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111131", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Atrioventricular Conduction ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_29", - "name": "Axis and Voltage ECG Assessment", - "label": "Axis and Voltage ECG Assessment", - "aliases": [ - "AXISVOLT", - "Axis and Voltage" - ], - "href": "/mdr/bc/biomedicalconcepts/C111132", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_126", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_127", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_128", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_129", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_130", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111132", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Axis and Voltage ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_30", - "name": "Chamber Hypertrophy or Enlargement ECG Assessment", - "label": "Chamber Hypertrophy or Enlargement ECG Assessment", - "aliases": [ - "CHYPTENL", - "Chamber Hypertrophy or Enlargement" - ], - "href": "/mdr/bc/biomedicalconcepts/C111155", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_131", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_132", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_133", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_134", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_135", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111155", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Chamber Hypertrophy or Enlargement ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_31", - "name": "ECG Technical Quality", - "label": "ECG Technical Quality", - "aliases": [ - "TECHQUAL" - ], - "href": "/mdr/bc/biomedicalconcepts/C117807", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_136", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C114120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ECG Recording Quality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_137", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_138", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_139", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117807", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "ECG Technical Quality" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_32", - "name": "Intraventricular and Intraatrial Conduction ECG Assessment", - "label": "Intraventricular and Intraatrial Conduction ECG Assessment", - "aliases": [ - "IVTIACD", - "Intraventricular-Intraatrial Conduction" - ], - "href": "/mdr/bc/biomedicalconcepts/C111238", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_140", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_141", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_142", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_143", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_144", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Intraventricular and Intraatrial Conduction ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_33", - "name": "Myocardial Infarction ECG Assessment", - "label": "Myocardial Infarction ECG Assessment", - "aliases": [ - "MI", - "Myocardial Infarction" - ], - "href": "/mdr/bc/biomedicalconcepts/C111280", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_145", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_146", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_147", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_148", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - } - ], - "coding": [ - { - "code": "C111280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Myocardial Infarction ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_34", - "name": "Pacemaker ECG Assessment", - "label": "Pacemaker ECG Assessment", - "aliases": [ - "PACEMAKR", - "Pacemaker" - ], - "href": "/mdr/bc/biomedicalconcepts/C111285", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_149", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_150", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_151", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_152", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_153", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Pacemaker ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_35", - "name": "Rhythm Not Otherwise Specified ECG Assessment", - "label": "Rhythm Not Otherwise Specified ECG Assessment", - "aliases": [ - "RHYNOS", - "Rhythm Not Otherwise Specified" - ], - "href": "/mdr/bc/biomedicalconcepts/C111307", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_154", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_155", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_156", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_157", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_158", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111307", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Rhythm Not Otherwise Specified ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_36", - "name": "ST Segment, T wave, and U wave ECG Assessment", - "label": "ST Segment, T wave, and U wave ECG Assessment", - "aliases": [ - "STSTWUW", - "ST Segment, T wave, and U wave" - ], - "href": "/mdr/bc/biomedicalconcepts/C111363", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_159", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_160", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_161", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_162", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_163", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111363", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "ST Segment, T wave, and U wave ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_37", - "name": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "label": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "aliases": [ - "SNRARRY", - "Sinus Node Rhythms and Arrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111312", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_164", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_165", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_166", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_167", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_168", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111312", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Sinus Node Rhythm and Arrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_38", - "name": "Supraventricular Arrhythmia ECG Assessment", - "label": "Supraventricular Arrhythmia ECG Assessment", - "aliases": [ - "SPRARRY", - "Supraventricular Arrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111320", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_169", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_170", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_171", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_172", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_173", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111320", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Arrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_39", - "name": "Supraventricular Tachyarrhythmia ECG Assessment", - "label": "Supraventricular Tachyarrhythmia ECG Assessment", - "aliases": [ - "SPRTARRY", - "Supraventricular Tachyarrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111321", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_174", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_175", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_176", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_177", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_178", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Tachyarrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_40", - "name": "Aggregate PR Interval", - "label": "Aggregate PR Interval", - "aliases": [ - "PR Interval Aggregate", - "PQ Interval Aggregate", - "PRAG", - "PQAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117773", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_179", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_180", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_181", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_182", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_183", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_184", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_185", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117773", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate PR Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_41", - "name": "Aggregate QRS Duration", - "label": "Aggregate QRS Duration", - "aliases": [ - "QRS Aggregate Duration", - "QRSAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117779", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_186", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_187", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_188", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_189", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_190", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_191", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_192", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117779", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QRS Duration" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_42", - "name": "Aggregate QT Interval", - "label": "Aggregate QT Interval", - "aliases": [ - "QT Interval Aggregate", - "QTAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117783", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_193", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_194", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_195", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_196", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_197", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_198", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_199", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117783", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QT Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_43", - "name": "Aggregate QTCB Interval", - "label": "Aggregate QTCB Interval", - "aliases": [ - "QTCB Interval Aggregate", - "QTCBAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117784", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_200", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_201", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_202", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_203", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_204", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_205", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_206", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117784", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCB Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_44", - "name": "Aggregate QTCF Interval", - "label": "Aggregate QTCF Interval", - "aliases": [ - "QTCF Interval Aggregate", - "QTCFAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117786", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_207", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_208", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_209", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_210", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_211", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_212", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_213", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCF Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_45", - "name": "Aggregate RR Interval", - "label": "Aggregate RR Interval", - "aliases": [ - "RR Interval Aggregate", - "RRAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117791", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_214", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_215", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_216", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_217", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_218", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_219", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_220", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117791", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Aggregate RR Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_46", - "name": "Mean Heart Rate by Electrocardiogram", - "label": "Mean Heart Rate by Electrocardiogram", - "aliases": [ - "ECG Mean Heart Rate", - "EKG Mean Heart Rate", - "EGHRMN" - ], - "href": "/mdr/bc/biomedicalconcepts/C119259", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_221", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_222", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_223", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_224", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_225", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_226", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C119259", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Mean Heart Rate by Electrocardiogram" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_47", - "name": "QRS Axis", - "label": "QRS Axis", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C118165", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Degree Unit of Plane Angle" - } - ], - "codeList": "CL.798c8fb6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_230", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_231", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_232", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C118165", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QRS Axis" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_48", - "name": "QTc Correction Method Unspecified, Aggregate", - "label": "QTc Correction Method Unspecified, Aggregate", - "aliases": [ - "QTCUNSAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C174285", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_233", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_234", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_235", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_236", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_237", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_238", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C174285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QTc Correction Method Unspecified, Aggregate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_49", - "name": "Ventricular Arrhythmia ECG Assessment", - "label": "Ventricular Arrhythmia ECG Assessment", - "aliases": [ - "VTARRY", - "Ventricular Arrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111330", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Arrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_50", - "name": "Ventricular Tachyarrhythmia ECG Assessment", - "label": "Ventricular Tachyarrhythmia ECG Assessment", - "aliases": [ - "VTTARRY", - "Ventricular Tachyarrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111331", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Tachyarrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_51", - "name": "Computed Tomography", - "label": "Computed Tomography", - "aliases": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "href": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.6751dc8e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.5ae118a0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_52", - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "aliases": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "href": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.35f151cb" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.bfc80e1f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_54", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "aliases": [ - "CMYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_55", - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "aliases": [ - "Concomitant Medication" - ], - "href": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_56", - "name": "Hemoglobin Measurement", - "label": "Hemoglobin Measurement", - "aliases": [ - "Hemoglobin", - "HGB" - ], - "href": "/mdr/bc/biomedicalconcepts/C64848", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64848", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_57", - "name": "Hematocrit Measurement", - "label": "Hematocrit Measurement", - "aliases": [ - "Hematocrit", - "Packed Cell Volume", - "PCV", - "Erythrocyte Volume Fraction", - "EVF" - ], - "href": "/mdr/bc/biomedicalconcepts/C64796", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C69174", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume Fraction" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64796", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hematocrit Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_58", - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "aliases": [ - "RBC", - "Red Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_59", - "name": "Erythrocyte Mean Corpuscular Hemoglobin", - "label": "Erythrocyte Mean Corpuscular Hemoglobin", - "aliases": [ - "RBC Mean Corpuscular Hemoglobin", - "MCH" - ], - "href": "/mdr/bc/biomedicalconcepts/C64797", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C25709", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Measure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1aeb2034" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_302", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_303", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Hemoglobin" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_60", - "name": "Erythrocyte Mean Corpuscular Volume", - "label": "Erythrocyte Mean Corpuscular Volume", - "aliases": [ - "RBC Mean Corpuscular Volume", - "MCV" - ], - "href": "/mdr/bc/biomedicalconcepts/C64799", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_304", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_305", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" - } - ], - "codeList": "CL.a00fe0a9" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_306", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1aeb2034" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_307", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_308", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64799", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Volume" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_61", - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "aliases": [ - "WBC", - "White Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_309", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_310", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_311", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_312", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_313", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_62", - "name": "Segmented Neutrophil Count", - "label": "Segmented Neutrophil Count", - "aliases": [ - "Segmented Neutrophils", - "NEUTSG" - ], - "href": "/mdr/bc/biomedicalconcepts/C81997", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_314", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_315", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.68e5ab5a" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_316", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C81997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Segmented Neutrophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_63", - "name": "Neutrophil Band Form Count", - "label": "Neutrophil Band Form Count", - "aliases": [ - "Neutrophil Bands", - "Bands", - "NEUTB" - ], - "href": "/mdr/bc/biomedicalconcepts/C64830", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.2c53325c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64830", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Neutrophil Band Form Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_64", - "name": "Absolute Neutrophil Count", - "label": "Absolute Neutrophil Count", - "aliases": [ - "Neutrophils", - "Total Neutrophil Count", - "NEUT" - ], - "href": "/mdr/bc/biomedicalconcepts/C63321", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.68e5ab5a" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C63321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Neutrophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_65", - "name": "Monocyte Count", - "label": "Monocyte Count", - "aliases": [ - "Monocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C64823", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64823", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Monocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_66", - "name": "Eosinophil Count", - "label": "Eosinophil Count", - "aliases": [ - "Eosinophils" - ], - "href": "/mdr/bc/biomedicalconcepts/C64550", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64550", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Eosinophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_67", - "name": "Absolute Basophil Count", - "label": "Absolute Basophil Count", - "aliases": [ - "Basophils", - "Total Basophil Count" - ], - "href": "/mdr/bc/biomedicalconcepts/C64470", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_341", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_342", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_343", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64470", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Basophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_68", - "name": "Platelet Count", - "label": "Platelet Count", - "aliases": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_344", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_345", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_69", - "name": "Microcyte Count", - "label": "Microcyte Count", - "aliases": [ - "Microcytes", - "MICROCY" - ], - "href": "/mdr/bc/biomedicalconcepts/C64822", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64822", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Microcyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_70", - "name": "Macrocyte Count", - "label": "Macrocyte Count", - "aliases": [ - "Macrocytes", - "MACROCY" - ], - "href": "/mdr/bc/biomedicalconcepts/C64821", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_354", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_355", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_356", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64821", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Macrocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_71", - "name": "Anisocyte Measurement", - "label": "Anisocyte Measurement", - "aliases": [ - "Anisocytes", - "Anisocytosis", - "ANISO" - ], - "href": "/mdr/bc/biomedicalconcepts/C74797", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_358", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_359", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_360", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anisocyte Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_72", - "name": "Poikilocyte Measurement", - "label": "Poikilocyte Measurement", - "aliases": [ - "POIKILO", - "Poikilocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C79602", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_361", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C79602", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Poikilocyte Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_73", - "name": "Polychromasia", - "label": "Polychromasia", - "aliases": [ - "POLYCHR" - ], - "href": "/mdr/bc/biomedicalconcepts/C64803", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_365", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_366", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_367", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_368", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64803", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Polychromasia" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_74", - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "aliases": [ - "ALT", - "SGPT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_369", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_370", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_371", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_372", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_373", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_75", - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "aliases": [ - "Albumin" - ], - "href": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_374", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_375", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_376", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_377", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_378", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_76", - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "aliases": [ - "Alkaline Phosphatase" - ], - "href": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_379", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_380", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_381", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_382", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_383", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_77", - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "aliases": [ - "AST", - "SGOT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_384", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_385", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_386", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_387", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_388", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_78", - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "aliases": [ - "Creatinine" - ], - "href": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_389", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_390", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_391", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_392", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_393", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_79", - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "aliases": [ - "Potassium", - "K" - ], - "href": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_394", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_395", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_396", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_397", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_398", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_80", - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "aliases": [ - "Sodium", - "NA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_399", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_400", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_401", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_402", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_403", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_81", - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "aliases": [ - "Urea Nitrogen" - ], - "href": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_404", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_405", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_406", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_407", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_408", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_82", - "name": "Bicarbonate Measurement", - "label": "Bicarbonate Measurement", - "aliases": [ - "Bicarbonate", - "HCO3" - ], - "href": "/mdr/bc/biomedicalconcepts/C74667", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_419", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_420", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_421", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_422", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_423", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Bicarbonate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_83", - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "aliases": [ - "Chloride", - "CL" - ], - "href": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_429", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_430", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_431", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_432", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_433", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_84", - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "aliases": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "href": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_439", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_440", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_441", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_442", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_443", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_85", - "name": "Gamma Glutamyl Transpeptidase Measurement", - "label": "Gamma Glutamyl Transpeptidase Measurement", - "aliases": [ - "Gamma Glutamyl Transferase", - "GGT", - "GGTP" - ], - "href": "/mdr/bc/biomedicalconcepts/C64847", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_449", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_450", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_451", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_452", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_453", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64847", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Gamma Glutamyl Transpeptidase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_86", - "name": "Urate Measurement", - "label": "Urate Measurement", - "aliases": [ - "Urate", - "Uric Acid" - ], - "href": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_459", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_460", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_461", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_462", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_463", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_87", - "name": "Phosphate Measurement", - "label": "Phosphate Measurement", - "aliases": [ - "Phosphorus", - "Phosphate" - ], - "href": "/mdr/bc/biomedicalconcepts/C64857", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_469", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_470", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_471", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_472", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_473", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64857", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Phosphate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_88", - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "aliases": [ - "Calcium", - "CA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_480", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_481", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_482", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_483", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_484", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_89", - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "aliases": [ - "Glucose" - ], - "href": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_495", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_496", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_497", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_498", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_499", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_500", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_90", - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "aliases": [ - "Protein" - ], - "href": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_506", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_507", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_508", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_509", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_510", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_91", - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "aliases": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_516", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_517", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_518", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_519", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_520", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_92", - "name": "Triiodothyronine Uptake Measurement", - "label": "Triiodothyronine Uptake Measurement", - "aliases": [ - "T3UP", - "T3U", - "Triiodothyronine Resin Uptake" - ], - "href": "/mdr/bc/biomedicalconcepts/C74748", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_526", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_527", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48570", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_528", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_529", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_530", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74748", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Uptake Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_93", - "name": "Triiodothyronine Measurement", - "label": "Triiodothyronine Measurement", - "aliases": [ - "T3", - "Total T3" - ], - "href": "/mdr/bc/biomedicalconcepts/C74747", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_535", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_536", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_537", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_538", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_539", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74747", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_94", - "name": "Free Thyroxine Measurement", - "label": "Free Thyroxine Measurement", - "aliases": [ - "Free T4", - "T4FR" - ], - "href": "/mdr/bc/biomedicalconcepts/C74786", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_545", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_546", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_547", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_548", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_549", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_95", - "name": "Free Thyroxine Index", - "label": "Free Thyroxine Index", - "aliases": [ - "T4FRIDX" - ], - "href": "/mdr/bc/biomedicalconcepts/C170598", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_555", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_556", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_557", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_558", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C170598", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Index" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_96", - "name": "Thyrotropin Measurement", - "label": "Thyrotropin Measurement", - "aliases": [ - "TSH", - "Thyrotropin" - ], - "href": "/mdr/bc/biomedicalconcepts/C64813", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_564", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_565", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_566", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_567", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_568", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64813", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Thyrotropin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_97", - "name": "Folic Acid Measurement", - "label": "Folic Acid Measurement", - "aliases": [ - "Folate", - "Folic Acid", - "Vitamin B9", - "VITB9" - ], - "href": "/mdr/bc/biomedicalconcepts/C74676", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_574", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_575", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_576", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_577", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_578", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Folic Acid Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_98", - "name": "Vitamin B12 Measurement", - "label": "Vitamin B12 Measurement", - "aliases": [ - "Cobalamin", - "Vitamin B12", - "VITB12" - ], - "href": "/mdr/bc/biomedicalconcepts/C64817", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_584", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_585", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_586", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_587", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_588", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64817", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Vitamin B12 Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_99", - "name": "Treponema pallidum Antibody Measurement", - "label": "Treponema pallidum Antibody Measurement", - "aliases": [ - "TPLAB", - "Treponema pallidum Antibody", - "Syphilis Antibody" - ], - "href": "/mdr/bc/biomedicalconcepts/C132388", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_592", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.c75bb752" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_593", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_594", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.bbc50609" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_595", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_596", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C132388", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum Antibody Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_100", - "name": "Treponema pallidum DNA Measurement", - "label": "Treponema pallidum DNA Measurement", - "aliases": [ - "TPADNA", - "Syphilis DNA" - ], - "href": "/mdr/bc/biomedicalconcepts/C198341", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_606", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.c75bb752" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_607", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_608", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_609", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ], - "codeList": "CL.bdb73f2b" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_610", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C198341", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum DNA Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_101", - "name": "Color Assessment", - "label": "Color Assessment", - "aliases": [ - "COLOR", - "Color" - ], - "href": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_616", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_617", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_618", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_102", - "name": "Specific Gravity", - "label": "Specific Gravity", - "aliases": [ - "SPGRAV" - ], - "href": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_629", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_630", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_631", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_632", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_103", - "name": "Total Protein Measurement", - "label": null, - "aliases": [ - "Protein" - ], - "href": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_633", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_634", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_635", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_636", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_637", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_104", - "name": "Glucose Measurement", - "label": null, - "aliases": [ - "Glucose" - ], - "href": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_643", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_644", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_645", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_646", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_647", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_105", - "name": "Ketone Measurement", - "label": "Ketone Measurement", - "aliases": [ - "Ketones" - ], - "href": "/mdr/bc/biomedicalconcepts/C64854", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_652", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_653", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_654", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_655", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_656", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64854", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Ketone Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_106", - "name": "Total Bilirubin Measurement", - "label": null, - "aliases": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "href": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_657", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_658", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_659", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_660", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_661", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_107", - "name": "Urobilinogen Measurement", - "label": "Urobilinogen Measurement", - "aliases": [ - "Urobilinogen", - "UROBIL" - ], - "href": "/mdr/bc/biomedicalconcepts/C64816", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_667", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_668", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_669", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_670", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_671", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64816", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urobilinogen Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_108", - "name": "Occult Blood Measurement", - "label": "Occult Blood Measurement", - "aliases": [ - "Occult Blood", - "OCCBLD" - ], - "href": "/mdr/bc/biomedicalconcepts/C74686", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_676", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_677", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5fc938fc" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_678", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_679", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74686", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occult Blood Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_109", - "name": "Nitrite Measurement", - "label": "Nitrite Measurement", - "aliases": [ - "NITRITE" - ], - "href": "/mdr/bc/biomedicalconcepts/C64810", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_684", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_685", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_686", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_687", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_688", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64810", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Nitrite Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_110", - "name": "Hemoglobin A1C Measurement", - "label": "Hemoglobin A1C Measurement", - "aliases": [ - "Hemoglobin A1C", - "HBA1C", - "Glycosylated Hemoglobin A1C" - ], - "href": "/mdr/bc/biomedicalconcepts/C64849", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_703", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_704", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_705", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_706", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64849", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin A1C Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_111", - "name": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "label": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "aliases": [ - "Hemoglobin A1C/Hemoglobin", - "HBA1CHGB" - ], - "href": "/mdr/bc/biomedicalconcepts/C111207", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_713", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_714", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_715", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_716", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Hemoglobin A1C to Hemoglobin Ratio Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_112", - "name": "Exposure as Collected Domain", - "label": "Exposure as Collected Domain", - "aliases": [ - "EC", - "Exposure as Collected" - ], - "href": "/mdr/bc/biomedicalconcepts/C117466", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_720", - "name": "ECTRT", - "label": "ECTRT", - "mandatory": true, - "coding": [ - { - "code": "C117473", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Name of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_721", - "name": "ECREFID", - "label": "ECREFID", - "mandatory": false, - "coding": [ - { - "code": "C117469", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_722", - "name": "ECDOSE", - "label": "ECDOSE", - "mandatory": false, - "coding": [ - { - "code": "C117479", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_723", - "name": "ECDOSTXT", - "label": "ECDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C117480", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_724", - "name": "ECDOSU", - "label": "ECDOSU", - "mandatory": false, - "coding": [ - { - "code": "C117481", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Units" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_725", - "name": "ECDOSFRM", - "label": "ECDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C117482", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_726", - "name": "ECDOSFRQ", - "label": "ECDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C117483", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dosing Frequency per Interval" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_727", - "name": "ECDOSRGM", - "label": "ECDOSRGM", - "mandatory": false, - "coding": [ - { - "code": "C117485", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Intended Dose Regimen" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_728", - "name": "ECROUTE", - "label": "ECROUTE", - "mandatory": false, - "coding": [ - { - "code": "C117486", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_729", - "name": "ECLOC", - "label": "ECLOC", - "mandatory": false, - "coding": [ - { - "code": "C117488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_730", - "name": "ECLAT", - "label": "ECLAT", - "mandatory": false, - "coding": [ - { - "code": "C117489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_731", - "name": "ECDIR", - "label": "ECDIR", - "mandatory": false, - "coding": [ - { - "code": "C117490", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_732", - "name": "ECSTDTC", - "label": "ECSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Start Date and Time of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_733", - "name": "ECENDTC", - "label": "ECENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117497", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected End Date and Time of Treatment" - } - ] - } - ], - "coding": [ - { - "code": "C117466", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Exposure as Collected Domain" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_113", - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_734", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_735", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_736", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - } - ], - "coding": [ - { - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_114", - "name": "TTS Acceptability Survey - Patch Acceptability", - "label": "TTS Acceptability Survey - Patch Acceptability", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT4", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_740", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_741", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_742", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - } - ], - "coding": [ - { - "code": "NEW_LZZT4", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Acceptability" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_115", - "name": "TTS Acceptability Survey - Patch Appearance", - "label": "TTS Acceptability Survey - Patch Appearance", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT1", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_748", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_749", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_750", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - } - ], - "coding": [ - { - "code": "NEW_LZZT1", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Appearance" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_116", - "name": "TTS Acceptability Survey - Patch Durability", - "label": "TTS Acceptability Survey - Patch Durability", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT3", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_777", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_778", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_779", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - } - ], - "coding": [ - { - "code": "NEW_LZZT3", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Durability" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_117", - "name": "TTS Acceptability Survey - Patch Size", - "label": "TTS Acceptability Survey - Patch Size", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT2", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_780", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_781", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_782", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - } - ], - "coding": [ - { - "code": "NEW_LZZT2", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Size" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_134", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "aliases": [ - "AEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_783", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_784", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_135", - "name": "Solicited Adverse Event", - "label": "Solicited Adverse Event", - "aliases": [ - "Adverse Event" - ], - "href": "/mdr/bc/biomedicalconcepts/C179175", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_785", - "name": "AETERM", - "label": "AETERM", - "mandatory": true, - "coding": [ - { - "code": "C78541", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Verbatim Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_786", - "name": "AEDECOD", - "label": "AEDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83344", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_787", - "name": "AELOC", - "label": "AELOC", - "mandatory": false, - "coding": [ - { - "code": "C83205", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_788", - "name": "AESEV", - "label": "AESEV", - "mandatory": false, - "coding": [ - { - "code": "C53253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Severity of Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_789", - "name": "AESER", - "label": "AESER", - "mandatory": false, - "coding": [ - { - "code": "C53252", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Seriousness of Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_790", - "name": "AEACN", - "label": "AEACN", - "mandatory": false, - "coding": [ - { - "code": "C83013", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Action Taken with Study Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_791", - "name": "AEACNOTH", - "label": "AEACNOTH", - "mandatory": false, - "coding": [ - { - "code": "C83109", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Other Actions taken in Response to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_792", - "name": "AEREL", - "label": "AEREL", - "mandatory": false, - "coding": [ - { - "code": "C41358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Attribution to Product or Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_793", - "name": "AERELNST", - "label": "AERELNST", - "mandatory": false, - "coding": [ - { - "code": "C83210", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Relationship to Non Study Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_794", - "name": "AEPATT", - "label": "AEPATT", - "mandatory": false, - "coding": [ - { - "code": "C83208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Pattern" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_795", - "name": "AEOUT", - "label": "AEOUT", - "mandatory": false, - "coding": [ - { - "code": "C49489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Outcome" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_796", - "name": "AESCAN", - "label": "AESCAN", - "mandatory": false, - "coding": [ - { - "code": "C83211", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Involves Cancer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_797", - "name": "AESCONG", - "label": "AESCONG", - "mandatory": false, - "coding": [ - { - "code": "C83117", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_798", - "name": "AESDISAB", - "label": "AESDISAB", - "mandatory": false, - "coding": [ - { - "code": "C113380", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Disabling Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_799", - "name": "AESDTH", - "label": "AESDTH", - "mandatory": false, - "coding": [ - { - "code": "C48275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Death Related to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_800", - "name": "AESHOSP", - "label": "AESHOSP", - "mandatory": false, - "coding": [ - { - "code": "C83052", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event associated with Hospitalization" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_801", - "name": "AESLIFE", - "label": "AESLIFE", - "mandatory": false, - "coding": [ - { - "code": "C84266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Life Threatening Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_802", - "name": "AESOD", - "label": "AESOD", - "mandatory": false, - "coding": [ - { - "code": "C83214", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Occurred with Overdose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_803", - "name": "AESMIE", - "label": "AESMIE", - "mandatory": false, - "coding": [ - { - "code": "C83053", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Associated with Serious Medical Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_804", - "name": "AECONTRT", - "label": "AECONTRT", - "mandatory": false, - "coding": [ - { - "code": "C83199", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Concomitant Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_805", - "name": "AETOXGR", - "label": "AETOXGR", - "mandatory": false, - "coding": [ - { - "code": "C78605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Toxicity Grade" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_806", - "name": "AESTDTC", - "label": "AESTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_807", - "name": "AEENDTC", - "label": "AEENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83201", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_808", - "name": "AEENRF", - "label": "AEENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_809", - "name": "AEENRTPT", - "label": "AEENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_810", - "name": "AEENTPT", - "label": "AEENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C179175", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Adverse Event" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_136", - "name": "Complete", - "label": "Complete", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C25250", - "properties": [], - "coding": [ - { - "code": "C25250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Complete [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_137", - "name": "Failure To Meet Continuation Criteria", - "label": "Failure To Meet Continuation Criteria", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C139236", - "properties": [], - "coding": [ - { - "code": "C139236", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Failure To Meet Continuation Criteria [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_138", - "name": "Dead", - "label": "Dead", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C28554", - "properties": [], - "coding": [ - { - "code": "C28554", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Dead [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_139", - "name": "Lack of Efficacy", - "label": "Lack of Efficacy", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C48226", - "properties": [], - "coding": [ - { - "code": "C48226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lack of Efficacy [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_140", - "name": "Lost To Follow-Up", - "label": "Lost To Follow-Up", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C48227", - "properties": [], - "coding": [ - { - "code": "C48227", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lost To Follow-Up [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_141", - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "coding": [ - { - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_142", - "name": "Physician Decision", - "label": "Physician Decision", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C48250", - "properties": [], - "coding": [ - { - "code": "C48250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Physician Decision [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_143", - "name": "Pregnant Subject", - "label": "Pregnant Subject", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C191656", - "properties": [], - "coding": [ - { - "code": "C191656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Pregnant Subject [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_144", - "name": "Progressive Disease", - "label": "Progressive Disease", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C35571", - "properties": [], - "coding": [ - { - "code": "C35571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Progressive Disease [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_145", - "name": "Protocol Deviation", - "label": "Protocol Deviation", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C50996", - "properties": [], - "coding": [ - { - "code": "C50996", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Protocol Deviation" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_146", - "name": "Study Site Transfer", - "label": "Study Site Transfer", - "aliases": [ - "Site Transfer", - "Study Subject Site Transfer" - ], - "href": "/mdr/bc/biomedicalconcepts/C186208", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_811", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.d8fccc32" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_812", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_813", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Site Transfer" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_147", - "name": "Study Terminated By Sponsor", - "label": "Study Terminated By Sponsor", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C49632", - "properties": [], - "coding": [ - { - "code": "C49632", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Terminated By Sponsor" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_148", - "name": "Subject Removed at Sponsor Request", - "label": "Subject Removed at Sponsor Request", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C161410", - "properties": [], - "coding": [ - { - "code": "C161410", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Subject Removed at Sponsor Request [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_149", - "name": "Trial Screen Failure", - "label": "Trial Screen Failure", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C49628", - "properties": [], - "coding": [ - { - "code": "C49628", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Screen Failure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_150", - "name": "Trial Site Terminated by Sponsor", - "label": "Trial Site Terminated by Sponsor", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C106576", - "properties": [], - "coding": [ - { - "code": "C106576", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Site Terminated by Sponsor" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_151", - "name": "Withdrawal by Subject", - "label": "Withdrawal by Subject", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C49634", - "properties": [], - "coding": [ - { - "code": "C49634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Withdrawal by Subject" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_152", - "name": "Withdrawal of Consent From Protocol-Specified Activity", - "label": "Withdrawal of Consent From Protocol-Specified Activity", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C170610", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_823", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.a3e2e2db" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_824", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_825", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Withdrawal of Consent From Protocol-Specified Activity" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_153", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "aliases": [ - "SYSBP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_832", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_833", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_834", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_835", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_836", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_837", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_154", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "aliases": [ - "DIABP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_862", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_863", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_864", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_865", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_866", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_867", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_155", - "name": "Heart Rate", - "label": "Heart Rate", - "aliases": [ - "HR" - ], - "href": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_880", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_881", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_882", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_883", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_884", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_885", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_156", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "aliases": [ - "SYSBP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_886", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_887", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_888", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_889", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_890", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_891", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_157", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "aliases": [ - "DIABP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_892", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_893", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_894", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_895", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_896", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_897", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_158", - "name": "Heart Rate", - "label": "Heart Rate", - "aliases": [ - "HR" - ], - "href": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_898", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_899", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_900", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_901", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_902", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_903", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_159", - "name": "Isometric Muscle Strength", - "label": "Isometric Muscle Strength", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C138967", - "properties": [], - "coding": [ - { - "code": "C138967", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Isometric Muscle Strength" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_160", - "name": "Skeletal Muscle Mass Measurement", - "label": "Skeletal Muscle Mass Measurement", - "aliases": [ - "SMMASS", - "Skeletal Muscle Mass" - ], - "href": "/mdr/bc/biomedicalconcepts/C178017", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_920", - "name": "MKORRES", - "label": "MKORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_921", - "name": "MKORRESU", - "label": "MKORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42579", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_922", - "name": "MKLOC", - "label": "MKLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_923", - "name": "MKLAT", - "label": "MKLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_924", - "name": "MKMETHOD", - "label": "MKMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_925", - "name": "MKDTC", - "label": "MKDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C178017", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Skeletal Muscle Mass Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_161", - "name": "Muscle Endurance Measurement", - "label": "Muscle Endurance Measurement", - "aliases": [ - "ENDURM", - "Muscle Endurance" - ], - "href": "/mdr/bc/biomedicalconcepts/C181501", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_933", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_934", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_935", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_936", - "name": "Laterality", - "label": "Laterality", - "mandatory": true, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_937", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_938", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C181501", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Muscle Endurance Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_162", - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "aliases": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "href": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_949", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_950", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_951", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_952", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_953", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_954", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ], - "coding": [ - { - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_164", - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_955", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_956", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_957", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - } - ], - "coding": [ - { - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_165", - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "aliases": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "href": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_974", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_975", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.35f151cb" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_976", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_977", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_978", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.bfc80e1f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_979", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_980", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_166", - "name": "Computed Tomography", - "label": "Computed Tomography", - "aliases": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "href": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_997", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_998", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.6751dc8e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_999", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1000", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1001", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1002", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1003", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_168", - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "aliases": [ - "Vital Signs", - "VS" - ], - "href": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "coding": [ - { - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_169", - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "aliases": [ - "Vital Signs", - "VS" - ], - "href": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "coding": [ - { - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_170", - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "coding": [ - { - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_171", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "aliases": [ - "AEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1012", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1013", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_172", - "name": "CDISC ADAS-Cog - Word Recall Average Score", - "label": "CDISC ADAS-Cog - Word Recall Average Score", - "aliases": [ - "ADCRL", - "Word Recall", - "CDISC ADAS-Cog - Word Recall Average Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100177", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1022", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1023", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1024", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1025", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1026", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1027", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1028", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1029", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100177", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recall Average Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_173", - "name": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "label": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "aliases": [ - "ADCOF", - "Naming Objects and Fingers", - "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100191", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1030", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1031", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1032", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1033", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1034", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1035", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1036", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1037", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100191", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_174", - "name": "CDISC ADAS-Cog - Commands Summary Score", - "label": "CDISC ADAS-Cog - Commands Summary Score", - "aliases": [ - "ADCCMD", - "Commands", - "CDISC ADAS-Cog - Commands Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100209", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1046", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1047", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1048", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1049", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1050", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1051", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1052", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1053", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Commands Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_175", - "name": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "label": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "aliases": [ - "ADCDRL", - "Delayed Word Recall", - "CDISC ADAS-Cog - Delayed Word Recall Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100215", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1062", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1063", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1064", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1065", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1066", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1067", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1068", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1069", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Delayed Word Recall Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_176", - "name": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "label": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "aliases": [ - "ADCCP", - "Constructional Praxis", - "CDISC ADAS-Cog - Constructional Praxis Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100226", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1078", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1079", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1080", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1081", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1082", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1083", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1084", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1085", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - } - ], - "coding": [ - { - "code": "C100226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Constructional Praxis Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_177", - "name": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "label": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "aliases": [ - "ADCIP", - "Ideational Praxis", - "CDISC ADAS-Cog - Ideational Praxis Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100232", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1094", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1095", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1096", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1097", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1098", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1099", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1100", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1101", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - } - ], - "coding": [ - { - "code": "C100232", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Ideational Praxis Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_178", - "name": "CDISC ADAS-Cog - Orientation Summary Score", - "label": "CDISC ADAS-Cog - Orientation Summary Score", - "aliases": [ - "ADCOR", - "Orientation", - "CDISC ADAS-Cog - Orientation Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100238", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1110", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1111", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1112", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1113", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1114", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1115", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1116", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1117", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - } - ], - "coding": [ - { - "code": "C100238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Orientation Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_179", - "name": "CDISC ADAS-Cog - Word Recognition Summary Score", - "label": "CDISC ADAS-Cog - Word Recognition Summary Score", - "aliases": [ - "ADCRG", - "Word Recognition", - "CDISC ADAS-Cog - Word Recognition Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100247", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1126", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1127", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1128", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1129", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1130", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1131", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1132", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1133", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - } - ], - "coding": [ - { - "code": "C100247", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recognition Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_180", - "name": "CDISC ADAS-Cog - Remembering Test Instructions", - "label": "CDISC ADAS-Cog - Remembering Test Instructions", - "aliases": [ - "ADCRI", - "Remembering Test Instructions", - "CDISC ADAS-Cog - Remembering Test Instructions" - ], - "href": "/mdr/bc/biomedicalconcepts/C100275", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1142", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1143", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1144", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1145", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1146", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1147", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1148", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1149", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - } - ], - "coding": [ - { - "code": "C100275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Remembering Test Instructions" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_181", - "name": "CDISC ADAS-Cog - Spoken Language Ability", - "label": "CDISC ADAS-Cog - Spoken Language Ability", - "aliases": [ - "ADCSL", - "Spoken Language Ability", - "CDISC ADAS-Cog - Spoken Language Ability" - ], - "href": "/mdr/bc/biomedicalconcepts/C100276", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1167", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1168", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1169", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1170", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1171", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1172", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1173", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1174", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Spoken Language Ability" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_182", - "name": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "label": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "aliases": [ - "ADCDIF", - "Word Finding Difficulty in Spont Speech", - "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" - ], - "href": "/mdr/bc/biomedicalconcepts/C100277", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1181", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1182", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1183", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1184", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1185", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1186", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1187", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1188", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - } - ], - "coding": [ - { - "code": "C100277", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_183", - "name": "CDISC ADAS-Cog - Comprehension", - "label": "CDISC ADAS-Cog - Comprehension", - "aliases": [ - "ADCCMP", - "Comprehension", - "CDISC ADAS-Cog - Comprehension" - ], - "href": "/mdr/bc/biomedicalconcepts/C100278", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1189", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1190", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1191", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1192", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1193", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1194", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1195", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1196", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100278", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Comprehension" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_184", - "name": "CDISC ADAS-Cog - Concentration/Distractibility", - "label": "CDISC ADAS-Cog - Concentration/Distractibility", - "aliases": [ - "ADCCON", - "Concentration/Distractibility", - "CDISC ADAS-Cog - Concentration/Distractibility" - ], - "href": "/mdr/bc/biomedicalconcepts/C100279", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1197", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1198", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1199", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1200", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1201", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1202", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1203", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1204", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - } - ], - "coding": [ - { - "code": "C100279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Concentration/Distractibility" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_185", - "name": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "label": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "aliases": [ - "ADCNC", - "Number Cancellation", - "CDISC ADAS-Cog - Number Cancellation Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100280", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1205", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1206", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1207", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1208", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1209", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1210", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1211", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1212", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Number Cancellation Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_186", - "name": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "label": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "aliases": [ - "ADCMZ01", - "Executive Function Maze: Errors", - "CDISC ADAS-Cog - Executive Function Maze: Errors" - ], - "href": "/mdr/bc/biomedicalconcepts/C100285", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1213", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1214", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1215", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1216", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1217", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1218", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1219", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1220", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - } - ], - "coding": [ - { - "code": "C100285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Errors" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_187", - "name": "CDISC ADAS-Cog - Executive Function Maze: Time", - "label": "CDISC ADAS-Cog - Executive Function Maze: Time", - "aliases": [ - "ADCMZ02", - "Executive Function Maze: Time", - "CDISC ADAS-Cog - Executive Function Maze: Time" - ], - "href": "/mdr/bc/biomedicalconcepts/C100286", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1221", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1222", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1223", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1224", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1225", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1226", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1227", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1228", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1229", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100286", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_163", - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "aliases": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "href": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1230", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1231", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1232", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1233", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1234", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1235", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ], - "coding": [ - { - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator" - } - ] - } - ], - "conceptProperties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_2", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_3", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_4", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_5", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_6", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_7", - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_8", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_9", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_10", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_11", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_12", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.39e500d6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_13", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_14", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_15", - "name": "RACE", - "label": "RACE", - "mandatory": false, - "coding": [ - { - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Race" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_16", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_17", - "name": "ETHNIC", - "label": "ETHNIC", - "mandatory": false, - "coding": [ - { - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ethnic Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_18", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_19", - "name": "AGE", - "label": "AGE", - "mandatory": false, - "coding": [ - { - "code": "C170981", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Numeric Age for Data Tabulation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_20", - "name": "AGEU", - "label": "AGEU", - "mandatory": false, - "coding": [ - { - "code": "C50400", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Age Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_21", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_22", - "name": "BRTHDTC", - "label": "BRTHDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_23", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_24", - "name": "SEX", - "label": "SEX", - "mandatory": false, - "coding": [ - { - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_25", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_26", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_27", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_28", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_29", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_30", - "name": "MHTERM", - "label": "MHTERM", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_31", - "name": "MHDECOD", - "label": "MHDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_32", - "name": "MHSTDTC", - "label": "MHSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83338", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_33", - "name": "MHENDTC", - "label": "MHENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_34", - "name": "MHENRF", - "label": "MHENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_35", - "name": "MHENRTPT", - "label": "MHENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_36", - "name": "MHENTPT", - "label": "MHENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_37", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_38", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_39", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_40", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_41", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_42", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_43", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_44", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_45", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_46", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_47", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_48", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_49", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_50", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_51", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_52", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_53", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_54", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_55", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_56", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_57", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_58", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_59", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_60", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_61", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_62", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_63", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_64", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_65", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_66", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_67", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_68", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_69", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_70", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_71", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_72", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_73", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_74", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_75", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_76", - "name": "SUDUR", - "label": "SUDUR", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_77", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_78", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_79", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_80", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_81", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_82", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_83", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_84", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.30a86bdd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_85", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_86", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_87", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_88", - "name": "PRLAT", - "label": "PRLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_89", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_90", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_91", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.39e500d6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_92", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_93", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_94", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_95", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_96", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_97", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_98", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_99", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_100", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_101", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_102", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C168688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Height" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_103", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_104", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_105", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_106", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_107", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_108", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_109", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_110", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_111", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.da016f8d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_112", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_113", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_114", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Density" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_115", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_116", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C125009", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Interpretation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_117", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_118", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_119", - "name": "EGCLSIG", - "label": "EGCLSIG", - "mandatory": false, - "coding": [ - { - "code": "C93532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinically Significant Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_120", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_121", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_122", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_123", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_124", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_125", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_126", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_127", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_128", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_129", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_130", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_131", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_132", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_133", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_134", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_135", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_136", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C114120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ECG Recording Quality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_137", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_138", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_139", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_140", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_141", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_142", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_143", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_144", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_145", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_146", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_147", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_148", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_149", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_150", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_151", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_152", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_153", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_154", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_155", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_156", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_157", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_158", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_159", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_160", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_161", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_162", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_163", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_164", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_165", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_166", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_167", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_168", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_169", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_170", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_171", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_172", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_173", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_174", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_175", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_176", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_177", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_178", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_179", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_180", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_181", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_182", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_183", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_184", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_185", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_186", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_187", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_188", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_189", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_190", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_191", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_192", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_193", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_194", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_195", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_196", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_197", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_198", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_199", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_200", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_201", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_202", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_203", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_204", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_205", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_206", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_207", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_208", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_209", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_210", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_211", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_212", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_213", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_214", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_215", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_216", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_217", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_218", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_219", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_220", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_221", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_222", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_223", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_224", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_225", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_226", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Degree Unit of Plane Angle" - } - ], - "codeList": "CL.798c8fb6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_230", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_231", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_232", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_233", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_234", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_235", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_236", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_237", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_238", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.6751dc8e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.5ae118a0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.35f151cb" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.bfc80e1f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C69174", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume Fraction" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C25709", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Measure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1aeb2034" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_302", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_303", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_304", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_305", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" - } - ], - "codeList": "CL.a00fe0a9" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_306", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1aeb2034" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_307", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_308", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_309", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_310", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_311", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_312", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_313", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_314", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_315", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.68e5ab5a" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_316", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.2c53325c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.68e5ab5a" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_341", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_342", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_343", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_344", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_345", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_354", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_355", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_356", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_358", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_359", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_360", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_361", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_365", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_366", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_367", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_368", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_369", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_370", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_371", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_372", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_373", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_374", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_375", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_376", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_377", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_378", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_379", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_380", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_381", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_382", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_383", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_384", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_385", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_386", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_387", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_388", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_389", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_390", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_391", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_392", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_393", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_394", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_395", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_396", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_397", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_398", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_399", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_400", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_401", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_402", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_403", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_404", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_405", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_406", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_407", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_408", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_419", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_420", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_421", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_422", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_423", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_429", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_430", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_431", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_432", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_433", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_439", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_440", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_441", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_442", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_443", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_449", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_450", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_451", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_452", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_453", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_459", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_460", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_461", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_462", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_463", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_469", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_470", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_471", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_472", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_473", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_480", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_481", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_482", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_483", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_484", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_495", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_496", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_497", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_498", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_499", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_500", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_506", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_507", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_508", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_509", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_510", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_516", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_517", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_518", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_519", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_520", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_526", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_527", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48570", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_528", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_529", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_530", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_535", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_536", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_537", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_538", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_539", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_545", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_546", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_547", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_548", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_549", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_555", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_556", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_557", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_558", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_564", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_565", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_566", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_567", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_568", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_574", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_575", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_576", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_577", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_578", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_584", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_585", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_586", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_587", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_588", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_592", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.c75bb752" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_593", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_594", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.bbc50609" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_595", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_596", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_606", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.c75bb752" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_607", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_608", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_609", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ], - "codeList": "CL.bdb73f2b" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_610", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_616", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_617", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_618", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_629", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_630", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_631", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_632", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_633", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_634", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_635", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_636", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_637", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_643", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_644", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_645", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_646", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_647", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_652", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_653", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_654", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_655", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_656", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_657", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_658", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_659", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_660", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_661", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_667", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_668", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_669", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_670", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_671", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_676", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_677", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5fc938fc" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_678", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_679", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_684", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_685", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_686", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_687", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_688", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_703", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_704", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_705", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_706", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_713", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_714", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_715", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_716", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_720", - "name": "ECTRT", - "label": "ECTRT", - "mandatory": true, - "coding": [ - { - "code": "C117473", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Name of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_721", - "name": "ECREFID", - "label": "ECREFID", - "mandatory": false, - "coding": [ - { - "code": "C117469", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_722", - "name": "ECDOSE", - "label": "ECDOSE", - "mandatory": false, - "coding": [ - { - "code": "C117479", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_723", - "name": "ECDOSTXT", - "label": "ECDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C117480", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_724", - "name": "ECDOSU", - "label": "ECDOSU", - "mandatory": false, - "coding": [ - { - "code": "C117481", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Units" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_725", - "name": "ECDOSFRM", - "label": "ECDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C117482", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_726", - "name": "ECDOSFRQ", - "label": "ECDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C117483", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dosing Frequency per Interval" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_727", - "name": "ECDOSRGM", - "label": "ECDOSRGM", - "mandatory": false, - "coding": [ - { - "code": "C117485", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Intended Dose Regimen" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_728", - "name": "ECROUTE", - "label": "ECROUTE", - "mandatory": false, - "coding": [ - { - "code": "C117486", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_729", - "name": "ECLOC", - "label": "ECLOC", - "mandatory": false, - "coding": [ - { - "code": "C117488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_730", - "name": "ECLAT", - "label": "ECLAT", - "mandatory": false, - "coding": [ - { - "code": "C117489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_731", - "name": "ECDIR", - "label": "ECDIR", - "mandatory": false, - "coding": [ - { - "code": "C117490", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_732", - "name": "ECSTDTC", - "label": "ECSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Start Date and Time of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_733", - "name": "ECENDTC", - "label": "ECENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117497", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected End Date and Time of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_734", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_735", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_736", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_740", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_741", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_742", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_748", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_749", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_750", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_777", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_778", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_779", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_780", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_781", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_782", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_783", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_784", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_785", - "name": "AETERM", - "label": "AETERM", - "mandatory": true, - "coding": [ - { - "code": "C78541", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Verbatim Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_786", - "name": "AEDECOD", - "label": "AEDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83344", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_787", - "name": "AELOC", - "label": "AELOC", - "mandatory": false, - "coding": [ - { - "code": "C83205", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_788", - "name": "AESEV", - "label": "AESEV", - "mandatory": false, - "coding": [ - { - "code": "C53253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Severity of Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_789", - "name": "AESER", - "label": "AESER", - "mandatory": false, - "coding": [ - { - "code": "C53252", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Seriousness of Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_790", - "name": "AEACN", - "label": "AEACN", - "mandatory": false, - "coding": [ - { - "code": "C83013", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Action Taken with Study Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_791", - "name": "AEACNOTH", - "label": "AEACNOTH", - "mandatory": false, - "coding": [ - { - "code": "C83109", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Other Actions taken in Response to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_792", - "name": "AEREL", - "label": "AEREL", - "mandatory": false, - "coding": [ - { - "code": "C41358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Attribution to Product or Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_793", - "name": "AERELNST", - "label": "AERELNST", - "mandatory": false, - "coding": [ - { - "code": "C83210", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Relationship to Non Study Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_794", - "name": "AEPATT", - "label": "AEPATT", - "mandatory": false, - "coding": [ - { - "code": "C83208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Pattern" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_795", - "name": "AEOUT", - "label": "AEOUT", - "mandatory": false, - "coding": [ - { - "code": "C49489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Outcome" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_796", - "name": "AESCAN", - "label": "AESCAN", - "mandatory": false, - "coding": [ - { - "code": "C83211", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Involves Cancer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_797", - "name": "AESCONG", - "label": "AESCONG", - "mandatory": false, - "coding": [ - { - "code": "C83117", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_798", - "name": "AESDISAB", - "label": "AESDISAB", - "mandatory": false, - "coding": [ - { - "code": "C113380", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Disabling Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_799", - "name": "AESDTH", - "label": "AESDTH", - "mandatory": false, - "coding": [ - { - "code": "C48275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Death Related to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_800", - "name": "AESHOSP", - "label": "AESHOSP", - "mandatory": false, - "coding": [ - { - "code": "C83052", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event associated with Hospitalization" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_801", - "name": "AESLIFE", - "label": "AESLIFE", - "mandatory": false, - "coding": [ - { - "code": "C84266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Life Threatening Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_802", - "name": "AESOD", - "label": "AESOD", - "mandatory": false, - "coding": [ - { - "code": "C83214", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Occurred with Overdose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_803", - "name": "AESMIE", - "label": "AESMIE", - "mandatory": false, - "coding": [ - { - "code": "C83053", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Associated with Serious Medical Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_804", - "name": "AECONTRT", - "label": "AECONTRT", - "mandatory": false, - "coding": [ - { - "code": "C83199", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Concomitant Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_805", - "name": "AETOXGR", - "label": "AETOXGR", - "mandatory": false, - "coding": [ - { - "code": "C78605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Toxicity Grade" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_806", - "name": "AESTDTC", - "label": "AESTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_807", - "name": "AEENDTC", - "label": "AEENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83201", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_808", - "name": "AEENRF", - "label": "AEENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_809", - "name": "AEENRTPT", - "label": "AEENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_810", - "name": "AEENTPT", - "label": "AEENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_811", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.d8fccc32" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_812", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_813", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_823", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.a3e2e2db" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_824", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_825", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_832", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_833", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_834", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_835", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_836", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_837", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_862", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_863", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_864", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_865", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_866", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_867", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_880", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_881", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_882", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_883", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_884", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_885", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_886", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_887", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_888", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_889", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_890", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_891", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_892", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_893", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_894", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_895", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_896", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_897", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_898", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_899", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_900", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_901", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_902", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_903", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_920", - "name": "MKORRES", - "label": "MKORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_921", - "name": "MKORRESU", - "label": "MKORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42579", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_922", - "name": "MKLOC", - "label": "MKLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_923", - "name": "MKLAT", - "label": "MKLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_924", - "name": "MKMETHOD", - "label": "MKMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_925", - "name": "MKDTC", - "label": "MKDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_933", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_934", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_935", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_936", - "name": "Laterality", - "label": "Laterality", - "mandatory": true, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_937", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_938", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_949", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_950", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_951", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_952", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_953", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_954", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_955", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_956", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_957", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_974", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_975", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.35f151cb" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_976", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_977", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_978", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.bfc80e1f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_979", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_980", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_997", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_998", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.6751dc8e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_999", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1000", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1001", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1002", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1003", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1012", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1013", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1022", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1023", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1024", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1025", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1026", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1027", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1028", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1029", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1030", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1031", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1032", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1033", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1034", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1035", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1036", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1037", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1046", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1047", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1048", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1049", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1050", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1051", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1052", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1053", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1062", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1063", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1064", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1065", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1066", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1067", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1068", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1069", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1078", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1079", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1080", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1081", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1082", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1083", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1084", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1085", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1094", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1095", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1096", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1097", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1098", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1099", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1100", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1101", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1110", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1111", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1112", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1113", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1114", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1115", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1116", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1117", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1126", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1127", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1128", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1129", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1130", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1131", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1132", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1133", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1142", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1143", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1144", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1145", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1146", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1147", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1148", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1149", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1167", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1168", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1169", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1170", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1171", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1172", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1173", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1174", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1181", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1182", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1183", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1184", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1185", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1186", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1187", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1188", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1189", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1190", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1191", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1192", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1193", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1194", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1195", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1196", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1197", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1198", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1199", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1200", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1201", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1202", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1203", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1204", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1205", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1206", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1207", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1208", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1209", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1210", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1211", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1212", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1213", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1214", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1215", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1216", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1217", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1218", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1219", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1220", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1221", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1222", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1223", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1224", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1225", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1226", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1227", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1228", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1229", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1230", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1231", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1232", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1233", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1234", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1235", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ] -} diff --git a/output/json/NCT12345678-define-latest.json b/output/json/NCT12345678-define-latest.json deleted file mode 100644 index ef4daa9..0000000 --- a/output/json/NCT12345678-define-latest.json +++ /dev/null @@ -1,33435 +0,0 @@ -{ - "OID": "MDV.LZZT - Pilot.Version1.Design1", - "name": "MDV LZZT - Pilot", - "description": "Data Definitions for LZZT - Pilot", - "fileOID": "ODM.DEFINE-JSON.LZZT - Pilot.Version1.Design1", - "creationDateTime": "2026-07-16T11:33:00.031383+00:00", - "odmVersion": "1.3.2", - "fileType": "Snapshot", - "originator": "Define-JSON Processor", - "context": "Other", - "defineVersion": "2.1.0", - "studyOID": "ODM.LZZT - Pilot.Version1.Design1", - "studyName": "LZZT - Pilot", - "studyDescription": "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease", - "protocolName": "LZZT - Pilot", - "itemGroups": [ - { - "OID": "IG.DS", - "name": "DS", - "description": "Disposition", - "domain": "DS", - "purpose": "Tabulation", - "structure": "One record per disposition status or protocol milestone per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "DSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.DS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSSEQ", - "mandatory": true, - "name": "DSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.DS.DSTERM", - "mandatory": true, - "name": "DSTERM", - "description": "Reported Term for the Disposition Event", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_2", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSDECOD", - "mandatory": true, - "name": "DSDECOD", - "description": "Standardized Disposition Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_1", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NCOMPLT" - }, - { - "OID": "IT.DS.DSCAT", - "mandatory": false, - "name": "DSCAT", - "description": "Category for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSCAT" - }, - { - "OID": "IT.DS.DSSCAT", - "mandatory": false, - "name": "DSSCAT", - "description": "Subcategory for Disposition Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.DSSCAT" - }, - { - "OID": "IT.DS.DSSTDTC", - "mandatory": false, - "name": "DSSTDTC", - "description": "Start Date/Time of Disposition Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_3", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.DS.DSSTDY", - "mandatory": false, - "name": "DSSTDY", - "description": "Study Day of Start of Disposition Event", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_1" - }, - { - "OID": "IG.IE", - "name": "IE", - "description": "Inclusion/Exclusion Criteria Not Met", - "domain": "IE", - "purpose": "Tabulation", - "structure": "One record per inclusion/exclusion criterion not met per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "IESEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.IE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IESEQ", - "mandatory": true, - "name": "IESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IETESTCD", - "mandatory": true, - "name": "IETESTCD", - "description": "Inclusion/Exclusion Criterion Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IETEST", - "mandatory": true, - "name": "IETEST", - "description": "Inclusion/Exclusion Criterion", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.IE.IECAT", - "mandatory": true, - "name": "IECAT", - "description": "Inclusion/Exclusion Category", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.IECAT" - }, - { - "OID": "IT.IE.IEORRES", - "mandatory": true, - "name": "IEORRES", - "description": "I/E Criterion Original Result", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_5", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.IE.IESTRESC", - "mandatory": true, - "name": "IESTRESC", - "description": "I/E Criterion Result in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.IE.IEDTC", - "mandatory": false, - "name": "IEDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_6", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_2" - }, - { - "OID": "IG.SC", - "name": "SC", - "description": "Subject Characteristics", - "domain": "SC", - "purpose": "Tabulation", - "structure": "One record per characteristic per visit per subject.", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SCSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.SC.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCSEQ", - "mandatory": true, - "name": "SCSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCTESTCD", - "mandatory": true, - "name": "SCTESTCD", - "description": "Subject Characteristic Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.SCTESTCD" - }, - { - "OID": "IT.SC.SCTEST", - "mandatory": true, - "name": "SCTEST", - "description": "Subject Characteristic", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.SCTEST" - }, - { - "OID": "IT.SC.SCCAT", - "mandatory": false, - "name": "SCCAT", - "description": "Category for Subject Characteristic", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCORRES", - "mandatory": false, - "name": "SCORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_26", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SC.SCSTRESC", - "mandatory": false, - "name": "SCSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCSTRESN", - "mandatory": false, - "name": "SCSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SC.SCDTC", - "mandatory": false, - "name": "SCDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_27", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_11" - }, - { - "OID": "IG.MH", - "name": "MH", - "description": "Medical History", - "domain": "MH", - "purpose": "Tabulation", - "structure": "One record per medical history event per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "MHSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.MH.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHSEQ", - "mandatory": true, - "name": "MHSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHTERM", - "mandatory": true, - "name": "MHTERM", - "description": "Reported Term for the Medical History", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_30", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MH.MHDECOD", - "mandatory": false, - "name": "MHDECOD", - "description": "Dictionary-Derived Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_31", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHCAT", - "mandatory": false, - "name": "MHCAT", - "description": "Category for Medical History", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHSCAT", - "mandatory": false, - "name": "MHSCAT", - "description": "Subcategory for Medical History", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MH.MHPRESP", - "mandatory": false, - "name": "MHPRESP", - "description": "Medical History Event Pre-Specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.MH.MHOCCUR", - "mandatory": false, - "name": "MHOCCUR", - "description": "Medical History Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.MH.MHSTDTC", - "mandatory": false, - "name": "MHSTDTC", - "description": "Start Date/Time of Medical History Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_32", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MH.MHENDTC", - "mandatory": false, - "name": "MHENDTC", - "description": "End Date/Time of Medical History Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_33", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MH.MHENRF", - "mandatory": false, - "name": "MHENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_34", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.MH.MHENRTPT", - "mandatory": false, - "name": "MHENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_35", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.MH.MHENTPT", - "mandatory": false, - "name": "MHENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_36", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_14" - }, - { - "OID": "IG.SU", - "name": "SU", - "description": "Substance Use", - "domain": "SU", - "purpose": "Tabulation", - "structure": "One record per substance type per reported occurrence per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SUSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.SU.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUSEQ", - "mandatory": true, - "name": "SUSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUTRT", - "mandatory": true, - "name": "SUTRT", - "description": "Reported Name of Substance", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_37", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUCAT", - "mandatory": false, - "name": "SUCAT", - "description": "Category for Substance Use", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUSCAT", - "mandatory": false, - "name": "SUSCAT", - "description": "Subcategory for Substance Use", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUPRESP", - "mandatory": false, - "name": "SUPRESP", - "description": "SU Pre-Specified", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_38", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY_Y" - }, - { - "OID": "IT.SU.SUOCCUR", - "mandatory": false, - "name": "SUOCCUR", - "description": "SU Occurrence", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_39", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.SU.SUDOSE", - "mandatory": false, - "name": "SUDOSE", - "description": "Substance Use Consumption", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_40", - "dataType": "float", - "length": 12, - "displayFormat": "12.4", - "significantDigits": 4, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUDOSTXT", - "mandatory": false, - "name": "SUDOSTXT", - "description": "Substance Use Consumption Text", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_41", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUDOSU", - "mandatory": false, - "name": "SUDOSU", - "description": "Consumption Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_42", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.SU.SUDOSFRQ", - "mandatory": false, - "name": "SUDOSFRQ", - "description": "Use Frequency Per Interval", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_43", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.SU.SUSTDTC", - "mandatory": false, - "name": "SUSTDTC", - "description": "Start Date/Time of Substance Use", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_44", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUENDTC", - "mandatory": false, - "name": "SUENDTC", - "description": "End Date/Time of Substance Use", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_45", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUDUR", - "mandatory": false, - "name": "SUDUR", - "description": "Duration of Substance Use", - "role": "Timing", - "dataType": "durationDatetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SU.SUSTRF", - "mandatory": false, - "name": "SUSTRF", - "description": "Start Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_46", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUENRF", - "mandatory": false, - "name": "SUENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_49", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUSTRTPT", - "mandatory": false, - "name": "SUSTRTPT", - "description": "Start Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_47", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUSTTPT", - "mandatory": false, - "name": "SUSTTPT", - "description": "Start Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_48", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SU.SUENRTPT", - "mandatory": false, - "name": "SUENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_50", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.SU.SUENTPT", - "mandatory": false, - "name": "SUENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_51", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_15" - }, - { - "OID": "IG.PR", - "name": "PR", - "description": "Procedures", - "domain": "PR", - "purpose": "Tabulation", - "structure": "One record per recorded procedure per occurrence per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "PRSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.PR.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRSEQ", - "mandatory": true, - "name": "PRSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRTRT", - "mandatory": true, - "name": "PRTRT", - "description": "Reported Name of Procedure", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_83", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.PR.PRDECOD", - "mandatory": false, - "name": "PRDECOD", - "description": "Standardized Procedure Name", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_84", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.PROCEDUR" - }, - { - "OID": "IT.PR.PRCAT", - "mandatory": false, - "name": "PRCAT", - "description": "Category", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRSCAT", - "mandatory": false, - "name": "PRSCAT", - "description": "Subcategory", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.PR.PRPRESP", - "mandatory": false, - "name": "PRPRESP", - "description": "Pre-specified", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_85", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY_Y" - }, - { - "OID": "IT.PR.PROCCUR", - "mandatory": false, - "name": "PROCCUR", - "description": "Occurrence", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_86", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.PR.PRLOC", - "mandatory": false, - "name": "PRLOC", - "description": "Location of Procedure", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_87", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.PR.PRLAT", - "mandatory": false, - "name": "PRLAT", - "description": "Laterality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_88", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.PR.PRSTDTC", - "mandatory": false, - "name": "PRSTDTC", - "description": "Start Date/Time of Procedure", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_89", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.PR.PRENDTC", - "mandatory": false, - "name": "PRENDTC", - "description": "End Date/Time of Procedure", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_90", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_18" - }, - { - "OID": "IG.VS", - "name": "VS", - "description": "Vital Signs", - "domain": "VS", - "purpose": "Tabulation", - "structure": "One record per vital sign measurement per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.VS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSEQ", - "mandatory": true, - "name": "VSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSTESTCD", - "mandatory": true, - "name": "VSTESTCD", - "description": "Vital Signs Test Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTESTCD" - }, - { - "OID": "IT.VS.VSTEST", - "mandatory": true, - "name": "VSTEST", - "description": "Vital Signs Test Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSTEST" - }, - { - "OID": "IT.VS.VSPOS", - "mandatory": false, - "name": "VSPOS", - "description": "Vital Signs Position of Subject", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.POSITION" - }, - { - "OID": "IT.VS.VSORRES", - "mandatory": false, - "name": "VSORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_94", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSORRESU", - "mandatory": false, - "name": "VSORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_95", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSSTRESC", - "mandatory": false, - "name": "VSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESN", - "mandatory": false, - "name": "VSSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.VS.VSSTRESU", - "mandatory": false, - "name": "VSSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.VSRESU" - }, - { - "OID": "IT.VS.VSLOC", - "mandatory": false, - "name": "VSLOC", - "description": "Location of Vital Signs Measurement", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_96", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.VS.VSLAT", - "mandatory": false, - "name": "VSLAT", - "description": "Laterality", - "role": "Result Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.VS.VSLOBXFL", - "mandatory": false, - "name": "VSLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.VS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.VS.VSDTC", - "mandatory": false, - "name": "VSDTC", - "description": "Date/Time of Measurements", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_97", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_20" - }, - { - "OID": "IG.EG", - "name": "EG", - "description": "ECG Test Results", - "domain": "EG", - "purpose": "Tabulation", - "structure": "One record per ECG observation per replicate per time point or one record per ECG observation per beat per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "EGSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.EG.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.EGSEQ", - "mandatory": true, - "name": "EGSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.EGTESTCD", - "mandatory": true, - "name": "EGTESTCD", - "description": "ECG Test or Examination Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EGTESTCD" - }, - { - "OID": "IT.EG.EGTEST", - "mandatory": true, - "name": "EGTEST", - "description": "ECG Test or Examination Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.EGTEST" - }, - { - "OID": "IT.EG.EGCAT", - "mandatory": false, - "name": "EGCAT", - "description": "Category for ECG", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EG.EGPOS", - "mandatory": false, - "name": "EGPOS", - "description": "ECG Position of Subject", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.POSITION" - }, - { - "OID": "IT.EG.EGORRES", - "mandatory": false, - "name": "EGORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_116", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Vendor" - } - }, - { - "OID": "IT.EG.EGORRESU", - "mandatory": false, - "name": "EGORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Vendor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.EG.EGSTRESC", - "mandatory": false, - "name": "EGSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Derived", - "source": "Vendor" - }, - "codeList": "CL.EGSTRESC" - }, - { - "OID": "IT.EG.EGSTRESN", - "mandatory": false, - "name": "EGSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Vendor" - } - }, - { - "OID": "IT.EG.EGSTRESU", - "mandatory": false, - "name": "EGSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Vendor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.EG.EGMETHOD", - "mandatory": false, - "name": "EGMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_117", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.EGMETHOD" - }, - { - "OID": "IT.EG.EGLOBXFL", - "mandatory": false, - "name": "EGLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.EG.EGEVAL", - "mandatory": false, - "name": "EGEVAL", - "description": "Evaluator", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_118", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.EVAL" - }, - { - "OID": "IT.EG.EGCLSIG", - "mandatory": false, - "name": "EGCLSIG", - "description": "Clinically Significant, Collected", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_119", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.EG.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EG.EGDTC", - "mandatory": false, - "name": "EGDTC", - "description": "Date/Time of ECG", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_120", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_27" - }, - { - "OID": "IG.CM", - "name": "CM", - "description": "Concomitant/Prior Medications", - "domain": "CM", - "purpose": "Tabulation", - "structure": "One record per recorded intervention occurrence or constant-dosing interval per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "CMSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.CM.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSEQ", - "mandatory": true, - "name": "CMSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMTRT", - "mandatory": true, - "name": "CMTRT", - "description": "Reported Name of Drug, Med, or Therapy", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_266", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDECOD", - "mandatory": false, - "name": "CMDECOD", - "description": "Standardized Medication Name", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_267", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCAT", - "mandatory": false, - "name": "CMCAT", - "description": "Category for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMSCAT", - "mandatory": false, - "name": "CMSCAT", - "description": "Subcategory for Medication", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMPRESP", - "mandatory": false, - "name": "CMPRESP", - "description": "CM Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMOCCUR", - "mandatory": false, - "name": "CMOCCUR", - "description": "CM Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.CM.CMINDC", - "mandatory": false, - "name": "CMINDC", - "description": "Indication", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_269", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMCLAS", - "mandatory": false, - "name": "CMCLAS", - "description": "Medication Class", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_268", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMCLASCD", - "mandatory": false, - "name": "CMCLASCD", - "description": "Medication Class Code", - "role": "Variable Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMDOSE", - "mandatory": false, - "name": "CMDOSE", - "description": "Dose per Administration", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_270", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSTXT", - "mandatory": false, - "name": "CMDOSTXT", - "description": "Dose Description", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_271", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMDOSU", - "mandatory": false, - "name": "CMDOSU", - "description": "Dose Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_272", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.CM.CMDOSFRM", - "mandatory": false, - "name": "CMDOSFRM", - "description": "Dose Form", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_273", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FRM" - }, - { - "OID": "IT.CM.CMDOSFRQ", - "mandatory": false, - "name": "CMDOSFRQ", - "description": "Dosing Frequency per Interval", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_274", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.CM.CMROUTE", - "mandatory": false, - "name": "CMROUTE", - "description": "Route of Administration", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_275", - "dataType": "text", - "length": 40, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ROUTE" - }, - { - "OID": "IT.CM.CMSTDTC", - "mandatory": false, - "name": "CMSTDTC", - "description": "Start Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_276", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMENDTC", - "mandatory": false, - "name": "CMENDTC", - "description": "End Date/Time of Medication", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_277", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.CM.CMSTRF", - "mandatory": false, - "name": "CMSTRF", - "description": "Start Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_278", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENRF", - "mandatory": false, - "name": "CMENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_281", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTRTPT", - "mandatory": false, - "name": "CMSTRTPT", - "description": "Start Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_279", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMSTTPT", - "mandatory": false, - "name": "CMSTTPT", - "description": "Start Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_280", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.CM.CMENRTPT", - "mandatory": false, - "name": "CMENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_282", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.CM.CMENTPT", - "mandatory": false, - "name": "CMENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_283", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_55" - }, - { - "OID": "IG.MB", - "name": "MB", - "description": "Microbiology Specimen", - "domain": "MB", - "purpose": "Tabulation", - "structure": "One record per microbiology specimen finding per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "MBSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.MB.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.MBSEQ", - "mandatory": true, - "name": "MBSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MB.MBTESTCD", - "mandatory": true, - "name": "MBTESTCD", - "description": "Microbiology Test or Finding Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MBTESTCD" - }, - { - "OID": "IT.MB.MBTEST", - "mandatory": true, - "name": "MBTEST", - "description": "Microbiology Test or Finding Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MBTEST" - }, - { - "OID": "IT.MB.MBTSTDTL", - "mandatory": false, - "name": "MBTSTDTL", - "description": "Measurement, Test or Examination Detail", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_592", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MBFTSDTL" - }, - { - "OID": "IT.MB.MBORRES", - "mandatory": false, - "name": "MBORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_593", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Vendor" - } - }, - { - "OID": "IT.MB.MBSTRESC", - "mandatory": false, - "name": "MBSTRESC", - "description": "Result or Finding in Standard Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Derived", - "source": "Vendor" - } - }, - { - "OID": "IT.MB.MBSPEC", - "mandatory": false, - "name": "MBSPEC", - "description": "Specimen Material Type", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_594", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.SPECTYPE" - }, - { - "OID": "IT.MB.MBMETHOD", - "mandatory": false, - "name": "MBMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_595", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.MB.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MB.MBDTC", - "mandatory": false, - "name": "MBDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_596", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_99" - }, - { - "OID": "IG.UR", - "name": "UR", - "description": "Urinary System Findings", - "domain": "UR", - "purpose": "Tabulation", - "structure": "One record per finding per location per per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "URSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.UR.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URSEQ", - "mandatory": true, - "name": "URSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URTESTCD", - "mandatory": true, - "name": "URTESTCD", - "description": "Short Name of Urinary Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTSCD" - }, - { - "OID": "IT.UR.URTEST", - "mandatory": true, - "name": "URTEST", - "description": "Name of Urinary Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.URNSTS" - }, - { - "OID": "IT.UR.URORRES", - "mandatory": false, - "name": "URORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URSTRESC", - "mandatory": false, - "name": "URSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "text", - "length": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.UR.URMETHOD", - "mandatory": false, - "name": "URMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.UR.URLOBXFL", - "mandatory": false, - "name": "URLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.UR.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.UR.URDTC", - "mandatory": false, - "name": "URDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_101" - }, - { - "OID": "IG.EC", - "name": "EC", - "description": "Exposure as Collected", - "domain": "EC", - "purpose": "Tabulation", - "structure": "One record per protocol-specified study treatment, collected-dosing interval, per subject, per mood", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "ECSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "INTERVENTIONS" - }, - "items": [ - { - "OID": "IT.EC.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.ECSEQ", - "mandatory": true, - "name": "ECSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.EC.ECREFID", - "mandatory": false, - "name": "ECREFID", - "description": "Reference ID", - "role": "Identifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_721", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECTRT", - "mandatory": true, - "name": "ECTRT", - "description": "Name of Treatment", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_720", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECDOSE", - "mandatory": false, - "name": "ECDOSE", - "description": "Dose", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_722", - "dataType": "integer", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECDOSTXT", - "mandatory": false, - "name": "ECDOSTXT", - "description": "Dose Description", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_723", - "dataType": "text", - "length": 100, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECDOSU", - "mandatory": false, - "name": "ECDOSU", - "description": "Dose Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_724", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.EC.ECDOSFRM", - "mandatory": false, - "name": "ECDOSFRM", - "description": "Dose Form", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_725", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FRM" - }, - { - "OID": "IT.EC.ECDOSFRQ", - "mandatory": false, - "name": "ECDOSFRQ", - "description": "Dosing Frequency per Interval", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_726", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.FREQ" - }, - { - "OID": "IT.EC.ECDOSRGM", - "mandatory": false, - "name": "ECDOSRGM", - "description": "Intended Dose Regimen", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_727", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECROUTE", - "mandatory": false, - "name": "ECROUTE", - "description": "Route of Administration", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_728", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ROUTE" - }, - { - "OID": "IT.EC.ECLOC", - "mandatory": false, - "name": "ECLOC", - "description": "Location of Dose Administration", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_729", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.EC.ECLAT", - "mandatory": false, - "name": "ECLAT", - "description": "Laterality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_730", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.EC.ECDIR", - "mandatory": false, - "name": "ECDIR", - "description": "Directionality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_731", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DIR" - }, - { - "OID": "IT.EC.ECSTDTC", - "mandatory": false, - "name": "ECSTDTC", - "description": "Start Date/Time of Treatment", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_732", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.EC.ECENDTC", - "mandatory": false, - "name": "ECENDTC", - "description": "End Date/Time of Treatment", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_733", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_112" - }, - { - "OID": "IG.QS", - "name": "QS", - "description": "Questionnaires", - "domain": "QS", - "purpose": "Tabulation", - "structure": "One record per questionnaire per question per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "QSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.QS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSSEQ", - "mandatory": true, - "name": "QSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSTESTCD", - "mandatory": true, - "name": "QSTESTCD", - "description": "Question Short Name", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSTEST", - "mandatory": true, - "name": "QSTEST", - "description": "Question Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSCAT", - "mandatory": true, - "name": "QSCAT", - "description": "Category of Question", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.QSCAT" - }, - { - "OID": "IT.QS.QSORRES", - "mandatory": false, - "name": "QSORRES", - "description": "Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_740", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.QS.QSSTRESC", - "mandatory": false, - "name": "QSSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSSTRESN", - "mandatory": false, - "name": "QSSTRESN", - "description": "Numeric Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "integer", - "length": 1, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.QS.QSLOBXFL", - "mandatory": false, - "name": "QSLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.QS.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.QS.QSDTC", - "mandatory": false, - "name": "QSDTC", - "description": "Date/Time of Finding", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_741", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_114" - }, - { - "OID": "IG.AE", - "name": "AE", - "description": "Adverse Events", - "domain": "AE", - "purpose": "Tabulation", - "structure": "One record per adverse event per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "AESEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "EVENTS" - }, - "items": [ - { - "OID": "IT.AE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESEQ", - "mandatory": true, - "name": "AESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AETERM", - "mandatory": true, - "name": "AETERM", - "description": "Reported Term for the Adverse Event", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_785", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AELLT", - "mandatory": false, - "name": "AELLT", - "description": "Lowest Level Term", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AELLTCD", - "mandatory": false, - "name": "AELLTCD", - "description": "Lowest Level Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEDECOD", - "mandatory": true, - "name": "AEDECOD", - "description": "Dictionary-Derived Term", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_786", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEPTCD", - "mandatory": false, - "name": "AEPTCD", - "description": "Preferred Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLT", - "mandatory": false, - "name": "AEHLT", - "description": "High Level Term", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLTCD", - "mandatory": false, - "name": "AEHLTCD", - "description": "High Level Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLGT", - "mandatory": false, - "name": "AEHLGT", - "description": "High Level Group Term", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEHLGTCD", - "mandatory": false, - "name": "AEHLGTCD", - "description": "High Level Group Term Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AECAT", - "mandatory": false, - "name": "AECAT", - "description": "Category for Adverse Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESCAT", - "mandatory": false, - "name": "AESCAT", - "description": "Subcategory for Adverse Event", - "role": "Grouping Qualifier", - "dataType": "text", - "length": 200, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AEPRESP", - "mandatory": false, - "name": "AEPRESP", - "description": "Pre-Specified Adverse Event", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.AE.AEBODSYS", - "mandatory": false, - "name": "AEBODSYS", - "description": "Body System or Organ Class", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEBDSYCD", - "mandatory": false, - "name": "AEBDSYCD", - "description": "Body System or Organ Class Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESOC", - "mandatory": false, - "name": "AESOC", - "description": "Primary System Organ Class", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AESOCCD", - "mandatory": false, - "name": "AESOCCD", - "description": "Primary System Organ Class Code", - "role": "Variable Qualifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.AE.AELOC", - "mandatory": false, - "name": "AELOC", - "description": "Location of Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_787", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.AE.AESEV", - "mandatory": false, - "name": "AESEV", - "description": "Severity/Intensity", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_788", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.AESEV" - }, - { - "OID": "IT.AE.AESER", - "mandatory": false, - "name": "AESER", - "description": "Serious Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_789", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AEACN", - "mandatory": false, - "name": "AEACN", - "description": "Action Taken with Study Treatment", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_790", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ACN" - }, - { - "OID": "IT.AE.AEACNOTH", - "mandatory": false, - "name": "AEACNOTH", - "description": "Other Action Taken", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_791", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEREL", - "mandatory": false, - "name": "AEREL", - "description": "Causality", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_792", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AERELNST", - "mandatory": false, - "name": "AERELNST", - "description": "Relationship to Non-Study Treatment", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_793", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEPATT", - "mandatory": false, - "name": "AEPATT", - "description": "Pattern of Adverse Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_794", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEOUT", - "mandatory": false, - "name": "AEOUT", - "description": "Outcome of Adverse Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_795", - "dataType": "text", - "length": 200, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.OUT" - }, - { - "OID": "IT.AE.AESCAN", - "mandatory": false, - "name": "AESCAN", - "description": "Involves Cancer", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_796", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESCONG", - "mandatory": false, - "name": "AESCONG", - "description": "Congenital Anomaly or Birth Defect", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_797", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESDISAB", - "mandatory": false, - "name": "AESDISAB", - "description": "Persist or Signif Disability/Incapacity", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_798", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESDTH", - "mandatory": false, - "name": "AESDTH", - "description": "Results in Death", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_799", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESHOSP", - "mandatory": false, - "name": "AESHOSP", - "description": "Requires or Prolongs Hospitalization", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_800", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESLIFE", - "mandatory": false, - "name": "AESLIFE", - "description": "Is Life Threatening", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_801", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESOD", - "mandatory": false, - "name": "AESOD", - "description": "Occurred with Overdose", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_802", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AESMIE", - "mandatory": false, - "name": "AESMIE", - "description": "Other Medically Important Serious Event", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_803", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AECONTRT", - "mandatory": false, - "name": "AECONTRT", - "description": "Concomitant or Additional Trtmnt Given", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_804", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY_NY" - }, - { - "OID": "IT.AE.AETOXGR", - "mandatory": false, - "name": "AETOXGR", - "description": "Standard Toxicity Grade", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_805", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AESTDTC", - "mandatory": false, - "name": "AESTDTC", - "description": "Start Date/Time of Adverse Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_806", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEENDTC", - "mandatory": false, - "name": "AEENDTC", - "description": "End Date/Time of Adverse Event", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_807", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.AE.AEENRF", - "mandatory": false, - "name": "AEENRF", - "description": "End Relative to Reference Period", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_808", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.AE.AEENRTPT", - "mandatory": false, - "name": "AEENRTPT", - "description": "End Relative to Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_809", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.STENRF" - }, - { - "OID": "IT.AE.AEENTPT", - "mandatory": false, - "name": "AEENTPT", - "description": "End Reference Time Point", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_810", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_135" - }, - { - "OID": "IG.MK", - "name": "MK", - "description": "Musculoskeletal System Findings", - "domain": "MK", - "purpose": "Tabulation", - "structure": "One record per assessment per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "MKSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.MK.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKSEQ", - "mandatory": true, - "name": "MKSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKTESTCD", - "mandatory": true, - "name": "MKTESTCD", - "description": "Short Name of Musculoskeletal Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MUSCTSCD" - }, - { - "OID": "IT.MK.MKTEST", - "mandatory": true, - "name": "MKTEST", - "description": "Name of Musculoskeletal Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.MUSCTS" - }, - { - "OID": "IT.MK.MKORRES", - "mandatory": false, - "name": "MKORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_920", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MK.MKORRESU", - "mandatory": false, - "name": "MKORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_921", - "dataType": "text", - "length": 20, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.MK.MKSTRESC", - "mandatory": false, - "name": "MKSTRESC", - "description": "Character Result/Finding in Std Format", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKSTRESN", - "mandatory": false, - "name": "MKSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 8, - "displayFormat": "8.3", - "significantDigits": 3, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.MK.MKSTRESU", - "mandatory": false, - "name": "MKSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 20, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.MK.MKLOC", - "mandatory": false, - "name": "MKLOC", - "description": "Location Used for the Measurement", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_922", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.LOC" - }, - { - "OID": "IT.MK.MKLAT", - "mandatory": false, - "name": "MKLAT", - "description": "Laterality", - "role": "Variable Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_923", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.LAT" - }, - { - "OID": "IT.MK.MKMETHOD", - "mandatory": false, - "name": "MKMETHOD", - "description": "Method of Test or Examination", - "role": "Record Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_924", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.METHOD" - }, - { - "OID": "IT.MK.MKLOBXFL", - "mandatory": false, - "name": "MKLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.MK.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.MK.MKDTC", - "mandatory": false, - "name": "MKDTC", - "description": "Date/Time of Collection", - "role": "Timing", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_925", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_160" - }, - { - "OID": "IG.TS", - "name": "TS", - "description": "Trial Summary", - "domain": "TS", - "purpose": "Tabulation", - "structure": "One record per trial summary parameter value", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "TSPARMCD", - "TSSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TS.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSSEQ", - "mandatory": true, - "name": "TSSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.TS.TSPARMCD", - "mandatory": true, - "name": "TSPARMCD", - "description": "Trial Summary Parameter Short Name", - "role": "Topic", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_949", - "dataType": "text", - "length": null, - "codeList": "CL.TSPARMCD" - }, - { - "OID": "IT.TS.TSPARM", - "mandatory": true, - "name": "TSPARM", - "description": "Trial Summary Parameter", - "role": "Synonym Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_950", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.TSPARM" - }, - { - "OID": "IT.TS.TSVAL", - "mandatory": false, - "name": "TSVAL", - "description": "Parameter Value", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_951", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVALCD", - "mandatory": false, - "name": "TSVALCD", - "description": "Parameter Value Code", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_952", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TS.TSVCDREF", - "mandatory": false, - "name": "TSVCDREF", - "description": "Name of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_953", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.DICTNAM" - }, - { - "OID": "IT.TS.TSVCDVER", - "mandatory": false, - "name": "TSVCDVER", - "description": "Version of the Reference Terminology", - "role": "Result Qualifier", - "conceptProperty": "CONCPROP.BiomedicalConceptProperty_954", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_162", - "slices": [ - { - "OID": "VL.TS.TSPARMCD", - "name": "VL_TS_TSPARMCD", - "type": "ValueList", - "wasDerivedFrom": "IT.TS.TSPARMCD", - "items": [ - { - "OID": "IT.TS.TSPARMCD.COMPTRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.8c559472" - ] - }, - { - "OID": "IT.TS.TSPARMCD.CRMDUR", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.bcc79825" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INDIC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e5769859" - ] - }, - { - "OID": "IT.TS.TSPARMCD.INTTYPE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d3e89d3f" - ] - }, - { - "OID": "IT.TS.TSPARMCD.NARMS", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.efd2a465" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJPRIM", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.fe255586" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OBJSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.62794b6c" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSPRI", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.4266ae9d" - ] - }, - { - "OID": "IT.TS.TSPARMCD.OUTMSSEC", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.1d6311e2" - ] - }, - { - "OID": "IT.TS.TSPARMCD.SPONSOR", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.e06f8db5" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TITLE", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d94c6616" - ] - }, - { - "OID": "IT.TS.TSPARMCD.TRT", - "mandatory": false, - "name": "TSPARMCD", - "dataType": "text", - "length": 200, - "origin": { - "type": "Protocol", - "source": "Sponsor" - }, - "applicableWhen": [ - "WC.TS.d368cfb2" - ] - } - ] - } - ] - }, - { - "OID": "IG.FT", - "name": "FT", - "description": "Functional Tests", - "domain": "FT", - "purpose": "Tabulation", - "structure": "One record per Functional Test finding per time point per visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "FTSEQ" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "FINDINGS" - }, - "items": [ - { - "OID": "IT.FT.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTSEQ", - "mandatory": true, - "name": "FTSEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTTESTCD", - "mandatory": true, - "name": "FTTESTCD", - "description": "Short Name of Test", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTTEST", - "mandatory": true, - "name": "FTTEST", - "description": "Name of Test", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTCAT", - "mandatory": true, - "name": "FTCAT", - "description": "Category", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.FTCAT" - }, - { - "OID": "IT.FT.FTSCAT", - "mandatory": false, - "name": "FTSCAT", - "description": "Subcategory", - "role": "Grouping Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTORRES", - "mandatory": false, - "name": "FTORRES", - "description": "Result or Finding in Original Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 4, - "displayFormat": "5.2", - "significantDigits": 2, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.FT.FTORRESU", - "mandatory": false, - "name": "FTORRESU", - "description": "Original Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.FT.FTSTRESC", - "mandatory": false, - "name": "FTSTRESC", - "description": "Result or Finding in Standard Format", - "role": "Result Qualifier", - "dataType": "float", - "length": 4, - "displayFormat": "5.2", - "significantDigits": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTSTRESN", - "mandatory": false, - "name": "FTSTRESN", - "description": "Numeric Result/Finding in Standard Units", - "role": "Result Qualifier", - "dataType": "float", - "length": 4, - "displayFormat": "5.2", - "significantDigits": 2, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.FT.FTSTRESU", - "mandatory": false, - "name": "FTSTRESU", - "description": "Standard Units", - "role": "Variable Qualifier", - "dataType": "text", - "length": 1, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.UNIT" - }, - { - "OID": "IT.FT.FTSTAT", - "mandatory": false, - "name": "FTSTAT", - "description": "Completion Status", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ND" - }, - { - "OID": "IT.FT.FTREASND", - "mandatory": false, - "name": "FTREASND", - "description": "Reason Not Done", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.FT.FTLOBXFL", - "mandatory": false, - "name": "FTLOBXFL", - "description": "Last Observation Before Exposure Flag", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.FT.VISITNUM", - "mandatory": false, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.FT.FTDTC", - "mandatory": false, - "name": "FTDTC", - "description": "Date/Time of Test", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ], - "implementsConcept": "CONC.BiomedicalConcept_172" - }, - { - "OID": "IG.TA", - "name": "TA", - "description": "Trial Arms", - "domain": "TA", - "purpose": "Tabulation", - "structure": "One record per planned Element per Arm", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ARMCD", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TA.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.ARMCD", - "mandatory": true, - "name": "ARMCD", - "description": "Planned Arm Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARMCD" - }, - { - "OID": "IT.TA.ARM", - "mandatory": true, - "name": "ARM", - "description": "Description of Planned Arm", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ARM" - }, - { - "OID": "IT.TA.TAETORD", - "mandatory": true, - "name": "TAETORD", - "description": "Planned Order of Element within Arm", - "role": "Timing", - "dataType": "integer", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.TA.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TA.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TA.TABRANCH", - "mandatory": false, - "name": "TABRANCH", - "description": "Branch", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.TATRANS", - "mandatory": false, - "name": "TATRANS", - "description": "Transition Rule", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TA.EPOCH", - "mandatory": true, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - } - ] - }, - { - "OID": "IG.TE", - "name": "TE", - "description": "Trial Elements", - "domain": "TE", - "purpose": "Tabulation", - "structure": "One record per planned Element", - "isReferenceData": true, - "keySequence": [ - "STUDYID", - "ETCD" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "TRIAL DESIGN" - }, - "items": [ - { - "OID": "IT.TE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.TE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.TE.ELEMENT", - "mandatory": true, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.TE.TESTRL", - "mandatory": true, - "name": "TESTRL", - "description": "Rule for Start of Element", - "role": "Rule", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - } - ] - }, - { - "OID": "IG.SV", - "name": "SV", - "description": "Subject Visits", - "domain": "SV", - "purpose": "Tabulation", - "structure": "One record per actual or planned visit per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "VISITNUM" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SV.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISITNUM", - "mandatory": true, - "name": "VISITNUM", - "description": "Visit Number", - "role": "Topic", - "dataType": "integer", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.VISIT", - "mandatory": false, - "name": "VISIT", - "description": "Visit Name", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SV.SVPRESP", - "mandatory": false, - "name": "SVPRESP", - "description": "Pre-specified", - "role": "Variable Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVOCCUR", - "mandatory": false, - "name": "SVOCCUR", - "description": "Occurrence", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.NY" - }, - { - "OID": "IT.SV.SVCNTMOD", - "mandatory": false, - "name": "SVCNTMOD", - "description": "Contact Mode", - "role": "Record Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Collected", - "source": "Investigator" - }, - "codeList": "CL.CNTMODE" - }, - { - "OID": "IT.SV.SVSTDTC", - "mandatory": false, - "name": "SVSTDTC", - "description": "Start Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SV.SVENDTC", - "mandatory": false, - "name": "SVENDTC", - "description": "End Date/Time of Observation", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - }, - { - "OID": "IG.SE", - "name": "SE", - "description": "Subject Elements", - "domain": "SE", - "purpose": "Tabulation", - "structure": "One record per actual Element per subject", - "isReferenceData": false, - "keySequence": [ - "STUDYID", - "USUBJID", - "SESTDTC" - ], - "standard": "STD.SDTMIG", - "observationClass": { - "name": "SPECIAL-PURPOSE" - }, - "items": [ - { - "OID": "IT.SE.STUDYID", - "mandatory": true, - "name": "STUDYID", - "description": "Study Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.DOMAIN", - "mandatory": true, - "name": "DOMAIN", - "description": "Domain Abbreviation", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.USUBJID", - "mandatory": true, - "name": "USUBJID", - "description": "Unique Subject Identifier", - "role": "Identifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.SESEQ", - "mandatory": true, - "name": "SESEQ", - "description": "Sequence Number", - "role": "Identifier", - "dataType": "integer", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - } - }, - { - "OID": "IT.SE.ETCD", - "mandatory": true, - "name": "ETCD", - "description": "Element Code", - "role": "Topic", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ETCD" - }, - { - "OID": "IT.SE.ELEMENT", - "mandatory": false, - "name": "ELEMENT", - "description": "Description of Element", - "role": "Synonym Qualifier", - "dataType": "text", - "length": null, - "origin": { - "type": "Assigned", - "source": "Sponsor" - }, - "codeList": "CL.ELEMENT" - }, - { - "OID": "IT.SE.EPOCH", - "mandatory": false, - "name": "EPOCH", - "description": "Epoch", - "role": "Timing", - "dataType": "text", - "length": null, - "origin": { - "type": "Derived", - "source": "Sponsor" - }, - "codeList": "CL.EPOCH" - }, - { - "OID": "IT.SE.SESTDTC", - "mandatory": true, - "name": "SESTDTC", - "description": "Start Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - }, - { - "OID": "IT.SE.SEENDTC", - "mandatory": false, - "name": "SEENDTC", - "description": "End Date/Time of Element", - "role": "Timing", - "dataType": "datetime", - "origin": { - "type": "Collected", - "source": "Investigator" - } - } - ] - } - ], - "conditions": [ - { - "OID": "COND.TS.TSPARMCD.4b2c750e", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "COMPTRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.745804cb", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "CRMDUR" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.82dcbb4a", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INDIC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.de0404c1", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "INTTYPE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.1d8ed13f", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "NARMS" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.cccc9db0", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJPRIM" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.863c5858", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OBJSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.69b92c86", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSPRI" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.df99032e", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "OUTMSSEC" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.5b1e67a5", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "SPONSOR" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.90f47ac3", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TITLE" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - }, - { - "OID": "COND.TS.TSPARMCD.e2190e21", - "rangeChecks": [ - { - "comparator": "EQ", - "checkValues": [ - "TRT" - ], - "item": "IT.TS.TSPARMCD", - "softHard": "Soft" - } - ] - } - ], - "whereClauses": [ - { - "OID": "WC.TS.8c559472", - "conditions": [ - "COND.TS.TSPARMCD.4b2c750e" - ] - }, - { - "OID": "WC.TS.bcc79825", - "conditions": [ - "COND.TS.TSPARMCD.745804cb" - ] - }, - { - "OID": "WC.TS.e5769859", - "conditions": [ - "COND.TS.TSPARMCD.82dcbb4a" - ] - }, - { - "OID": "WC.TS.d3e89d3f", - "conditions": [ - "COND.TS.TSPARMCD.de0404c1" - ] - }, - { - "OID": "WC.TS.efd2a465", - "conditions": [ - "COND.TS.TSPARMCD.1d8ed13f" - ] - }, - { - "OID": "WC.TS.fe255586", - "conditions": [ - "COND.TS.TSPARMCD.cccc9db0" - ] - }, - { - "OID": "WC.TS.62794b6c", - "conditions": [ - "COND.TS.TSPARMCD.863c5858" - ] - }, - { - "OID": "WC.TS.4266ae9d", - "conditions": [ - "COND.TS.TSPARMCD.69b92c86" - ] - }, - { - "OID": "WC.TS.1d6311e2", - "conditions": [ - "COND.TS.TSPARMCD.df99032e" - ] - }, - { - "OID": "WC.TS.e06f8db5", - "conditions": [ - "COND.TS.TSPARMCD.5b1e67a5" - ] - }, - { - "OID": "WC.TS.d94c6616", - "conditions": [ - "COND.TS.TSPARMCD.90f47ac3" - ] - }, - { - "OID": "WC.TS.d368cfb2", - "conditions": [ - "COND.TS.TSPARMCD.e2190e21" - ] - } - ], - "codeLists": [ - { - "OID": "CL.ARMCD", - "name": "ARM Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Placebo" - }, - { - "codedValue": "Xanomeline Low Dose" - }, - { - "codedValue": "Xanomeline High Dose" - } - ] - }, - { - "OID": "CL.ARM", - "name": "ARM", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Placebo" - }, - { - "codedValue": "Xanomeline Low Dose" - }, - { - "codedValue": "Xanomeline High Dose" - } - ] - }, - { - "OID": "CL.ELEMENT", - "name": "Description of Element", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "Screening" - }, - { - "codedValue": "Placebo" - }, - { - "codedValue": "Low" - }, - { - "codedValue": "High - Start" - }, - { - "codedValue": "High - Middle" - }, - { - "codedValue": "High - End" - }, - { - "codedValue": "Follow up" - } - ] - }, - { - "OID": "CL.ETCD", - "name": "Element Code", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "EL1", - "decode": "Screening" - }, - { - "codedValue": "EL2", - "decode": "Placebo" - }, - { - "codedValue": "EL3", - "decode": "Low" - }, - { - "codedValue": "EL4", - "decode": "High - Start" - }, - { - "codedValue": "EL5", - "decode": "High - Middle" - }, - { - "codedValue": "EL6", - "decode": "High - End" - }, - { - "codedValue": "EL7", - "decode": "Follow up" - } - ] - }, - { - "OID": "CL.EPOCH", - "name": "Epoch", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99079", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "Screening", - "coding": { - "code": "C202487", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Treatment 1", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Treatment 2", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Treatment 3", - "coding": { - "code": "C101526", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "Follow-up", - "coding": { - "code": "C202578", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.ad42d7e1", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "INFORMED CONSENT OBTAINED", - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED" - } - ] - } - ] - }, - { - "OID": "CL.39e500d6", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "RANDOMIZED", - "coding": [ - { - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED" - } - ] - } - ] - }, - { - "OID": "CL.30a86bdd", - "name": "PRDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "X-RAY", - "coding": [ - { - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "X-RAY" - } - ] - } - ] - }, - { - "OID": "CL.20024ecd", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "beats/min", - "coding": [ - { - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min" - } - ] - } - ] - }, - { - "OID": "CL.da016f8d", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "breaths/min", - "coding": [ - { - "code": "C49674", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "breaths/min" - } - ] - } - ] - }, - { - "OID": "CL.798c8fb6", - "name": "EGORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "deg", - "coding": [ - { - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "deg" - } - ] - } - ] - }, - { - "OID": "CL.6751dc8e", - "name": "PRDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "CT SCAN", - "coding": [ - { - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "CT SCAN" - } - ] - } - ] - }, - { - "OID": "CL.5ae118a0", - "name": "PRLOC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "CHEST", - "coding": [ - { - "code": "C25389", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "CHEST" - } - ] - } - ] - }, - { - "OID": "CL.35f151cb", - "name": "PRDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "MRI", - "coding": [ - { - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI" - } - ] - } - ] - }, - { - "OID": "CL.bfc80e1f", - "name": "PRLOC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "BRAIN", - "coding": [ - { - "code": "C12439", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "BRAIN" - } - ] - } - ] - }, - { - "OID": "CL.af8f8a19", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "BLOOD", - "coding": [ - { - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD" - } - ] - } - ] - }, - { - "OID": "CL.1aeb2034", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "ERYTHROCYTES", - "coding": [ - { - "code": "C12521", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ERYTHROCYTES" - } - ] - } - ] - }, - { - "OID": "CL.a00fe0a9", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "fL", - "coding": [ - { - "code": "C64780", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "fL" - } - ] - } - ] - }, - { - "OID": "CL.68e5ab5a", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "10^9/L", - "coding": [ - { - "code": "C67255", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^9/L" - } - ] - } - ] - }, - { - "OID": "CL.2c53325c", - "name": "LBORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "10^6/L", - "coding": [ - { - "code": "C67452", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^6/L" - } - ] - } - ] - }, - { - "OID": "CL.9e69169e", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SERUM OR PLASMA", - "coding": [ - { - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA" - } - ] - } - ] - }, - { - "OID": "CL.c75bb752", - "name": "MBTSTDTL Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "DETECTION", - "coding": [ - { - "code": "C174330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "DETECTION" - } - ] - } - ] - }, - { - "OID": "CL.bbc50609", - "name": "MBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SERUM", - "coding": [ - { - "code": "C13325", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM" - } - ] - } - ] - }, - { - "OID": "CL.bdb73f2b", - "name": "MBMETHOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "LINE PROBE ASSAY", - "coding": [ - { - "code": "C102656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "LINE PROBE ASSAY" - } - ] - } - ] - }, - { - "OID": "CL.5183f82c", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "URINE", - "coding": [ - { - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE" - } - ] - } - ] - }, - { - "OID": "CL.5fc938fc", - "name": "LBSPEC Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "STOOL", - "coding": [ - { - "code": "C13234", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "STOOL" - } - ] - } - ] - }, - { - "OID": "CL.b8dca4b6", - "name": "QSEVAL Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "CAREGIVER", - "coding": [ - { - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER" - } - ] - } - ] - }, - { - "OID": "CL.d8fccc32", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "SITE TRANSFER", - "coding": [ - { - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SITE TRANSFER" - } - ] - } - ] - }, - { - "OID": "CL.a3e2e2db", - "name": "DSDECOD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "coding": [ - { - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY" - } - ] - } - ] - }, - { - "OID": "CL.7cfd6cc5", - "name": "VSORRESU Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "mmHg", - "coding": [ - { - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg" - } - ] - } - ] - }, - { - "OID": "CL.1e00cfce", - "name": "TSPARMCD Response Codes", - "dataType": "text", - "isNonStandard": true, - "codeListItems": [ - { - "codedValue": "EGCTMON", - "coding": [ - { - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "EGCTMON" - } - ] - } - ] - }, - { - "OID": "CL.NCOMPLT", - "name": "Completion/Reason for Non-Completion", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66727", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSCAT", - "name": "Category of Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74558", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DSSCAT", - "name": "Subcategory for Disposition Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C170443", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.IECAT", - "name": "Category of Inclusion/Exclusion", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66797", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY", - "name": "No Yes Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.AGEU", - "name": "Age Unit", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66781", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.SEX", - "name": "Sex", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66731", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.SCTESTCD", - "name": "Subject Characteristic Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74559", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.SCTEST", - "name": "Subject Characteristic Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C103330", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.STENRF", - "name": "Relation to Reference Period", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66728", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY_Y", - "name": "No Yes Response (Subset Y)", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.NY_NY", - "name": "No Yes Response (Subset NY)", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66742", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.UNIT", - "name": "Unit", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71620", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FREQ", - "name": "Frequency", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71113", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.PROCEDUR", - "name": "Procedure", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C101858", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "CT SCAN", - "decode": "CAT Scan", - "coding": { - "code": "C17204", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "MRI", - "decode": "Magnetic Resonance Imaging", - "coding": { - "code": "C16809", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "X-RAY", - "decode": "Static X-Ray", - "coding": { - "code": "C38101", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.LOC", - "name": "Anatomical Location", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C74456", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "BRAIN", - "decode": "Nervous System, Brain", - "coding": { - "code": "C12439", - "codeSystem": "nci:ExtCodeID" - } - }, - { - "codedValue": "CHEST", - "decode": "Chest", - "coding": { - "code": "C25389", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.LAT", - "name": "Laterality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99073", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTESTCD", - "name": "Vital Signs Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66741", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSTEST", - "name": "Vital Signs Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67153", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.POSITION", - "name": "Position", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71148", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.VSRESU", - "name": "Units for Vital Signs Results", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66770", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGTESTCD", - "name": "ECG Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71153", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGTEST", - "name": "ECG Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71152", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGSTRESC", - "name": "ECG Result", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71150", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EGMETHOD", - "name": "ECG Test Method", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C71151", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.EVAL", - "name": "Evaluator", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C78735", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "CAREGIVER", - "decode": "Caregiver", - "coding": { - "code": "C17445", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.FRM", - "name": "Dosage Form", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66726", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ROUTE", - "name": "Route of Administration Response", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66729", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTESTCD", - "name": "Laboratory Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C65047", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.LBTEST", - "name": "Laboratory Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67154", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MBTESTCD", - "name": "Microbiology Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C120527", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MBTEST", - "name": "Microbiology Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C120528", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MBFTSDTL", - "name": "Microbiology Findings Test Details", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C174225", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "DETECTION", - "decode": "", - "coding": { - "code": "C174330", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.SPECTYPE", - "name": "Specimen Type", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C78734", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "SERUM", - "decode": "Sera", - "coding": { - "code": "C13325", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.METHOD", - "name": "Method", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C85492", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "LINE PROBE ASSAY", - "decode": "LiPA", - "coding": { - "code": "C102656", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.URNSTSCD", - "name": "Urinary System Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129942", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.URNSTS", - "name": "Urinary System Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C129941", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.DIR", - "name": "Directionality", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C99074", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.QSCAT", - "name": "Category of Questionnaire", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C100129", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.AESEV", - "name": "Severity/Intensity Scale for Adverse Events", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66769", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ACN", - "name": "Action Taken with Study Treatment", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66767", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.OUT", - "name": "Outcome of Event", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66768", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MUSCTSCD", - "name": "Musculoskeletal System Finding Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C127269", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.MUSCTS", - "name": "Musculoskeletal System Finding Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C127270", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.TSPARMCD", - "name": "Trial Summary Parameter Test Code", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66738", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "EGCTMON", - "decode": "ECG Continuous Monitoring", - "coding": { - "code": "C119561", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.TSPARM", - "name": "Trial Summary Parameter Test Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C67152", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "ECG Continuous Monitoring", - "decode": "ECG Continuous Monitoring", - "coding": { - "code": "C119561", - "codeSystem": "nci:ExtCodeID" - } - } - ] - }, - { - "OID": "CL.DICTNAM", - "name": "Dictionary Name", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66788", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.FTCAT", - "name": "Category of Functional Test", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C115304", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.ND", - "name": "Not Done", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C66789", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "__PLACEHOLDER__", - "decode": "__PLACEHOLDER__" - } - ] - }, - { - "OID": "CL.CNTMODE", - "name": "Mode of Subject Contact", - "dataType": "text", - "standard": "STD.SDTMCT", - "coding": [ - { - "code": "C171445", - "codeSystem": "nci:ExtCodeID" - } - ], - "codeListItems": [ - { - "codedValue": "IN PERSON", - "decode": "In-Person", - "coding": { - "code": "C175574", - "codeSystem": "nci:ExtCodeID" - } - } - ] - } - ], - "methods": [], - "comments": [], - "standards": [ - { - "OID": "STD.SDTMIG", - "name": "SDTMIG", - "type": "IG", - "version": "3.4", - "status": "FINAL" - }, - { - "OID": "STD.SDTMCT", - "name": "CDISC/NCI", - "type": "CT", - "version": "2026-03-27", - "status": "FINAL", - "publishingSet": "SDTM" - } - ], - "annotatedCRF": [], - "concepts": [ - { - "OID": "CONC.BiomedicalConcept_1", - "name": "Informed Consent", - "label": null, - "aliases": [ - "Informed Consent Obtained" - ], - "href": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_2", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_3", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_2", - "name": "Inclusion Criteria", - "label": "Inclusion Criteria", - "aliases": [ - "Inclusion" - ], - "href": "/mdr/bc/biomedicalconcepts/C25532", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_4", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_5", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_6", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Inclusion Criteria" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_3", - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "aliases": [ - "Inclusion Exclusion Criteria Yes No Indicator", - "IEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83063", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_7", - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_8", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_4", - "name": "Exclusion Criteria", - "label": "Exclusion Criteria", - "aliases": [ - "Exclusion" - ], - "href": "/mdr/bc/biomedicalconcepts/C25370", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_9", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_10", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_11", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25370", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Exclusion Criteria" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_5", - "name": "Subject is Randomized", - "label": "Subject is Randomized", - "aliases": [ - "Randomized" - ], - "href": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_12", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.39e500d6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_13", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_14", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_6", - "name": "Race", - "label": "Race", - "aliases": [ - "Racial Group" - ], - "href": "/mdr/bc/biomedicalconcepts/C17049", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_15", - "name": "RACE", - "label": "RACE", - "mandatory": false, - "coding": [ - { - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Race" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_16", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Race" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_7", - "name": "Ethnic Group", - "label": "Ethnic Group", - "aliases": [ - "Ethnicity", - "Ethnic Origin" - ], - "href": "/mdr/bc/biomedicalconcepts/C16564", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_17", - "name": "ETHNIC", - "label": "ETHNIC", - "mandatory": false, - "coding": [ - { - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ethnic Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_18", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Ethnic Group" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_8", - "name": "Subject Age", - "label": "Subject Age", - "aliases": [ - "Age" - ], - "href": "/mdr/bc/biomedicalconcepts/C69260", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_19", - "name": "AGE", - "label": "AGE", - "mandatory": false, - "coding": [ - { - "code": "C170981", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Numeric Age for Data Tabulation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_20", - "name": "AGEU", - "label": "AGEU", - "mandatory": false, - "coding": [ - { - "code": "C50400", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Age Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_21", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C69260", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Subject Age" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_9", - "name": "Birth Date and Time", - "label": "Birth Date and Time", - "aliases": [ - "BRTHDTC", - "Date/Time of Birth" - ], - "href": "/mdr/bc/biomedicalconcepts/C83217", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_22", - "name": "BRTHDTC", - "label": "BRTHDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_23", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83217", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Birth Date and Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_10", - "name": "Sex", - "label": null, - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C28421", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_24", - "name": "SEX", - "label": "SEX", - "mandatory": false, - "coding": [ - { - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_25", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_11", - "name": "Education Level", - "label": "Education Level", - "aliases": [ - "EDULEVEL", - "Education", - "Education Level", - "Education Level Completed", - "education_level", - "Educational Attainment", - "Educational Level", - "Level of Education Attained" - ], - "href": "/mdr/bc/biomedicalconcepts/C17953", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_26", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_27", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C17953", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Education Level" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_12", - "name": "Number of Years of Education", - "label": "Number of Years of Education", - "aliases": [ - "EDUYRNUM", - "Number of Years of Education" - ], - "href": "/mdr/bc/biomedicalconcepts/C122393", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_28", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_29", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C122393", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Number of Years of Education" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_14", - "name": "Solicited Medical History", - "label": "Solicited Medical History", - "aliases": [ - "Medical History", - "Medical History Collection" - ], - "href": "/mdr/bc/biomedicalconcepts/C200145", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_30", - "name": "MHTERM", - "label": "MHTERM", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_31", - "name": "MHDECOD", - "label": "MHDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_32", - "name": "MHSTDTC", - "label": "MHSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83338", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_33", - "name": "MHENDTC", - "label": "MHENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_34", - "name": "MHENRF", - "label": "MHENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_35", - "name": "MHENRTPT", - "label": "MHENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_36", - "name": "MHENTPT", - "label": "MHENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C200145", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Medical History" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_15", - "name": "Alcohol Use History", - "label": "Alcohol Use History", - "aliases": [ - "Alcohol History", - "Alcohol Use" - ], - "href": "/mdr/bc/biomedicalconcepts/C81229", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_37", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_38", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_39", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_40", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_41", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_42", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_43", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_44", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_45", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_46", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_47", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_48", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_49", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_50", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_51", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C81229", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alcohol Use History" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_16", - "name": "Caffeine Use History", - "label": "Caffeine Use History", - "aliases": [ - "Caffeine History", - "Caffeine Use" - ], - "href": "/mdr/bc/biomedicalconcepts/C201990", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_52", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_53", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_54", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_55", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_56", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_57", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_58", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_59", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_60", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_61", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_62", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_63", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_64", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_65", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_66", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C201990", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Caffeine Use History" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_17", - "name": "History of Tobacco Use", - "label": "History of Tobacco Use", - "aliases": [ - "Tobacco Use", - "Tobacco Use History" - ], - "href": "/mdr/bc/biomedicalconcepts/C181760", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_67", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_68", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_69", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_70", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_71", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_72", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_73", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_74", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_75", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_76", - "name": "SUDUR", - "label": "SUDUR", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_77", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_78", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_79", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_80", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_81", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_82", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C181760", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "History of Tobacco Use" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_18", - "name": "X-Ray Imaging", - "label": "X-Ray Imaging", - "aliases": [ - "Conventional X-Ray", - "Medical Imaging", - "X-Ray", - "Static X-Ray" - ], - "href": "/mdr/bc/biomedicalconcepts/C38101", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_83", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_84", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.30a86bdd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_85", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_86", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_87", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_88", - "name": "PRLAT", - "label": "PRLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_89", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_90", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "X-Ray Imaging" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_19", - "name": "Subject is Randomized", - "label": null, - "aliases": [ - "Randomized" - ], - "href": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_91", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.39e500d6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_92", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_93", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_20", - "name": "Body Temperature", - "label": "Body Temperature", - "aliases": [ - "Temperature" - ], - "href": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_94", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_95", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_96", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_97", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_21", - "name": "Body Weight", - "label": "Body Weight", - "aliases": [ - "WEIGHT" - ], - "href": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_98", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_99", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_100", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_22", - "name": "Body Height", - "label": "Body Height", - "aliases": [ - "HEIGHT" - ], - "href": "/mdr/bc/biomedicalconcepts/C164634", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_101", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_102", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C168688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Height" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_103", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C164634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Height" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_23", - "name": "Pulse Rate", - "label": "Pulse Rate", - "aliases": [ - "Pulse" - ], - "href": "/mdr/bc/biomedicalconcepts/C49676", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_104", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_105", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_106", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_107", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_108", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_109", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_24", - "name": "Respiratory Rate", - "label": "Respiratory Rate", - "aliases": [ - "RESP", - "RESPRATE" - ], - "href": "/mdr/bc/biomedicalconcepts/C49678", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_110", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_111", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.da016f8d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_112", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49678", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_25", - "name": "Body Mass Index", - "label": "Body Mass Index", - "aliases": [ - "BMI", - "Quetelet Index" - ], - "href": "/mdr/bc/biomedicalconcepts/C16358", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_113", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_114", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Density" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_115", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C16358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Mass Index" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_26", - "name": "Blood Pressure", - "label": "Blood Pressure", - "aliases": [ - "BP" - ], - "href": "/mdr/bc/biomedicalconcepts/C54706", - "properties": [], - "coding": [ - { - "code": "C54706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_27", - "name": "Electrocardiogram Analysis", - "label": "Electrocardiogram Analysis", - "aliases": [ - "ECG Analysis", - "EKG Analysis", - "Electrocardiogram Interpretation", - "ECG Interpretation", - "EKG Interpretation" - ], - "href": "/mdr/bc/biomedicalconcepts/C181655", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_116", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C125009", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Interpretation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_117", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_118", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_119", - "name": "EGCLSIG", - "label": "EGCLSIG", - "mandatory": false, - "coding": [ - { - "code": "C93532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinically Significant Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_120", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C181655", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Electrocardiogram Analysis" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_28", - "name": "Atrioventricular Conduction ECG Assessment", - "label": "Atrioventricular Conduction ECG Assessment", - "aliases": [ - "AVCOND", - "Atrioventricular Conduction" - ], - "href": "/mdr/bc/biomedicalconcepts/C111131", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_121", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_122", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_123", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_124", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_125", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111131", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Atrioventricular Conduction ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_29", - "name": "Axis and Voltage ECG Assessment", - "label": "Axis and Voltage ECG Assessment", - "aliases": [ - "AXISVOLT", - "Axis and Voltage" - ], - "href": "/mdr/bc/biomedicalconcepts/C111132", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_126", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_127", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_128", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_129", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_130", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111132", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Axis and Voltage ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_30", - "name": "Chamber Hypertrophy or Enlargement ECG Assessment", - "label": "Chamber Hypertrophy or Enlargement ECG Assessment", - "aliases": [ - "CHYPTENL", - "Chamber Hypertrophy or Enlargement" - ], - "href": "/mdr/bc/biomedicalconcepts/C111155", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_131", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_132", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_133", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_134", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_135", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111155", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Chamber Hypertrophy or Enlargement ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_31", - "name": "ECG Technical Quality", - "label": "ECG Technical Quality", - "aliases": [ - "TECHQUAL" - ], - "href": "/mdr/bc/biomedicalconcepts/C117807", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_136", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C114120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ECG Recording Quality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_137", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_138", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_139", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117807", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "ECG Technical Quality" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_32", - "name": "Intraventricular and Intraatrial Conduction ECG Assessment", - "label": "Intraventricular and Intraatrial Conduction ECG Assessment", - "aliases": [ - "IVTIACD", - "Intraventricular-Intraatrial Conduction" - ], - "href": "/mdr/bc/biomedicalconcepts/C111238", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_140", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_141", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_142", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_143", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_144", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Intraventricular and Intraatrial Conduction ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_33", - "name": "Myocardial Infarction ECG Assessment", - "label": "Myocardial Infarction ECG Assessment", - "aliases": [ - "MI", - "Myocardial Infarction" - ], - "href": "/mdr/bc/biomedicalconcepts/C111280", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_145", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_146", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_147", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_148", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - } - ], - "coding": [ - { - "code": "C111280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Myocardial Infarction ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_34", - "name": "Pacemaker ECG Assessment", - "label": "Pacemaker ECG Assessment", - "aliases": [ - "PACEMAKR", - "Pacemaker" - ], - "href": "/mdr/bc/biomedicalconcepts/C111285", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_149", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_150", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_151", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_152", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_153", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Pacemaker ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_35", - "name": "Rhythm Not Otherwise Specified ECG Assessment", - "label": "Rhythm Not Otherwise Specified ECG Assessment", - "aliases": [ - "RHYNOS", - "Rhythm Not Otherwise Specified" - ], - "href": "/mdr/bc/biomedicalconcepts/C111307", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_154", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_155", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_156", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_157", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_158", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111307", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Rhythm Not Otherwise Specified ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_36", - "name": "ST Segment, T wave, and U wave ECG Assessment", - "label": "ST Segment, T wave, and U wave ECG Assessment", - "aliases": [ - "STSTWUW", - "ST Segment, T wave, and U wave" - ], - "href": "/mdr/bc/biomedicalconcepts/C111363", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_159", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_160", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_161", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_162", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_163", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111363", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "ST Segment, T wave, and U wave ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_37", - "name": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "label": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "aliases": [ - "SNRARRY", - "Sinus Node Rhythms and Arrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111312", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_164", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_165", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_166", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_167", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_168", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111312", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Sinus Node Rhythm and Arrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_38", - "name": "Supraventricular Arrhythmia ECG Assessment", - "label": "Supraventricular Arrhythmia ECG Assessment", - "aliases": [ - "SPRARRY", - "Supraventricular Arrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111320", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_169", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_170", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_171", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_172", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_173", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111320", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Arrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_39", - "name": "Supraventricular Tachyarrhythmia ECG Assessment", - "label": "Supraventricular Tachyarrhythmia ECG Assessment", - "aliases": [ - "SPRTARRY", - "Supraventricular Tachyarrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111321", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_174", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_175", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_176", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_177", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_178", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Tachyarrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_40", - "name": "Aggregate PR Interval", - "label": "Aggregate PR Interval", - "aliases": [ - "PR Interval Aggregate", - "PQ Interval Aggregate", - "PRAG", - "PQAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117773", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_179", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_180", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_181", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_182", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_183", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_184", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_185", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117773", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate PR Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_41", - "name": "Aggregate QRS Duration", - "label": "Aggregate QRS Duration", - "aliases": [ - "QRS Aggregate Duration", - "QRSAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117779", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_186", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_187", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_188", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_189", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_190", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_191", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_192", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117779", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QRS Duration" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_42", - "name": "Aggregate QT Interval", - "label": "Aggregate QT Interval", - "aliases": [ - "QT Interval Aggregate", - "QTAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117783", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_193", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_194", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_195", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_196", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_197", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_198", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_199", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117783", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QT Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_43", - "name": "Aggregate QTCB Interval", - "label": "Aggregate QTCB Interval", - "aliases": [ - "QTCB Interval Aggregate", - "QTCBAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117784", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_200", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_201", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_202", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_203", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_204", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_205", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_206", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117784", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCB Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_44", - "name": "Aggregate QTCF Interval", - "label": "Aggregate QTCF Interval", - "aliases": [ - "QTCF Interval Aggregate", - "QTCFAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117786", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_207", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_208", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_209", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_210", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_211", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_212", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_213", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCF Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_45", - "name": "Aggregate RR Interval", - "label": "Aggregate RR Interval", - "aliases": [ - "RR Interval Aggregate", - "RRAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C117791", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_214", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_215", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_216", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_217", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_218", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_219", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_220", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C117791", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Aggregate RR Interval" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_46", - "name": "Mean Heart Rate by Electrocardiogram", - "label": "Mean Heart Rate by Electrocardiogram", - "aliases": [ - "ECG Mean Heart Rate", - "EKG Mean Heart Rate", - "EGHRMN" - ], - "href": "/mdr/bc/biomedicalconcepts/C119259", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_221", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_222", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_223", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_224", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_225", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_226", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C119259", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Mean Heart Rate by Electrocardiogram" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_47", - "name": "QRS Axis", - "label": "QRS Axis", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C118165", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Degree Unit of Plane Angle" - } - ], - "codeList": "CL.798c8fb6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_230", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_231", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_232", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C118165", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QRS Axis" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_48", - "name": "QTc Correction Method Unspecified, Aggregate", - "label": "QTc Correction Method Unspecified, Aggregate", - "aliases": [ - "QTCUNSAG" - ], - "href": "/mdr/bc/biomedicalconcepts/C174285", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_233", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_234", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_235", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_236", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_237", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_238", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C174285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QTc Correction Method Unspecified, Aggregate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_49", - "name": "Ventricular Arrhythmia ECG Assessment", - "label": "Ventricular Arrhythmia ECG Assessment", - "aliases": [ - "VTARRY", - "Ventricular Arrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111330", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Arrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_50", - "name": "Ventricular Tachyarrhythmia ECG Assessment", - "label": "Ventricular Tachyarrhythmia ECG Assessment", - "aliases": [ - "VTTARRY", - "Ventricular Tachyarrhythmias" - ], - "href": "/mdr/bc/biomedicalconcepts/C111331", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Tachyarrhythmia ECG Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_51", - "name": "Computed Tomography", - "label": "Computed Tomography", - "aliases": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "href": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.6751dc8e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.5ae118a0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_52", - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "aliases": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "href": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.35f151cb" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.bfc80e1f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_54", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "aliases": [ - "CMYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_55", - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "aliases": [ - "Concomitant Medication" - ], - "href": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_56", - "name": "Hemoglobin Measurement", - "label": "Hemoglobin Measurement", - "aliases": [ - "Hemoglobin", - "HGB" - ], - "href": "/mdr/bc/biomedicalconcepts/C64848", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64848", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_57", - "name": "Hematocrit Measurement", - "label": "Hematocrit Measurement", - "aliases": [ - "Hematocrit", - "Packed Cell Volume", - "PCV", - "Erythrocyte Volume Fraction", - "EVF" - ], - "href": "/mdr/bc/biomedicalconcepts/C64796", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C69174", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume Fraction" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64796", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hematocrit Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_58", - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "aliases": [ - "RBC", - "Red Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_59", - "name": "Erythrocyte Mean Corpuscular Hemoglobin", - "label": "Erythrocyte Mean Corpuscular Hemoglobin", - "aliases": [ - "RBC Mean Corpuscular Hemoglobin", - "MCH" - ], - "href": "/mdr/bc/biomedicalconcepts/C64797", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C25709", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Measure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1aeb2034" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_302", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_303", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Hemoglobin" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_60", - "name": "Erythrocyte Mean Corpuscular Volume", - "label": "Erythrocyte Mean Corpuscular Volume", - "aliases": [ - "RBC Mean Corpuscular Volume", - "MCV" - ], - "href": "/mdr/bc/biomedicalconcepts/C64799", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_304", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_305", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" - } - ], - "codeList": "CL.a00fe0a9" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_306", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1aeb2034" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_307", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_308", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64799", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Volume" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_61", - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "aliases": [ - "WBC", - "White Blood Cells" - ], - "href": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_309", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_310", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_311", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_312", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_313", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_62", - "name": "Segmented Neutrophil Count", - "label": "Segmented Neutrophil Count", - "aliases": [ - "Segmented Neutrophils", - "NEUTSG" - ], - "href": "/mdr/bc/biomedicalconcepts/C81997", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_314", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_315", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.68e5ab5a" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_316", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C81997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Segmented Neutrophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_63", - "name": "Neutrophil Band Form Count", - "label": "Neutrophil Band Form Count", - "aliases": [ - "Neutrophil Bands", - "Bands", - "NEUTB" - ], - "href": "/mdr/bc/biomedicalconcepts/C64830", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.2c53325c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64830", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Neutrophil Band Form Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_64", - "name": "Absolute Neutrophil Count", - "label": "Absolute Neutrophil Count", - "aliases": [ - "Neutrophils", - "Total Neutrophil Count", - "NEUT" - ], - "href": "/mdr/bc/biomedicalconcepts/C63321", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.68e5ab5a" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C63321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Neutrophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_65", - "name": "Monocyte Count", - "label": "Monocyte Count", - "aliases": [ - "Monocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C64823", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64823", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Monocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_66", - "name": "Eosinophil Count", - "label": "Eosinophil Count", - "aliases": [ - "Eosinophils" - ], - "href": "/mdr/bc/biomedicalconcepts/C64550", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64550", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Eosinophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_67", - "name": "Absolute Basophil Count", - "label": "Absolute Basophil Count", - "aliases": [ - "Basophils", - "Total Basophil Count" - ], - "href": "/mdr/bc/biomedicalconcepts/C64470", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_341", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_342", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_343", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64470", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Basophil Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_68", - "name": "Platelet Count", - "label": "Platelet Count", - "aliases": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_344", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_345", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_69", - "name": "Microcyte Count", - "label": "Microcyte Count", - "aliases": [ - "Microcytes", - "MICROCY" - ], - "href": "/mdr/bc/biomedicalconcepts/C64822", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64822", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Microcyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_70", - "name": "Macrocyte Count", - "label": "Macrocyte Count", - "aliases": [ - "Macrocytes", - "MACROCY" - ], - "href": "/mdr/bc/biomedicalconcepts/C64821", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_354", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_355", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_356", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64821", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Macrocyte Count" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_71", - "name": "Anisocyte Measurement", - "label": "Anisocyte Measurement", - "aliases": [ - "Anisocytes", - "Anisocytosis", - "ANISO" - ], - "href": "/mdr/bc/biomedicalconcepts/C74797", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_358", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_359", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_360", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anisocyte Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_72", - "name": "Poikilocyte Measurement", - "label": "Poikilocyte Measurement", - "aliases": [ - "POIKILO", - "Poikilocytes" - ], - "href": "/mdr/bc/biomedicalconcepts/C79602", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_361", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C79602", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Poikilocyte Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_73", - "name": "Polychromasia", - "label": "Polychromasia", - "aliases": [ - "POLYCHR" - ], - "href": "/mdr/bc/biomedicalconcepts/C64803", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_365", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_366", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_367", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_368", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64803", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Polychromasia" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_74", - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "aliases": [ - "ALT", - "SGPT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_369", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_370", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_371", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_372", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_373", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_75", - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "aliases": [ - "Albumin" - ], - "href": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_374", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_375", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_376", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_377", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_378", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_76", - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "aliases": [ - "Alkaline Phosphatase" - ], - "href": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_379", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_380", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_381", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_382", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_383", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_77", - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "aliases": [ - "AST", - "SGOT" - ], - "href": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_384", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_385", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_386", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_387", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_388", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_78", - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "aliases": [ - "Creatinine" - ], - "href": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_389", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_390", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_391", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_392", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_393", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_79", - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "aliases": [ - "Potassium", - "K" - ], - "href": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_394", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_395", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_396", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_397", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_398", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_80", - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "aliases": [ - "Sodium", - "NA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_399", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_400", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_401", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_402", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_403", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_81", - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "aliases": [ - "Urea Nitrogen" - ], - "href": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_404", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_405", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_406", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_407", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_408", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_82", - "name": "Bicarbonate Measurement", - "label": "Bicarbonate Measurement", - "aliases": [ - "Bicarbonate", - "HCO3" - ], - "href": "/mdr/bc/biomedicalconcepts/C74667", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_419", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_420", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_421", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_422", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_423", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Bicarbonate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_83", - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "aliases": [ - "Chloride", - "CL" - ], - "href": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_429", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_430", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_431", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_432", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_433", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_84", - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "aliases": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "href": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_439", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_440", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_441", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_442", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_443", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_85", - "name": "Gamma Glutamyl Transpeptidase Measurement", - "label": "Gamma Glutamyl Transpeptidase Measurement", - "aliases": [ - "Gamma Glutamyl Transferase", - "GGT", - "GGTP" - ], - "href": "/mdr/bc/biomedicalconcepts/C64847", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_449", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_450", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_451", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_452", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_453", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64847", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Gamma Glutamyl Transpeptidase Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_86", - "name": "Urate Measurement", - "label": "Urate Measurement", - "aliases": [ - "Urate", - "Uric Acid" - ], - "href": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_459", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_460", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_461", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_462", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_463", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_87", - "name": "Phosphate Measurement", - "label": "Phosphate Measurement", - "aliases": [ - "Phosphorus", - "Phosphate" - ], - "href": "/mdr/bc/biomedicalconcepts/C64857", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_469", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_470", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_471", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_472", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_473", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64857", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Phosphate Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_88", - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "aliases": [ - "Calcium", - "CA" - ], - "href": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_480", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_481", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_482", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_483", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_484", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_89", - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "aliases": [ - "Glucose" - ], - "href": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_495", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_496", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_497", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_498", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_499", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_500", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_90", - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "aliases": [ - "Protein" - ], - "href": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_506", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_507", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_508", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_509", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_510", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_91", - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "aliases": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "href": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_516", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_517", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_518", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_519", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_520", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_92", - "name": "Triiodothyronine Uptake Measurement", - "label": "Triiodothyronine Uptake Measurement", - "aliases": [ - "T3UP", - "T3U", - "Triiodothyronine Resin Uptake" - ], - "href": "/mdr/bc/biomedicalconcepts/C74748", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_526", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_527", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48570", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_528", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_529", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_530", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74748", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Uptake Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_93", - "name": "Triiodothyronine Measurement", - "label": "Triiodothyronine Measurement", - "aliases": [ - "T3", - "Total T3" - ], - "href": "/mdr/bc/biomedicalconcepts/C74747", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_535", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_536", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_537", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_538", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_539", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74747", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_94", - "name": "Free Thyroxine Measurement", - "label": "Free Thyroxine Measurement", - "aliases": [ - "Free T4", - "T4FR" - ], - "href": "/mdr/bc/biomedicalconcepts/C74786", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_545", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_546", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_547", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_548", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_549", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_95", - "name": "Free Thyroxine Index", - "label": "Free Thyroxine Index", - "aliases": [ - "T4FRIDX" - ], - "href": "/mdr/bc/biomedicalconcepts/C170598", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_555", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_556", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_557", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_558", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C170598", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Index" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_96", - "name": "Thyrotropin Measurement", - "label": "Thyrotropin Measurement", - "aliases": [ - "TSH", - "Thyrotropin" - ], - "href": "/mdr/bc/biomedicalconcepts/C64813", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_564", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_565", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_566", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_567", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_568", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64813", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Thyrotropin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_97", - "name": "Folic Acid Measurement", - "label": "Folic Acid Measurement", - "aliases": [ - "Folate", - "Folic Acid", - "Vitamin B9", - "VITB9" - ], - "href": "/mdr/bc/biomedicalconcepts/C74676", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_574", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_575", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_576", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_577", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_578", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Folic Acid Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_98", - "name": "Vitamin B12 Measurement", - "label": "Vitamin B12 Measurement", - "aliases": [ - "Cobalamin", - "Vitamin B12", - "VITB12" - ], - "href": "/mdr/bc/biomedicalconcepts/C64817", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_584", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_585", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_586", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_587", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_588", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64817", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Vitamin B12 Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_99", - "name": "Treponema pallidum Antibody Measurement", - "label": "Treponema pallidum Antibody Measurement", - "aliases": [ - "TPLAB", - "Treponema pallidum Antibody", - "Syphilis Antibody" - ], - "href": "/mdr/bc/biomedicalconcepts/C132388", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_592", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.c75bb752" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_593", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_594", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.bbc50609" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_595", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_596", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C132388", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum Antibody Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_100", - "name": "Treponema pallidum DNA Measurement", - "label": "Treponema pallidum DNA Measurement", - "aliases": [ - "TPADNA", - "Syphilis DNA" - ], - "href": "/mdr/bc/biomedicalconcepts/C198341", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_606", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.c75bb752" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_607", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_608", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_609", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ], - "codeList": "CL.bdb73f2b" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_610", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C198341", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum DNA Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_101", - "name": "Color Assessment", - "label": "Color Assessment", - "aliases": [ - "COLOR", - "Color" - ], - "href": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_616", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_617", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_618", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_102", - "name": "Specific Gravity", - "label": "Specific Gravity", - "aliases": [ - "SPGRAV" - ], - "href": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_629", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_630", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_631", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_632", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_103", - "name": "Total Protein Measurement", - "label": null, - "aliases": [ - "Protein" - ], - "href": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_633", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_634", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_635", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_636", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_637", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_104", - "name": "Glucose Measurement", - "label": null, - "aliases": [ - "Glucose" - ], - "href": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_643", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_644", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_645", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_646", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_647", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_105", - "name": "Ketone Measurement", - "label": "Ketone Measurement", - "aliases": [ - "Ketones" - ], - "href": "/mdr/bc/biomedicalconcepts/C64854", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_652", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_653", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_654", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_655", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_656", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64854", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Ketone Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_106", - "name": "Total Bilirubin Measurement", - "label": null, - "aliases": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "href": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_657", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_658", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_659", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_660", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_661", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_107", - "name": "Urobilinogen Measurement", - "label": "Urobilinogen Measurement", - "aliases": [ - "Urobilinogen", - "UROBIL" - ], - "href": "/mdr/bc/biomedicalconcepts/C64816", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_667", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_668", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_669", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_670", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_671", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64816", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urobilinogen Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_108", - "name": "Occult Blood Measurement", - "label": "Occult Blood Measurement", - "aliases": [ - "Occult Blood", - "OCCBLD" - ], - "href": "/mdr/bc/biomedicalconcepts/C74686", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_676", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_677", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5fc938fc" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_678", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_679", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C74686", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occult Blood Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_109", - "name": "Nitrite Measurement", - "label": "Nitrite Measurement", - "aliases": [ - "NITRITE" - ], - "href": "/mdr/bc/biomedicalconcepts/C64810", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_684", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_685", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_686", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_687", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_688", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64810", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Nitrite Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_110", - "name": "Hemoglobin A1C Measurement", - "label": "Hemoglobin A1C Measurement", - "aliases": [ - "Hemoglobin A1C", - "HBA1C", - "Glycosylated Hemoglobin A1C" - ], - "href": "/mdr/bc/biomedicalconcepts/C64849", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_703", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_704", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_705", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_706", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C64849", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin A1C Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_111", - "name": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "label": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "aliases": [ - "Hemoglobin A1C/Hemoglobin", - "HBA1CHGB" - ], - "href": "/mdr/bc/biomedicalconcepts/C111207", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_713", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_714", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_715", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_716", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C111207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Hemoglobin A1C to Hemoglobin Ratio Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_112", - "name": "Exposure as Collected Domain", - "label": "Exposure as Collected Domain", - "aliases": [ - "EC", - "Exposure as Collected" - ], - "href": "/mdr/bc/biomedicalconcepts/C117466", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_720", - "name": "ECTRT", - "label": "ECTRT", - "mandatory": true, - "coding": [ - { - "code": "C117473", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Name of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_721", - "name": "ECREFID", - "label": "ECREFID", - "mandatory": false, - "coding": [ - { - "code": "C117469", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_722", - "name": "ECDOSE", - "label": "ECDOSE", - "mandatory": false, - "coding": [ - { - "code": "C117479", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_723", - "name": "ECDOSTXT", - "label": "ECDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C117480", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_724", - "name": "ECDOSU", - "label": "ECDOSU", - "mandatory": false, - "coding": [ - { - "code": "C117481", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Units" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_725", - "name": "ECDOSFRM", - "label": "ECDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C117482", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_726", - "name": "ECDOSFRQ", - "label": "ECDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C117483", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dosing Frequency per Interval" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_727", - "name": "ECDOSRGM", - "label": "ECDOSRGM", - "mandatory": false, - "coding": [ - { - "code": "C117485", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Intended Dose Regimen" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_728", - "name": "ECROUTE", - "label": "ECROUTE", - "mandatory": false, - "coding": [ - { - "code": "C117486", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_729", - "name": "ECLOC", - "label": "ECLOC", - "mandatory": false, - "coding": [ - { - "code": "C117488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_730", - "name": "ECLAT", - "label": "ECLAT", - "mandatory": false, - "coding": [ - { - "code": "C117489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_731", - "name": "ECDIR", - "label": "ECDIR", - "mandatory": false, - "coding": [ - { - "code": "C117490", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_732", - "name": "ECSTDTC", - "label": "ECSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Start Date and Time of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_733", - "name": "ECENDTC", - "label": "ECENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117497", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected End Date and Time of Treatment" - } - ] - } - ], - "coding": [ - { - "code": "C117466", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Exposure as Collected Domain" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_113", - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_734", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_735", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_736", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - } - ], - "coding": [ - { - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_114", - "name": "TTS Acceptability Survey - Patch Acceptability", - "label": "TTS Acceptability Survey - Patch Acceptability", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT4", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_740", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_741", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_742", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - } - ], - "coding": [ - { - "code": "NEW_LZZT4", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Acceptability" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_115", - "name": "TTS Acceptability Survey - Patch Appearance", - "label": "TTS Acceptability Survey - Patch Appearance", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT1", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_748", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_749", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_750", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - } - ], - "coding": [ - { - "code": "NEW_LZZT1", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Appearance" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_116", - "name": "TTS Acceptability Survey - Patch Durability", - "label": "TTS Acceptability Survey - Patch Durability", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT3", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_777", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_778", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_779", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - } - ], - "coding": [ - { - "code": "NEW_LZZT3", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Durability" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_117", - "name": "TTS Acceptability Survey - Patch Size", - "label": "TTS Acceptability Survey - Patch Size", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT2", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_780", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_781", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_782", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - } - ], - "coding": [ - { - "code": "NEW_LZZT2", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Size" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_134", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "aliases": [ - "AEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_783", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_784", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_135", - "name": "Solicited Adverse Event", - "label": "Solicited Adverse Event", - "aliases": [ - "Adverse Event" - ], - "href": "/mdr/bc/biomedicalconcepts/C179175", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_785", - "name": "AETERM", - "label": "AETERM", - "mandatory": true, - "coding": [ - { - "code": "C78541", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Verbatim Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_786", - "name": "AEDECOD", - "label": "AEDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83344", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_787", - "name": "AELOC", - "label": "AELOC", - "mandatory": false, - "coding": [ - { - "code": "C83205", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_788", - "name": "AESEV", - "label": "AESEV", - "mandatory": false, - "coding": [ - { - "code": "C53253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Severity of Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_789", - "name": "AESER", - "label": "AESER", - "mandatory": false, - "coding": [ - { - "code": "C53252", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Seriousness of Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_790", - "name": "AEACN", - "label": "AEACN", - "mandatory": false, - "coding": [ - { - "code": "C83013", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Action Taken with Study Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_791", - "name": "AEACNOTH", - "label": "AEACNOTH", - "mandatory": false, - "coding": [ - { - "code": "C83109", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Other Actions taken in Response to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_792", - "name": "AEREL", - "label": "AEREL", - "mandatory": false, - "coding": [ - { - "code": "C41358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Attribution to Product or Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_793", - "name": "AERELNST", - "label": "AERELNST", - "mandatory": false, - "coding": [ - { - "code": "C83210", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Relationship to Non Study Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_794", - "name": "AEPATT", - "label": "AEPATT", - "mandatory": false, - "coding": [ - { - "code": "C83208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Pattern" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_795", - "name": "AEOUT", - "label": "AEOUT", - "mandatory": false, - "coding": [ - { - "code": "C49489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Outcome" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_796", - "name": "AESCAN", - "label": "AESCAN", - "mandatory": false, - "coding": [ - { - "code": "C83211", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Involves Cancer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_797", - "name": "AESCONG", - "label": "AESCONG", - "mandatory": false, - "coding": [ - { - "code": "C83117", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_798", - "name": "AESDISAB", - "label": "AESDISAB", - "mandatory": false, - "coding": [ - { - "code": "C113380", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Disabling Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_799", - "name": "AESDTH", - "label": "AESDTH", - "mandatory": false, - "coding": [ - { - "code": "C48275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Death Related to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_800", - "name": "AESHOSP", - "label": "AESHOSP", - "mandatory": false, - "coding": [ - { - "code": "C83052", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event associated with Hospitalization" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_801", - "name": "AESLIFE", - "label": "AESLIFE", - "mandatory": false, - "coding": [ - { - "code": "C84266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Life Threatening Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_802", - "name": "AESOD", - "label": "AESOD", - "mandatory": false, - "coding": [ - { - "code": "C83214", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Occurred with Overdose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_803", - "name": "AESMIE", - "label": "AESMIE", - "mandatory": false, - "coding": [ - { - "code": "C83053", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Associated with Serious Medical Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_804", - "name": "AECONTRT", - "label": "AECONTRT", - "mandatory": false, - "coding": [ - { - "code": "C83199", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Concomitant Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_805", - "name": "AETOXGR", - "label": "AETOXGR", - "mandatory": false, - "coding": [ - { - "code": "C78605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Toxicity Grade" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_806", - "name": "AESTDTC", - "label": "AESTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_807", - "name": "AEENDTC", - "label": "AEENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83201", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_808", - "name": "AEENRF", - "label": "AEENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_809", - "name": "AEENRTPT", - "label": "AEENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_810", - "name": "AEENTPT", - "label": "AEENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - } - ], - "coding": [ - { - "code": "C179175", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Adverse Event" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_136", - "name": "Complete", - "label": "Complete", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C25250", - "properties": [], - "coding": [ - { - "code": "C25250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Complete [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_137", - "name": "Failure To Meet Continuation Criteria", - "label": "Failure To Meet Continuation Criteria", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C139236", - "properties": [], - "coding": [ - { - "code": "C139236", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Failure To Meet Continuation Criteria [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_138", - "name": "Dead", - "label": "Dead", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C28554", - "properties": [], - "coding": [ - { - "code": "C28554", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Dead [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_139", - "name": "Lack of Efficacy", - "label": "Lack of Efficacy", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C48226", - "properties": [], - "coding": [ - { - "code": "C48226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lack of Efficacy [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_140", - "name": "Lost To Follow-Up", - "label": "Lost To Follow-Up", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C48227", - "properties": [], - "coding": [ - { - "code": "C48227", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lost To Follow-Up [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_141", - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "coding": [ - { - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_142", - "name": "Physician Decision", - "label": "Physician Decision", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C48250", - "properties": [], - "coding": [ - { - "code": "C48250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Physician Decision [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_143", - "name": "Pregnant Subject", - "label": "Pregnant Subject", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C191656", - "properties": [], - "coding": [ - { - "code": "C191656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Pregnant Subject [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_144", - "name": "Progressive Disease", - "label": "Progressive Disease", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C35571", - "properties": [], - "coding": [ - { - "code": "C35571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Progressive Disease [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_145", - "name": "Protocol Deviation", - "label": "Protocol Deviation", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C50996", - "properties": [], - "coding": [ - { - "code": "C50996", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Protocol Deviation" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_146", - "name": "Study Site Transfer", - "label": "Study Site Transfer", - "aliases": [ - "Site Transfer", - "Study Subject Site Transfer" - ], - "href": "/mdr/bc/biomedicalconcepts/C186208", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_811", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.d8fccc32" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_812", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_813", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Site Transfer" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_147", - "name": "Study Terminated By Sponsor", - "label": "Study Terminated By Sponsor", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C49632", - "properties": [], - "coding": [ - { - "code": "C49632", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Terminated By Sponsor" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_148", - "name": "Subject Removed at Sponsor Request", - "label": "Subject Removed at Sponsor Request", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C161410", - "properties": [], - "coding": [ - { - "code": "C161410", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Subject Removed at Sponsor Request [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_149", - "name": "Trial Screen Failure", - "label": "Trial Screen Failure", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C49628", - "properties": [], - "coding": [ - { - "code": "C49628", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Screen Failure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_150", - "name": "Trial Site Terminated by Sponsor", - "label": "Trial Site Terminated by Sponsor", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C106576", - "properties": [], - "coding": [ - { - "code": "C106576", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Site Terminated by Sponsor" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_151", - "name": "Withdrawal by Subject", - "label": "Withdrawal by Subject", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C49634", - "properties": [], - "coding": [ - { - "code": "C49634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Withdrawal by Subject" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_152", - "name": "Withdrawal of Consent From Protocol-Specified Activity", - "label": "Withdrawal of Consent From Protocol-Specified Activity", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C170610", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_823", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.a3e2e2db" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_824", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_825", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Withdrawal of Consent From Protocol-Specified Activity" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_153", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "aliases": [ - "SYSBP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_832", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_833", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_834", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_835", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_836", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_837", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_154", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "aliases": [ - "DIABP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_862", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_863", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_864", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_865", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_866", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_867", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_155", - "name": "Heart Rate", - "label": "Heart Rate", - "aliases": [ - "HR" - ], - "href": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_880", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_881", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_882", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_883", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_884", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_885", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_156", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "aliases": [ - "SYSBP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_886", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_887", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_888", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_889", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_890", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_891", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_157", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "aliases": [ - "DIABP" - ], - "href": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_892", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_893", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_894", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_895", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_896", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_897", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_158", - "name": "Heart Rate", - "label": "Heart Rate", - "aliases": [ - "HR" - ], - "href": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_898", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_899", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_900", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_901", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_902", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_903", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_159", - "name": "Isometric Muscle Strength", - "label": "Isometric Muscle Strength", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C138967", - "properties": [], - "coding": [ - { - "code": "C138967", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Isometric Muscle Strength" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_160", - "name": "Skeletal Muscle Mass Measurement", - "label": "Skeletal Muscle Mass Measurement", - "aliases": [ - "SMMASS", - "Skeletal Muscle Mass" - ], - "href": "/mdr/bc/biomedicalconcepts/C178017", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_920", - "name": "MKORRES", - "label": "MKORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_921", - "name": "MKORRESU", - "label": "MKORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42579", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_922", - "name": "MKLOC", - "label": "MKLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_923", - "name": "MKLAT", - "label": "MKLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_924", - "name": "MKMETHOD", - "label": "MKMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_925", - "name": "MKDTC", - "label": "MKDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C178017", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Skeletal Muscle Mass Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_161", - "name": "Muscle Endurance Measurement", - "label": "Muscle Endurance Measurement", - "aliases": [ - "ENDURM", - "Muscle Endurance" - ], - "href": "/mdr/bc/biomedicalconcepts/C181501", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_933", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_934", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_935", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_936", - "name": "Laterality", - "label": "Laterality", - "mandatory": true, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_937", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_938", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C181501", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Muscle Endurance Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_162", - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "aliases": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "href": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_949", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_950", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_951", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_952", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_953", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_954", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ], - "coding": [ - { - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_164", - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_955", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_956", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_957", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - } - ], - "coding": [ - { - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_165", - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "aliases": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "href": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_974", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_975", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.35f151cb" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_976", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_977", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_978", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.bfc80e1f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_979", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_980", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_166", - "name": "Computed Tomography", - "label": "Computed Tomography", - "aliases": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "href": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_997", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_998", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.6751dc8e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_999", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1000", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1001", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1002", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1003", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure" - } - ] - } - ], - "coding": [ - { - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_168", - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "aliases": [ - "Vital Signs", - "VS" - ], - "href": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "coding": [ - { - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_169", - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "aliases": [ - "Vital Signs", - "VS" - ], - "href": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "coding": [ - { - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_170", - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "aliases": null, - "href": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "coding": [ - { - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_171", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "aliases": [ - "AEYN" - ], - "href": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1012", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1013", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_172", - "name": "CDISC ADAS-Cog - Word Recall Average Score", - "label": "CDISC ADAS-Cog - Word Recall Average Score", - "aliases": [ - "ADCRL", - "Word Recall", - "CDISC ADAS-Cog - Word Recall Average Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100177", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1022", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1023", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1024", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1025", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1026", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1027", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1028", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1029", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100177", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recall Average Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_173", - "name": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "label": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "aliases": [ - "ADCOF", - "Naming Objects and Fingers", - "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100191", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1030", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1031", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1032", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1033", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1034", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1035", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1036", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1037", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100191", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_174", - "name": "CDISC ADAS-Cog - Commands Summary Score", - "label": "CDISC ADAS-Cog - Commands Summary Score", - "aliases": [ - "ADCCMD", - "Commands", - "CDISC ADAS-Cog - Commands Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100209", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1046", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1047", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1048", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1049", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1050", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1051", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1052", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1053", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Commands Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_175", - "name": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "label": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "aliases": [ - "ADCDRL", - "Delayed Word Recall", - "CDISC ADAS-Cog - Delayed Word Recall Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100215", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1062", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1063", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1064", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1065", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1066", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1067", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1068", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1069", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Delayed Word Recall Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_176", - "name": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "label": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "aliases": [ - "ADCCP", - "Constructional Praxis", - "CDISC ADAS-Cog - Constructional Praxis Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100226", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1078", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1079", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1080", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1081", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1082", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1083", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1084", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1085", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - } - ], - "coding": [ - { - "code": "C100226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Constructional Praxis Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_177", - "name": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "label": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "aliases": [ - "ADCIP", - "Ideational Praxis", - "CDISC ADAS-Cog - Ideational Praxis Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100232", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1094", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1095", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1096", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1097", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1098", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1099", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1100", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1101", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - } - ], - "coding": [ - { - "code": "C100232", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Ideational Praxis Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_178", - "name": "CDISC ADAS-Cog - Orientation Summary Score", - "label": "CDISC ADAS-Cog - Orientation Summary Score", - "aliases": [ - "ADCOR", - "Orientation", - "CDISC ADAS-Cog - Orientation Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100238", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1110", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1111", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1112", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1113", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1114", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1115", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1116", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1117", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - } - ], - "coding": [ - { - "code": "C100238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Orientation Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_179", - "name": "CDISC ADAS-Cog - Word Recognition Summary Score", - "label": "CDISC ADAS-Cog - Word Recognition Summary Score", - "aliases": [ - "ADCRG", - "Word Recognition", - "CDISC ADAS-Cog - Word Recognition Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100247", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1126", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1127", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1128", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1129", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1130", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1131", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1132", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1133", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - } - ], - "coding": [ - { - "code": "C100247", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recognition Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_180", - "name": "CDISC ADAS-Cog - Remembering Test Instructions", - "label": "CDISC ADAS-Cog - Remembering Test Instructions", - "aliases": [ - "ADCRI", - "Remembering Test Instructions", - "CDISC ADAS-Cog - Remembering Test Instructions" - ], - "href": "/mdr/bc/biomedicalconcepts/C100275", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1142", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1143", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1144", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1145", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1146", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1147", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1148", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1149", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - } - ], - "coding": [ - { - "code": "C100275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Remembering Test Instructions" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_181", - "name": "CDISC ADAS-Cog - Spoken Language Ability", - "label": "CDISC ADAS-Cog - Spoken Language Ability", - "aliases": [ - "ADCSL", - "Spoken Language Ability", - "CDISC ADAS-Cog - Spoken Language Ability" - ], - "href": "/mdr/bc/biomedicalconcepts/C100276", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1167", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1168", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1169", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1170", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1171", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1172", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1173", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1174", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Spoken Language Ability" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_182", - "name": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "label": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "aliases": [ - "ADCDIF", - "Word Finding Difficulty in Spont Speech", - "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" - ], - "href": "/mdr/bc/biomedicalconcepts/C100277", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1181", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1182", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1183", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1184", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1185", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1186", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1187", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1188", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - } - ], - "coding": [ - { - "code": "C100277", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_183", - "name": "CDISC ADAS-Cog - Comprehension", - "label": "CDISC ADAS-Cog - Comprehension", - "aliases": [ - "ADCCMP", - "Comprehension", - "CDISC ADAS-Cog - Comprehension" - ], - "href": "/mdr/bc/biomedicalconcepts/C100278", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1189", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1190", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1191", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1192", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1193", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1194", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1195", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1196", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100278", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Comprehension" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_184", - "name": "CDISC ADAS-Cog - Concentration/Distractibility", - "label": "CDISC ADAS-Cog - Concentration/Distractibility", - "aliases": [ - "ADCCON", - "Concentration/Distractibility", - "CDISC ADAS-Cog - Concentration/Distractibility" - ], - "href": "/mdr/bc/biomedicalconcepts/C100279", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1197", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1198", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1199", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1200", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1201", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1202", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1203", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1204", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - } - ], - "coding": [ - { - "code": "C100279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Concentration/Distractibility" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_185", - "name": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "label": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "aliases": [ - "ADCNC", - "Number Cancellation", - "CDISC ADAS-Cog - Number Cancellation Summary Score" - ], - "href": "/mdr/bc/biomedicalconcepts/C100280", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1205", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1206", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1207", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1208", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1209", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1210", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1211", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1212", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Number Cancellation Summary Score" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_186", - "name": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "label": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "aliases": [ - "ADCMZ01", - "Executive Function Maze: Errors", - "CDISC ADAS-Cog - Executive Function Maze: Errors" - ], - "href": "/mdr/bc/biomedicalconcepts/C100285", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1213", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1214", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1215", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1216", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1217", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1218", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1219", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1220", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - } - ], - "coding": [ - { - "code": "C100285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Errors" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_187", - "name": "CDISC ADAS-Cog - Executive Function Maze: Time", - "label": "CDISC ADAS-Cog - Executive Function Maze: Time", - "aliases": [ - "ADCMZ02", - "Executive Function Maze: Time", - "CDISC ADAS-Cog - Executive Function Maze: Time" - ], - "href": "/mdr/bc/biomedicalconcepts/C100286", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1221", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1222", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1223", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1224", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1225", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1226", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1227", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1228", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1229", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - } - ], - "coding": [ - { - "code": "C100286", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Time" - } - ] - }, - { - "OID": "CONC.BiomedicalConcept_163", - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "aliases": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "href": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1230", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1231", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1232", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1233", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1234", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1235", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ], - "coding": [ - { - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator" - } - ] - } - ], - "conceptProperties": [ - { - "OID": "CONCPROP.BiomedicalConceptProperty_1", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_2", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_3", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_4", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_5", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_6", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_7", - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_8", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_9", - "name": "TIVERS", - "label": "TIVERS", - "mandatory": false, - "coding": [ - { - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - } - ], - "codeList": "CL.ad42d7e1" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_10", - "name": "IEORRES", - "label": "IEORRES", - "mandatory": false, - "coding": [ - { - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_11", - "name": "IEDTC", - "label": "IEDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_12", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.39e500d6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_13", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_14", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_15", - "name": "RACE", - "label": "RACE", - "mandatory": false, - "coding": [ - { - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Race" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_16", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_17", - "name": "ETHNIC", - "label": "ETHNIC", - "mandatory": false, - "coding": [ - { - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ethnic Group" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_18", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_19", - "name": "AGE", - "label": "AGE", - "mandatory": false, - "coding": [ - { - "code": "C170981", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Numeric Age for Data Tabulation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_20", - "name": "AGEU", - "label": "AGEU", - "mandatory": false, - "coding": [ - { - "code": "C50400", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Age Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_21", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_22", - "name": "BRTHDTC", - "label": "BRTHDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_23", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_24", - "name": "SEX", - "label": "SEX", - "mandatory": false, - "coding": [ - { - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_25", - "name": "DMDTC", - "label": "DMDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_26", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_27", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_28", - "name": "SCORRES", - "label": "SCORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_29", - "name": "SCDTC", - "label": "SCDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_30", - "name": "MHTERM", - "label": "MHTERM", - "mandatory": true, - "coding": [ - { - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_31", - "name": "MHDECOD", - "label": "MHDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_32", - "name": "MHSTDTC", - "label": "MHSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83338", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_33", - "name": "MHENDTC", - "label": "MHENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_34", - "name": "MHENRF", - "label": "MHENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_35", - "name": "MHENRTPT", - "label": "MHENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_36", - "name": "MHENTPT", - "label": "MHENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_37", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_38", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_39", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_40", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_41", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_42", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_43", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_44", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_45", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_46", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_47", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_48", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_49", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_50", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_51", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_52", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_53", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_54", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_55", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_56", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_57", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_58", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_59", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_60", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_61", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_62", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_63", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_64", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_65", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_66", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_67", - "name": "SUTRT", - "label": "SUTRT", - "mandatory": true, - "coding": [ - { - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_68", - "name": "SUPRESP", - "label": "SUPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_69", - "name": "SUOCCUR", - "label": "SUOCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_70", - "name": "SUDOSE", - "label": "SUDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_71", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_72", - "name": "SUDOSU", - "label": "SUDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_73", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_74", - "name": "SUSTDTC", - "label": "SUSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_75", - "name": "SUENDTC", - "label": "SUENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_76", - "name": "SUDUR", - "label": "SUDUR", - "mandatory": false, - "coding": [ - { - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_77", - "name": "SUSTRF", - "label": "SUSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_78", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_79", - "name": "SUSTTPT", - "label": "SUSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_80", - "name": "SUENRF", - "label": "SUENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_81", - "name": "SUENRTPT", - "label": "SUENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_82", - "name": "SUENTPT", - "label": "SUENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_83", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_84", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.30a86bdd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_85", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_86", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_87", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_88", - "name": "PRLAT", - "label": "PRLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_89", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_90", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_91", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.39e500d6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_92", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_93", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_94", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_95", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_96", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_97", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_98", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_99", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_100", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_101", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_102", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C168688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Height" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_103", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_104", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_105", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_106", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_107", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_108", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_109", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_110", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_111", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.da016f8d" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_112", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_113", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_114", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Density" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_115", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_116", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C125009", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Interpretation" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_117", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_118", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_119", - "name": "EGCLSIG", - "label": "EGCLSIG", - "mandatory": false, - "coding": [ - { - "code": "C93532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinically Significant Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_120", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_121", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_122", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_123", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_124", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_125", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_126", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_127", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_128", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_129", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_130", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_131", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_132", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_133", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_134", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_135", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_136", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C114120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ECG Recording Quality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_137", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_138", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_139", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_140", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_141", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_142", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_143", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_144", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_145", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_146", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_147", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_148", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_149", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_150", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_151", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_152", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_153", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_154", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_155", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_156", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_157", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_158", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_159", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_160", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_161", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_162", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_163", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_164", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_165", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_166", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_167", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_168", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_169", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_170", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_171", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_172", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_173", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_174", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_175", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_176", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_177", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_178", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_179", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_180", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_181", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_182", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_183", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_184", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_185", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_186", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_187", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_188", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_189", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_190", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_191", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_192", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_193", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_194", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_195", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_196", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_197", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_198", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_199", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_200", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_201", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_202", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_203", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_204", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_205", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_206", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_207", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_208", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_209", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_210", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_211", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_212", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_213", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_214", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_215", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_216", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_217", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_218", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_219", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_220", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_221", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_222", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_223", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_224", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_225", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_226", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_227", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_228", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Degree Unit of Plane Angle" - } - ], - "codeList": "CL.798c8fb6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_229", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_230", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_231", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_232", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_233", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_234", - "name": "EGORRESU", - "label": "EGORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_235", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_236", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_237", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_238", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_239", - "name": "EGENDTC", - "label": "EGENDTC", - "mandatory": false, - "coding": [ - { - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_240", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_241", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_242", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_243", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_244", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_245", - "name": "EGORRES", - "label": "EGORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_246", - "name": "EGPOS", - "label": "EGPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_247", - "name": "EGMETHOD", - "label": "EGMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_248", - "name": "EGEVAL", - "label": "EGEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_249", - "name": "EGDTC", - "label": "EGDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_250", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_251", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.6751dc8e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_252", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_253", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_254", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.5ae118a0" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_255", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_256", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_257", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_258", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.35f151cb" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_259", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_260", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_261", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.bfc80e1f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_262", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_263", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_264", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_265", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_266", - "name": "CMTRT", - "label": "CMTRT", - "mandatory": true, - "coding": [ - { - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_267", - "name": "CMDECOD", - "label": "CMDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_268", - "name": "CMCLAS", - "label": "CMCLAS", - "mandatory": false, - "coding": [ - { - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_269", - "name": "CMINDC", - "label": "CMINDC", - "mandatory": false, - "coding": [ - { - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_270", - "name": "CMDOSE", - "label": "CMDOSE", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_271", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_272", - "name": "CMDOSU", - "label": "CMDOSU", - "mandatory": false, - "coding": [ - { - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_273", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_274", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_275", - "name": "CMROUTE", - "label": "CMROUTE", - "mandatory": false, - "coding": [ - { - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_276", - "name": "CMSTDTC", - "label": "CMSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_277", - "name": "CMENDTC", - "label": "CMENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_278", - "name": "CMSTRF", - "label": "CMSTRF", - "mandatory": false, - "coding": [ - { - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_279", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_280", - "name": "CMSTTPT", - "label": "CMSTTPT", - "mandatory": false, - "coding": [ - { - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_281", - "name": "CMENRF", - "label": "CMENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_282", - "name": "CMENRTPT", - "label": "CMENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_283", - "name": "CMENTPT", - "label": "CMENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_284", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_285", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_286", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_287", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_288", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_289", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_290", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C69174", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume Fraction" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_291", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_292", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_293", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_294", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_295", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_296", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_297", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_298", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_299", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_300", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C25709", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Measure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_301", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1aeb2034" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_302", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_303", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_304", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_305", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C44279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume" - } - ], - "codeList": "CL.a00fe0a9" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_306", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.1aeb2034" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_307", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_308", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_309", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_310", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_311", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_312", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_313", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_314", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_315", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.68e5ab5a" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_316", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_317", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_318", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_319", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_320", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.2c53325c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_321", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_322", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_323", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_324", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_325", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ], - "codeList": "CL.68e5ab5a" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_326", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_327", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_328", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_329", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_330", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_331", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_332", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_333", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_334", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_335", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_336", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_337", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_338", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_339", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_340", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_341", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_342", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_343", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_344", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_345", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_346", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_347", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_348", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_349", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_350", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_351", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_352", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_353", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_354", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_355", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_356", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_357", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_358", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_359", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_360", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_361", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_365", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_366", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_367", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_368", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_369", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_370", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_371", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_372", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_373", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_374", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_375", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_376", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_377", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_378", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_379", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_380", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_381", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_382", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_383", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_384", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_385", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_386", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_387", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_388", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_389", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_390", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_391", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_392", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_393", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_394", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_395", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_396", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_397", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_398", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_399", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_400", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_401", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_402", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_403", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_404", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_405", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_406", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_407", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_408", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_419", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_420", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_421", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_422", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_423", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_429", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_430", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_431", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_432", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_433", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_439", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_440", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_441", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_442", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_443", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_449", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_450", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_451", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_452", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_453", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_459", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_460", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_461", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_462", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_463", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_469", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_470", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_471", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_472", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_473", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_480", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_481", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_482", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_483", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_484", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_495", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_496", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_497", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_498", - "name": "LBMETHOD", - "label": "LBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_499", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_500", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_506", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_507", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_508", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_509", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_510", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_516", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_517", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_518", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_519", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_520", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_526", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_527", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48570", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_528", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_529", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_530", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_535", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_536", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_537", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_538", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_539", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_545", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_546", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_547", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_548", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_549", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_555", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_556", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_557", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_558", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_564", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_565", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_566", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_567", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_568", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_574", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_575", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_576", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_577", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_578", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_584", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_585", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_586", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_587", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_588", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_592", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.c75bb752" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_593", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_594", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.bbc50609" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_595", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_596", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_606", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "mandatory": false, - "coding": [ - { - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - } - ], - "codeList": "CL.c75bb752" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_607", - "name": "MBORRES", - "label": "MBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_608", - "name": "MBSPEC", - "label": "MBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_609", - "name": "MBMETHOD", - "label": "MBMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ], - "codeList": "CL.bdb73f2b" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_610", - "name": "MBDTC", - "label": "MBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_616", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_617", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_618", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_629", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_630", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_631", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_632", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_633", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_634", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_635", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_636", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_637", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_643", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_644", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_645", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_646", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_647", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_652", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_653", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_654", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_655", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_656", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_657", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_658", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_659", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.9e69169e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_660", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_661", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_667", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_668", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_669", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_670", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_671", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_676", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_677", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5fc938fc" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_678", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_679", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_684", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_685", - "name": "LBORRESU", - "label": "LBORRESU", - "mandatory": false, - "coding": [ - { - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_686", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.5183f82c" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_687", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_688", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_703", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_704", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_705", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_706", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_713", - "name": "LBORRES", - "label": "LBORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_714", - "name": "LBSPEC", - "label": "LBSPEC", - "mandatory": false, - "coding": [ - { - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type" - } - ], - "codeList": "CL.af8f8a19" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_715", - "name": "LBFAST", - "label": "LBFAST", - "mandatory": false, - "coding": [ - { - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_716", - "name": "LBDTC", - "label": "LBDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_720", - "name": "ECTRT", - "label": "ECTRT", - "mandatory": true, - "coding": [ - { - "code": "C117473", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Name of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_721", - "name": "ECREFID", - "label": "ECREFID", - "mandatory": false, - "coding": [ - { - "code": "C117469", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Reference Identifier" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_722", - "name": "ECDOSE", - "label": "ECDOSE", - "mandatory": false, - "coding": [ - { - "code": "C117479", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_723", - "name": "ECDOSTXT", - "label": "ECDOSTXT", - "mandatory": false, - "coding": [ - { - "code": "C117480", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_724", - "name": "ECDOSU", - "label": "ECDOSU", - "mandatory": false, - "coding": [ - { - "code": "C117481", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Units" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_725", - "name": "ECDOSFRM", - "label": "ECDOSFRM", - "mandatory": false, - "coding": [ - { - "code": "C117482", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Form" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_726", - "name": "ECDOSFRQ", - "label": "ECDOSFRQ", - "mandatory": false, - "coding": [ - { - "code": "C117483", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dosing Frequency per Interval" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_727", - "name": "ECDOSRGM", - "label": "ECDOSRGM", - "mandatory": false, - "coding": [ - { - "code": "C117485", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Intended Dose Regimen" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_728", - "name": "ECROUTE", - "label": "ECROUTE", - "mandatory": false, - "coding": [ - { - "code": "C117486", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Route of Administration" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_729", - "name": "ECLOC", - "label": "ECLOC", - "mandatory": false, - "coding": [ - { - "code": "C117488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_730", - "name": "ECLAT", - "label": "ECLAT", - "mandatory": false, - "coding": [ - { - "code": "C117489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_731", - "name": "ECDIR", - "label": "ECDIR", - "mandatory": false, - "coding": [ - { - "code": "C117490", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Directionality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_732", - "name": "ECSTDTC", - "label": "ECSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Start Date and Time of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_733", - "name": "ECENDTC", - "label": "ECENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117497", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected End Date and Time of Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_734", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_735", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_736", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_740", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_741", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_742", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_748", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_749", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_750", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_777", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_778", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_779", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_780", - "name": "QSORRES", - "label": "QSORRES", - "mandatory": false, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_781", - "name": "QSDTC", - "label": "QSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_782", - "name": "QSEVAL", - "label": "QSEVAL", - "mandatory": false, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator" - } - ], - "codeList": "CL.b8dca4b6" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_783", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_784", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_785", - "name": "AETERM", - "label": "AETERM", - "mandatory": true, - "coding": [ - { - "code": "C78541", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Verbatim Description" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_786", - "name": "AEDECOD", - "label": "AEDECOD", - "mandatory": false, - "coding": [ - { - "code": "C83344", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Dictionary Derived Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_787", - "name": "AELOC", - "label": "AELOC", - "mandatory": false, - "coding": [ - { - "code": "C83205", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Location" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_788", - "name": "AESEV", - "label": "AESEV", - "mandatory": false, - "coding": [ - { - "code": "C53253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Severity of Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_789", - "name": "AESER", - "label": "AESER", - "mandatory": false, - "coding": [ - { - "code": "C53252", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Seriousness of Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_790", - "name": "AEACN", - "label": "AEACN", - "mandatory": false, - "coding": [ - { - "code": "C83013", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Action Taken with Study Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_791", - "name": "AEACNOTH", - "label": "AEACNOTH", - "mandatory": false, - "coding": [ - { - "code": "C83109", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Other Actions taken in Response to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_792", - "name": "AEREL", - "label": "AEREL", - "mandatory": false, - "coding": [ - { - "code": "C41358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Attribution to Product or Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_793", - "name": "AERELNST", - "label": "AERELNST", - "mandatory": false, - "coding": [ - { - "code": "C83210", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Relationship to Non Study Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_794", - "name": "AEPATT", - "label": "AEPATT", - "mandatory": false, - "coding": [ - { - "code": "C83208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Pattern" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_795", - "name": "AEOUT", - "label": "AEOUT", - "mandatory": false, - "coding": [ - { - "code": "C49489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Outcome" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_796", - "name": "AESCAN", - "label": "AESCAN", - "mandatory": false, - "coding": [ - { - "code": "C83211", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Involves Cancer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_797", - "name": "AESCONG", - "label": "AESCONG", - "mandatory": false, - "coding": [ - { - "code": "C83117", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_798", - "name": "AESDISAB", - "label": "AESDISAB", - "mandatory": false, - "coding": [ - { - "code": "C113380", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Disabling Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_799", - "name": "AESDTH", - "label": "AESDTH", - "mandatory": false, - "coding": [ - { - "code": "C48275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Death Related to Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_800", - "name": "AESHOSP", - "label": "AESHOSP", - "mandatory": false, - "coding": [ - { - "code": "C83052", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event associated with Hospitalization" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_801", - "name": "AESLIFE", - "label": "AESLIFE", - "mandatory": false, - "coding": [ - { - "code": "C84266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Life Threatening Adverse Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_802", - "name": "AESOD", - "label": "AESOD", - "mandatory": false, - "coding": [ - { - "code": "C83214", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Occurred with Overdose" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_803", - "name": "AESMIE", - "label": "AESMIE", - "mandatory": false, - "coding": [ - { - "code": "C83053", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Associated with Serious Medical Event" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_804", - "name": "AECONTRT", - "label": "AECONTRT", - "mandatory": false, - "coding": [ - { - "code": "C83199", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Concomitant Treatment" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_805", - "name": "AETOXGR", - "label": "AETOXGR", - "mandatory": false, - "coding": [ - { - "code": "C78605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Toxicity Grade" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_806", - "name": "AESTDTC", - "label": "AESTDTC", - "mandatory": false, - "coding": [ - { - "code": "C83215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_807", - "name": "AEENDTC", - "label": "AEENDTC", - "mandatory": false, - "coding": [ - { - "code": "C83201", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event End Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_808", - "name": "AEENRF", - "label": "AEENRF", - "mandatory": false, - "coding": [ - { - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_809", - "name": "AEENRTPT", - "label": "AEENRTPT", - "mandatory": false, - "coding": [ - { - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_810", - "name": "AEENTPT", - "label": "AEENTPT", - "mandatory": false, - "coding": [ - { - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_811", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.d8fccc32" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_812", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_813", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_823", - "name": "DSDECOD", - "label": "DSDECOD", - "mandatory": true, - "coding": [ - { - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term" - } - ], - "codeList": "CL.a3e2e2db" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_824", - "name": "DSTERM", - "label": "DSTERM", - "mandatory": true, - "coding": [ - { - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_825", - "name": "DSSTDTC", - "label": "DSSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_832", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_833", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_834", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_835", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_836", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_837", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_862", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_863", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_864", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_865", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_866", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_867", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_880", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_881", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_882", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_883", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_884", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_885", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_886", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_887", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_888", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_889", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_890", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_891", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_892", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_893", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure" - } - ], - "codeList": "CL.7cfd6cc5" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_894", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_895", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_896", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_897", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_898", - "name": "VSORRES", - "label": "VSORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_899", - "name": "VSORRESU", - "label": "VSORRESU", - "mandatory": false, - "coding": [ - { - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute" - } - ], - "codeList": "CL.20024ecd" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_900", - "name": "VSPOS", - "label": "VSPOS", - "mandatory": false, - "coding": [ - { - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_901", - "name": "VSLOC", - "label": "VSLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_902", - "name": "VSLAT", - "label": "VSLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_903", - "name": "VSDTC", - "label": "VSDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_920", - "name": "MKORRES", - "label": "MKORRES", - "mandatory": false, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_921", - "name": "MKORRESU", - "label": "MKORRESU", - "mandatory": false, - "coding": [ - { - "code": "C42579", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_922", - "name": "MKLOC", - "label": "MKLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_923", - "name": "MKLAT", - "label": "MKLAT", - "mandatory": false, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_924", - "name": "MKMETHOD", - "label": "MKMETHOD", - "mandatory": false, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_925", - "name": "MKDTC", - "label": "MKDTC", - "mandatory": false, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_933", - "name": "Observation Result", - "label": "Observation Result", - "mandatory": true, - "coding": [ - { - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Observation Result" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_934", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_935", - "name": "Anatomic Site", - "label": "Anatomic Site", - "mandatory": true, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_936", - "name": "Laterality", - "label": "Laterality", - "mandatory": true, - "coding": [ - { - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Laterality" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_937", - "name": "Test Method", - "label": "Test Method", - "mandatory": true, - "coding": [ - { - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Test Method" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_938", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_949", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_950", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_951", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_952", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_953", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_954", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_955", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_956", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_957", - "name": "Test Occurrence", - "label": "Test Occurrence", - "mandatory": true, - "coding": [ - { - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_974", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_975", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.35f151cb" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_976", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_977", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_978", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site" - } - ], - "codeList": "CL.bfc80e1f" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_979", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_980", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_997", - "name": "PRTRT", - "label": "PRTRT", - "mandatory": true, - "coding": [ - { - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_998", - "name": "PRDECOD", - "label": "PRDECOD", - "mandatory": true, - "coding": [ - { - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure" - } - ], - "codeList": "CL.6751dc8e" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_999", - "name": "PRPRESP", - "label": "PRPRESP", - "mandatory": false, - "coding": [ - { - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1000", - "name": "PROCCUR", - "label": "PROCCUR", - "mandatory": false, - "coding": [ - { - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1001", - "name": "PRLOC", - "label": "PRLOC", - "mandatory": false, - "coding": [ - { - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1002", - "name": "PRSTDTC", - "label": "PRSTDTC", - "mandatory": false, - "coding": [ - { - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1003", - "name": "PRENDTC", - "label": "PRENDTC", - "mandatory": false, - "coding": [ - { - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1012", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "mandatory": true, - "coding": [ - { - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1013", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1022", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1023", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1024", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1025", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1026", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1027", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1028", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1029", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1030", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1031", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1032", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1033", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1034", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1035", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1036", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1037", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1046", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1047", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1048", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1049", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1050", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1051", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1052", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1053", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1062", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1063", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1064", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1065", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1066", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1067", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1068", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1069", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1078", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1079", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1080", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1081", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1082", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1083", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1084", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1085", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1094", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1095", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1096", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1097", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1098", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1099", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1100", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1101", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1110", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1111", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1112", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1113", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1114", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1115", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1116", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1117", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1126", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1127", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1128", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1129", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1130", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1131", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1132", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1133", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1142", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1143", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1144", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1145", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1146", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1147", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1148", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1149", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1167", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1168", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1169", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1170", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1171", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1172", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1173", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1174", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1181", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1182", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1183", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1184", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1185", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1186", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1187", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1188", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1189", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1190", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1191", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1192", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1193", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1194", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1195", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1196", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1197", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1198", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1199", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1200", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1201", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1202", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1203", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1204", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1205", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1206", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1207", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1208", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1209", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1210", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1211", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1212", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1213", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1214", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1215", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1216", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1217", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1218", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1219", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1220", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1221", - "name": "Ordinal Position", - "label": "Ordinal Position", - "mandatory": true, - "coding": [ - { - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1222", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "mandatory": true, - "coding": [ - { - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1223", - "name": "Unit of Time", - "label": "Unit of Time", - "mandatory": true, - "coding": [ - { - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Unit of Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1224", - "name": "Category", - "label": "Category", - "mandatory": true, - "coding": [ - { - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1225", - "name": "Subcategory", - "label": "Subcategory", - "mandatory": true, - "coding": [ - { - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1226", - "name": "Completion Status", - "label": "Completion Status", - "mandatory": true, - "coding": [ - { - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1227", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "mandatory": true, - "coding": [ - { - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1228", - "name": "Evaluator", - "label": "Evaluator", - "mandatory": true, - "coding": [ - { - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1229", - "name": "Collection Date Time", - "label": "Collection Date Time", - "mandatory": true, - "coding": [ - { - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1230", - "name": "TSPARMCD", - "label": "TSPARMCD", - "mandatory": false, - "coding": [ - { - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1231", - "name": "TSPARM", - "label": "TSPARM", - "mandatory": false, - "coding": [ - { - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter" - } - ], - "codeList": "CL.1e00cfce" - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1232", - "name": "TSVAL", - "label": "TSVAL", - "mandatory": false, - "coding": [ - { - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1233", - "name": "TSVALCD", - "label": "TSVALCD", - "mandatory": false, - "coding": [ - { - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1234", - "name": "TSVCDREF", - "label": "TSVCDREF", - "mandatory": false, - "coding": [ - { - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - } - ] - }, - { - "OID": "CONCPROP.BiomedicalConceptProperty_1235", - "name": "TSVCDVER", - "label": "TSVCDVER", - "mandatory": false, - "coding": [ - { - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ] - } - ] -} diff --git a/output/json/NCT12345678-latest.json b/output/json/NCT12345678-latest.json deleted file mode 100644 index acffcfe..0000000 --- a/output/json/NCT12345678-latest.json +++ /dev/null @@ -1,33031 +0,0 @@ -{ - "study": { - "id": "Study_3", - "extensionAttributes": [], - "name": "NCT12345678", - "description": "Patients with probable mild to moderate AD will be studied in a randomized, double-blind, parallel (3 arm), placebo-controlled trial of 26 weeks duration. The study will be conducted on an outpatient basis. Approximately 300 patients will be enrolled", - "label": "CDISC Pilot LZZT", - "versions": [ - { - "id": "StudyVersion_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_153", - "url": "http://www.cdisc.org/usdm/extensions/studyDesignSolution", - "valueExtensionClass": { - "id": "ExtensionClass_1", - "url": "http://www.cdisc.org/usdm/extensions/StudyDesignSolution", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_154", - "url": "tool-name", - "valueString": "SoA Workbench", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_155", - "url": "tool-version", - "valueString": "pi-fix-bc-props-specs-in-usdm", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_156", - "url": "usdm-creation-date", - "valueString": "20260716T11:24", - "instanceType": "ExtensionAttribute" - } - ], - "instanceType": "ExtensionClass" - }, - "instanceType": "ExtensionAttribute" - } - ], - "versionIdentifier": "1", - "rationale": "", - "studyIdentifiers": [ - { - "id": "StudyIdentifier_1", - "extensionAttributes": [], - "text": "NCT12345678", - "scopeId": "Organization_1", - "instanceType": "StudyIdentifier" - } - ], - "referenceIdentifiers": [], - "studyDesigns": [ - { - "id": "InterventionalStudyDesign_1", - "extensionAttributes": [], - "name": "H2Q-MC-LZZT", - "label": "CDISC Pilot LZZT", - "description": "Patients with probable mild to moderate AD will be studied in a randomized, double-blind, parallel (3 arm), placebo-controlled trial of 26 weeks duration. The study will be conducted on an outpatient basis. Approximately 300 patients will be enrolled", - "studyType": null, - "studyPhase": null, - "therapeuticAreas": [], - "characteristics": [], - "encounters": [ - { - "id": "Encounter_1", - "extensionAttributes": [], - "name": "SCREEN1", - "label": "Screening 1", - "description": "Screening encounter", - "type": { - "id": "Code_55", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "Encounter_2", - "scheduledAtId": "Timing_1", - "environmentalSettings": [ - { - "id": "Code_84", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_164", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_17", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_1", - "label": null, - "description": null, - "text": "Subject identifier", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_18", - "extensionAttributes": [], - "name": "ENCOUNTER_END_RULE_2", - "label": null, - "description": null, - "text": "completion of screening activities", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_2", - "extensionAttributes": [], - "name": "SCREEN2", - "label": "Screening 2", - "description": "Screening encounter - Ambulatory ECG Placement", - "type": { - "id": "Code_56", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_1", - "nextId": "Encounter_3", - "scheduledAtId": "Timing_2", - "environmentalSettings": [ - { - "id": "Code_85", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_165", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": { - "id": "TransitionRule_19", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_2", - "label": null, - "description": null, - "text": "subject leaves clinic after connection of ambulatory ECG machine", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_3", - "extensionAttributes": [], - "name": "DOSE", - "label": "Baseline", - "description": "Baseline encounter - Ambulatory ECG Removal", - "type": { - "id": "Code_57", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_2", - "nextId": "Encounter_4", - "scheduledAtId": "Timing_3", - "environmentalSettings": [ - { - "id": "Code_86", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_166", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_20", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_3", - "label": null, - "description": null, - "text": "subject has connection of ambulatory ECG machine removed", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_21", - "extensionAttributes": [], - "name": "ENCOUNTER_END_RULE_5", - "label": null, - "description": null, - "text": "Radomized", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_4", - "extensionAttributes": [], - "name": "WEEK2", - "label": "Week 2", - "description": "Day 14", - "type": { - "id": "Code_58", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_3", - "nextId": "Encounter_5", - "scheduledAtId": "Timing_4", - "environmentalSettings": [ - { - "id": "Code_87", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_167", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_5", - "extensionAttributes": [], - "name": "WEEK4", - "label": "Week 4", - "description": "Day 28", - "type": { - "id": "Code_59", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_4", - "nextId": "Encounter_6", - "scheduledAtId": "Timing_5", - "environmentalSettings": [ - { - "id": "Code_88", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_168", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_6", - "extensionAttributes": [], - "name": "WEEK6", - "label": "Week 6", - "description": "Day 42", - "type": { - "id": "Code_60", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_5", - "nextId": "Encounter_7", - "scheduledAtId": "Timing_6", - "environmentalSettings": [ - { - "id": "Code_89", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_169", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_7", - "extensionAttributes": [], - "name": "WEEK8", - "label": "Week 8", - "description": "Day 56", - "type": { - "id": "Code_61", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_6", - "nextId": "Encounter_9", - "scheduledAtId": "Timing_7", - "environmentalSettings": [ - { - "id": "Code_90", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_170", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_9", - "extensionAttributes": [], - "name": "WEEK12", - "label": "Week 12", - "description": "Day 84", - "type": { - "id": "Code_63", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_7", - "nextId": "Encounter_11", - "scheduledAtId": "Timing_8", - "environmentalSettings": [ - { - "id": "Code_92", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_171", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_11", - "extensionAttributes": [], - "name": "WEEK16", - "label": "Week 16", - "description": "Day 112", - "type": { - "id": "Code_65", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_9", - "nextId": "Encounter_13", - "scheduledAtId": "Timing_9", - "environmentalSettings": [ - { - "id": "Code_94", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_172", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_13", - "extensionAttributes": [], - "name": "WEEK20", - "label": "Week 20", - "description": "Day 140", - "type": { - "id": "Code_67", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_11", - "nextId": "Encounter_15", - "scheduledAtId": "Timing_10", - "environmentalSettings": [ - { - "id": "Code_96", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_173", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_15", - "extensionAttributes": [], - "name": "WEEK24", - "label": "Week 24", - "description": "Day 168", - "type": { - "id": "Code_69", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_13", - "nextId": "Encounter_16", - "scheduledAtId": "Timing_11", - "environmentalSettings": [ - { - "id": "Code_98", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_174", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_16", - "extensionAttributes": [], - "name": "WEEK26", - "label": "Week 26", - "description": "Day 182", - "type": { - "id": "Code_70", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_15", - "nextId": null, - "scheduledAtId": "Timing_12", - "environmentalSettings": [ - { - "id": "Code_99", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_175", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": { - "id": "TransitionRule_22", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_12", - "label": null, - "description": null, - "text": "End of treatment", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - } - ], - "activities": [ - { - "id": "Activity_1", - "extensionAttributes": [], - "name": "Informed Consent", - "label": "Informed Consent", - "description": "Informed consent activity", - "previousId": null, - "nextId": "Activity_2", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_1" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_2", - "extensionAttributes": [], - "name": "Inclusion/Exclusion Criteria", - "label": "Inclusion/Exclusion Criteria", - "description": "Inclusion/Exclusion Criteria activity", - "previousId": "Activity_1", - "nextId": "Activity_3", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_2", - "BiomedicalConcept_3", - "BiomedicalConcept_4" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_3", - "extensionAttributes": [], - "name": "Patient number assigned", - "label": "Patient Number assigned", - "description": "Patient Number assigned activity", - "previousId": "Activity_2", - "nextId": "Activity_4", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_5" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_4", - "extensionAttributes": [], - "name": "Demographics", - "label": "Demographics", - "description": "Demographics activity", - "previousId": "Activity_3", - "nextId": "Activity_5", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_6", - "BiomedicalConcept_7", - "BiomedicalConcept_8", - "BiomedicalConcept_9", - "BiomedicalConcept_10" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_5", - "extensionAttributes": [], - "name": "Education", - "label": "Education", - "description": "Education activity", - "previousId": "Activity_4", - "nextId": "Activity_6", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_11", - "BiomedicalConcept_12" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_6", - "extensionAttributes": [], - "name": "Hachinski", - "label": "Hachinski", - "description": "Hachinski test", - "previousId": "Activity_5", - "nextId": "Activity_7", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_10", - "BiomedicalConceptSurrogate_11", - "BiomedicalConceptSurrogate_12", - "BiomedicalConceptSurrogate_13", - "BiomedicalConceptSurrogate_14", - "BiomedicalConceptSurrogate_15", - "BiomedicalConceptSurrogate_16", - "BiomedicalConceptSurrogate_17", - "BiomedicalConceptSurrogate_18", - "BiomedicalConceptSurrogate_9" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_7", - "extensionAttributes": [], - "name": "MMSE", - "label": "MMSE", - "description": "MMSE test", - "previousId": "Activity_6", - "nextId": "Activity_8", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_20", - "BiomedicalConceptSurrogate_21", - "BiomedicalConceptSurrogate_22", - "BiomedicalConceptSurrogate_23", - "BiomedicalConceptSurrogate_24", - "BiomedicalConceptSurrogate_25", - "BiomedicalConceptSurrogate_26" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_8", - "extensionAttributes": [], - "name": "Physical examination", - "label": "Physical examination", - "description": "Physical examination results", - "previousId": "Activity_7", - "nextId": "Activity_9", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_159", - "BiomedicalConcept_160", - "BiomedicalConcept_161" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_9", - "extensionAttributes": [], - "name": "Medical History", - "label": "Medical History", - "description": "Medical History response", - "previousId": "Activity_8", - "nextId": "Activity_10", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_14" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_10", - "extensionAttributes": [], - "name": "Habits", - "label": "Habits", - "description": "List of habits", - "previousId": "Activity_9", - "nextId": "Activity_11", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_15", - "BiomedicalConcept_16", - "BiomedicalConcept_17" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_11", - "extensionAttributes": [], - "name": "Chest X-ray", - "label": "Chest X-ray", - "description": "Chest X-ray result", - "previousId": "Activity_10", - "nextId": "Activity_12", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_18" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_12", - "extensionAttributes": [], - "name": "Apo E genotyping", - "label": "Apo E genotyping", - "description": "Apo E genotyping test", - "previousId": "Activity_11", - "nextId": "Activity_13", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_19" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_13", - "extensionAttributes": [], - "name": "Patient randomised", - "label": "Patient randomized", - "description": "Patient randomized activity", - "previousId": "Activity_12", - "nextId": "Activity_14", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_19" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_14", - "extensionAttributes": [], - "name": "Vital Signs", - "label": "Vital Signs", - "description": "Vital Signs result", - "previousId": "Activity_13", - "nextId": "Activity_15", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_20", - "BiomedicalConcept_21", - "BiomedicalConcept_22", - "BiomedicalConcept_23", - "BiomedicalConcept_24", - "BiomedicalConcept_25", - "BiomedicalConcept_26" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_15", - "extensionAttributes": [], - "name": "Ambulatory ECG placed", - "label": "Ambulatory ECG placed", - "description": "Ambulatory ECG placed activity", - "previousId": "Activity_14", - "nextId": "Activity_16", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_162" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_16", - "extensionAttributes": [], - "name": "Ambulatory ECG removed", - "label": "Ambulatory ECG removed", - "description": "Ambulatory ECG removed activity", - "previousId": "Activity_15", - "nextId": "Activity_17", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_163" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_17", - "extensionAttributes": [], - "name": "ECG", - "label": "ECG", - "description": "ECG results", - "previousId": "Activity_16", - "nextId": "Activity_18", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_27", - "BiomedicalConcept_28", - "BiomedicalConcept_29", - "BiomedicalConcept_30", - "BiomedicalConcept_31", - "BiomedicalConcept_32", - "BiomedicalConcept_33", - "BiomedicalConcept_34", - "BiomedicalConcept_35", - "BiomedicalConcept_36", - "BiomedicalConcept_37", - "BiomedicalConcept_38", - "BiomedicalConcept_39", - "BiomedicalConcept_40", - "BiomedicalConcept_41", - "BiomedicalConcept_42", - "BiomedicalConcept_43", - "BiomedicalConcept_44", - "BiomedicalConcept_45", - "BiomedicalConcept_46", - "BiomedicalConcept_47", - "BiomedicalConcept_48", - "BiomedicalConcept_49", - "BiomedicalConcept_50" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_18", - "extensionAttributes": [], - "name": "Placebo TTS Test", - "label": "Placebo TTS Test", - "description": "Placebo TTS Test results", - "previousId": "Activity_17", - "nextId": "Activity_19", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_164" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_19", - "extensionAttributes": [], - "name": "CT Scan", - "label": "CT Scan", - "description": "CT Scan results", - "previousId": "Activity_18", - "nextId": "Activity_20", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_51" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_20", - "extensionAttributes": [], - "name": "MRI", - "label": "MRI", - "description": "MRI results", - "previousId": "Activity_19", - "nextId": "Activity_21", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_52" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_21", - "extensionAttributes": [], - "name": "MRI, CT Scan", - "label": "MRI, CT Scan", - "description": "MRI, CT Scan results", - "previousId": "Activity_20", - "nextId": "Activity_22", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_165", - "BiomedicalConcept_166" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_22", - "extensionAttributes": [], - "name": "Concomitant medications", - "label": "Concomitant medications", - "description": "Concomitant medications information", - "previousId": "Activity_21", - "nextId": "Activity_23", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_54", - "BiomedicalConcept_55" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_23", - "extensionAttributes": [], - "name": "Hematology", - "label": "Hematology", - "description": "Hematology results", - "previousId": "Activity_22", - "nextId": "Activity_24", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_56", - "BiomedicalConcept_57", - "BiomedicalConcept_58", - "BiomedicalConcept_59", - "BiomedicalConcept_60", - "BiomedicalConcept_61", - "BiomedicalConcept_62", - "BiomedicalConcept_63", - "BiomedicalConcept_64", - "BiomedicalConcept_65", - "BiomedicalConcept_66", - "BiomedicalConcept_67", - "BiomedicalConcept_68", - "BiomedicalConcept_69", - "BiomedicalConcept_70", - "BiomedicalConcept_71", - "BiomedicalConcept_72", - "BiomedicalConcept_73" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_24", - "extensionAttributes": [], - "name": "Chemistry", - "label": "Chemistry", - "description": "Chemistry test results", - "previousId": "Activity_23", - "nextId": "Activity_25", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_74", - "BiomedicalConcept_75", - "BiomedicalConcept_76", - "BiomedicalConcept_77", - "BiomedicalConcept_78", - "BiomedicalConcept_79", - "BiomedicalConcept_80", - "BiomedicalConcept_81", - "BiomedicalConcept_82", - "BiomedicalConcept_83", - "BiomedicalConcept_84", - "BiomedicalConcept_85", - "BiomedicalConcept_86", - "BiomedicalConcept_87", - "BiomedicalConcept_88", - "BiomedicalConcept_89", - "BiomedicalConcept_90", - "BiomedicalConcept_91", - "BiomedicalConcept_92", - "BiomedicalConcept_93", - "BiomedicalConcept_94", - "BiomedicalConcept_95", - "BiomedicalConcept_96", - "BiomedicalConcept_97", - "BiomedicalConcept_98", - "BiomedicalConcept_99", - "BiomedicalConcept_100" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_25", - "extensionAttributes": [], - "name": "Urinalysis", - "label": "Urinalysis", - "description": "Urinalysis results", - "previousId": "Activity_24", - "nextId": "Activity_26", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_101", - "BiomedicalConcept_102", - "BiomedicalConcept_103", - "BiomedicalConcept_104", - "BiomedicalConcept_105", - "BiomedicalConcept_106", - "BiomedicalConcept_107", - "BiomedicalConcept_108", - "BiomedicalConcept_109" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_26", - "extensionAttributes": [], - "name": "Plasma Specimen (Xanomeline)", - "label": "Plasma Specimen (Xanomeline)", - "description": "Plasma Specimen (Xanomeline) results", - "previousId": "Activity_25", - "nextId": "Activity_27", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_27", - "extensionAttributes": [], - "name": "Hemoglobin A1C", - "label": "Hemoglobin A1C", - "description": "Hemoglobin A1C results", - "previousId": "Activity_26", - "nextId": "Activity_28", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_110", - "BiomedicalConcept_111" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_28", - "extensionAttributes": [], - "name": "Study Drug", - "label": "Study Drug", - "description": "Study Drug activity", - "previousId": "Activity_27", - "nextId": "Activity_29", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_112" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_29", - "extensionAttributes": [], - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "description": "TTS Acceptability Survey results", - "previousId": "Activity_28", - "nextId": "Activity_30", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_113", - "BiomedicalConcept_114", - "BiomedicalConcept_115", - "BiomedicalConcept_116", - "BiomedicalConcept_117" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_30", - "extensionAttributes": [], - "name": "ADAS-Cog", - "label": "ADAS-Cog", - "description": "ADAS-Cog results", - "previousId": "Activity_29", - "nextId": "Activity_31", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_172", - "BiomedicalConcept_173", - "BiomedicalConcept_174", - "BiomedicalConcept_175", - "BiomedicalConcept_176", - "BiomedicalConcept_177", - "BiomedicalConcept_178", - "BiomedicalConcept_179", - "BiomedicalConcept_180", - "BiomedicalConcept_181", - "BiomedicalConcept_182", - "BiomedicalConcept_183", - "BiomedicalConcept_184", - "BiomedicalConcept_185", - "BiomedicalConcept_186", - "BiomedicalConcept_187" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_31", - "extensionAttributes": [], - "name": "CIBIC+", - "label": "CIBIC+", - "description": "CIBIC+ results", - "previousId": "Activity_30", - "nextId": "Activity_32", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_27" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_32", - "extensionAttributes": [], - "name": "DAD", - "label": "DAD", - "description": "DAD results", - "previousId": "Activity_31", - "nextId": "Activity_33", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_28" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_33", - "extensionAttributes": [], - "name": "NPI-X", - "label": "NPI-X", - "description": "NPI-X results", - "previousId": "Activity_32", - "nextId": "Activity_34", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_29", - "BiomedicalConceptSurrogate_30", - "BiomedicalConceptSurrogate_31", - "BiomedicalConceptSurrogate_32", - "BiomedicalConceptSurrogate_33", - "BiomedicalConceptSurrogate_34" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_34", - "extensionAttributes": [], - "name": "Adverse Events", - "label": "Adverse Events", - "description": "Activities to conduct if occurence of Adverse Event", - "previousId": "Activity_33", - "nextId": "Activity_35", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_134", - "BiomedicalConcept_135" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_35", - "extensionAttributes": [], - "name": "Check Adverse Events", - "label": "Check Adverse Events", - "description": "TL: Adverse Event Timeline", - "previousId": "Activity_34", - "nextId": "Activity_36", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_170", - "BiomedicalConcept_171" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_36", - "extensionAttributes": [], - "name": "Patient Summary", - "label": "Patient Summary", - "description": "Patient Summary (Study Conclusion)", - "previousId": "Activity_35", - "nextId": "Activity_37", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_136", - "BiomedicalConcept_137", - "BiomedicalConcept_138", - "BiomedicalConcept_139", - "BiomedicalConcept_140", - "BiomedicalConcept_141", - "BiomedicalConcept_142", - "BiomedicalConcept_143", - "BiomedicalConcept_144", - "BiomedicalConcept_145", - "BiomedicalConcept_146", - "BiomedicalConcept_147", - "BiomedicalConcept_148", - "BiomedicalConcept_149", - "BiomedicalConcept_150", - "BiomedicalConcept_151", - "BiomedicalConcept_152" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_37", - "extensionAttributes": [], - "name": "Supine", - "label": "Supine", - "description": "Supine", - "previousId": "Activity_36", - "nextId": "Activity_38", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_168" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_38", - "extensionAttributes": [], - "name": "Vital Signs Supine", - "label": "Vital Signs Supine", - "description": "Vital Signs Supine", - "previousId": "Activity_37", - "nextId": "Activity_39", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_153", - "BiomedicalConcept_154", - "BiomedicalConcept_155" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_39", - "extensionAttributes": [], - "name": "Stand", - "label": "Stand", - "description": "Stand", - "previousId": "Activity_38", - "nextId": "Activity_40", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_169" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_40", - "extensionAttributes": [], - "name": "Vital Signs Standing", - "label": "Vital Signs Standing", - "description": "Vital Signs Standing", - "previousId": "Activity_39", - "nextId": null, - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_156", - "BiomedicalConcept_157", - "BiomedicalConcept_158" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - } - ], - "arms": [ - { - "id": "StudyArm_1", - "extensionAttributes": [], - "name": "Placebo", - "label": "Placebo", - "description": "Placebo ARM", - "type": { - "id": "Code_1", - "extensionAttributes": [], - "code": "C174268", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Placebo Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_2", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - }, - { - "id": "StudyArm_2", - "extensionAttributes": [], - "name": "Xanomeline Low Dose", - "label": "Xanomeline Low Dose", - "description": "Active substance low dose", - "type": { - "id": "Code_3", - "extensionAttributes": [], - "code": "C174267", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Active Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_4", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - }, - { - "id": "StudyArm_3", - "extensionAttributes": [], - "name": "Xanomeline High Dose", - "label": "Xanomeline High Dose", - "description": "Active Substance high dose", - "type": { - "id": "Code_5", - "extensionAttributes": [], - "code": "C174267", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Active Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_6", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - } - ], - "studyCells": [ - { - "id": "StudyCell_1", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_2", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_3", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_4", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_5", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_5", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_7" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_11", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_12", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_4" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_13", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_5" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_14", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_5", - "elementIds": [ - "StudyElement_6" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_15", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_7" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_16", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_17", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_18", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_19", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_5", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_20", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_7" - ], - "instanceType": "StudyCell" - } - ], - "rationale": "", - "epochs": [ - { - "id": "StudyEpoch_1", - "extensionAttributes": [], - "name": "Screening", - "label": "Screening", - "description": "Screening Epoch", - "type": { - "id": "Code_10", - "extensionAttributes": [], - "code": "C202487", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "SCREENING", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "StudyEpoch_3", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_3", - "extensionAttributes": [], - "name": "Treatment 1", - "label": "Treatment 1", - "description": "Treatment 1 Epoch", - "type": { - "id": "Code_11", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_1", - "nextId": "StudyEpoch_4", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_4", - "extensionAttributes": [], - "name": "Treatment 2", - "label": "Treatment 2", - "description": "Treatment 2 Epoch", - "type": { - "id": "Code_13", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_3", - "nextId": "StudyEpoch_5", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_5", - "extensionAttributes": [], - "name": "Treatment 3", - "label": "Treatment 3", - "description": "Treatment 3 Epoch", - "type": { - "id": "Code_14", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_4", - "nextId": "StudyEpoch_2", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_2", - "extensionAttributes": [], - "name": "Follow-up", - "label": "Follow-up", - "description": "Follow-up Epoch", - "type": { - "id": "Code_12", - "extensionAttributes": [], - "code": "C202578", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "FOLLOW-UP", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_5", - "nextId": null, - "notes": [], - "instanceType": "StudyEpoch" - } - ], - "elements": [ - { - "id": "StudyElement_1", - "extensionAttributes": [], - "name": "EL1", - "label": "Screening", - "description": "Screening Element", - "transitionStartRule": { - "id": "TransitionRule_23", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_1", - "label": null, - "description": null, - "text": "Informed consent", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_24", - "extensionAttributes": [], - "name": "ELEMENT_END_RULE_1", - "label": null, - "description": null, - "text": "Completion of all screening activities and no more than 2 weeks from informed consent", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_2", - "extensionAttributes": [], - "name": "EL2", - "label": "Placebo", - "description": "Placebo TTS (adhesive patches)", - "transitionStartRule": { - "id": "TransitionRule_27", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_2", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_3", - "extensionAttributes": [], - "name": "EL3", - "label": "Low", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "transitionStartRule": { - "id": "TransitionRule_28", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_3", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_4", - "extensionAttributes": [], - "name": "EL4", - "label": "High - Start", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "transitionStartRule": { - "id": "TransitionRule_29", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_4", - "label": null, - "description": null, - "text": "Randomized", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_5", - "extensionAttributes": [], - "name": "EL5", - "label": "High - Middle", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg + 25 cm2, 27 mg", - "transitionStartRule": { - "id": "TransitionRule_30", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_5", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose\\u00a0(from\\u00a0patches\\u00a0supplied\\u00a0at\\u00a0Visit\\u00a04)", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_6", - "extensionAttributes": [], - "name": "EL6", - "label": "High - End", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "transitionStartRule": { - "id": "TransitionRule_31", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_6", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose\\u00a0(from\\u00a0patches\\u00a0supplied\\u00a0at\\u00a0Visit\\u00a012)", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_7", - "extensionAttributes": [], - "name": "EL7", - "label": "Follow up", - "description": "Follow up Element", - "transitionStartRule": { - "id": "TransitionRule_25", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_7", - "label": null, - "description": null, - "text": "End\\u00a0of\\u00a0last\\u00a0scheduled\\u00a0visit\\u00a0on\\u00a0study\\u00a0(including\\u00a0early\\u00a0termination)", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_26", - "extensionAttributes": [], - "name": "ELEMENT_END_RULE_7", - "label": null, - "description": null, - "text": "Completion\\u00a0of\\u00a0all\\u00a0specified\\u00a0followup\\u00a0activities\\u00a0(which\\u00a0vary\\u00a0on\\u00a0a\\u00a0patient-by-patient\\u00a0basis)", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - } - ], - "estimands": [ - { - "id": "Estimand_1", - "extensionAttributes": [], - "name": "Estimand 1", - "label": "Estimand 1", - "description": "Estimand 1", - "populationSummary": "Group mean changes from baseline in the primary efficacy parameters", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_1", - "interventionIds": [ - "StudyIntervention_1" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_1", - "extensionAttributes": [], - "name": "Disruption", - "label": "Disruption", - "description": "The disruption of treatment to the subject", - "text": "Temporary Treatment Interruption", - "strategy": "Treatment Policy. Continue to measure effect of treatment assignment regardless of interruption.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - } - ], - "indications": [ - { - "id": "Indication_1", - "extensionAttributes": [], - "name": "Indication 1", - "label": "Alzheimer's disease", - "description": "Alzheimer's disease", - "isRareDisease": false, - "codes": [ - { - "id": "Code_36968", - "extensionAttributes": [], - "code": "G30.9", - "codeSystem": "ICD-10-CM", - "codeSystemVersion": "1", - "decode": "Alzheimer's disease; unspecified", - "instanceType": "Code" - } - ], - "notes": [], - "instanceType": "Indication" - }, - { - "id": "Indication_2", - "extensionAttributes": [], - "name": "Indication 2", - "label": "Alzheimer's disease", - "description": "Alzheimer's disease", - "isRareDisease": false, - "codes": [ - { - "id": "Code_36969", - "extensionAttributes": [], - "code": "26929004", - "codeSystem": "SNOMED", - "codeSystemVersion": "2018-01-31", - "decode": "Alzheimer's disease", - "instanceType": "Code" - } - ], - "notes": [], - "instanceType": "Indication" - } - ], - "studyInterventionIds": [ - "StudyIntervention_1" - ], - "objectives": [ - { - "id": "Objective_1", - "extensionAttributes": [], - "name": "OBJ1", - "label": "Objective 1", - "description": "Main Objective", - "text": "To determine if there is a statistically significant relationship (overall Type 1 erroralpha=0.05) between the change in both the ADAS-Cog (11) and CIBIC+ scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2508", - "extensionAttributes": [], - "code": "C85826", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85826", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_1", - "extensionAttributes": [], - "name": "ENDPT1", - "label": "Endpoint 1", - "description": "ADAS-Cog Week 24 Endpoint", - "text": "Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] at Week 24", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2514", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_2", - "extensionAttributes": [], - "name": "ENDPT2", - "label": "Endpoint 2", - "description": "Clinician Week 24 impression of change", - "text": "Video-referenced Clinician\\u2019s Interview-based Impression of Change (CIBIC+) at Week 24", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2515", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_2", - "extensionAttributes": [], - "name": "OBJ2", - "label": "Objective 2", - "description": "Safety", - "text": "To document the safety profile of the xanomeline TTS.", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2509", - "extensionAttributes": [], - "code": "C85826", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85826", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_3", - "extensionAttributes": [], - "name": "ENDPT3", - "label": "Endpoint 3", - "description": "Adverse events", - "text": "Adverse events", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2516", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_4", - "extensionAttributes": [], - "name": "ENDPT4", - "label": "Endpoint 4", - "description": "Vital Signs", - "text": "Vital signs (weight, standing and supine blood pressure, heart rate)", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2517", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_5", - "extensionAttributes": [], - "name": "ENDPT5", - "label": "Endpoint 5", - "description": "Baseline", - "text": "The change from baseline laboratory value will be calculated as the difference between the baseline lab value and the endpoint value (i.e., the value at the specified visit) or the end of treatment observation\", \"text\": \"Laboratory evaluations (Change from Baseline)", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2518", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_3", - "extensionAttributes": [], - "name": "OBJ3", - "label": "Objective 3", - "description": "Behaviour", - "text": "To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2510", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_6", - "extensionAttributes": [], - "name": "ENDPT6", - "label": "Endpoint 6", - "description": "Cognitive Scale", - "text": "Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] at Weeks 8 and 16", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2519", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_7", - "extensionAttributes": [], - "name": "ENDPT7", - "label": "Endpoint 7", - "description": "Clinician impression at Week8 and Week16", - "text": "Video-referenced Clinician\\u2019s Interview-based Impression of Change (CIBIC+) at Weeks 8 and 16", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2520", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_8", - "extensionAttributes": [], - "name": "ENDPT8", - "label": "Endpoint 8", - "description": "NPI-X", - "text": "Mean Revised Neuropsychiatric Inventory (NPI-X) from Week 4 to Week 24", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2521", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_4", - "extensionAttributes": [], - "name": "OBJ4", - "label": "Objective 4", - "description": "Improvements", - "text": "To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas (see Attachment LZZT.5).", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2511", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_9", - "extensionAttributes": [], - "name": "ENDPT9", - "label": "Endpoint 9", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2522", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_5", - "extensionAttributes": [], - "name": "OBJ5", - "label": "Objective 5", - "description": "Improvements", - "text": "To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer's Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment (see Attachment LZZT.2).", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2512", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_10", - "extensionAttributes": [], - "name": "ENDPT10", - "label": "Endpoint 10", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2523", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_6", - "extensionAttributes": [], - "name": "OBJ6", - "label": "Objective 6", - "description": "Response", - "text": "To assess the treatment response as a function of Apo E genotype.", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2513", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_11", - "extensionAttributes": [], - "name": "ENDPT11", - "label": "Endpoint 11", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2524", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - } - ], - "population": { - "id": "StudyDesignPopulation_1", - "extensionAttributes": [], - "name": "Population_1", - "label": null, - "description": null, - "includesHealthySubjects": false, - "plannedEnrollmentNumber": null, - "plannedCompletionNumber": null, - "plannedSex": [], - "criterionIds": [], - "plannedAge": null, - "notes": [], - "cohorts": [], - "instanceType": "StudyDesignPopulation" - }, - "scheduleTimelines": [ - { - "id": "ScheduleTimeline_1", - "extensionAttributes": [], - "name": "Main Timeline", - "label": "Main Timeline", - "description": "This is the main timeline for the study design", - "mainTimeline": true, - "entryCondition": "Potential subject identified", - "entryId": "ScheduledActivityInstance_1", - "exits": [], - "timings": [ - { - "id": "Timing_1", - "extensionAttributes": [], - "name": "TIM1", - "label": "Screening", - "description": "Screening Timing", - "type": { - "id": "Code_20", - "extensionAttributes": [], - "code": "C201357", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Before", - "instanceType": "Code" - }, - "value": "-P2W", - "valueLabel": "2 Weeks Before Dose", - "relativeToFrom": { - "id": "Code_27", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_1", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_2", - "extensionAttributes": [], - "name": "TIM2", - "label": "Pre-dose", - "description": "Pre-dose Timing", - "type": { - "id": "Code_22", - "extensionAttributes": [], - "code": "C201357", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Before", - "instanceType": "Code" - }, - "value": "-P2D", - "valueLabel": "2 Days Before Dose", - "relativeToFrom": { - "id": "Code_28", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "PT4H", - "windowUpper": "PT0H", - "windowLabel": "-4..0 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_3", - "extensionAttributes": [], - "name": "TIM3", - "label": "Dosing", - "description": "Dosing Anchor", - "type": { - "id": "Code_18", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "P1D", - "valueLabel": "1 Day", - "relativeToFrom": { - "id": "Code_19", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_3", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_4", - "extensionAttributes": [], - "name": "TIM4", - "label": "Week 2", - "description": "Week 2 timing", - "type": { - "id": "Code_29", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_25", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_4", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_5", - "extensionAttributes": [], - "name": "TIM5", - "label": "Week 4", - "description": "Week 4 Timing", - "type": { - "id": "Code_30", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P4W", - "valueLabel": "4 Weeks", - "relativeToFrom": { - "id": "Code_31", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_5", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_6", - "extensionAttributes": [], - "name": "TIM6", - "label": "Week 6", - "description": "Week 6 Timing", - "type": { - "id": "Code_32", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P6W", - "valueLabel": "6 Weeks", - "relativeToFrom": { - "id": "Code_33", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_6", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_7", - "extensionAttributes": [], - "name": "TIM7", - "label": "Week 8", - "description": "Week 8 Timing", - "type": { - "id": "Code_34", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P8W", - "valueLabel": "8 Weeks", - "relativeToFrom": { - "id": "Code_35", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_7", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_8", - "extensionAttributes": [], - "name": "TIM9", - "label": "Week 12", - "description": "Week 12 Timing", - "type": { - "id": "Code_36", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P12W", - "valueLabel": "12 Weeks", - "relativeToFrom": { - "id": "Code_37", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_19", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_9", - "extensionAttributes": [], - "name": "TIM11", - "label": "Week 16", - "description": "Week 16 Timing", - "type": { - "id": "Code_38", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P16W", - "valueLabel": "16 Weeks", - "relativeToFrom": { - "id": "Code_39", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_21", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_10", - "extensionAttributes": [], - "name": "TIM13", - "label": "Week 20", - "description": "Week 20 Timing", - "type": { - "id": "Code_40", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P20W", - "valueLabel": "20 Weeks", - "relativeToFrom": { - "id": "Code_41", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_23", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_11", - "extensionAttributes": [], - "name": "TIM15", - "label": "Week 24", - "description": "Week 24 Timing", - "type": { - "id": "Code_42", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P24W", - "valueLabel": "24 Weeks", - "relativeToFrom": { - "id": "Code_43", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_25", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_12", - "extensionAttributes": [], - "name": "TIM16", - "label": "Week 26", - "description": "Week 26 Timing", - "type": { - "id": "Code_44", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P26W", - "valueLabel": "26 Weeks", - "relativeToFrom": { - "id": "Code_45", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_26", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_13", - "extensionAttributes": [], - "name": "TIM8", - "label": "Week 8 Home", - "description": "Week 8 Home Timing", - "type": { - "id": "Code_46", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_47", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_8", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_7", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_14", - "extensionAttributes": [], - "name": "TIM10", - "label": "Week 12 Home", - "description": "Week 12 Home Timing", - "type": { - "id": "Code_48", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_49", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_20", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_19", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_15", - "extensionAttributes": [], - "name": "TIM12", - "label": "Week 16 Home", - "description": "Week 16 Home Timing", - "type": { - "id": "Code_50", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_51", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_22", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_21", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_16", - "extensionAttributes": [], - "name": "TIM14", - "label": "Week 20 Home", - "description": "Week 20 Home Timing", - "type": { - "id": "Code_52", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_53", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_24", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_23", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_1", - "extensionAttributes": [], - "name": "SCREEN1", - "label": "Screen 1", - "description": "Screen 1 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_2", - "epochId": "StudyEpoch_1", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_1", - "Activity_2", - "Activity_3", - "Activity_4", - "Activity_5", - "Activity_6", - "Activity_7", - "Activity_8", - "Activity_9", - "Activity_10", - "Activity_11", - "Activity_14", - "Activity_17", - "Activity_18", - "Activity_19", - "Activity_20", - "Activity_21", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_25", - "Activity_27", - "Activity_31", - "Activity_32", - "Activity_30", - "Activity_33" - ], - "encounterId": "Encounter_1" - }, - { - "id": "ScheduledActivityInstance_2", - "extensionAttributes": [], - "name": "SCREEN2", - "label": "Screen 2", - "description": "Screen 2 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_3", - "epochId": "StudyEpoch_1", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_15", - "Activity_33" - ], - "encounterId": "Encounter_2" - }, - { - "id": "ScheduledActivityInstance_3", - "extensionAttributes": [], - "name": "DOSE", - "label": "Dose", - "description": "Dose Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_4", - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_13", - "Activity_14", - "Activity_16", - "Activity_22", - "Activity_28", - "Activity_26", - "Activity_30", - "Activity_31", - "Activity_32", - "Activity_33" - ], - "encounterId": "Encounter_3" - }, - { - "id": "ScheduledActivityInstance_4", - "extensionAttributes": [], - "name": "WEEK2", - "label": "Week 2", - "description": "Week 2 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_5", - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_12", - "Activity_14", - "Activity_22", - "Activity_23", - "Activity_25", - "Activity_26", - "Activity_28", - "Activity_17", - "Activity_24", - "Activity_33" - ], - "encounterId": "Encounter_4" - }, - { - "id": "ScheduledActivityInstance_5", - "extensionAttributes": [], - "name": "WEEK4", - "label": "Week 4", - "description": "Week 4 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_6", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_26", - "Activity_28", - "Activity_33" - ], - "encounterId": "Encounter_5" - }, - { - "id": "ScheduledActivityInstance_6", - "extensionAttributes": [], - "name": "WEEK6", - "label": "Week 6", - "description": "Week 6 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_7", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_26", - "Activity_28", - "Activity_33" - ], - "encounterId": "Encounter_6" - }, - { - "id": "ScheduledActivityInstance_7", - "extensionAttributes": [], - "name": "WEEK8", - "label": "Week 8", - "description": "Week 8 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_8", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_31", - "Activity_31", - "Activity_32", - "Activity_32", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_7" - }, - { - "id": "ScheduledActivityInstance_8", - "extensionAttributes": [], - "name": "WEEK8N", - "label": "Week 8 NPI", - "description": "Week 8 NPI Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_19", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_31", - "Activity_31", - "Activity_32", - "Activity_32", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_7" - }, - { - "id": "ScheduledActivityInstance_19", - "extensionAttributes": [], - "name": "WEEK12", - "label": "Week 12", - "description": "Week 12", - "defaultConditionId": "ScheduledActivityInstance_20", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_25", - "Activity_25", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_9" - }, - { - "id": "ScheduledActivityInstance_20", - "extensionAttributes": [], - "name": "WEEK12N", - "label": "Week 12 NPI", - "description": "Week 12 NPI", - "defaultConditionId": "ScheduledActivityInstance_21", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_25", - "Activity_25", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_9" - }, - { - "id": "ScheduledActivityInstance_21", - "extensionAttributes": [], - "name": "WEEK16", - "label": "Week 16", - "description": "Week 16", - "defaultConditionId": "ScheduledActivityInstance_22", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_32", - "Activity_32", - "Activity_31", - "Activity_31", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_11" - }, - { - "id": "ScheduledActivityInstance_22", - "extensionAttributes": [], - "name": "WEEK16N", - "label": "Week 16 NPI", - "description": "Week 16 NPI", - "defaultConditionId": "ScheduledActivityInstance_23", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_32", - "Activity_32", - "Activity_31", - "Activity_31", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_11" - }, - { - "id": "ScheduledActivityInstance_23", - "extensionAttributes": [], - "name": "WEEK20", - "label": "Week 20", - "description": "Week 20", - "defaultConditionId": "ScheduledActivityInstance_24", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_13" - }, - { - "id": "ScheduledActivityInstance_24", - "extensionAttributes": [], - "name": "WEEK20N", - "label": "Week 20 NPI", - "description": "Week 20 NPI", - "defaultConditionId": "ScheduledActivityInstance_25", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_13" - }, - { - "id": "ScheduledActivityInstance_25", - "extensionAttributes": [], - "name": "WEEK24", - "label": "Week 24", - "description": "Week 24", - "defaultConditionId": "ScheduledActivityInstance_26", - "epochId": "StudyEpoch_5", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_25", - "Activity_28", - "Activity_30", - "Activity_32", - "Activity_31" - ], - "encounterId": "Encounter_15" - }, - { - "id": "ScheduledActivityInstance_26", - "extensionAttributes": [], - "name": "WEEK26", - "label": "Week 26", - "description": "Week 26", - "defaultConditionId": null, - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_28", - "Activity_29" - ], - "encounterId": "Encounter_16" - }, - { - "id": "ScheduledDecisionInstance_1", - "extensionAttributes": [], - "name": "testDecisionInstance", - "label": "testDecisionInstance", - "description": "testDecisionInstance", - "defaultConditionId": null, - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [ - { - "id": "Condition_1", - "extensionAttributes": [], - "condition": "is not null", - "conditionTargetId": "ScheduledActivityInstance_3", - "instanceType": "Condition" - } - ] - }, - { - "id": "ScheduledDecisionInstance_2", - "extensionAttributes": [], - "name": "test_2", - "label": "test_2", - "description": "test_2", - "defaultConditionId": "blahblahblah", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [] - }, - { - "id": "ScheduledDecisionInstance_3", - "extensionAttributes": [], - "name": "test3", - "label": "test3", - "description": "test3", - "defaultConditionId": "ScheduledActivityInstance_11", - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [] - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - }, - { - "id": "ScheduleTimeline_6", - "extensionAttributes": [], - "name": "Adverse Event Timeline", - "label": "Adverse Event Timeline", - "description": "This is the adverse event timeline", - "mainTimeline": false, - "entryCondition": "Subject suffers an adverse event", - "entryId": "ScheduledActivityInstance_11", - "exits": [], - "timings": [ - { - "id": "Timing_17", - "extensionAttributes": [], - "name": "TIM17", - "label": "Adverse Event", - "description": "Adverse Event Timing", - "type": { - "id": "Code_105", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "P1D", - "valueLabel": "1 Day", - "relativeToFrom": { - "id": "Code_106", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_11", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_11", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_11", - "extensionAttributes": [], - "name": "AE", - "label": "Adverse Event", - "description": "Occurrence of Adverse Event", - "defaultConditionId": null, - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - }, - { - "id": "ScheduleTimeline_7", - "extensionAttributes": [], - "name": "Early Termination Timeline", - "label": "Early Termination Timeline", - "description": "This is the early termination processing", - "mainTimeline": false, - "entryCondition": "Subject terminates the study early", - "entryId": "ScheduledActivityInstance_12", - "exits": [], - "timings": [ - { - "id": "Timing_18", - "extensionAttributes": [], - "name": "TIM18", - "label": "Early Termination", - "description": "Early Termination Timing", - "type": { - "id": "Code_107", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "P1D", - "valueLabel": "1 Day", - "relativeToFrom": { - "id": "Code_108", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_12", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_12", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_12", - "extensionAttributes": [], - "name": "ET", - "label": "Early Termination", - "description": "Early Termination", - "defaultConditionId": null, - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - }, - { - "id": "ScheduleTimeline_8", - "extensionAttributes": [], - "name": "Vital Sign Blood Pressure Timeline", - "label": "Vital Sign Blood Pressure Timeline", - "description": "BP Profile", - "mainTimeline": false, - "entryCondition": "Automatic execution", - "entryId": "ScheduledActivityInstance_13", - "exits": [], - "timings": [ - { - "id": "Timing_19", - "extensionAttributes": [], - "name": "TIM19", - "label": "Supine", - "description": "VS Supine", - "type": { - "id": "Code_109", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "PT0M", - "valueLabel": "0 mins", - "relativeToFrom": { - "id": "Code_110", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_13", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_13", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_20", - "extensionAttributes": [], - "name": "TIM20", - "label": "VS while supine", - "description": "VS while supine", - "type": { - "id": "Code_111", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT5M", - "valueLabel": "5 mins", - "relativeToFrom": { - "id": "Code_112", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_14", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_13", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_21", - "extensionAttributes": [], - "name": "TIM21", - "label": "Standing", - "description": "VS Standing", - "type": { - "id": "Code_113", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT0M", - "valueLabel": "0 mins", - "relativeToFrom": { - "id": "Code_114", - "extensionAttributes": [], - "code": "C201353", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "End to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_15", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_14", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_22", - "extensionAttributes": [], - "name": "TIM22", - "label": "VS while standing", - "description": "VS while standing", - "type": { - "id": "Code_115", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT1M", - "valueLabel": "1 min", - "relativeToFrom": { - "id": "Code_116", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_16", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_15", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_23", - "extensionAttributes": [], - "name": "TIM23", - "label": "Standing", - "description": "VS Standing", - "type": { - "id": "Code_117", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT0M", - "valueLabel": "0 min", - "relativeToFrom": { - "id": "Code_118", - "extensionAttributes": [], - "code": "C201353", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "End to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_17", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_16", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_24", - "extensionAttributes": [], - "name": "TIM24", - "label": "VS while standing", - "description": "VS while standing", - "type": { - "id": "Code_119", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT2M", - "valueLabel": "2 min", - "relativeToFrom": { - "id": "Code_120", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_18", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_17", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_13", - "extensionAttributes": [], - "name": "VS_5MIN", - "label": "5 minute supine", - "description": "VS 5 minute supine", - "defaultConditionId": "ScheduledActivityInstance_14", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_14", - "extensionAttributes": [], - "name": "VS_SUPINE", - "label": "Vital signs supine", - "description": "VS Vital signs supine", - "defaultConditionId": "ScheduledActivityInstance_15", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_15", - "extensionAttributes": [], - "name": "VS_1MIN", - "label": "1 minute standing", - "description": "VS 1 minute standing", - "defaultConditionId": "ScheduledActivityInstance_16", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_16", - "extensionAttributes": [], - "name": "VS_STAND1", - "label": "Vital signs after 1 min standing", - "description": "VS Vital signs after 1 min standing", - "defaultConditionId": "ScheduledActivityInstance_17", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_17", - "extensionAttributes": [], - "name": "VS_2MIN", - "label": "2 minute standing", - "description": "VS 2 minute standing", - "defaultConditionId": "ScheduledActivityInstance_18", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_18", - "extensionAttributes": [], - "name": "VS_STAND3", - "label": "Vital signs after 3 min standing", - "description": "VS Vital signs after 3 min standing", - "defaultConditionId": null, - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - } - ], - "biospecimenRetentions": [], - "documentVersionIds": [], - "eligibilityCriteria": [], - "analysisPopulations": [], - "notes": [], - "subTypes": [], - "model": { - "id": "Code_StudyDesignModel", - "extensionAttributes": [], - "code": "", - "codeSystem": "", - "codeSystemVersion": "", - "decode": "", - "instanceType": "Code" - }, - "intentTypes": [], - "blindingSchema": null, - "instanceType": "InterventionalStudyDesign" - } - ], - "titles": [ - { - "id": "StudyTitle_1", - "extensionAttributes": [], - "text": "LZZT - Pilot", - "type": { - "id": "Code_27557", - "extensionAttributes": [], - "code": "C207646", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Study Acronym", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - }, - { - "id": "StudyTitle_2", - "extensionAttributes": [], - "text": "Xanomeline (LY246708)", - "type": { - "id": "Code_27601", - "extensionAttributes": [], - "code": "C207615", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Brief Study Title", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - }, - { - "id": "StudyTitle_3", - "extensionAttributes": [], - "text": "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease", - "type": { - "id": "Code_27813", - "extensionAttributes": [], - "code": "C207616", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Official Study Title", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - } - ], - "documentVersionIds": [], - "dateValues": [], - "amendments": [ - { - "id": "StudyAmendment_1", - "extensionAttributes": [], - "notes": [], - "name": "AMEND_1", - "label": "Amendment 1", - "description": "First amendment", - "number": "1", - "summary": "Updated inclusion criteria", - "primaryReason": { - "id": "StudyAmendmentReason_1", - "extensionAttributes": [], - "code": { - "id": "Code_2525", - "extensionAttributes": [], - "code": "C207605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "IRB/IEC Feedback", - "instanceType": "Code" - }, - "otherReason": null, - "instanceType": "StudyAmendmentReason" - }, - "secondaryReasons": [ - { - "id": "StudyAmendmentReason_2", - "extensionAttributes": [], - "code": { - "id": "Code_2526", - "extensionAttributes": [], - "code": "C17649", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "OTHER", - "instanceType": "Code" - }, - "otherReason": "Fix typographical errors", - "instanceType": "StudyAmendmentReason" - } - ], - "changes": [ - { - "id": "StudyChange_2", - "extensionAttributes": [], - "name": "AMEND_CHG_1", - "label": "Change 1", - "description": "Typographical errors lead to ambiguity when interpreting Inclusion Criteria", - "summary": "Fixed inclusion criteria text", - "rationale": "Subject safety", - "changedSections": [ - { - "id": "DocumentContentReference_2", - "extensionAttributes": [], - "sectionNumber": "1.5", - "sectionTitle": "Header 1.5", - "appliesToId": "StudyDefinitionDocument_1", - "instanceType": "DocumentContentReference" - } - ], - "instanceType": "StudyChange" - } - ], - "impacts": [ - { - "id": "StudyAmendmentImpact_1", - "extensionAttributes": [], - "notes": [], - "type": { - "id": "Code_2527", - "extensionAttributes": [], - "code": "C215665", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Study Subject Safety", - "instanceType": "Code" - }, - "text": "Enhance subject safety", - "isSubstantial": false, - "instanceType": "StudyAmendmentImpact" - } - ], - "geographicScopes": [ - { - "id": "GeographicScope_1", - "extensionAttributes": [], - "type": { - "id": "Code_12462", - "extensionAttributes": [], - "code": "C68846", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Global", - "instanceType": "Code" - }, - "code": null, - "instanceType": "GeographicScope" - }, - { - "id": "GeographicScope_5", - "extensionAttributes": [], - "type": { - "id": "Code_20010", - "extensionAttributes": [], - "code": "C41129", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Region", - "instanceType": "Code" - }, - "code": { - "id": "AliasCode_20011", - "extensionAttributes": [], - "standardCode": { - "id": "Code_20011", - "extensionAttributes": [], - "code": "150", - "codeSystem": "UN M49", - "codeSystemVersion": "2026", - "decode": "Europe", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "GeographicScope" - } - ], - "enrollments": [ - { - "id": "SubjectEnrollment_1", - "extensionAttributes": [], - "name": "Enrollment 1", - "label": null, - "description": null, - "quantity": { - "id": "SubjectEnrollment_1_Qty", - "extensionAttributes": [], - "value": 15.0, - "unit": null, - "instanceType": "Quantity" - }, - "forGeographicScope": { - "id": "GeographicScope_5", - "extensionAttributes": [], - "type": { - "id": "Code_20010", - "extensionAttributes": [], - "code": "C41129", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Region", - "instanceType": "Code" - }, - "code": { - "id": "AliasCode_20011", - "extensionAttributes": [], - "standardCode": { - "id": "Code_20011", - "extensionAttributes": [], - "code": "150", - "codeSystem": "UN M49", - "codeSystemVersion": "2026", - "decode": "Europe", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "GeographicScope" - }, - "forStudyCohortId": null, - "forStudySiteId": null, - "instanceType": "SubjectEnrollment" - } - ], - "dateValues": [ - { - "id": "GovernanceDate_1", - "extensionAttributes": [], - "name": "Protocol Approval", - "label": null, - "description": null, - "type": { - "id": "Code_13051", - "extensionAttributes": [], - "code": "C215663", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Effective Date", - "instanceType": "Code" - }, - "dateValue": "2006-06-01", - "geographicScopes": [ - { - "id": "GeographicScope_1", - "extensionAttributes": [], - "type": { - "id": "Code_12462", - "extensionAttributes": [], - "code": "C68846", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Global", - "instanceType": "Code" - }, - "code": null, - "instanceType": "GeographicScope" - } - ], - "instanceType": "GovernanceDate" - } - ], - "instanceType": "StudyAmendment" - } - ], - "organizations": [ - { - "id": "Organization_1", - "extensionAttributes": [], - "name": "LILLY", - "label": "Eli Lilly", - "identifier": "00-642-1325", - "identifierScheme": "DUNS", - "type": { - "id": "Code_28637", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_1", - "extensionAttributes": [], - "text": "Lilly Corporate Ctr, Indianapolis, , IN, 4628, United States of America", - "lines": [ - "Lilly Corporate Ctr" - ], - "city": "Indianapolis", - "district": null, - "state": "IN", - "postalCode": "4628", - "country": { - "id": "Code_28638", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_2", - "extensionAttributes": [], - "name": "CT-GOV", - "label": "ClinicalTrials.gov", - "identifier": "CT-GOV", - "identifierScheme": "USGOV", - "type": { - "id": "Code_28639", - "extensionAttributes": [], - "code": "C142578", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Independent Data Monitoring Committee", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_2", - "extensionAttributes": [], - "text": "National Library of Medicine, Bethesda, 8600 Rockville Pike, MD, 20894, United States of America", - "lines": [ - "National Library of Medicine" - ], - "city": "Bethesda", - "district": "8600 Rockville Pike", - "state": "MD", - "postalCode": "20894", - "country": { - "id": "Code_28640", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_3", - "extensionAttributes": [], - "name": "MLM Medical Labs", - "label": "Central Labu", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_39641", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_3", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_39642", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - } - ], - "roles": [ - { - "id": "StudyRole_1", - "extensionAttributes": [], - "name": "Role 1", - "label": "Sponsor", - "description": "Study Sponsor", - "code": { - "id": "Code_35642", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": { - "id": "Masking_1", - "extensionAttributes": [], - "text": "Masked", - "isMasked": true, - "instanceType": "Masking" - }, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_3", - "extensionAttributes": [], - "name": "Laboratory Contact", - "label": "Lab Primary Contact", - "description": "The primary person to contact at the Central Lab", - "code": { - "id": "Code_40467", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_3" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_2", - "extensionAttributes": [], - "name": "John Smith", - "label": null, - "description": null, - "personName": { - "id": "PersonName_2", - "extensionAttributes": [], - "text": null, - "familyName": "Smith", - "givenNames": [ - "John" - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "PhD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - } - ], - "studyInterventions": [ - { - "id": "StudyIntervention_1", - "extensionAttributes": [], - "name": "XINONILINE", - "label": "Xinomiline", - "description": "Xinomiline", - "role": { - "id": "Code_36026", - "extensionAttributes": [], - "code": "C41161", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Experimental Intervention", - "instanceType": "Code" - }, - "type": { - "id": "Code_36027", - "extensionAttributes": [], - "code": "C1909", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Pharmacologic Substance", - "instanceType": "Code" - }, - "minimumResponseDuration": { - "id": "Quantity_1", - "extensionAttributes": [], - "value": 1.0, - "unit": { - "id": "AliasCode_30645", - "extensionAttributes": [], - "standardCode": { - "id": "Code_36028", - "extensionAttributes": [], - "code": "C25301", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Day", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "Quantity" - }, - "codes": [ - { - "id": "Code_36144", - "extensionAttributes": [], - "code": "XIN", - "codeSystem": "SPONSOR", - "codeSystemVersion": "12", - "decode": "XIN", - "instanceType": "Code" - } - ], - "administrations": [], - "notes": [], - "instanceType": "StudyIntervention" - } - ], - "businessTherapeuticAreas": [], - "biomedicalConcepts": [ - { - "id": "BiomedicalConcept_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_126", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Informed Consent", - "label": null, - "synonyms": [ - "Informed Consent Obtained" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "id": "BiomedicalConceptProperty_1", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3021", - "instanceType": "ResponseCode", - "name": "INFORMED CONSENT OBTAINED", - "label": "INFORMED CONSENT OBTAINED", - "isEnabled": true, - "code": { - "id": "Code_42410", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37997", - "standardCode": { - "id": "Code_45284", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_2", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37998", - "standardCode": { - "id": "Code_45285", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_3", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37999", - "standardCode": { - "id": "Code_45286", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3151", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3361", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_2", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_127", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/INCL01", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Inclusion Criteria", - "label": "Inclusion Criteria", - "synonyms": [ - "Inclusion" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25532", - "properties": [ - { - "id": "BiomedicalConceptProperty_4", - "extensionAttributes": [], - "name": "TIVERS", - "label": "TIVERS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38000", - "standardCode": { - "id": "Code_45287", - "extensionAttributes": [], - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_5", - "extensionAttributes": [], - "name": "IEORRES", - "label": "IEORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38001", - "standardCode": { - "id": "Code_45288", - "extensionAttributes": [], - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_6", - "extensionAttributes": [], - "name": "IEDTC", - "label": "IEDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38002", - "standardCode": { - "id": "Code_45289", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24523", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28641", - "extensionAttributes": [], - "code": "C25532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Inclusion Criteria", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_3", - "extensionAttributes": [], - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "synonyms": [ - "Inclusion Exclusion Criteria Yes No Indicator", - "IEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83063", - "properties": [ - { - "id": "BiomedicalConceptProperty_7", - "extensionAttributes": [], - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38003", - "standardCode": { - "id": "Code_45290", - "extensionAttributes": [], - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_8", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38004", - "standardCode": { - "id": "Code_45291", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_31819", - "extensionAttributes": [], - "standardCode": { - "id": "Code_38143", - "extensionAttributes": [], - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_4", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_1", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EXCL01", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Exclusion Criteria", - "label": "Exclusion Criteria", - "synonyms": [ - "Exclusion" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25370", - "properties": [ - { - "id": "BiomedicalConceptProperty_9", - "extensionAttributes": [], - "name": "TIVERS", - "label": "TIVERS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2841", - "instanceType": "ResponseCode", - "name": "INFORMED CONSENT OBTAINED", - "label": "INFORMED CONSENT OBTAINED", - "isEnabled": true, - "code": { - "id": "Code_40605", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38005", - "standardCode": { - "id": "Code_45292", - "extensionAttributes": [], - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_10", - "extensionAttributes": [], - "name": "IEORRES", - "label": "IEORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38006", - "standardCode": { - "id": "Code_45293", - "extensionAttributes": [], - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_11", - "extensionAttributes": [], - "name": "IEDTC", - "label": "IEDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38007", - "standardCode": { - "id": "Code_45294", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3153", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3363", - "extensionAttributes": [], - "code": "C25370", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Exclusion Criteria", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_5", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_2", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RAND", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Subject is Randomized", - "label": "Subject is Randomized", - "synonyms": [ - "Randomized" - ], - "reference": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "id": "BiomedicalConceptProperty_12", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3022", - "instanceType": "ResponseCode", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "isEnabled": true, - "code": { - "id": "Code_45298", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38010", - "standardCode": { - "id": "Code_45297", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_13", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38012", - "standardCode": { - "id": "Code_45299", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_14", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38013", - "standardCode": { - "id": "Code_45300", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3160", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3370", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_6", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_125", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RACE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Race", - "label": "Race", - "synonyms": [ - "Racial Group" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17049", - "properties": [ - { - "id": "BiomedicalConceptProperty_15", - "extensionAttributes": [], - "name": "RACE", - "label": "RACE", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38014", - "standardCode": { - "id": "Code_45301", - "extensionAttributes": [], - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Race", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_16", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38015", - "standardCode": { - "id": "Code_45302", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_31820", - "extensionAttributes": [], - "standardCode": { - "id": "Code_38144", - "extensionAttributes": [], - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Race", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_7", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_3", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ETHNIC", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ethnic Group", - "label": "Ethnic Group", - "synonyms": [ - "Ethnicity", - "Ethnic Origin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16564", - "properties": [ - { - "id": "BiomedicalConceptProperty_17", - "extensionAttributes": [], - "name": "ETHNIC", - "label": "ETHNIC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38016", - "standardCode": { - "id": "Code_45303", - "extensionAttributes": [], - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ethnic Group", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_18", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38017", - "standardCode": { - "id": "Code_45304", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_31821", - "extensionAttributes": [], - "standardCode": { - "id": "Code_38145", - "extensionAttributes": [], - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Ethnic Group", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_8", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_4", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AGE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Subject Age", - "label": "Subject Age", - "synonyms": [ - "Age" - ], - "reference": "/mdr/bc/biomedicalconcepts/C69260", - "properties": [ - { - "id": "BiomedicalConceptProperty_19", - "extensionAttributes": [], - "name": "AGE", - "label": "AGE", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38018", - "standardCode": { - "id": "Code_45305", - "extensionAttributes": [], - "code": "C170981", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Numeric Age for Data Tabulation", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_20", - "extensionAttributes": [], - "name": "AGEU", - "label": "AGEU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38019", - "standardCode": { - "id": "Code_45306", - "extensionAttributes": [], - "code": "C50400", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Age Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_21", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38020", - "standardCode": { - "id": "Code_45307", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24524", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28642", - "extensionAttributes": [], - "code": "C69260", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Subject Age", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_9", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_5", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BRTHDTC", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Birth Date and Time", - "label": "Birth Date and Time", - "synonyms": [ - "BRTHDTC", - "Date/Time of Birth" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83217", - "properties": [ - { - "id": "BiomedicalConceptProperty_22", - "extensionAttributes": [], - "name": "BRTHDTC", - "label": "BRTHDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38021", - "standardCode": { - "id": "Code_45308", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_23", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38022", - "standardCode": { - "id": "Code_45309", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3155", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3365", - "extensionAttributes": [], - "code": "C83217", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Birth Date and Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_10", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_6", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SEX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sex", - "label": null, - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C28421", - "properties": [ - { - "id": "BiomedicalConceptProperty_24", - "extensionAttributes": [], - "name": "SEX", - "label": "SEX", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38023", - "standardCode": { - "id": "Code_45310", - "extensionAttributes": [], - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_25", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38024", - "standardCode": { - "id": "Code_45311", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24525", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28643", - "extensionAttributes": [], - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_11", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_7", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EDULEVEL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Education Level", - "label": "Education Level", - "synonyms": [ - "EDULEVEL", - "Education", - "Education Level", - "Education Level Completed", - "education_level", - "Educational Attainment", - "Educational Level", - "Level of Education Attained" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17953", - "properties": [ - { - "id": "BiomedicalConceptProperty_26", - "extensionAttributes": [], - "name": "SCORRES", - "label": "SCORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38025", - "standardCode": { - "id": "Code_45312", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_27", - "extensionAttributes": [], - "name": "SCDTC", - "label": "SCDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38026", - "standardCode": { - "id": "Code_45313", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24526", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28644", - "extensionAttributes": [], - "code": "C17953", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Education Level", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_12", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_8", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EDUYRNUM", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Number of Years of Education", - "label": "Number of Years of Education", - "synonyms": [ - "EDUYRNUM", - "Number of Years of Education" - ], - "reference": "/mdr/bc/biomedicalconcepts/C122393", - "properties": [ - { - "id": "BiomedicalConceptProperty_28", - "extensionAttributes": [], - "name": "SCORRES", - "label": "SCORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38027", - "standardCode": { - "id": "Code_45314", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_29", - "extensionAttributes": [], - "name": "SCDTC", - "label": "SCDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38028", - "standardCode": { - "id": "Code_45315", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24527", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28645", - "extensionAttributes": [], - "code": "C122393", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Number of Years of Education", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_14", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_123", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MEDHISTFREE", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_124", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MHALZHEIMERS", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_128", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MHVISUALHALLUCINATIONS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Solicited Medical History", - "label": "Solicited Medical History", - "synonyms": [ - "Medical History", - "Medical History Collection" - ], - "reference": "/mdr/bc/biomedicalconcepts/C200145", - "properties": [ - { - "id": "BiomedicalConceptProperty_30", - "extensionAttributes": [], - "name": "MHTERM", - "label": "MHTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38029", - "standardCode": { - "id": "Code_45316", - "extensionAttributes": [], - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_31", - "extensionAttributes": [], - "name": "MHDECOD", - "label": "MHDECOD", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38030", - "standardCode": { - "id": "Code_45317", - "extensionAttributes": [], - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_32", - "extensionAttributes": [], - "name": "MHSTDTC", - "label": "MHSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38031", - "standardCode": { - "id": "Code_45318", - "extensionAttributes": [], - "code": "C83338", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_33", - "extensionAttributes": [], - "name": "MHENDTC", - "label": "MHENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38032", - "standardCode": { - "id": "Code_45319", - "extensionAttributes": [], - "code": "C83330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_34", - "extensionAttributes": [], - "name": "MHENRF", - "label": "MHENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38033", - "standardCode": { - "id": "Code_45320", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_35", - "extensionAttributes": [], - "name": "MHENRTPT", - "label": "MHENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38034", - "standardCode": { - "id": "Code_45321", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_36", - "extensionAttributes": [], - "name": "MHENTPT", - "label": "MHENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38035", - "standardCode": { - "id": "Code_45322", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3156", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3366", - "extensionAttributes": [], - "code": "C200145", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Medical History", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_15", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_134", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALCOHOLHX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alcohol Use History", - "label": "Alcohol Use History", - "synonyms": [ - "Alcohol History", - "Alcohol Use" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81229", - "properties": [ - { - "id": "BiomedicalConceptProperty_37", - "extensionAttributes": [], - "name": "SUTRT", - "label": "SUTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38036", - "standardCode": { - "id": "Code_45323", - "extensionAttributes": [], - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_38", - "extensionAttributes": [], - "name": "SUPRESP", - "label": "SUPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38037", - "standardCode": { - "id": "Code_45324", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_39", - "extensionAttributes": [], - "name": "SUOCCUR", - "label": "SUOCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38038", - "standardCode": { - "id": "Code_45325", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_40", - "extensionAttributes": [], - "name": "SUDOSE", - "label": "SUDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38039", - "standardCode": { - "id": "Code_45326", - "extensionAttributes": [], - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_41", - "extensionAttributes": [], - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38040", - "standardCode": { - "id": "Code_45327", - "extensionAttributes": [], - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_42", - "extensionAttributes": [], - "name": "SUDOSU", - "label": "SUDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38041", - "standardCode": { - "id": "Code_45328", - "extensionAttributes": [], - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_43", - "extensionAttributes": [], - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38042", - "standardCode": { - "id": "Code_45329", - "extensionAttributes": [], - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_44", - "extensionAttributes": [], - "name": "SUSTDTC", - "label": "SUSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38043", - "standardCode": { - "id": "Code_45330", - "extensionAttributes": [], - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_45", - "extensionAttributes": [], - "name": "SUENDTC", - "label": "SUENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38044", - "standardCode": { - "id": "Code_45331", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_46", - "extensionAttributes": [], - "name": "SUSTRF", - "label": "SUSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38045", - "standardCode": { - "id": "Code_45332", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_47", - "extensionAttributes": [], - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38046", - "standardCode": { - "id": "Code_45333", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_48", - "extensionAttributes": [], - "name": "SUSTTPT", - "label": "SUSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38047", - "standardCode": { - "id": "Code_45334", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_49", - "extensionAttributes": [], - "name": "SUENRF", - "label": "SUENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38048", - "standardCode": { - "id": "Code_45335", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_50", - "extensionAttributes": [], - "name": "SUENRTPT", - "label": "SUENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38049", - "standardCode": { - "id": "Code_45336", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_51", - "extensionAttributes": [], - "name": "SUENTPT", - "label": "SUENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38050", - "standardCode": { - "id": "Code_45337", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24528", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28646", - "extensionAttributes": [], - "code": "C81229", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alcohol Use History", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_16", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_135", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CAFFEINEHX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Caffeine Use History", - "label": "Caffeine Use History", - "synonyms": [ - "Caffeine History", - "Caffeine Use" - ], - "reference": "/mdr/bc/biomedicalconcepts/C201990", - "properties": [ - { - "id": "BiomedicalConceptProperty_52", - "extensionAttributes": [], - "name": "SUTRT", - "label": "SUTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38051", - "standardCode": { - "id": "Code_45338", - "extensionAttributes": [], - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_53", - "extensionAttributes": [], - "name": "SUPRESP", - "label": "SUPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38052", - "standardCode": { - "id": "Code_45339", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_54", - "extensionAttributes": [], - "name": "SUOCCUR", - "label": "SUOCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38053", - "standardCode": { - "id": "Code_45340", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_55", - "extensionAttributes": [], - "name": "SUDOSE", - "label": "SUDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38054", - "standardCode": { - "id": "Code_45341", - "extensionAttributes": [], - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_56", - "extensionAttributes": [], - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38055", - "standardCode": { - "id": "Code_45342", - "extensionAttributes": [], - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_57", - "extensionAttributes": [], - "name": "SUDOSU", - "label": "SUDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38056", - "standardCode": { - "id": "Code_45343", - "extensionAttributes": [], - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_58", - "extensionAttributes": [], - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38057", - "standardCode": { - "id": "Code_45344", - "extensionAttributes": [], - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_59", - "extensionAttributes": [], - "name": "SUSTDTC", - "label": "SUSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38058", - "standardCode": { - "id": "Code_45345", - "extensionAttributes": [], - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_60", - "extensionAttributes": [], - "name": "SUENDTC", - "label": "SUENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38059", - "standardCode": { - "id": "Code_45346", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_61", - "extensionAttributes": [], - "name": "SUSTRF", - "label": "SUSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38060", - "standardCode": { - "id": "Code_45347", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_62", - "extensionAttributes": [], - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38061", - "standardCode": { - "id": "Code_45348", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_63", - "extensionAttributes": [], - "name": "SUSTTPT", - "label": "SUSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38062", - "standardCode": { - "id": "Code_45349", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_64", - "extensionAttributes": [], - "name": "SUENRF", - "label": "SUENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38063", - "standardCode": { - "id": "Code_45350", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_65", - "extensionAttributes": [], - "name": "SUENRTPT", - "label": "SUENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38064", - "standardCode": { - "id": "Code_45351", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_66", - "extensionAttributes": [], - "name": "SUENTPT", - "label": "SUENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38065", - "standardCode": { - "id": "Code_45352", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3157", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3367", - "extensionAttributes": [], - "code": "C201990", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Caffeine Use History", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_17", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_130", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CIGARHX", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_131", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CIGARETTEHX", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_132", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PIPEHX", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_133", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TOBACCOHX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "History of Tobacco Use", - "label": "History of Tobacco Use", - "synonyms": [ - "Tobacco Use", - "Tobacco Use History" - ], - "reference": "/mdr/bc/biomedicalconcepts/C181760", - "properties": [ - { - "id": "BiomedicalConceptProperty_67", - "extensionAttributes": [], - "name": "SUTRT", - "label": "SUTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38066", - "standardCode": { - "id": "Code_45353", - "extensionAttributes": [], - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_68", - "extensionAttributes": [], - "name": "SUPRESP", - "label": "SUPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38067", - "standardCode": { - "id": "Code_45354", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_69", - "extensionAttributes": [], - "name": "SUOCCUR", - "label": "SUOCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38068", - "standardCode": { - "id": "Code_45355", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_70", - "extensionAttributes": [], - "name": "SUDOSE", - "label": "SUDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38069", - "standardCode": { - "id": "Code_45356", - "extensionAttributes": [], - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_71", - "extensionAttributes": [], - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38070", - "standardCode": { - "id": "Code_45357", - "extensionAttributes": [], - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_72", - "extensionAttributes": [], - "name": "SUDOSU", - "label": "SUDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38071", - "standardCode": { - "id": "Code_45358", - "extensionAttributes": [], - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_73", - "extensionAttributes": [], - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38072", - "standardCode": { - "id": "Code_45359", - "extensionAttributes": [], - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_74", - "extensionAttributes": [], - "name": "SUSTDTC", - "label": "SUSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38073", - "standardCode": { - "id": "Code_45360", - "extensionAttributes": [], - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_75", - "extensionAttributes": [], - "name": "SUENDTC", - "label": "SUENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38074", - "standardCode": { - "id": "Code_45361", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_76", - "extensionAttributes": [], - "name": "SUDUR", - "label": "SUDUR", - "isRequired": false, - "isEnabled": true, - "datatype": "durationDatetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38075", - "standardCode": { - "id": "Code_45362", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_77", - "extensionAttributes": [], - "name": "SUSTRF", - "label": "SUSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38076", - "standardCode": { - "id": "Code_45363", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_78", - "extensionAttributes": [], - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38077", - "standardCode": { - "id": "Code_45364", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_79", - "extensionAttributes": [], - "name": "SUSTTPT", - "label": "SUSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38078", - "standardCode": { - "id": "Code_45365", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_80", - "extensionAttributes": [], - "name": "SUENRF", - "label": "SUENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38079", - "standardCode": { - "id": "Code_45366", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_81", - "extensionAttributes": [], - "name": "SUENRTPT", - "label": "SUENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38080", - "standardCode": { - "id": "Code_45367", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_82", - "extensionAttributes": [], - "name": "SUENTPT", - "label": "SUENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38081", - "standardCode": { - "id": "Code_45368", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3158", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3368", - "extensionAttributes": [], - "code": "C181760", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "History of Tobacco Use", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_18", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_136", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/XRAY", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_137", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/XRAYCHEST", - "instanceType": "ExtensionAttribute" - } - ], - "name": "X-Ray Imaging", - "label": "X-Ray Imaging", - "synonyms": [ - "Conventional X-Ray", - "Medical Imaging", - "X-Ray", - "Static X-Ray" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38101", - "properties": [ - { - "id": "BiomedicalConceptProperty_83", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38082", - "standardCode": { - "id": "Code_45369", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_84", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3023", - "instanceType": "ResponseCode", - "name": "X-RAY", - "label": "X-RAY", - "isEnabled": true, - "code": { - "id": "Code_45371", - "extensionAttributes": [], - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "X-RAY", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38083", - "standardCode": { - "id": "Code_45370", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_85", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38085", - "standardCode": { - "id": "Code_45372", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_86", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38086", - "standardCode": { - "id": "Code_45373", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_87", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38087", - "standardCode": { - "id": "Code_45374", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_88", - "extensionAttributes": [], - "name": "PRLAT", - "label": "PRLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38088", - "standardCode": { - "id": "Code_45375", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_89", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38089", - "standardCode": { - "id": "Code_45376", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_90", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38090", - "standardCode": { - "id": "Code_45377", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_38008", - "extensionAttributes": [], - "standardCode": { - "id": "Code_45295", - "extensionAttributes": [], - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "X-Ray Imaging", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_19", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_138", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RAND", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Subject is Randomized", - "label": null, - "synonyms": [ - "Randomized" - ], - "reference": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "id": "BiomedicalConceptProperty_91", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3024", - "instanceType": "ResponseCode", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "isEnabled": true, - "code": { - "id": "Code_45379", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38091", - "standardCode": { - "id": "Code_45378", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_92", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38093", - "standardCode": { - "id": "Code_45380", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_93", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38094", - "standardCode": { - "id": "Code_45381", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3160", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3370", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_20", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_9", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TEMP", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_145", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/TEMP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Temperature", - "label": "Body Temperature", - "synonyms": [ - "Temperature" - ], - "reference": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ - { - "id": "BiomedicalConceptProperty_94", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38095", - "standardCode": { - "id": "Code_45382", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_95", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38096", - "standardCode": { - "id": "Code_45383", - "extensionAttributes": [], - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_96", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38097", - "standardCode": { - "id": "Code_45384", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_97", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38098", - "standardCode": { - "id": "Code_45385", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2640", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2850", - "extensionAttributes": [], - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_21", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_10", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WEIGHT", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_146", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/WEIGHT_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Weight", - "label": "Body Weight", - "synonyms": [ - "WEIGHT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ - { - "id": "BiomedicalConceptProperty_98", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38099", - "standardCode": { - "id": "Code_45386", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_99", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38100", - "standardCode": { - "id": "Code_45387", - "extensionAttributes": [], - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_100", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38101", - "standardCode": { - "id": "Code_45388", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3161", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3371", - "extensionAttributes": [], - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_22", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_11", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HEIGHT", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_147", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/HEIGHT_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Height", - "label": "Body Height", - "synonyms": [ - "HEIGHT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C164634", - "properties": [ - { - "id": "BiomedicalConceptProperty_101", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38102", - "standardCode": { - "id": "Code_45389", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_102", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38103", - "standardCode": { - "id": "Code_45390", - "extensionAttributes": [], - "code": "C168688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Height", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_103", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38104", - "standardCode": { - "id": "Code_45391", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24529", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28647", - "extensionAttributes": [], - "code": "C164634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Height", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_23", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_12", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PULSE", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_148", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/PULSE_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Pulse Rate", - "label": "Pulse Rate", - "synonyms": [ - "Pulse" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49676", - "properties": [ - { - "id": "BiomedicalConceptProperty_104", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38105", - "standardCode": { - "id": "Code_45392", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_105", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3025", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_45394", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38106", - "standardCode": { - "id": "Code_45393", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_106", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38108", - "standardCode": { - "id": "Code_45395", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_107", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38109", - "standardCode": { - "id": "Code_45396", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_108", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38110", - "standardCode": { - "id": "Code_45397", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_109", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38111", - "standardCode": { - "id": "Code_45398", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2664", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2874", - "extensionAttributes": [], - "code": "C49676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_24", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_13", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RESP", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_149", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/RESP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Respiratory Rate", - "label": "Respiratory Rate", - "synonyms": [ - "RESP", - "RESPRATE" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49678", - "properties": [ - { - "id": "BiomedicalConceptProperty_110", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38112", - "standardCode": { - "id": "Code_45399", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_111", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3026", - "instanceType": "ResponseCode", - "name": "breaths/min", - "label": "breaths/min", - "isEnabled": true, - "code": { - "id": "Code_45401", - "extensionAttributes": [], - "code": "C49674", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "breaths/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38113", - "standardCode": { - "id": "Code_45400", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_112", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38115", - "standardCode": { - "id": "Code_45402", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2680", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2890", - "extensionAttributes": [], - "code": "C49678", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_25", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_14", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BMI", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_150", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/BMI_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Mass Index", - "label": "Body Mass Index", - "synonyms": [ - "BMI", - "Quetelet Index" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16358", - "properties": [ - { - "id": "BiomedicalConceptProperty_113", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38116", - "standardCode": { - "id": "Code_45403", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_114", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38117", - "standardCode": { - "id": "Code_45404", - "extensionAttributes": [], - "code": "C42575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Density", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_115", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38118", - "standardCode": { - "id": "Code_45405", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24530", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28648", - "extensionAttributes": [], - "code": "C16358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Mass Index", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_26", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_151", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/DIABP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_152", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/SYSBP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Blood Pressure", - "label": "Blood Pressure", - "synonyms": [ - "BP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C54706", - "properties": [], - "code": { - "id": "AliasCode_3162", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3372", - "extensionAttributes": [], - "code": "C54706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_27", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_15", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGINTP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Electrocardiogram Analysis", - "label": "Electrocardiogram Analysis", - "synonyms": [ - "ECG Analysis", - "EKG Analysis", - "Electrocardiogram Interpretation", - "ECG Interpretation", - "EKG Interpretation" - ], - "reference": "/mdr/bc/biomedicalconcepts/C181655", - "properties": [ - { - "id": "BiomedicalConceptProperty_116", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38119", - "standardCode": { - "id": "Code_45406", - "extensionAttributes": [], - "code": "C125009", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Interpretation", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_117", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38120", - "standardCode": { - "id": "Code_45407", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_118", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38121", - "standardCode": { - "id": "Code_45408", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_119", - "extensionAttributes": [], - "name": "EGCLSIG", - "label": "EGCLSIG", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38122", - "standardCode": { - "id": "Code_45409", - "extensionAttributes": [], - "code": "C93532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinically Significant Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_120", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38123", - "standardCode": { - "id": "Code_45410", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24531", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28649", - "extensionAttributes": [], - "code": "C181655", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Electrocardiogram Analysis", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_28", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_16", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AVCOND", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Atrioventricular Conduction ECG Assessment", - "label": "Atrioventricular Conduction ECG Assessment", - "synonyms": [ - "AVCOND", - "Atrioventricular Conduction" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111131", - "properties": [ - { - "id": "BiomedicalConceptProperty_121", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38124", - "standardCode": { - "id": "Code_45411", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_122", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38125", - "standardCode": { - "id": "Code_45412", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_123", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38126", - "standardCode": { - "id": "Code_45413", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_124", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38127", - "standardCode": { - "id": "Code_45414", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_125", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38128", - "standardCode": { - "id": "Code_45415", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24532", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28650", - "extensionAttributes": [], - "code": "C111131", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Atrioventricular Conduction ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_29", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_17", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AXISVOLT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Axis and Voltage ECG Assessment", - "label": "Axis and Voltage ECG Assessment", - "synonyms": [ - "AXISVOLT", - "Axis and Voltage" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111132", - "properties": [ - { - "id": "BiomedicalConceptProperty_126", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38129", - "standardCode": { - "id": "Code_45416", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_127", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38130", - "standardCode": { - "id": "Code_45417", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_128", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38131", - "standardCode": { - "id": "Code_45418", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_129", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38132", - "standardCode": { - "id": "Code_45419", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_130", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38133", - "standardCode": { - "id": "Code_45420", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24533", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28651", - "extensionAttributes": [], - "code": "C111132", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Axis and Voltage ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_30", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_18", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHYPTENL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Chamber Hypertrophy or Enlargement ECG Assessment", - "label": "Chamber Hypertrophy or Enlargement ECG Assessment", - "synonyms": [ - "CHYPTENL", - "Chamber Hypertrophy or Enlargement" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111155", - "properties": [ - { - "id": "BiomedicalConceptProperty_131", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38134", - "standardCode": { - "id": "Code_45421", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_132", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38135", - "standardCode": { - "id": "Code_45422", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_133", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38136", - "standardCode": { - "id": "Code_45423", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_134", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38137", - "standardCode": { - "id": "Code_45424", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_135", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38138", - "standardCode": { - "id": "Code_45425", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24534", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28652", - "extensionAttributes": [], - "code": "C111155", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Chamber Hypertrophy or Enlargement ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_31", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_19", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TECHQUAL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECG Technical Quality", - "label": "ECG Technical Quality", - "synonyms": [ - "TECHQUAL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117807", - "properties": [ - { - "id": "BiomedicalConceptProperty_136", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38139", - "standardCode": { - "id": "Code_45426", - "extensionAttributes": [], - "code": "C114120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ECG Recording Quality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_137", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38140", - "standardCode": { - "id": "Code_45427", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_138", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38141", - "standardCode": { - "id": "Code_45428", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_139", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38142", - "standardCode": { - "id": "Code_45429", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24535", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28653", - "extensionAttributes": [], - "code": "C117807", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "ECG Technical Quality", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_32", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_20", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/IVTIACD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Intraventricular and Intraatrial Conduction ECG Assessment", - "label": "Intraventricular and Intraatrial Conduction ECG Assessment", - "synonyms": [ - "IVTIACD", - "Intraventricular-Intraatrial Conduction" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111238", - "properties": [ - { - "id": "BiomedicalConceptProperty_140", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38143", - "standardCode": { - "id": "Code_45430", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_141", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38144", - "standardCode": { - "id": "Code_45431", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_142", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38145", - "standardCode": { - "id": "Code_45432", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_143", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38146", - "standardCode": { - "id": "Code_45433", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_144", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38147", - "standardCode": { - "id": "Code_45434", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24536", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28654", - "extensionAttributes": [], - "code": "C111238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Intraventricular and Intraatrial Conduction ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_33", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_21", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MI", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Myocardial Infarction ECG Assessment", - "label": "Myocardial Infarction ECG Assessment", - "synonyms": [ - "MI", - "Myocardial Infarction" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111280", - "properties": [ - { - "id": "BiomedicalConceptProperty_145", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38148", - "standardCode": { - "id": "Code_45435", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_146", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38149", - "standardCode": { - "id": "Code_45436", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_147", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38150", - "standardCode": { - "id": "Code_45437", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_148", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38151", - "standardCode": { - "id": "Code_45438", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24537", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28655", - "extensionAttributes": [], - "code": "C111280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Myocardial Infarction ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_34", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_22", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PACEMAKR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Pacemaker ECG Assessment", - "label": "Pacemaker ECG Assessment", - "synonyms": [ - "PACEMAKR", - "Pacemaker" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111285", - "properties": [ - { - "id": "BiomedicalConceptProperty_149", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38152", - "standardCode": { - "id": "Code_45439", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_150", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38153", - "standardCode": { - "id": "Code_45440", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_151", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38154", - "standardCode": { - "id": "Code_45441", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_152", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38155", - "standardCode": { - "id": "Code_45442", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_153", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38156", - "standardCode": { - "id": "Code_45443", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24538", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28656", - "extensionAttributes": [], - "code": "C111285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Pacemaker ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_35", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_23", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RHYNOS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Rhythm Not Otherwise Specified ECG Assessment", - "label": "Rhythm Not Otherwise Specified ECG Assessment", - "synonyms": [ - "RHYNOS", - "Rhythm Not Otherwise Specified" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111307", - "properties": [ - { - "id": "BiomedicalConceptProperty_154", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38157", - "standardCode": { - "id": "Code_45444", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_155", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38158", - "standardCode": { - "id": "Code_45445", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_156", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38159", - "standardCode": { - "id": "Code_45446", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_157", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38160", - "standardCode": { - "id": "Code_45447", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_158", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38161", - "standardCode": { - "id": "Code_45448", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24539", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28657", - "extensionAttributes": [], - "code": "C111307", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Rhythm Not Otherwise Specified ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_36", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_24", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/STSTWUW", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ST Segment, T wave, and U wave ECG Assessment", - "label": "ST Segment, T wave, and U wave ECG Assessment", - "synonyms": [ - "STSTWUW", - "ST Segment, T wave, and U wave" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111363", - "properties": [ - { - "id": "BiomedicalConceptProperty_159", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38162", - "standardCode": { - "id": "Code_45449", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_160", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38163", - "standardCode": { - "id": "Code_45450", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_161", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38164", - "standardCode": { - "id": "Code_45451", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_162", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38165", - "standardCode": { - "id": "Code_45452", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_163", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38166", - "standardCode": { - "id": "Code_45453", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24540", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28658", - "extensionAttributes": [], - "code": "C111363", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "ST Segment, T wave, and U wave ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_37", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_25", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SNRARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "label": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "synonyms": [ - "SNRARRY", - "Sinus Node Rhythms and Arrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111312", - "properties": [ - { - "id": "BiomedicalConceptProperty_164", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38167", - "standardCode": { - "id": "Code_45454", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_165", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38168", - "standardCode": { - "id": "Code_45455", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_166", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38169", - "standardCode": { - "id": "Code_45456", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_167", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38170", - "standardCode": { - "id": "Code_45457", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_168", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38171", - "standardCode": { - "id": "Code_45458", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24541", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28659", - "extensionAttributes": [], - "code": "C111312", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_38", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_26", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPRARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Supraventricular Arrhythmia ECG Assessment", - "label": "Supraventricular Arrhythmia ECG Assessment", - "synonyms": [ - "SPRARRY", - "Supraventricular Arrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111320", - "properties": [ - { - "id": "BiomedicalConceptProperty_169", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38172", - "standardCode": { - "id": "Code_45459", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_170", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38173", - "standardCode": { - "id": "Code_45460", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_171", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38174", - "standardCode": { - "id": "Code_45461", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_172", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38175", - "standardCode": { - "id": "Code_45462", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_173", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38176", - "standardCode": { - "id": "Code_45463", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24542", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28660", - "extensionAttributes": [], - "code": "C111320", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Arrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_39", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_27", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPRTARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Supraventricular Tachyarrhythmia ECG Assessment", - "label": "Supraventricular Tachyarrhythmia ECG Assessment", - "synonyms": [ - "SPRTARRY", - "Supraventricular Tachyarrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111321", - "properties": [ - { - "id": "BiomedicalConceptProperty_174", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38177", - "standardCode": { - "id": "Code_45464", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_175", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38178", - "standardCode": { - "id": "Code_45465", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_176", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38179", - "standardCode": { - "id": "Code_45466", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_177", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38180", - "standardCode": { - "id": "Code_45467", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_178", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38181", - "standardCode": { - "id": "Code_45468", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24543", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28661", - "extensionAttributes": [], - "code": "C111321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Tachyarrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_40", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_28", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PRAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate PR Interval", - "label": "Aggregate PR Interval", - "synonyms": [ - "PR Interval Aggregate", - "PQ Interval Aggregate", - "PRAG", - "PQAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117773", - "properties": [ - { - "id": "BiomedicalConceptProperty_179", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38182", - "standardCode": { - "id": "Code_45469", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_180", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38183", - "standardCode": { - "id": "Code_45470", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_181", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38184", - "standardCode": { - "id": "Code_45471", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_182", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38185", - "standardCode": { - "id": "Code_45472", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_183", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38186", - "standardCode": { - "id": "Code_45473", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_184", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38187", - "standardCode": { - "id": "Code_45474", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_185", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38188", - "standardCode": { - "id": "Code_45475", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24544", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28662", - "extensionAttributes": [], - "code": "C117773", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate PR Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_41", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_29", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QRSAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QRS Duration", - "label": "Aggregate QRS Duration", - "synonyms": [ - "QRS Aggregate Duration", - "QRSAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117779", - "properties": [ - { - "id": "BiomedicalConceptProperty_186", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38189", - "standardCode": { - "id": "Code_45476", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_187", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38190", - "standardCode": { - "id": "Code_45477", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_188", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38191", - "standardCode": { - "id": "Code_45478", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_189", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38192", - "standardCode": { - "id": "Code_45479", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_190", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38193", - "standardCode": { - "id": "Code_45480", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_191", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38194", - "standardCode": { - "id": "Code_45481", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_192", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38195", - "standardCode": { - "id": "Code_45482", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24545", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28663", - "extensionAttributes": [], - "code": "C117779", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QRS Duration", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_42", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_30", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QT Interval", - "label": "Aggregate QT Interval", - "synonyms": [ - "QT Interval Aggregate", - "QTAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117783", - "properties": [ - { - "id": "BiomedicalConceptProperty_193", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38196", - "standardCode": { - "id": "Code_45483", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_194", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38197", - "standardCode": { - "id": "Code_45484", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_195", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38198", - "standardCode": { - "id": "Code_45485", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_196", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38199", - "standardCode": { - "id": "Code_45486", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_197", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38200", - "standardCode": { - "id": "Code_45487", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_198", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38201", - "standardCode": { - "id": "Code_45488", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_199", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38202", - "standardCode": { - "id": "Code_45489", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24546", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28664", - "extensionAttributes": [], - "code": "C117783", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QT Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_43", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_31", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCBAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QTCB Interval", - "label": "Aggregate QTCB Interval", - "synonyms": [ - "QTCB Interval Aggregate", - "QTCBAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117784", - "properties": [ - { - "id": "BiomedicalConceptProperty_200", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38203", - "standardCode": { - "id": "Code_45490", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_201", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38204", - "standardCode": { - "id": "Code_45491", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_202", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38205", - "standardCode": { - "id": "Code_45492", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_203", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38206", - "standardCode": { - "id": "Code_45493", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_204", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38207", - "standardCode": { - "id": "Code_45494", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_205", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38208", - "standardCode": { - "id": "Code_45495", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_206", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38209", - "standardCode": { - "id": "Code_45496", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24547", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28665", - "extensionAttributes": [], - "code": "C117784", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCB Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_44", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_32", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCFAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QTCF Interval", - "label": "Aggregate QTCF Interval", - "synonyms": [ - "QTCF Interval Aggregate", - "QTCFAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117786", - "properties": [ - { - "id": "BiomedicalConceptProperty_207", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38210", - "standardCode": { - "id": "Code_45497", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_208", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38211", - "standardCode": { - "id": "Code_45498", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_209", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38212", - "standardCode": { - "id": "Code_45499", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_210", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38213", - "standardCode": { - "id": "Code_45500", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_211", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38214", - "standardCode": { - "id": "Code_45501", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_212", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38215", - "standardCode": { - "id": "Code_45502", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_213", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38216", - "standardCode": { - "id": "Code_45503", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24548", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28666", - "extensionAttributes": [], - "code": "C117786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCF Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_45", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_33", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RRAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate RR Interval", - "label": "Aggregate RR Interval", - "synonyms": [ - "RR Interval Aggregate", - "RRAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117791", - "properties": [ - { - "id": "BiomedicalConceptProperty_214", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38217", - "standardCode": { - "id": "Code_45504", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_215", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38218", - "standardCode": { - "id": "Code_45505", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_216", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38219", - "standardCode": { - "id": "Code_45506", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_217", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38220", - "standardCode": { - "id": "Code_45507", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_218", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38221", - "standardCode": { - "id": "Code_45508", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_219", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38222", - "standardCode": { - "id": "Code_45509", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_220", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38223", - "standardCode": { - "id": "Code_45510", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24549", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28667", - "extensionAttributes": [], - "code": "C117791", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Aggregate RR Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_46", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_34", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGHRMN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Mean Heart Rate by Electrocardiogram", - "label": "Mean Heart Rate by Electrocardiogram", - "synonyms": [ - "ECG Mean Heart Rate", - "EKG Mean Heart Rate", - "EGHRMN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C119259", - "properties": [ - { - "id": "BiomedicalConceptProperty_221", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38224", - "standardCode": { - "id": "Code_45511", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_222", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3027", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_45513", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38225", - "standardCode": { - "id": "Code_45512", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_223", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38227", - "standardCode": { - "id": "Code_45514", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_224", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38228", - "standardCode": { - "id": "Code_45515", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_225", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38229", - "standardCode": { - "id": "Code_45516", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_226", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38230", - "standardCode": { - "id": "Code_45517", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24550", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28668", - "extensionAttributes": [], - "code": "C119259", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Mean Heart Rate by Electrocardiogram", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_47", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_35", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QRS_AXIS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "QRS Axis", - "label": "QRS Axis", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C118165", - "properties": [ - { - "id": "BiomedicalConceptProperty_227", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38231", - "standardCode": { - "id": "Code_45518", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_228", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3028", - "instanceType": "ResponseCode", - "name": "deg", - "label": "deg", - "isEnabled": true, - "code": { - "id": "Code_45520", - "extensionAttributes": [], - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "deg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38232", - "standardCode": { - "id": "Code_45519", - "extensionAttributes": [], - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Degree Unit of Plane Angle", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_229", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38234", - "standardCode": { - "id": "Code_45521", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_230", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38235", - "standardCode": { - "id": "Code_45522", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_231", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38236", - "standardCode": { - "id": "Code_45523", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_232", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38237", - "standardCode": { - "id": "Code_45524", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24551", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28669", - "extensionAttributes": [], - "code": "C118165", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QRS Axis", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_48", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_36", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCUNSAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "QTc Correction Method Unspecified, Aggregate", - "label": "QTc Correction Method Unspecified, Aggregate", - "synonyms": [ - "QTCUNSAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C174285", - "properties": [ - { - "id": "BiomedicalConceptProperty_233", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38238", - "standardCode": { - "id": "Code_45525", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_234", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38239", - "standardCode": { - "id": "Code_45526", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_235", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38240", - "standardCode": { - "id": "Code_45527", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_236", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38241", - "standardCode": { - "id": "Code_45528", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_237", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38242", - "standardCode": { - "id": "Code_45529", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_238", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38243", - "standardCode": { - "id": "Code_45530", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_239", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38244", - "standardCode": { - "id": "Code_45531", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24552", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28670", - "extensionAttributes": [], - "code": "C174285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QTc Correction Method Unspecified, Aggregate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_49", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_37", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VTARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ventricular Arrhythmia ECG Assessment", - "label": "Ventricular Arrhythmia ECG Assessment", - "synonyms": [ - "VTARRY", - "Ventricular Arrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111330", - "properties": [ - { - "id": "BiomedicalConceptProperty_240", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38245", - "standardCode": { - "id": "Code_45532", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_241", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38246", - "standardCode": { - "id": "Code_45533", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_242", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38247", - "standardCode": { - "id": "Code_45534", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_243", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38248", - "standardCode": { - "id": "Code_45535", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_244", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38249", - "standardCode": { - "id": "Code_45536", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24553", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28671", - "extensionAttributes": [], - "code": "C111330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Arrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_50", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_38", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VTTARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ventricular Tachyarrhythmia ECG Assessment", - "label": "Ventricular Tachyarrhythmia ECG Assessment", - "synonyms": [ - "VTTARRY", - "Ventricular Tachyarrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111331", - "properties": [ - { - "id": "BiomedicalConceptProperty_245", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38250", - "standardCode": { - "id": "Code_45537", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_246", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38251", - "standardCode": { - "id": "Code_45538", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_247", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38252", - "standardCode": { - "id": "Code_45539", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_248", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38253", - "standardCode": { - "id": "Code_45540", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_249", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38254", - "standardCode": { - "id": "Code_45541", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24554", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28672", - "extensionAttributes": [], - "code": "C111331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Tachyarrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_51", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_39", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CTSCANCHEST", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Computed Tomography", - "label": "Computed Tomography", - "synonyms": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "id": "BiomedicalConceptProperty_250", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38255", - "standardCode": { - "id": "Code_45542", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_251", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3029", - "instanceType": "ResponseCode", - "name": "CT SCAN", - "label": "CT SCAN", - "isEnabled": true, - "code": { - "id": "Code_45544", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "CT SCAN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38256", - "standardCode": { - "id": "Code_45543", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_252", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38258", - "standardCode": { - "id": "Code_45545", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_253", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38259", - "standardCode": { - "id": "Code_45546", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_254", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3030", - "instanceType": "ResponseCode", - "name": "CHEST", - "label": "CHEST", - "isEnabled": true, - "code": { - "id": "Code_45548", - "extensionAttributes": [], - "code": "C25389", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "CHEST", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38260", - "standardCode": { - "id": "Code_45547", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_255", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38262", - "standardCode": { - "id": "Code_45549", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_256", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38263", - "standardCode": { - "id": "Code_45550", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_28017", - "extensionAttributes": [], - "standardCode": { - "id": "Code_32135", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_52", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_40", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MRIBRAIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "synonyms": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "id": "BiomedicalConceptProperty_257", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38264", - "standardCode": { - "id": "Code_45551", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_258", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3031", - "instanceType": "ResponseCode", - "name": "MRI", - "label": "MRI", - "isEnabled": true, - "code": { - "id": "Code_45553", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38265", - "standardCode": { - "id": "Code_45552", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_259", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38267", - "standardCode": { - "id": "Code_45554", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_260", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38268", - "standardCode": { - "id": "Code_45555", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_261", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3032", - "instanceType": "ResponseCode", - "name": "BRAIN", - "label": "BRAIN", - "isEnabled": true, - "code": { - "id": "Code_45557", - "extensionAttributes": [], - "code": "C12439", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "BRAIN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38269", - "standardCode": { - "id": "Code_45556", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_262", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38271", - "standardCode": { - "id": "Code_45558", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_263", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38272", - "standardCode": { - "id": "Code_45559", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_15783", - "extensionAttributes": [], - "standardCode": { - "id": "Code_16598", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_54", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "synonyms": [ - "CMYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [ - { - "id": "BiomedicalConceptProperty_264", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38273", - "standardCode": { - "id": "Code_45560", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_265", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38274", - "standardCode": { - "id": "Code_45561", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24555", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28673", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_55", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_41", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMFREE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "synonyms": [ - "Concomitant Medication" - ], - "reference": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ - { - "id": "BiomedicalConceptProperty_266", - "extensionAttributes": [], - "name": "CMTRT", - "label": "CMTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38275", - "standardCode": { - "id": "Code_45562", - "extensionAttributes": [], - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_267", - "extensionAttributes": [], - "name": "CMDECOD", - "label": "CMDECOD", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38276", - "standardCode": { - "id": "Code_45563", - "extensionAttributes": [], - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_268", - "extensionAttributes": [], - "name": "CMCLAS", - "label": "CMCLAS", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38277", - "standardCode": { - "id": "Code_45564", - "extensionAttributes": [], - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_269", - "extensionAttributes": [], - "name": "CMINDC", - "label": "CMINDC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38278", - "standardCode": { - "id": "Code_45565", - "extensionAttributes": [], - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_270", - "extensionAttributes": [], - "name": "CMDOSE", - "label": "CMDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38279", - "standardCode": { - "id": "Code_45566", - "extensionAttributes": [], - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_271", - "extensionAttributes": [], - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38280", - "standardCode": { - "id": "Code_45567", - "extensionAttributes": [], - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_272", - "extensionAttributes": [], - "name": "CMDOSU", - "label": "CMDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38281", - "standardCode": { - "id": "Code_45568", - "extensionAttributes": [], - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_273", - "extensionAttributes": [], - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38282", - "standardCode": { - "id": "Code_45569", - "extensionAttributes": [], - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_274", - "extensionAttributes": [], - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38283", - "standardCode": { - "id": "Code_45570", - "extensionAttributes": [], - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_275", - "extensionAttributes": [], - "name": "CMROUTE", - "label": "CMROUTE", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38284", - "standardCode": { - "id": "Code_45571", - "extensionAttributes": [], - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_276", - "extensionAttributes": [], - "name": "CMSTDTC", - "label": "CMSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38285", - "standardCode": { - "id": "Code_45572", - "extensionAttributes": [], - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_277", - "extensionAttributes": [], - "name": "CMENDTC", - "label": "CMENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38286", - "standardCode": { - "id": "Code_45573", - "extensionAttributes": [], - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_278", - "extensionAttributes": [], - "name": "CMSTRF", - "label": "CMSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38287", - "standardCode": { - "id": "Code_45574", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_279", - "extensionAttributes": [], - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38288", - "standardCode": { - "id": "Code_45575", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_280", - "extensionAttributes": [], - "name": "CMSTTPT", - "label": "CMSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38289", - "standardCode": { - "id": "Code_45576", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_281", - "extensionAttributes": [], - "name": "CMENRF", - "label": "CMENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38290", - "standardCode": { - "id": "Code_45577", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_282", - "extensionAttributes": [], - "name": "CMENRTPT", - "label": "CMENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38291", - "standardCode": { - "id": "Code_45578", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_283", - "extensionAttributes": [], - "name": "CMENTPT", - "label": "CMENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38292", - "standardCode": { - "id": "Code_45579", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24556", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28674", - "extensionAttributes": [], - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_56", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_42", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HGBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hemoglobin Measurement", - "label": "Hemoglobin Measurement", - "synonyms": [ - "Hemoglobin", - "HGB" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64848", - "properties": [ - { - "id": "BiomedicalConceptProperty_284", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38293", - "standardCode": { - "id": "Code_45580", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_285", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38294", - "standardCode": { - "id": "Code_45581", - "extensionAttributes": [], - "code": "C64571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_286", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3033", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45583", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38295", - "standardCode": { - "id": "Code_45582", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_287", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38297", - "standardCode": { - "id": "Code_45584", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_288", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38298", - "standardCode": { - "id": "Code_45585", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24557", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28675", - "extensionAttributes": [], - "code": "C64848", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_57", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_43", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HCTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hematocrit Measurement", - "label": "Hematocrit Measurement", - "synonyms": [ - "Hematocrit", - "Packed Cell Volume", - "PCV", - "Erythrocyte Volume Fraction", - "EVF" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64796", - "properties": [ - { - "id": "BiomedicalConceptProperty_289", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38299", - "standardCode": { - "id": "Code_45586", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_290", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38300", - "standardCode": { - "id": "Code_45587", - "extensionAttributes": [], - "code": "C69174", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume Fraction", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_291", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3034", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45589", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38301", - "standardCode": { - "id": "Code_45588", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_292", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38303", - "standardCode": { - "id": "Code_45590", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_293", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38304", - "standardCode": { - "id": "Code_45591", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24558", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28676", - "extensionAttributes": [], - "code": "C64796", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hematocrit Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_58", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_44", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "synonyms": [ - "RBC", - "Red Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ - { - "id": "BiomedicalConceptProperty_294", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38305", - "standardCode": { - "id": "Code_45592", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_295", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38306", - "standardCode": { - "id": "Code_45593", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_296", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3035", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45595", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38307", - "standardCode": { - "id": "Code_45594", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_297", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38309", - "standardCode": { - "id": "Code_45596", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_298", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38310", - "standardCode": { - "id": "Code_45597", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24559", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28677", - "extensionAttributes": [], - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_59", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_45", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MCH", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Mean Corpuscular Hemoglobin", - "label": "Erythrocyte Mean Corpuscular Hemoglobin", - "synonyms": [ - "RBC Mean Corpuscular Hemoglobin", - "MCH" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64797", - "properties": [ - { - "id": "BiomedicalConceptProperty_299", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38311", - "standardCode": { - "id": "Code_45598", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_300", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38312", - "standardCode": { - "id": "Code_45599", - "extensionAttributes": [], - "code": "C25709", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Measure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_301", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3036", - "instanceType": "ResponseCode", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "isEnabled": true, - "code": { - "id": "Code_45601", - "extensionAttributes": [], - "code": "C12521", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ERYTHROCYTES", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38313", - "standardCode": { - "id": "Code_45600", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_302", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38315", - "standardCode": { - "id": "Code_45602", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_303", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38316", - "standardCode": { - "id": "Code_45603", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24560", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28678", - "extensionAttributes": [], - "code": "C64797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Hemoglobin", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_60", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_46", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MCV", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Mean Corpuscular Volume", - "label": "Erythrocyte Mean Corpuscular Volume", - "synonyms": [ - "RBC Mean Corpuscular Volume", - "MCV" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64799", - "properties": [ - { - "id": "BiomedicalConceptProperty_304", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38317", - "standardCode": { - "id": "Code_45604", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_305", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3037", - "instanceType": "ResponseCode", - "name": "fL", - "label": "fL", - "isEnabled": true, - "code": { - "id": "Code_45606", - "extensionAttributes": [], - "code": "C64780", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "fL", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38318", - "standardCode": { - "id": "Code_45605", - "extensionAttributes": [], - "code": "C44279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_306", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3038", - "instanceType": "ResponseCode", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "isEnabled": true, - "code": { - "id": "Code_45608", - "extensionAttributes": [], - "code": "C12521", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ERYTHROCYTES", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38320", - "standardCode": { - "id": "Code_45607", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_307", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38322", - "standardCode": { - "id": "Code_45609", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_308", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38323", - "standardCode": { - "id": "Code_45610", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24561", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28679", - "extensionAttributes": [], - "code": "C64799", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Volume", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_61", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_47", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "synonyms": [ - "WBC", - "White Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [ - { - "id": "BiomedicalConceptProperty_309", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38324", - "standardCode": { - "id": "Code_45611", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_310", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38325", - "standardCode": { - "id": "Code_45612", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_311", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3039", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45614", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38326", - "standardCode": { - "id": "Code_45613", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_312", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38328", - "standardCode": { - "id": "Code_45615", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_313", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38329", - "standardCode": { - "id": "Code_45616", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24562", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28680", - "extensionAttributes": [], - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_62", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_48", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTSGBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Segmented Neutrophil Count", - "label": "Segmented Neutrophil Count", - "synonyms": [ - "Segmented Neutrophils", - "NEUTSG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81997", - "properties": [ - { - "id": "BiomedicalConceptProperty_314", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38330", - "standardCode": { - "id": "Code_45617", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_315", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3040", - "instanceType": "ResponseCode", - "name": "10^9/L", - "label": "10^9/L", - "isEnabled": true, - "code": { - "id": "Code_45619", - "extensionAttributes": [], - "code": "C67255", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^9/L", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38331", - "standardCode": { - "id": "Code_45618", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_316", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3041", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45621", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38333", - "standardCode": { - "id": "Code_45620", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_317", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38335", - "standardCode": { - "id": "Code_45622", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_318", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38336", - "standardCode": { - "id": "Code_45623", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24563", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28681", - "extensionAttributes": [], - "code": "C81997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Segmented Neutrophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_63", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_49", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Neutrophil Band Form Count", - "label": "Neutrophil Band Form Count", - "synonyms": [ - "Neutrophil Bands", - "Bands", - "NEUTB" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64830", - "properties": [ - { - "id": "BiomedicalConceptProperty_319", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38337", - "standardCode": { - "id": "Code_45624", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_320", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3042", - "instanceType": "ResponseCode", - "name": "10^6/L", - "label": "10^6/L", - "isEnabled": true, - "code": { - "id": "Code_45626", - "extensionAttributes": [], - "code": "C67452", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^6/L", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38338", - "standardCode": { - "id": "Code_45625", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_321", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3043", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45628", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38340", - "standardCode": { - "id": "Code_45627", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_322", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38342", - "standardCode": { - "id": "Code_45629", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_323", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38343", - "standardCode": { - "id": "Code_45630", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24564", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28682", - "extensionAttributes": [], - "code": "C64830", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Neutrophil Band Form Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_64", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_50", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Absolute Neutrophil Count", - "label": "Absolute Neutrophil Count", - "synonyms": [ - "Neutrophils", - "Total Neutrophil Count", - "NEUT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C63321", - "properties": [ - { - "id": "BiomedicalConceptProperty_324", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38344", - "standardCode": { - "id": "Code_45631", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_325", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3044", - "instanceType": "ResponseCode", - "name": "10^9/L", - "label": "10^9/L", - "isEnabled": true, - "code": { - "id": "Code_45633", - "extensionAttributes": [], - "code": "C67255", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^9/L", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38345", - "standardCode": { - "id": "Code_45632", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_326", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3045", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45635", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38347", - "standardCode": { - "id": "Code_45634", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_327", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38349", - "standardCode": { - "id": "Code_45636", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_328", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38350", - "standardCode": { - "id": "Code_45637", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24565", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28683", - "extensionAttributes": [], - "code": "C63321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Neutrophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_65", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_51", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MONOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Monocyte Count", - "label": "Monocyte Count", - "synonyms": [ - "Monocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64823", - "properties": [ - { - "id": "BiomedicalConceptProperty_329", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38351", - "standardCode": { - "id": "Code_45638", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_330", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38352", - "standardCode": { - "id": "Code_45639", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_331", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3046", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45641", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38353", - "standardCode": { - "id": "Code_45640", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_332", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38355", - "standardCode": { - "id": "Code_45642", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_333", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38356", - "standardCode": { - "id": "Code_45643", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24566", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28684", - "extensionAttributes": [], - "code": "C64823", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Monocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_66", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_52", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EOSBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Eosinophil Count", - "label": "Eosinophil Count", - "synonyms": [ - "Eosinophils" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64550", - "properties": [ - { - "id": "BiomedicalConceptProperty_334", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38357", - "standardCode": { - "id": "Code_45644", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_335", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38358", - "standardCode": { - "id": "Code_45645", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_336", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3047", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45647", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38359", - "standardCode": { - "id": "Code_45646", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_337", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38361", - "standardCode": { - "id": "Code_45648", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_338", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38362", - "standardCode": { - "id": "Code_45649", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24567", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28685", - "extensionAttributes": [], - "code": "C64550", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Eosinophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_67", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_53", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BASOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Absolute Basophil Count", - "label": "Absolute Basophil Count", - "synonyms": [ - "Basophils", - "Total Basophil Count" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64470", - "properties": [ - { - "id": "BiomedicalConceptProperty_339", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38363", - "standardCode": { - "id": "Code_45650", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_340", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38364", - "standardCode": { - "id": "Code_45651", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_341", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3048", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45653", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38365", - "standardCode": { - "id": "Code_45652", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_342", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38367", - "standardCode": { - "id": "Code_45654", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_343", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38368", - "standardCode": { - "id": "Code_45655", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3354", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3564", - "extensionAttributes": [], - "code": "C64470", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Basophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_68", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_54", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PLATBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Platelet Count", - "label": "Platelet Count", - "synonyms": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ - { - "id": "BiomedicalConceptProperty_344", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38369", - "standardCode": { - "id": "Code_45656", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_345", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38370", - "standardCode": { - "id": "Code_45657", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_346", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3049", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45659", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38371", - "standardCode": { - "id": "Code_45658", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_347", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38373", - "standardCode": { - "id": "Code_45660", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_348", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38374", - "standardCode": { - "id": "Code_45661", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24568", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28686", - "extensionAttributes": [], - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_69", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_55", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MICROCYBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Microcyte Count", - "label": "Microcyte Count", - "synonyms": [ - "Microcytes", - "MICROCY" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64822", - "properties": [ - { - "id": "BiomedicalConceptProperty_349", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38375", - "standardCode": { - "id": "Code_45662", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_350", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3050", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45664", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38376", - "standardCode": { - "id": "Code_45663", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_351", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38378", - "standardCode": { - "id": "Code_45665", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_352", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38379", - "standardCode": { - "id": "Code_45666", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24569", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28687", - "extensionAttributes": [], - "code": "C64822", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Microcyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_70", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_56", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MACROCYBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Macrocyte Count", - "label": "Macrocyte Count", - "synonyms": [ - "Macrocytes", - "MACROCY" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64821", - "properties": [ - { - "id": "BiomedicalConceptProperty_353", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38380", - "standardCode": { - "id": "Code_45667", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_354", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3051", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45669", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38381", - "standardCode": { - "id": "Code_45668", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_355", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38383", - "standardCode": { - "id": "Code_45670", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_356", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38384", - "standardCode": { - "id": "Code_45671", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24570", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28688", - "extensionAttributes": [], - "code": "C64821", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Macrocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_71", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_57", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ANISOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Anisocyte Measurement", - "label": "Anisocyte Measurement", - "synonyms": [ - "Anisocytes", - "Anisocytosis", - "ANISO" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74797", - "properties": [ - { - "id": "BiomedicalConceptProperty_357", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38385", - "standardCode": { - "id": "Code_45672", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_358", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3052", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45674", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38386", - "standardCode": { - "id": "Code_45673", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_359", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38388", - "standardCode": { - "id": "Code_45675", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_360", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38389", - "standardCode": { - "id": "Code_45676", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24571", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28689", - "extensionAttributes": [], - "code": "C74797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anisocyte Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_72", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_58", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/POIKILOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Poikilocyte Measurement", - "label": "Poikilocyte Measurement", - "synonyms": [ - "POIKILO", - "Poikilocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C79602", - "properties": [ - { - "id": "BiomedicalConceptProperty_361", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38390", - "standardCode": { - "id": "Code_45677", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_362", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3053", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45679", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38391", - "standardCode": { - "id": "Code_45678", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_363", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38393", - "standardCode": { - "id": "Code_45680", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_364", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38394", - "standardCode": { - "id": "Code_45681", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24572", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28690", - "extensionAttributes": [], - "code": "C79602", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Poikilocyte Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_73", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_59", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/POLYCHRBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Polychromasia", - "label": "Polychromasia", - "synonyms": [ - "POLYCHR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64803", - "properties": [ - { - "id": "BiomedicalConceptProperty_365", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38395", - "standardCode": { - "id": "Code_45682", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_366", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3054", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45684", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38396", - "standardCode": { - "id": "Code_45683", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_367", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38398", - "standardCode": { - "id": "Code_45685", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_368", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38399", - "standardCode": { - "id": "Code_45686", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24573", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28691", - "extensionAttributes": [], - "code": "C64803", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Polychromasia", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_74", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_60", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "synonyms": [ - "ALT", - "SGPT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ - { - "id": "BiomedicalConceptProperty_369", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38400", - "standardCode": { - "id": "Code_45687", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_370", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38401", - "standardCode": { - "id": "Code_45688", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_371", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3055", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45690", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38402", - "standardCode": { - "id": "Code_45689", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_372", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38404", - "standardCode": { - "id": "Code_45691", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_373", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38405", - "standardCode": { - "id": "Code_45692", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24574", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28692", - "extensionAttributes": [], - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_75", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_61", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "synonyms": [ - "Albumin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ - { - "id": "BiomedicalConceptProperty_374", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38406", - "standardCode": { - "id": "Code_45693", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_375", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38407", - "standardCode": { - "id": "Code_45694", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_376", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3056", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45696", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38408", - "standardCode": { - "id": "Code_45695", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_377", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38410", - "standardCode": { - "id": "Code_45697", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_378", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38411", - "standardCode": { - "id": "Code_45698", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24575", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28693", - "extensionAttributes": [], - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_76", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_62", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "synonyms": [ - "Alkaline Phosphatase" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [ - { - "id": "BiomedicalConceptProperty_379", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38412", - "standardCode": { - "id": "Code_45699", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_380", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38413", - "standardCode": { - "id": "Code_45700", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_381", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3057", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45702", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38414", - "standardCode": { - "id": "Code_45701", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_382", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38416", - "standardCode": { - "id": "Code_45703", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_383", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38417", - "standardCode": { - "id": "Code_45704", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24576", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28694", - "extensionAttributes": [], - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_77", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_63", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "synonyms": [ - "AST", - "SGOT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ - { - "id": "BiomedicalConceptProperty_384", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38418", - "standardCode": { - "id": "Code_45705", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_385", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38419", - "standardCode": { - "id": "Code_45706", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_386", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3058", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45708", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38420", - "standardCode": { - "id": "Code_45707", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_387", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38422", - "standardCode": { - "id": "Code_45709", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_388", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38423", - "standardCode": { - "id": "Code_45710", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24577", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28695", - "extensionAttributes": [], - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_78", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_64", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "synonyms": [ - "Creatinine" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ - { - "id": "BiomedicalConceptProperty_389", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38424", - "standardCode": { - "id": "Code_45711", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_390", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38425", - "standardCode": { - "id": "Code_45712", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_391", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3059", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45714", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38426", - "standardCode": { - "id": "Code_45713", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_392", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38428", - "standardCode": { - "id": "Code_45715", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_393", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38429", - "standardCode": { - "id": "Code_45716", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3355", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3565", - "extensionAttributes": [], - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_79", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_65", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/KBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "synonyms": [ - "Potassium", - "K" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [ - { - "id": "BiomedicalConceptProperty_394", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38430", - "standardCode": { - "id": "Code_45717", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_395", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38431", - "standardCode": { - "id": "Code_45718", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_396", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3060", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45720", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38432", - "standardCode": { - "id": "Code_45719", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_397", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38434", - "standardCode": { - "id": "Code_45721", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_398", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38435", - "standardCode": { - "id": "Code_45722", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24578", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28696", - "extensionAttributes": [], - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_80", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_66", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "synonyms": [ - "Sodium", - "NA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [ - { - "id": "BiomedicalConceptProperty_399", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38436", - "standardCode": { - "id": "Code_45723", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_400", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38437", - "standardCode": { - "id": "Code_45724", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_401", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3061", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45726", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38438", - "standardCode": { - "id": "Code_45725", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_402", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38440", - "standardCode": { - "id": "Code_45727", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_403", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38441", - "standardCode": { - "id": "Code_45728", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24579", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28697", - "extensionAttributes": [], - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_81", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_67", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "synonyms": [ - "Urea Nitrogen" - ], - "reference": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [ - { - "id": "BiomedicalConceptProperty_404", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38442", - "standardCode": { - "id": "Code_45729", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_405", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38443", - "standardCode": { - "id": "Code_45730", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_406", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3062", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45732", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38444", - "standardCode": { - "id": "Code_45731", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_407", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38446", - "standardCode": { - "id": "Code_45733", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_408", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38447", - "standardCode": { - "id": "Code_45734", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24580", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28698", - "extensionAttributes": [], - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_82", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_68", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BICARBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Bicarbonate Measurement", - "label": "Bicarbonate Measurement", - "synonyms": [ - "Bicarbonate", - "HCO3" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74667", - "properties": [ - { - "id": "BiomedicalConceptProperty_419", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38460", - "standardCode": { - "id": "Code_45747", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_420", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38461", - "standardCode": { - "id": "Code_45748", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_421", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3065", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45750", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38462", - "standardCode": { - "id": "Code_45749", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_422", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38464", - "standardCode": { - "id": "Code_45751", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_423", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38465", - "standardCode": { - "id": "Code_45752", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24581", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28699", - "extensionAttributes": [], - "code": "C74667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Bicarbonate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_83", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_69", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CLBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "synonyms": [ - "Chloride", - "CL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [ - { - "id": "BiomedicalConceptProperty_429", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38472", - "standardCode": { - "id": "Code_45759", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_430", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38473", - "standardCode": { - "id": "Code_45760", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_431", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3067", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45762", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38474", - "standardCode": { - "id": "Code_45761", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_432", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38476", - "standardCode": { - "id": "Code_45763", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_433", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38477", - "standardCode": { - "id": "Code_45764", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24582", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28700", - "extensionAttributes": [], - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_84", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_70", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "synonyms": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "id": "BiomedicalConceptProperty_439", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38484", - "standardCode": { - "id": "Code_45771", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_440", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38485", - "standardCode": { - "id": "Code_45772", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_441", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3069", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45774", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38486", - "standardCode": { - "id": "Code_45773", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_442", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38488", - "standardCode": { - "id": "Code_45775", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_443", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38489", - "standardCode": { - "id": "Code_45776", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24583", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28701", - "extensionAttributes": [], - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_85", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_71", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GGTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Gamma Glutamyl Transpeptidase Measurement", - "label": "Gamma Glutamyl Transpeptidase Measurement", - "synonyms": [ - "Gamma Glutamyl Transferase", - "GGT", - "GGTP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64847", - "properties": [ - { - "id": "BiomedicalConceptProperty_449", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38496", - "standardCode": { - "id": "Code_45783", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_450", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38497", - "standardCode": { - "id": "Code_45784", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_451", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3071", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45786", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38498", - "standardCode": { - "id": "Code_45785", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_452", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38500", - "standardCode": { - "id": "Code_45787", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_453", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38501", - "standardCode": { - "id": "Code_45788", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_37996", - "extensionAttributes": [], - "standardCode": { - "id": "Code_45283", - "extensionAttributes": [], - "code": "C64847", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Gamma Glutamyl Transpeptidase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_86", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_72", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/URATESERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urate Measurement", - "label": "Urate Measurement", - "synonyms": [ - "Urate", - "Uric Acid" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [ - { - "id": "BiomedicalConceptProperty_459", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38508", - "standardCode": { - "id": "Code_45795", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_460", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38509", - "standardCode": { - "id": "Code_45796", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_461", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3073", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45798", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38510", - "standardCode": { - "id": "Code_45797", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_462", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38512", - "standardCode": { - "id": "Code_45799", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_463", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38513", - "standardCode": { - "id": "Code_45800", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24584", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28702", - "extensionAttributes": [], - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_87", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_73", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHOSSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Phosphate Measurement", - "label": "Phosphate Measurement", - "synonyms": [ - "Phosphorus", - "Phosphate" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64857", - "properties": [ - { - "id": "BiomedicalConceptProperty_469", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38520", - "standardCode": { - "id": "Code_45807", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_470", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38521", - "standardCode": { - "id": "Code_45808", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_471", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3075", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45810", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38522", - "standardCode": { - "id": "Code_45809", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_472", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38524", - "standardCode": { - "id": "Code_45811", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_473", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38525", - "standardCode": { - "id": "Code_45812", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24585", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28703", - "extensionAttributes": [], - "code": "C64857", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Phosphate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_88", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_74", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CABLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "synonyms": [ - "Calcium", - "CA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [ - { - "id": "BiomedicalConceptProperty_480", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38533", - "standardCode": { - "id": "Code_45820", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_481", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38534", - "standardCode": { - "id": "Code_45821", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_482", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3077", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45823", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38535", - "standardCode": { - "id": "Code_45822", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_483", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38537", - "standardCode": { - "id": "Code_45824", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_484", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38538", - "standardCode": { - "id": "Code_45825", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24586", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28704", - "extensionAttributes": [], - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_89", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_75", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "synonyms": [ - "Glucose" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "id": "BiomedicalConceptProperty_495", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38551", - "standardCode": { - "id": "Code_45838", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_496", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38552", - "standardCode": { - "id": "Code_45839", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_497", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3080", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45841", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38553", - "standardCode": { - "id": "Code_45840", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_498", - "extensionAttributes": [], - "name": "LBMETHOD", - "label": "LBMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38555", - "standardCode": { - "id": "Code_45842", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_499", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38556", - "standardCode": { - "id": "Code_45843", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_500", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38557", - "standardCode": { - "id": "Code_45844", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24587", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28705", - "extensionAttributes": [], - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_90", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_76", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "synonyms": [ - "Protein" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "id": "BiomedicalConceptProperty_506", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38564", - "standardCode": { - "id": "Code_45851", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_507", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38565", - "standardCode": { - "id": "Code_45852", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_508", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3082", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45854", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38566", - "standardCode": { - "id": "Code_45853", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_509", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38568", - "standardCode": { - "id": "Code_45855", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_510", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38569", - "standardCode": { - "id": "Code_45856", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24588", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28706", - "extensionAttributes": [], - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_91", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_77", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "synonyms": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [ - { - "id": "BiomedicalConceptProperty_516", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38576", - "standardCode": { - "id": "Code_45863", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_517", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38577", - "standardCode": { - "id": "Code_45864", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_518", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3084", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45866", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38578", - "standardCode": { - "id": "Code_45865", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_519", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38580", - "standardCode": { - "id": "Code_45867", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_520", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38581", - "standardCode": { - "id": "Code_45868", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24589", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28707", - "extensionAttributes": [], - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_92", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_78", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T3UPSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Triiodothyronine Uptake Measurement", - "label": "Triiodothyronine Uptake Measurement", - "synonyms": [ - "T3UP", - "T3U", - "Triiodothyronine Resin Uptake" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74748", - "properties": [ - { - "id": "BiomedicalConceptProperty_526", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38588", - "standardCode": { - "id": "Code_45875", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_527", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38589", - "standardCode": { - "id": "Code_45876", - "extensionAttributes": [], - "code": "C48570", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_528", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3086", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45878", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38590", - "standardCode": { - "id": "Code_45877", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_529", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38592", - "standardCode": { - "id": "Code_45879", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_530", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38593", - "standardCode": { - "id": "Code_45880", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24590", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28708", - "extensionAttributes": [], - "code": "C74748", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Uptake Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_93", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_79", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T3SERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Triiodothyronine Measurement", - "label": "Triiodothyronine Measurement", - "synonyms": [ - "T3", - "Total T3" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74747", - "properties": [ - { - "id": "BiomedicalConceptProperty_535", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38599", - "standardCode": { - "id": "Code_45886", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_536", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38600", - "standardCode": { - "id": "Code_45887", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_537", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3088", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45889", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38601", - "standardCode": { - "id": "Code_45888", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_538", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38603", - "standardCode": { - "id": "Code_45890", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_539", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38604", - "standardCode": { - "id": "Code_45891", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24591", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28709", - "extensionAttributes": [], - "code": "C74747", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_94", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_80", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T4FRSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Free Thyroxine Measurement", - "label": "Free Thyroxine Measurement", - "synonyms": [ - "Free T4", - "T4FR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74786", - "properties": [ - { - "id": "BiomedicalConceptProperty_545", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38611", - "standardCode": { - "id": "Code_45898", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_546", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38612", - "standardCode": { - "id": "Code_45899", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_547", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3090", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45901", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38613", - "standardCode": { - "id": "Code_45900", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_548", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38615", - "standardCode": { - "id": "Code_45902", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_549", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38616", - "standardCode": { - "id": "Code_45903", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24592", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28710", - "extensionAttributes": [], - "code": "C74786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_95", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_81", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T4FRIDXSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Free Thyroxine Index", - "label": "Free Thyroxine Index", - "synonyms": [ - "T4FRIDX" - ], - "reference": "/mdr/bc/biomedicalconcepts/C170598", - "properties": [ - { - "id": "BiomedicalConceptProperty_555", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38623", - "standardCode": { - "id": "Code_45910", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_556", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3092", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45912", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38624", - "standardCode": { - "id": "Code_45911", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_557", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38626", - "standardCode": { - "id": "Code_45913", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_558", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38627", - "standardCode": { - "id": "Code_45914", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24593", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28711", - "extensionAttributes": [], - "code": "C170598", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Index", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_96", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_82", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TSHBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Thyrotropin Measurement", - "label": "Thyrotropin Measurement", - "synonyms": [ - "TSH", - "Thyrotropin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64813", - "properties": [ - { - "id": "BiomedicalConceptProperty_564", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38634", - "standardCode": { - "id": "Code_45921", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_565", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38635", - "standardCode": { - "id": "Code_45922", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_566", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3094", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45924", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38636", - "standardCode": { - "id": "Code_45923", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_567", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38638", - "standardCode": { - "id": "Code_45925", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_568", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38639", - "standardCode": { - "id": "Code_45926", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24594", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28712", - "extensionAttributes": [], - "code": "C64813", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Thyrotropin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_97", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_83", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VITB9BLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Folic Acid Measurement", - "label": "Folic Acid Measurement", - "synonyms": [ - "Folate", - "Folic Acid", - "Vitamin B9", - "VITB9" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74676", - "properties": [ - { - "id": "BiomedicalConceptProperty_574", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38647", - "standardCode": { - "id": "Code_45934", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_575", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38648", - "standardCode": { - "id": "Code_45935", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_576", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3097", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45937", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38649", - "standardCode": { - "id": "Code_45936", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_577", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38651", - "standardCode": { - "id": "Code_45938", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_578", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38652", - "standardCode": { - "id": "Code_45939", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3218", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3428", - "extensionAttributes": [], - "code": "C74676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Folic Acid Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_98", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_84", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VITB12BLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Vitamin B12 Measurement", - "label": "Vitamin B12 Measurement", - "synonyms": [ - "Cobalamin", - "Vitamin B12", - "VITB12" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64817", - "properties": [ - { - "id": "BiomedicalConceptProperty_584", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38660", - "standardCode": { - "id": "Code_45947", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_585", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38661", - "standardCode": { - "id": "Code_45948", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_586", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3100", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45950", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38662", - "standardCode": { - "id": "Code_45949", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_587", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38664", - "standardCode": { - "id": "Code_45951", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_588", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38665", - "standardCode": { - "id": "Code_45952", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24595", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28713", - "extensionAttributes": [], - "code": "C64817", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Vitamin B12 Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_99", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_85", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TPLAB", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Treponema pallidum Antibody Measurement", - "label": "Treponema pallidum Antibody Measurement", - "synonyms": [ - "TPLAB", - "Treponema pallidum Antibody", - "Syphilis Antibody" - ], - "reference": "/mdr/bc/biomedicalconcepts/C132388", - "properties": [ - { - "id": "BiomedicalConceptProperty_592", - "extensionAttributes": [], - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3102", - "instanceType": "ResponseCode", - "name": "DETECTION", - "label": "DETECTION", - "isEnabled": true, - "code": { - "id": "Code_45958", - "extensionAttributes": [], - "code": "C174330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "DETECTION", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38670", - "standardCode": { - "id": "Code_45957", - "extensionAttributes": [], - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_593", - "extensionAttributes": [], - "name": "MBORRES", - "label": "MBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38672", - "standardCode": { - "id": "Code_45959", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_594", - "extensionAttributes": [], - "name": "MBSPEC", - "label": "MBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3103", - "instanceType": "ResponseCode", - "name": "SERUM", - "label": "SERUM", - "isEnabled": true, - "code": { - "id": "Code_45961", - "extensionAttributes": [], - "code": "C13325", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38673", - "standardCode": { - "id": "Code_45960", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_595", - "extensionAttributes": [], - "name": "MBMETHOD", - "label": "MBMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38675", - "standardCode": { - "id": "Code_45962", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_596", - "extensionAttributes": [], - "name": "MBDTC", - "label": "MBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38676", - "standardCode": { - "id": "Code_45963", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24596", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28714", - "extensionAttributes": [], - "code": "C132388", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum Antibody Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_100", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_86", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TPADNA", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Treponema pallidum DNA Measurement", - "label": "Treponema pallidum DNA Measurement", - "synonyms": [ - "TPADNA", - "Syphilis DNA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C198341", - "properties": [ - { - "id": "BiomedicalConceptProperty_606", - "extensionAttributes": [], - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3106", - "instanceType": "ResponseCode", - "name": "DETECTION", - "label": "DETECTION", - "isEnabled": true, - "code": { - "id": "Code_45976", - "extensionAttributes": [], - "code": "C174330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "DETECTION", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38688", - "standardCode": { - "id": "Code_45975", - "extensionAttributes": [], - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_607", - "extensionAttributes": [], - "name": "MBORRES", - "label": "MBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38690", - "standardCode": { - "id": "Code_45977", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_608", - "extensionAttributes": [], - "name": "MBSPEC", - "label": "MBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38691", - "standardCode": { - "id": "Code_45978", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_609", - "extensionAttributes": [], - "name": "MBMETHOD", - "label": "MBMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3107", - "instanceType": "ResponseCode", - "name": "LINE PROBE ASSAY", - "label": "LINE PROBE ASSAY", - "isEnabled": true, - "code": { - "id": "Code_45980", - "extensionAttributes": [], - "code": "C102656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "LINE PROBE ASSAY", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38692", - "standardCode": { - "id": "Code_45979", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_610", - "extensionAttributes": [], - "name": "MBDTC", - "label": "MBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38694", - "standardCode": { - "id": "Code_45981", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24597", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28715", - "extensionAttributes": [], - "code": "C198341", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum DNA Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_101", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_87", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/COLORURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Color Assessment", - "label": "Color Assessment", - "synonyms": [ - "COLOR", - "Color" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [ - { - "id": "BiomedicalConceptProperty_616", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38701", - "standardCode": { - "id": "Code_45988", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_617", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3109", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_45990", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38702", - "standardCode": { - "id": "Code_45989", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_618", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38704", - "standardCode": { - "id": "Code_45991", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24598", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28716", - "extensionAttributes": [], - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_102", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_88", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Specific Gravity", - "label": "Specific Gravity", - "synonyms": [ - "SPGRAV" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ - { - "id": "BiomedicalConceptProperty_629", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38717", - "standardCode": { - "id": "Code_46004", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_630", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3112", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_46006", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38718", - "standardCode": { - "id": "Code_46005", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_631", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38720", - "standardCode": { - "id": "Code_46007", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_632", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38721", - "standardCode": { - "id": "Code_46008", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3219", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3429", - "extensionAttributes": [], - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_103", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_89", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Protein Measurement", - "label": null, - "synonyms": [ - "Protein" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "id": "BiomedicalConceptProperty_633", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38722", - "standardCode": { - "id": "Code_46009", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_634", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38723", - "standardCode": { - "id": "Code_46010", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_635", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3113", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_46012", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38724", - "standardCode": { - "id": "Code_46011", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_636", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38726", - "standardCode": { - "id": "Code_46013", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_637", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38727", - "standardCode": { - "id": "Code_46014", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24588", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28706", - "extensionAttributes": [], - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_104", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_144", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Glucose Measurement", - "label": null, - "synonyms": [ - "Glucose" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "id": "BiomedicalConceptProperty_643", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38734", - "standardCode": { - "id": "Code_46021", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_644", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38735", - "standardCode": { - "id": "Code_46022", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_645", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3115", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_46024", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38736", - "standardCode": { - "id": "Code_46023", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_646", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38738", - "standardCode": { - "id": "Code_46025", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_647", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38739", - "standardCode": { - "id": "Code_46026", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24587", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28705", - "extensionAttributes": [], - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_105", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_91", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/KETONESURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ketone Measurement", - "label": "Ketone Measurement", - "synonyms": [ - "Ketones" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64854", - "properties": [ - { - "id": "BiomedicalConceptProperty_652", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38745", - "standardCode": { - "id": "Code_46032", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_653", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38746", - "standardCode": { - "id": "Code_46033", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_654", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3117", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_46035", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38747", - "standardCode": { - "id": "Code_46034", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_655", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38749", - "standardCode": { - "id": "Code_46036", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_656", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38750", - "standardCode": { - "id": "Code_46037", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24599", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28717", - "extensionAttributes": [], - "code": "C64854", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Ketone Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_106", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_92", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Bilirubin Measurement", - "label": null, - "synonyms": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "id": "BiomedicalConceptProperty_657", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38751", - "standardCode": { - "id": "Code_46038", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_658", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38752", - "standardCode": { - "id": "Code_46039", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_659", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3118", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_46041", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38753", - "standardCode": { - "id": "Code_46040", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_660", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38755", - "standardCode": { - "id": "Code_46042", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_661", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38756", - "standardCode": { - "id": "Code_46043", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24583", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28701", - "extensionAttributes": [], - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_107", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_93", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/UROBILURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urobilinogen Measurement", - "label": "Urobilinogen Measurement", - "synonyms": [ - "Urobilinogen", - "UROBIL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64816", - "properties": [ - { - "id": "BiomedicalConceptProperty_667", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38763", - "standardCode": { - "id": "Code_46050", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_668", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38764", - "standardCode": { - "id": "Code_46051", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_669", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3120", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_46053", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38765", - "standardCode": { - "id": "Code_46052", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_670", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38767", - "standardCode": { - "id": "Code_46054", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_671", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38768", - "standardCode": { - "id": "Code_46055", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24600", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28718", - "extensionAttributes": [], - "code": "C64816", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urobilinogen Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_108", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_94", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/OCCBLDSTOOL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Occult Blood Measurement", - "label": "Occult Blood Measurement", - "synonyms": [ - "Occult Blood", - "OCCBLD" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74686", - "properties": [ - { - "id": "BiomedicalConceptProperty_676", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38774", - "standardCode": { - "id": "Code_46061", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_677", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3122", - "instanceType": "ResponseCode", - "name": "STOOL", - "label": "STOOL", - "isEnabled": true, - "code": { - "id": "Code_46063", - "extensionAttributes": [], - "code": "C13234", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "STOOL", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38775", - "standardCode": { - "id": "Code_46062", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_678", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38777", - "standardCode": { - "id": "Code_46064", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_679", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38778", - "standardCode": { - "id": "Code_46065", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3356", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3566", - "extensionAttributes": [], - "code": "C74686", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occult Blood Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_109", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_95", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NITRITEURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Nitrite Measurement", - "label": "Nitrite Measurement", - "synonyms": [ - "NITRITE" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64810", - "properties": [ - { - "id": "BiomedicalConceptProperty_684", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38784", - "standardCode": { - "id": "Code_46071", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_685", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38785", - "standardCode": { - "id": "Code_46072", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_686", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3124", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_46074", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38786", - "standardCode": { - "id": "Code_46073", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_687", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38788", - "standardCode": { - "id": "Code_46075", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_688", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38789", - "standardCode": { - "id": "Code_46076", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3357", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3567", - "extensionAttributes": [], - "code": "C64810", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Nitrite Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_110", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_96", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HBA1CBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hemoglobin A1C Measurement", - "label": "Hemoglobin A1C Measurement", - "synonyms": [ - "Hemoglobin A1C", - "HBA1C", - "Glycosylated Hemoglobin A1C" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64849", - "properties": [ - { - "id": "BiomedicalConceptProperty_703", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38804", - "standardCode": { - "id": "Code_46091", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_704", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3125", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_46093", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38805", - "standardCode": { - "id": "Code_46092", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_705", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38807", - "standardCode": { - "id": "Code_46094", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_706", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38808", - "standardCode": { - "id": "Code_46095", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24601", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28719", - "extensionAttributes": [], - "code": "C64849", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin A1C Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_111", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_97", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HBA1CHGBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "label": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "synonyms": [ - "Hemoglobin A1C/Hemoglobin", - "HBA1CHGB" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111207", - "properties": [ - { - "id": "BiomedicalConceptProperty_713", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38816", - "standardCode": { - "id": "Code_46103", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_714", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3127", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_46105", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38817", - "standardCode": { - "id": "Code_46104", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_715", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38819", - "standardCode": { - "id": "Code_46106", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_716", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38820", - "standardCode": { - "id": "Code_46107", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24602", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28720", - "extensionAttributes": [], - "code": "C111207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_112", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_98", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EXPOSCOLL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Exposure as Collected Domain", - "label": "Exposure as Collected Domain", - "synonyms": [ - "EC", - "Exposure as Collected" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117466", - "properties": [ - { - "id": "BiomedicalConceptProperty_720", - "extensionAttributes": [], - "name": "ECTRT", - "label": "ECTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38825", - "standardCode": { - "id": "Code_46112", - "extensionAttributes": [], - "code": "C117473", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Name of Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_721", - "extensionAttributes": [], - "name": "ECREFID", - "label": "ECREFID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38826", - "standardCode": { - "id": "Code_46113", - "extensionAttributes": [], - "code": "C117469", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Reference Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_722", - "extensionAttributes": [], - "name": "ECDOSE", - "label": "ECDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38827", - "standardCode": { - "id": "Code_46114", - "extensionAttributes": [], - "code": "C117479", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_723", - "extensionAttributes": [], - "name": "ECDOSTXT", - "label": "ECDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38828", - "standardCode": { - "id": "Code_46115", - "extensionAttributes": [], - "code": "C117480", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_724", - "extensionAttributes": [], - "name": "ECDOSU", - "label": "ECDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38829", - "standardCode": { - "id": "Code_46116", - "extensionAttributes": [], - "code": "C117481", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Units", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_725", - "extensionAttributes": [], - "name": "ECDOSFRM", - "label": "ECDOSFRM", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38830", - "standardCode": { - "id": "Code_46117", - "extensionAttributes": [], - "code": "C117482", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Form", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_726", - "extensionAttributes": [], - "name": "ECDOSFRQ", - "label": "ECDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38831", - "standardCode": { - "id": "Code_46118", - "extensionAttributes": [], - "code": "C117483", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dosing Frequency per Interval", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_727", - "extensionAttributes": [], - "name": "ECDOSRGM", - "label": "ECDOSRGM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38832", - "standardCode": { - "id": "Code_46119", - "extensionAttributes": [], - "code": "C117485", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Intended Dose Regimen", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_728", - "extensionAttributes": [], - "name": "ECROUTE", - "label": "ECROUTE", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38833", - "standardCode": { - "id": "Code_46120", - "extensionAttributes": [], - "code": "C117486", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Route of Administration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_729", - "extensionAttributes": [], - "name": "ECLOC", - "label": "ECLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38834", - "standardCode": { - "id": "Code_46121", - "extensionAttributes": [], - "code": "C117488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Location", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_730", - "extensionAttributes": [], - "name": "ECLAT", - "label": "ECLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38835", - "standardCode": { - "id": "Code_46122", - "extensionAttributes": [], - "code": "C117489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_731", - "extensionAttributes": [], - "name": "ECDIR", - "label": "ECDIR", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38836", - "standardCode": { - "id": "Code_46123", - "extensionAttributes": [], - "code": "C117490", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Directionality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_732", - "extensionAttributes": [], - "name": "ECSTDTC", - "label": "ECSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38837", - "standardCode": { - "id": "Code_46124", - "extensionAttributes": [], - "code": "C117496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Start Date and Time of Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_733", - "extensionAttributes": [], - "name": "ECENDTC", - "label": "ECENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38838", - "standardCode": { - "id": "Code_46125", - "extensionAttributes": [], - "code": "C117497", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected End Date and Time of Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24603", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28721", - "extensionAttributes": [], - "code": "C117466", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Exposure as Collected Domain", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_113", - "extensionAttributes": [], - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "id": "BiomedicalConceptProperty_734", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38839", - "standardCode": { - "id": "Code_46126", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_735", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38840", - "standardCode": { - "id": "Code_46127", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_736", - "extensionAttributes": [], - "name": "Test Occurrence", - "label": "Test Occurrence", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38841", - "standardCode": { - "id": "Code_46128", - "extensionAttributes": [], - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24604", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28722", - "extensionAttributes": [], - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_114", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_99", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYACCEPTABILITY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Acceptability", - "label": "TTS Acceptability Survey - Patch Acceptability", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT4", - "properties": [ - { - "id": "BiomedicalConceptProperty_740", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38846", - "standardCode": { - "id": "Code_46133", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_741", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38847", - "standardCode": { - "id": "Code_46134", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_742", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3130", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_46136", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38848", - "standardCode": { - "id": "Code_46135", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24605", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28723", - "extensionAttributes": [], - "code": "NEW_LZZT4", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Acceptability", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_115", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_100", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYAPPEARANCE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Appearance", - "label": "TTS Acceptability Survey - Patch Appearance", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT1", - "properties": [ - { - "id": "BiomedicalConceptProperty_748", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38856", - "standardCode": { - "id": "Code_46143", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_749", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38857", - "standardCode": { - "id": "Code_46144", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_750", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3132", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_46146", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38858", - "standardCode": { - "id": "Code_46145", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24606", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28724", - "extensionAttributes": [], - "code": "NEW_LZZT1", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Appearance", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_116", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_101", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYDURABILITY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Durability", - "label": "TTS Acceptability Survey - Patch Durability", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT3", - "properties": [ - { - "id": "BiomedicalConceptProperty_777", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38886", - "standardCode": { - "id": "Code_46173", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_778", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38887", - "standardCode": { - "id": "Code_46174", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_779", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3133", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_46176", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38888", - "standardCode": { - "id": "Code_46175", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24607", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28725", - "extensionAttributes": [], - "code": "NEW_LZZT3", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Durability", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_117", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_102", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYSIZE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Size", - "label": "TTS Acceptability Survey - Patch Size", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT2", - "properties": [ - { - "id": "BiomedicalConceptProperty_780", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38890", - "standardCode": { - "id": "Code_46177", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_781", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38891", - "standardCode": { - "id": "Code_46178", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_782", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3134", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_46180", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38892", - "standardCode": { - "id": "Code_46179", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24608", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28726", - "extensionAttributes": [], - "code": "NEW_LZZT2", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Size", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_134", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "synonyms": [ - "AEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "id": "BiomedicalConceptProperty_783", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38894", - "standardCode": { - "id": "Code_46181", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_784", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38895", - "standardCode": { - "id": "Code_46182", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24609", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28727", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_135", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_103", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Solicited Adverse Event", - "label": "Solicited Adverse Event", - "synonyms": [ - "Adverse Event" - ], - "reference": "/mdr/bc/biomedicalconcepts/C179175", - "properties": [ - { - "id": "BiomedicalConceptProperty_785", - "extensionAttributes": [], - "name": "AETERM", - "label": "AETERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38896", - "standardCode": { - "id": "Code_46183", - "extensionAttributes": [], - "code": "C78541", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Verbatim Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_786", - "extensionAttributes": [], - "name": "AEDECOD", - "label": "AEDECOD", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38897", - "standardCode": { - "id": "Code_46184", - "extensionAttributes": [], - "code": "C83344", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_787", - "extensionAttributes": [], - "name": "AELOC", - "label": "AELOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38898", - "standardCode": { - "id": "Code_46185", - "extensionAttributes": [], - "code": "C83205", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Location", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_788", - "extensionAttributes": [], - "name": "AESEV", - "label": "AESEV", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38899", - "standardCode": { - "id": "Code_46186", - "extensionAttributes": [], - "code": "C53253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Severity of Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_789", - "extensionAttributes": [], - "name": "AESER", - "label": "AESER", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38900", - "standardCode": { - "id": "Code_46187", - "extensionAttributes": [], - "code": "C53252", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Seriousness of Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_790", - "extensionAttributes": [], - "name": "AEACN", - "label": "AEACN", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38901", - "standardCode": { - "id": "Code_46188", - "extensionAttributes": [], - "code": "C83013", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Action Taken with Study Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_791", - "extensionAttributes": [], - "name": "AEACNOTH", - "label": "AEACNOTH", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38902", - "standardCode": { - "id": "Code_46189", - "extensionAttributes": [], - "code": "C83109", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Other Actions taken in Response to Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_792", - "extensionAttributes": [], - "name": "AEREL", - "label": "AEREL", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38903", - "standardCode": { - "id": "Code_46190", - "extensionAttributes": [], - "code": "C41358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Attribution to Product or Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_793", - "extensionAttributes": [], - "name": "AERELNST", - "label": "AERELNST", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38904", - "standardCode": { - "id": "Code_46191", - "extensionAttributes": [], - "code": "C83210", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Relationship to Non Study Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_794", - "extensionAttributes": [], - "name": "AEPATT", - "label": "AEPATT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38905", - "standardCode": { - "id": "Code_46192", - "extensionAttributes": [], - "code": "C83208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Pattern", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_795", - "extensionAttributes": [], - "name": "AEOUT", - "label": "AEOUT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38906", - "standardCode": { - "id": "Code_46193", - "extensionAttributes": [], - "code": "C49489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Outcome", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_796", - "extensionAttributes": [], - "name": "AESCAN", - "label": "AESCAN", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38907", - "standardCode": { - "id": "Code_46194", - "extensionAttributes": [], - "code": "C83211", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Involves Cancer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_797", - "extensionAttributes": [], - "name": "AESCONG", - "label": "AESCONG", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38908", - "standardCode": { - "id": "Code_46195", - "extensionAttributes": [], - "code": "C83117", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_798", - "extensionAttributes": [], - "name": "AESDISAB", - "label": "AESDISAB", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38909", - "standardCode": { - "id": "Code_46196", - "extensionAttributes": [], - "code": "C113380", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Disabling Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_799", - "extensionAttributes": [], - "name": "AESDTH", - "label": "AESDTH", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38910", - "standardCode": { - "id": "Code_46197", - "extensionAttributes": [], - "code": "C48275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Death Related to Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_800", - "extensionAttributes": [], - "name": "AESHOSP", - "label": "AESHOSP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38911", - "standardCode": { - "id": "Code_46198", - "extensionAttributes": [], - "code": "C83052", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event associated with Hospitalization", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_801", - "extensionAttributes": [], - "name": "AESLIFE", - "label": "AESLIFE", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38912", - "standardCode": { - "id": "Code_46199", - "extensionAttributes": [], - "code": "C84266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Life Threatening Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_802", - "extensionAttributes": [], - "name": "AESOD", - "label": "AESOD", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38913", - "standardCode": { - "id": "Code_46200", - "extensionAttributes": [], - "code": "C83214", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Occurred with Overdose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_803", - "extensionAttributes": [], - "name": "AESMIE", - "label": "AESMIE", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38914", - "standardCode": { - "id": "Code_46201", - "extensionAttributes": [], - "code": "C83053", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Associated with Serious Medical Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_804", - "extensionAttributes": [], - "name": "AECONTRT", - "label": "AECONTRT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38915", - "standardCode": { - "id": "Code_46202", - "extensionAttributes": [], - "code": "C83199", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Concomitant Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_805", - "extensionAttributes": [], - "name": "AETOXGR", - "label": "AETOXGR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38916", - "standardCode": { - "id": "Code_46203", - "extensionAttributes": [], - "code": "C78605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Toxicity Grade", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_806", - "extensionAttributes": [], - "name": "AESTDTC", - "label": "AESTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38917", - "standardCode": { - "id": "Code_46204", - "extensionAttributes": [], - "code": "C83215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_807", - "extensionAttributes": [], - "name": "AEENDTC", - "label": "AEENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38918", - "standardCode": { - "id": "Code_46205", - "extensionAttributes": [], - "code": "C83201", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_808", - "extensionAttributes": [], - "name": "AEENRF", - "label": "AEENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38919", - "standardCode": { - "id": "Code_46206", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_809", - "extensionAttributes": [], - "name": "AEENRTPT", - "label": "AEENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38920", - "standardCode": { - "id": "Code_46207", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_810", - "extensionAttributes": [], - "name": "AEENTPT", - "label": "AEENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38921", - "standardCode": { - "id": "Code_46208", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24610", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28728", - "extensionAttributes": [], - "code": "C179175", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Adverse Event", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_136", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_104", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTCOMP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Complete", - "label": "Complete", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C25250", - "properties": [], - "code": { - "id": "AliasCode_24611", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28729", - "extensionAttributes": [], - "code": "C25250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Complete [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_137", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_105", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/FAILCONT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Failure To Meet Continuation Criteria", - "label": "Failure To Meet Continuation Criteria", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C139236", - "properties": [], - "code": { - "id": "AliasCode_24612", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28730", - "extensionAttributes": [], - "code": "C139236", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Failure To Meet Continuation Criteria [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_138", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_106", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DEAD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Dead", - "label": "Dead", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C28554", - "properties": [], - "code": { - "id": "AliasCode_24613", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28731", - "extensionAttributes": [], - "code": "C28554", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Dead [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_139", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_107", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/LACKEFFICACY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Lack of Efficacy", - "label": "Lack of Efficacy", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C48226", - "properties": [], - "code": { - "id": "AliasCode_24614", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28732", - "extensionAttributes": [], - "code": "C48226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lack of Efficacy [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_140", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_108", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/LTFUP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Lost To Follow-Up", - "label": "Lost To Follow-Up", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C48227", - "properties": [], - "code": { - "id": "AliasCode_24615", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28733", - "extensionAttributes": [], - "code": "C48227", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lost To Follow-Up [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_141", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_109", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "code": { - "id": "AliasCode_24616", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28734", - "extensionAttributes": [], - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_142", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_110", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHYDECISION", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Physician Decision", - "label": "Physician Decision", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C48250", - "properties": [], - "code": { - "id": "AliasCode_24617", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28735", - "extensionAttributes": [], - "code": "C48250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Physician Decision [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_143", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_111", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SUBJPREG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Pregnant Subject", - "label": "Pregnant Subject", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C191656", - "properties": [], - "code": { - "id": "AliasCode_24618", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28736", - "extensionAttributes": [], - "code": "C191656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Pregnant Subject [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_144", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_112", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROGDISEASE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Progressive Disease", - "label": "Progressive Disease", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C35571", - "properties": [], - "code": { - "id": "AliasCode_24619", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28737", - "extensionAttributes": [], - "code": "C35571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Progressive Disease [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_145", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_113", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTDEV", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Protocol Deviation", - "label": "Protocol Deviation", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C50996", - "properties": [], - "code": { - "id": "AliasCode_1747", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1937", - "extensionAttributes": [], - "code": "C50996", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Protocol Deviation", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_146", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_114", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SITETRANSFER", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Study Site Transfer", - "label": "Study Site Transfer", - "synonyms": [ - "Site Transfer", - "Study Subject Site Transfer" - ], - "reference": "/mdr/bc/biomedicalconcepts/C186208", - "properties": [ - { - "id": "BiomedicalConceptProperty_811", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3135", - "instanceType": "ResponseCode", - "name": "SITE TRANSFER", - "label": "SITE TRANSFER", - "isEnabled": true, - "code": { - "id": "Code_46210", - "extensionAttributes": [], - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SITE TRANSFER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38922", - "standardCode": { - "id": "Code_46209", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_812", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38924", - "standardCode": { - "id": "Code_46211", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_813", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38925", - "standardCode": { - "id": "Code_46212", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1753", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1943", - "extensionAttributes": [], - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Site Transfer", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_147", - "extensionAttributes": [], - "name": "Study Terminated By Sponsor", - "label": "Study Terminated By Sponsor", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C49632", - "properties": [], - "code": { - "id": "AliasCode_1758", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1948", - "extensionAttributes": [], - "code": "C49632", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Terminated By Sponsor", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_148", - "extensionAttributes": [], - "name": "Subject Removed at Sponsor Request", - "label": "Subject Removed at Sponsor Request", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C161410", - "properties": [], - "code": { - "id": "AliasCode_29205", - "extensionAttributes": [], - "standardCode": { - "id": "Code_33323", - "extensionAttributes": [], - "code": "C161410", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Subject Removed at Sponsor Request [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_149", - "extensionAttributes": [], - "name": "Trial Screen Failure", - "label": "Trial Screen Failure", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C49628", - "properties": [], - "code": { - "id": "AliasCode_1760", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1950", - "extensionAttributes": [], - "code": "C49628", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Screen Failure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_150", - "extensionAttributes": [], - "name": "Trial Site Terminated by Sponsor", - "label": "Trial Site Terminated by Sponsor", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C106576", - "properties": [], - "code": { - "id": "AliasCode_1761", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1951", - "extensionAttributes": [], - "code": "C106576", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Site Terminated by Sponsor", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_151", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_115", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SUBJWITHDRAW", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Withdrawal by Subject", - "label": "Withdrawal by Subject", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C49634", - "properties": [], - "code": { - "id": "AliasCode_1762", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1952", - "extensionAttributes": [], - "code": "C49634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Withdrawal by Subject", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_152", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_116", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSWDRL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Withdrawal of Consent From Protocol-Specified Activity", - "label": "Withdrawal of Consent From Protocol-Specified Activity", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C170610", - "properties": [ - { - "id": "BiomedicalConceptProperty_823", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3138", - "instanceType": "ResponseCode", - "name": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "label": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "isEnabled": true, - "code": { - "id": "Code_46225", - "extensionAttributes": [], - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38937", - "standardCode": { - "id": "Code_46224", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_824", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38939", - "standardCode": { - "id": "Code_46226", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_825", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38940", - "standardCode": { - "id": "Code_46227", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_38009", - "extensionAttributes": [], - "standardCode": { - "id": "Code_45296", - "extensionAttributes": [], - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Withdrawal of Consent From Protocol-Specified Activity", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_153", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_117", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "synonyms": [ - "SYSBP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "id": "BiomedicalConceptProperty_832", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38948", - "standardCode": { - "id": "Code_46235", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_833", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3140", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_46237", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38949", - "standardCode": { - "id": "Code_46236", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_834", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38951", - "standardCode": { - "id": "Code_46238", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_835", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38952", - "standardCode": { - "id": "Code_46239", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_836", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38953", - "standardCode": { - "id": "Code_46240", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_837", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38954", - "standardCode": { - "id": "Code_46241", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1834", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2024", - "extensionAttributes": [], - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_154", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_118", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "synonyms": [ - "DIABP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "id": "BiomedicalConceptProperty_862", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38983", - "standardCode": { - "id": "Code_46270", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_863", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3145", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_46272", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38984", - "standardCode": { - "id": "Code_46271", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_864", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38986", - "standardCode": { - "id": "Code_46273", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_865", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38987", - "standardCode": { - "id": "Code_46274", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_866", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38988", - "standardCode": { - "id": "Code_46275", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_867", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38989", - "standardCode": { - "id": "Code_46276", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_26219", - "extensionAttributes": [], - "standardCode": { - "id": "Code_30337", - "extensionAttributes": [], - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_155", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_119", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Heart Rate", - "label": "Heart Rate", - "synonyms": [ - "HR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "id": "BiomedicalConceptProperty_880", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39002", - "standardCode": { - "id": "Code_46289", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_881", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3146", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_46291", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39003", - "standardCode": { - "id": "Code_46290", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_882", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39005", - "standardCode": { - "id": "Code_46292", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_883", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39006", - "standardCode": { - "id": "Code_46293", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_884", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39007", - "standardCode": { - "id": "Code_46294", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_885", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39008", - "standardCode": { - "id": "Code_46295", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1833", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2023", - "extensionAttributes": [], - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_156", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_120", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "synonyms": [ - "SYSBP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "id": "BiomedicalConceptProperty_886", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39009", - "standardCode": { - "id": "Code_46296", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_887", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3147", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_46298", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39010", - "standardCode": { - "id": "Code_46297", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_888", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39012", - "standardCode": { - "id": "Code_46299", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_889", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39013", - "standardCode": { - "id": "Code_46300", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_890", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39014", - "standardCode": { - "id": "Code_46301", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_891", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39015", - "standardCode": { - "id": "Code_46302", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1834", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2024", - "extensionAttributes": [], - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_157", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_121", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "synonyms": [ - "DIABP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "id": "BiomedicalConceptProperty_892", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39016", - "standardCode": { - "id": "Code_46303", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_893", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3148", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_46305", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39017", - "standardCode": { - "id": "Code_46304", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_894", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39019", - "standardCode": { - "id": "Code_46306", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_895", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39020", - "standardCode": { - "id": "Code_46307", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_896", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39021", - "standardCode": { - "id": "Code_46308", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_897", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39022", - "standardCode": { - "id": "Code_46309", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_26219", - "extensionAttributes": [], - "standardCode": { - "id": "Code_30337", - "extensionAttributes": [], - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_158", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_122", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Heart Rate", - "label": "Heart Rate", - "synonyms": [ - "HR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "id": "BiomedicalConceptProperty_898", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39023", - "standardCode": { - "id": "Code_46310", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_899", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3149", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_46312", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39024", - "standardCode": { - "id": "Code_46311", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_900", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39026", - "standardCode": { - "id": "Code_46313", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_901", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39027", - "standardCode": { - "id": "Code_46314", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_902", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39028", - "standardCode": { - "id": "Code_46315", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_903", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39029", - "standardCode": { - "id": "Code_46316", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1833", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2023", - "extensionAttributes": [], - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_159", - "extensionAttributes": [], - "name": "Isometric Muscle Strength", - "label": "Isometric Muscle Strength", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C138967", - "properties": [], - "code": { - "id": "AliasCode_2312", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2502", - "extensionAttributes": [], - "code": "C138967", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Isometric Muscle Strength", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_160", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_129", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SMMASS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Skeletal Muscle Mass Measurement", - "label": "Skeletal Muscle Mass Measurement", - "synonyms": [ - "SMMASS", - "Skeletal Muscle Mass" - ], - "reference": "/mdr/bc/biomedicalconcepts/C178017", - "properties": [ - { - "id": "BiomedicalConceptProperty_920", - "extensionAttributes": [], - "name": "MKORRES", - "label": "MKORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_39050", - "standardCode": { - "id": "Code_46337", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_921", - "extensionAttributes": [], - "name": "MKORRESU", - "label": "MKORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39051", - "standardCode": { - "id": "Code_46338", - "extensionAttributes": [], - "code": "C42579", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_922", - "extensionAttributes": [], - "name": "MKLOC", - "label": "MKLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39052", - "standardCode": { - "id": "Code_46339", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_923", - "extensionAttributes": [], - "name": "MKLAT", - "label": "MKLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39053", - "standardCode": { - "id": "Code_46340", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_924", - "extensionAttributes": [], - "name": "MKMETHOD", - "label": "MKMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39054", - "standardCode": { - "id": "Code_46341", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_925", - "extensionAttributes": [], - "name": "MKDTC", - "label": "MKDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39055", - "standardCode": { - "id": "Code_46342", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2313", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2503", - "extensionAttributes": [], - "code": "C178017", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Skeletal Muscle Mass Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_161", - "extensionAttributes": [], - "name": "Muscle Endurance Measurement", - "label": "Muscle Endurance Measurement", - "synonyms": [ - "ENDURM", - "Muscle Endurance" - ], - "reference": "/mdr/bc/biomedicalconcepts/C181501", - "properties": [ - { - "id": "BiomedicalConceptProperty_933", - "extensionAttributes": [], - "name": "Observation Result", - "label": "Observation Result", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_39064", - "standardCode": { - "id": "Code_46351", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_934", - "extensionAttributes": [], - "name": "Unit of Time", - "label": "Unit of Time", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39065", - "standardCode": { - "id": "Code_46352", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_935", - "extensionAttributes": [], - "name": "Anatomic Site", - "label": "Anatomic Site", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39066", - "standardCode": { - "id": "Code_46353", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_936", - "extensionAttributes": [], - "name": "Laterality", - "label": "Laterality", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39067", - "standardCode": { - "id": "Code_46354", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_937", - "extensionAttributes": [], - "name": "Test Method", - "label": "Test Method", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39068", - "standardCode": { - "id": "Code_46355", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_938", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39069", - "standardCode": { - "id": "Code_46356", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24620", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28738", - "extensionAttributes": [], - "code": "C181501", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Muscle Endurance Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_162", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_139", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGCTMON", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "synonyms": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "reference": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "id": "BiomedicalConceptProperty_949", - "extensionAttributes": [], - "name": "TSPARMCD", - "label": "TSPARMCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3155", - "instanceType": "ResponseCode", - "name": "EGCTMON", - "label": "EGCTMON", - "isEnabled": true, - "code": { - "id": "Code_46368", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "EGCTMON", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39080", - "standardCode": { - "id": "Code_46367", - "extensionAttributes": [], - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_950", - "extensionAttributes": [], - "name": "TSPARM", - "label": "TSPARM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3156", - "instanceType": "ResponseCode", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "isEnabled": true, - "code": { - "id": "Code_46370", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39082", - "standardCode": { - "id": "Code_46369", - "extensionAttributes": [], - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_951", - "extensionAttributes": [], - "name": "TSVAL", - "label": "TSVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_39084", - "standardCode": { - "id": "Code_46371", - "extensionAttributes": [], - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_952", - "extensionAttributes": [], - "name": "TSVALCD", - "label": "TSVALCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39085", - "standardCode": { - "id": "Code_46372", - "extensionAttributes": [], - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_953", - "extensionAttributes": [], - "name": "TSVCDREF", - "label": "TSVCDREF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39086", - "standardCode": { - "id": "Code_46373", - "extensionAttributes": [], - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_954", - "extensionAttributes": [], - "name": "TSVCDVER", - "label": "TSVCDVER", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39087", - "standardCode": { - "id": "Code_46374", - "extensionAttributes": [], - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2311", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2501", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_164", - "extensionAttributes": [], - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "id": "BiomedicalConceptProperty_955", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39088", - "standardCode": { - "id": "Code_46375", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_956", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39089", - "standardCode": { - "id": "Code_46376", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_957", - "extensionAttributes": [], - "name": "Test Occurrence", - "label": "Test Occurrence", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39090", - "standardCode": { - "id": "Code_46377", - "extensionAttributes": [], - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24604", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28722", - "extensionAttributes": [], - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_165", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_141", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MRIBRAIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "synonyms": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "id": "BiomedicalConceptProperty_974", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39107", - "standardCode": { - "id": "Code_46394", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_975", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3157", - "instanceType": "ResponseCode", - "name": "MRI", - "label": "MRI", - "isEnabled": true, - "code": { - "id": "Code_46396", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39108", - "standardCode": { - "id": "Code_46395", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_976", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39110", - "standardCode": { - "id": "Code_46397", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_977", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39111", - "standardCode": { - "id": "Code_46398", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_978", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3158", - "instanceType": "ResponseCode", - "name": "BRAIN", - "label": "BRAIN", - "isEnabled": true, - "code": { - "id": "Code_46400", - "extensionAttributes": [], - "code": "C12439", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "BRAIN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39112", - "standardCode": { - "id": "Code_46399", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_979", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39114", - "standardCode": { - "id": "Code_46401", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_980", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39115", - "standardCode": { - "id": "Code_46402", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_15783", - "extensionAttributes": [], - "standardCode": { - "id": "Code_16598", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_166", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_142", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CTSCAN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Computed Tomography", - "label": "Computed Tomography", - "synonyms": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "id": "BiomedicalConceptProperty_997", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39132", - "standardCode": { - "id": "Code_46419", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_998", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3159", - "instanceType": "ResponseCode", - "name": "CT SCAN", - "label": "CT SCAN", - "isEnabled": true, - "code": { - "id": "Code_46421", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39133", - "standardCode": { - "id": "Code_46420", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_999", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39135", - "standardCode": { - "id": "Code_46422", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1000", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39136", - "standardCode": { - "id": "Code_46423", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1001", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39137", - "standardCode": { - "id": "Code_46424", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1002", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39138", - "standardCode": { - "id": "Code_46425", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1003", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39139", - "standardCode": { - "id": "Code_46426", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_28017", - "extensionAttributes": [], - "standardCode": { - "id": "Code_32135", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_168", - "extensionAttributes": [], - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "synonyms": [ - "Vital Signs", - "VS" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "code": { - "id": "AliasCode_24621", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28739", - "extensionAttributes": [], - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_169", - "extensionAttributes": [], - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "synonyms": [ - "Vital Signs", - "VS" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "code": { - "id": "AliasCode_24621", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28739", - "extensionAttributes": [], - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_170", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_143", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "code": { - "id": "AliasCode_24616", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28734", - "extensionAttributes": [], - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_171", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "synonyms": [ - "AEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "id": "BiomedicalConceptProperty_1012", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39148", - "standardCode": { - "id": "Code_46435", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1013", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39149", - "standardCode": { - "id": "Code_46436", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24609", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28727", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_172", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Word Recall Average Score", - "label": "CDISC ADAS-Cog - Word Recall Average Score", - "synonyms": [ - "ADCRL", - "Word Recall", - "CDISC ADAS-Cog - Word Recall Average Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100177", - "properties": [ - { - "id": "BiomedicalConceptProperty_1022", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39158", - "standardCode": { - "id": "Code_46445", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1023", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_39159", - "standardCode": { - "id": "Code_46446", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1024", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39160", - "standardCode": { - "id": "Code_46447", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1025", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39161", - "standardCode": { - "id": "Code_46448", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1026", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39162", - "standardCode": { - "id": "Code_46449", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1027", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_39163", - "standardCode": { - "id": "Code_46450", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1028", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39164", - "standardCode": { - "id": "Code_46451", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1029", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39165", - "standardCode": { - "id": "Code_46452", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24622", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28740", - "extensionAttributes": [], - "code": "C100177", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recall Average Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_173", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "label": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "synonyms": [ - "ADCOF", - "Naming Objects and Fingers", - "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100191", - "properties": [ - { - "id": "BiomedicalConceptProperty_1030", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39166", - "standardCode": { - "id": "Code_46453", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1031", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39167", - "standardCode": { - "id": "Code_46454", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1032", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39168", - "standardCode": { - "id": "Code_46455", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1033", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39169", - "standardCode": { - "id": "Code_46456", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1034", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39170", - "standardCode": { - "id": "Code_46457", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1035", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39171", - "standardCode": { - "id": "Code_46458", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1036", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39172", - "standardCode": { - "id": "Code_46459", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1037", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39173", - "standardCode": { - "id": "Code_46460", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27242", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31360", - "extensionAttributes": [], - "code": "C100191", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_174", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Commands Summary Score", - "label": "CDISC ADAS-Cog - Commands Summary Score", - "synonyms": [ - "ADCCMD", - "Commands", - "CDISC ADAS-Cog - Commands Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100209", - "properties": [ - { - "id": "BiomedicalConceptProperty_1046", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39182", - "standardCode": { - "id": "Code_46469", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1047", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39183", - "standardCode": { - "id": "Code_46470", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1048", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39184", - "standardCode": { - "id": "Code_46471", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1049", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39185", - "standardCode": { - "id": "Code_46472", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1050", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39186", - "standardCode": { - "id": "Code_46473", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1051", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39187", - "standardCode": { - "id": "Code_46474", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1052", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39188", - "standardCode": { - "id": "Code_46475", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1053", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39189", - "standardCode": { - "id": "Code_46476", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24623", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28741", - "extensionAttributes": [], - "code": "C100209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Commands Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_175", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "label": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "synonyms": [ - "ADCDRL", - "Delayed Word Recall", - "CDISC ADAS-Cog - Delayed Word Recall Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100215", - "properties": [ - { - "id": "BiomedicalConceptProperty_1062", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39198", - "standardCode": { - "id": "Code_46485", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1063", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39199", - "standardCode": { - "id": "Code_46486", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1064", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39200", - "standardCode": { - "id": "Code_46487", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1065", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39201", - "standardCode": { - "id": "Code_46488", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1066", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39202", - "standardCode": { - "id": "Code_46489", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1067", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39203", - "standardCode": { - "id": "Code_46490", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1068", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39204", - "standardCode": { - "id": "Code_46491", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1069", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39205", - "standardCode": { - "id": "Code_46492", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27243", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31361", - "extensionAttributes": [], - "code": "C100215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_176", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "label": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "synonyms": [ - "ADCCP", - "Constructional Praxis", - "CDISC ADAS-Cog - Constructional Praxis Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100226", - "properties": [ - { - "id": "BiomedicalConceptProperty_1078", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39214", - "standardCode": { - "id": "Code_46501", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1079", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39215", - "standardCode": { - "id": "Code_46502", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1080", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39216", - "standardCode": { - "id": "Code_46503", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1081", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39217", - "standardCode": { - "id": "Code_46504", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1082", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39218", - "standardCode": { - "id": "Code_46505", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1083", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39219", - "standardCode": { - "id": "Code_46506", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1084", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39220", - "standardCode": { - "id": "Code_46507", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1085", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39221", - "standardCode": { - "id": "Code_46508", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27244", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31362", - "extensionAttributes": [], - "code": "C100226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_177", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "label": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "synonyms": [ - "ADCIP", - "Ideational Praxis", - "CDISC ADAS-Cog - Ideational Praxis Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100232", - "properties": [ - { - "id": "BiomedicalConceptProperty_1094", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39230", - "standardCode": { - "id": "Code_46517", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1095", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39231", - "standardCode": { - "id": "Code_46518", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1096", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39232", - "standardCode": { - "id": "Code_46519", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1097", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39233", - "standardCode": { - "id": "Code_46520", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1098", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39234", - "standardCode": { - "id": "Code_46521", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1099", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39235", - "standardCode": { - "id": "Code_46522", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1100", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39236", - "standardCode": { - "id": "Code_46523", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1101", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39237", - "standardCode": { - "id": "Code_46524", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24624", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28742", - "extensionAttributes": [], - "code": "C100232", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_178", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Orientation Summary Score", - "label": "CDISC ADAS-Cog - Orientation Summary Score", - "synonyms": [ - "ADCOR", - "Orientation", - "CDISC ADAS-Cog - Orientation Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100238", - "properties": [ - { - "id": "BiomedicalConceptProperty_1110", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39246", - "standardCode": { - "id": "Code_46533", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1111", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39247", - "standardCode": { - "id": "Code_46534", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1112", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39248", - "standardCode": { - "id": "Code_46535", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1113", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39249", - "standardCode": { - "id": "Code_46536", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1114", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39250", - "standardCode": { - "id": "Code_46537", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1115", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39251", - "standardCode": { - "id": "Code_46538", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1116", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39252", - "standardCode": { - "id": "Code_46539", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1117", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39253", - "standardCode": { - "id": "Code_46540", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27245", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31363", - "extensionAttributes": [], - "code": "C100238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Orientation Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_179", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Word Recognition Summary Score", - "label": "CDISC ADAS-Cog - Word Recognition Summary Score", - "synonyms": [ - "ADCRG", - "Word Recognition", - "CDISC ADAS-Cog - Word Recognition Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100247", - "properties": [ - { - "id": "BiomedicalConceptProperty_1126", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_39262", - "standardCode": { - "id": "Code_46549", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1127", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39263", - "standardCode": { - "id": "Code_46550", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1128", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39264", - "standardCode": { - "id": "Code_46551", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1129", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39265", - "standardCode": { - "id": "Code_46552", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1130", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39266", - "standardCode": { - "id": "Code_46553", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1131", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39267", - "standardCode": { - "id": "Code_46554", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1132", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_39268", - "standardCode": { - "id": "Code_46555", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1133", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39269", - "standardCode": { - "id": "Code_46556", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24625", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28743", - "extensionAttributes": [], - "code": "C100247", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recognition Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_180", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Remembering Test Instructions", - "label": "CDISC ADAS-Cog - Remembering Test Instructions", - "synonyms": [ - "ADCRI", - "Remembering Test Instructions", - "CDISC ADAS-Cog - Remembering Test Instructions" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100275", - "properties": [ - { - "id": "BiomedicalConceptProperty_1142", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39278", - "standardCode": { - "id": "Code_46565", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1143", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39279", - "standardCode": { - "id": "Code_46566", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1144", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39280", - "standardCode": { - "id": "Code_46567", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1145", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39281", - "standardCode": { - "id": "Code_46568", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1146", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39282", - "standardCode": { - "id": "Code_46569", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1147", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39283", - "standardCode": { - "id": "Code_46570", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1148", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39284", - "standardCode": { - "id": "Code_46571", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1149", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39285", - "standardCode": { - "id": "Code_46572", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24626", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28744", - "extensionAttributes": [], - "code": "C100275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Remembering Test Instructions", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_181", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Spoken Language Ability", - "label": "CDISC ADAS-Cog - Spoken Language Ability", - "synonyms": [ - "ADCSL", - "Spoken Language Ability", - "CDISC ADAS-Cog - Spoken Language Ability" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100276", - "properties": [ - { - "id": "BiomedicalConceptProperty_1167", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39303", - "standardCode": { - "id": "Code_46590", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1168", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39304", - "standardCode": { - "id": "Code_46591", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1169", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39305", - "standardCode": { - "id": "Code_46592", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1170", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39306", - "standardCode": { - "id": "Code_46593", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1171", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39307", - "standardCode": { - "id": "Code_46594", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1172", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39308", - "standardCode": { - "id": "Code_46595", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1173", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39309", - "standardCode": { - "id": "Code_46596", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1174", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39310", - "standardCode": { - "id": "Code_46597", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24627", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28745", - "extensionAttributes": [], - "code": "C100276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Spoken Language Ability", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_182", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "label": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "synonyms": [ - "ADCDIF", - "Word Finding Difficulty in Spont Speech", - "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100277", - "properties": [ - { - "id": "BiomedicalConceptProperty_1181", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39319", - "standardCode": { - "id": "Code_46606", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1182", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39320", - "standardCode": { - "id": "Code_46607", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1183", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39321", - "standardCode": { - "id": "Code_46608", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1184", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39322", - "standardCode": { - "id": "Code_46609", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1185", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39323", - "standardCode": { - "id": "Code_46610", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1186", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39324", - "standardCode": { - "id": "Code_46611", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1187", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39325", - "standardCode": { - "id": "Code_46612", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1188", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39326", - "standardCode": { - "id": "Code_46613", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24628", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28746", - "extensionAttributes": [], - "code": "C100277", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_183", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Comprehension", - "label": "CDISC ADAS-Cog - Comprehension", - "synonyms": [ - "ADCCMP", - "Comprehension", - "CDISC ADAS-Cog - Comprehension" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100278", - "properties": [ - { - "id": "BiomedicalConceptProperty_1189", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39327", - "standardCode": { - "id": "Code_46614", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1190", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39328", - "standardCode": { - "id": "Code_46615", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1191", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39329", - "standardCode": { - "id": "Code_46616", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1192", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39330", - "standardCode": { - "id": "Code_46617", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1193", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39331", - "standardCode": { - "id": "Code_46618", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1194", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39332", - "standardCode": { - "id": "Code_46619", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1195", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39333", - "standardCode": { - "id": "Code_46620", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1196", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39334", - "standardCode": { - "id": "Code_46621", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24629", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28747", - "extensionAttributes": [], - "code": "C100278", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Comprehension", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_184", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Concentration/Distractibility", - "label": "CDISC ADAS-Cog - Concentration/Distractibility", - "synonyms": [ - "ADCCON", - "Concentration/Distractibility", - "CDISC ADAS-Cog - Concentration/Distractibility" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100279", - "properties": [ - { - "id": "BiomedicalConceptProperty_1197", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39335", - "standardCode": { - "id": "Code_46622", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1198", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39336", - "standardCode": { - "id": "Code_46623", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1199", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39337", - "standardCode": { - "id": "Code_46624", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1200", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39338", - "standardCode": { - "id": "Code_46625", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1201", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39339", - "standardCode": { - "id": "Code_46626", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1202", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39340", - "standardCode": { - "id": "Code_46627", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1203", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39341", - "standardCode": { - "id": "Code_46628", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1204", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39342", - "standardCode": { - "id": "Code_46629", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24630", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28748", - "extensionAttributes": [], - "code": "C100279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Concentration/Distractibility", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_185", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "label": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "synonyms": [ - "ADCNC", - "Number Cancellation", - "CDISC ADAS-Cog - Number Cancellation Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100280", - "properties": [ - { - "id": "BiomedicalConceptProperty_1205", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39343", - "standardCode": { - "id": "Code_46630", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1206", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39344", - "standardCode": { - "id": "Code_46631", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1207", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39345", - "standardCode": { - "id": "Code_46632", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1208", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39346", - "standardCode": { - "id": "Code_46633", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1209", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39347", - "standardCode": { - "id": "Code_46634", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1210", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39348", - "standardCode": { - "id": "Code_46635", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1211", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39349", - "standardCode": { - "id": "Code_46636", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1212", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39350", - "standardCode": { - "id": "Code_46637", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24631", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28749", - "extensionAttributes": [], - "code": "C100280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_186", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "label": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "synonyms": [ - "ADCMZ01", - "Executive Function Maze: Errors", - "CDISC ADAS-Cog - Executive Function Maze: Errors" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100285", - "properties": [ - { - "id": "BiomedicalConceptProperty_1213", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39351", - "standardCode": { - "id": "Code_46638", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1214", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39352", - "standardCode": { - "id": "Code_46639", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1215", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39353", - "standardCode": { - "id": "Code_46640", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1216", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39354", - "standardCode": { - "id": "Code_46641", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1217", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39355", - "standardCode": { - "id": "Code_46642", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1218", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39356", - "standardCode": { - "id": "Code_46643", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1219", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39357", - "standardCode": { - "id": "Code_46644", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1220", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39358", - "standardCode": { - "id": "Code_46645", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24632", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28750", - "extensionAttributes": [], - "code": "C100285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_187", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Executive Function Maze: Time", - "label": "CDISC ADAS-Cog - Executive Function Maze: Time", - "synonyms": [ - "ADCMZ02", - "Executive Function Maze: Time", - "CDISC ADAS-Cog - Executive Function Maze: Time" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100286", - "properties": [ - { - "id": "BiomedicalConceptProperty_1221", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39359", - "standardCode": { - "id": "Code_46646", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1222", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39360", - "standardCode": { - "id": "Code_46647", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1223", - "extensionAttributes": [], - "name": "Unit of Time", - "label": "Unit of Time", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39361", - "standardCode": { - "id": "Code_46648", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1224", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39362", - "standardCode": { - "id": "Code_46649", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1225", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39363", - "standardCode": { - "id": "Code_46650", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1226", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39364", - "standardCode": { - "id": "Code_46651", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1227", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39365", - "standardCode": { - "id": "Code_46652", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1228", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39366", - "standardCode": { - "id": "Code_46653", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1229", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39367", - "standardCode": { - "id": "Code_46654", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24633", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28751", - "extensionAttributes": [], - "code": "C100286", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_163", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_140", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGCTMON", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "synonyms": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "reference": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "id": "BiomedicalConceptProperty_1230", - "extensionAttributes": [], - "name": "TSPARMCD", - "label": "TSPARMCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3160", - "instanceType": "ResponseCode", - "name": "EGCTMON", - "label": "EGCTMON", - "isEnabled": true, - "code": { - "id": "Code_46656", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "EGCTMON", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39368", - "standardCode": { - "id": "Code_46655", - "extensionAttributes": [], - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1231", - "extensionAttributes": [], - "name": "TSPARM", - "label": "TSPARM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3161", - "instanceType": "ResponseCode", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "isEnabled": true, - "code": { - "id": "Code_46658", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39370", - "standardCode": { - "id": "Code_46657", - "extensionAttributes": [], - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1232", - "extensionAttributes": [], - "name": "TSVAL", - "label": "TSVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_39372", - "standardCode": { - "id": "Code_46659", - "extensionAttributes": [], - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1233", - "extensionAttributes": [], - "name": "TSVALCD", - "label": "TSVALCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39373", - "standardCode": { - "id": "Code_46660", - "extensionAttributes": [], - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1234", - "extensionAttributes": [], - "name": "TSVCDREF", - "label": "TSVCDREF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39374", - "standardCode": { - "id": "Code_46661", - "extensionAttributes": [], - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1235", - "extensionAttributes": [], - "name": "TSVCDVER", - "label": "TSVCDVER", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39375", - "standardCode": { - "id": "Code_46662", - "extensionAttributes": [], - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2311", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2501", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - } - ], - "bcSurrogates": [ - { - "id": "BiomedicalConceptSurrogate_9", - "extensionAttributes": [], - "name": "MHIS-NACC / MHIS01", - "label": "Modified Hachinski Ischemic Scale (C112523)", - "description": "Modified Hachinski Ischemic Scale-NACC Version Questionnaire", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112523", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_10", - "extensionAttributes": [], - "name": "MHIS0101", - "label": "Abrupt Onset (C112618)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Abrupt onset (re: cognitive status).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112618", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_11", - "extensionAttributes": [], - "name": "MHIS0102", - "label": "Stepwise Deterioration (C112619)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Stepwise deterioration (re: cognitive status).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112619", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_12", - "extensionAttributes": [], - "name": "MHIS0103", - "label": "Emotional Incontinence (C112620)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Emotional incontinence.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112620", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_13", - "extensionAttributes": [], - "name": "MHIS0104", - "label": "History or Presence of Hypertension (C112621)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - History or presence of hypertension.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112621", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_14", - "extensionAttributes": [], - "name": "MHIS0105", - "label": "History of Stroke (C112622)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - History of stroke.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112622", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_15", - "extensionAttributes": [], - "name": "MHIS0106", - "label": "Focal Neurological Symptoms (C112623)", - "description": "MHIS-NACC - Focal Neurological Symptoms", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112623", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_16", - "extensionAttributes": [], - "name": "MHIS0107", - "label": "Focal Neurological Signs (C112624)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Focal neurological signs.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112624", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_17", - "extensionAttributes": [], - "name": "MHIS0108", - "label": "Somatic Complaints (C112813)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Somatic complaints.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112813", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_18", - "extensionAttributes": [], - "name": "MHIS0109", - "label": "Total Score (C112625)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Sum all circled answers for a total score.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112625", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_19", - "extensionAttributes": [], - "name": "APOE Gene", - "label": "APOE Gene (C84468)", - "description": "This gene is involved in lipid transport and metabolism.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C84468", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_20", - "extensionAttributes": [], - "name": "Mini-Mental Status Exam", - "label": "Mini-Mental Status Exam (C74982)", - "description": "Mini-Mental State Examination (MMSE) (MMSE Copyright 1975, 1998, 2001 by MiniMental, LLC All rights reserved. Published 2001 by Psychological Assessment Resources, Inc. May not be reproduced in whole or in part in any form or by any means without written permission of Psychological Assessment Resources, Inc.).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C74982", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_21", - "extensionAttributes": [], - "name": "MMSE - Question 1", - "label": "MMSE - Question 1 (C100542)", - "description": "The Mini-Mental State Examination (MMSE) Question 1.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100542", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_22", - "extensionAttributes": [], - "name": "MMSE - Question 2", - "label": "MMSE - Question 2 (C100548)", - "description": "The Mini-Mental State Examination (MMSE) Question 2.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100548", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_23", - "extensionAttributes": [], - "name": "MMSE - Question 3", - "label": "MMSE - Question 3 (C100554)", - "description": "The Mini-Mental State Examination (MMSE) Question 3.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100554", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_24", - "extensionAttributes": [], - "name": "MMSE - Question 4", - "label": "MMSE - Question 4 (C100558)", - "description": "The Mini-Mental State Examination (MMSE) Question 4.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100558", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_25", - "extensionAttributes": [], - "name": "MMSE - Question 6", - "label": "MMSE - Question 6 (C100575)", - "description": "The Mini-Mental State Examination (MMSE) Question 6.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100575", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_26", - "extensionAttributes": [], - "name": "MMSE Functional Test Question", - "label": "MMSE Functional Test Question (C100118)", - "description": "A question associated with the MMSE functional test.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100118", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_27", - "extensionAttributes": [], - "name": "ADCS-CGIC", - "label": "ADCS-CGIC Questionnaire Question (C103490)", - "description": "A question associated with the ADCS-CGIC questionnaire.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103490", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_28", - "extensionAttributes": [], - "name": "DAD", - "label": "Disability Assessment for Dementia Questionnaire (C105165)", - "description": "Disability Assessment for Dementia (DAD) (copyright 1994 by L. Gauthier I. Gelinas. All rights reserved.).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C105165", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_29", - "extensionAttributes": [], - "name": "NPI - NPI Total Distress Score", - "label": "NPI - NPI Total Distress Score (C112482)", - "description": "Neuropsychiatric Inventory - Sub-total of distress score.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112482", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_30", - "extensionAttributes": [], - "name": "NPI - Anxiety Severity", - "label": "NPI - Anxiety Severity (C103615)", - "description": "Neuropsychiatric Inventory - Severity of the anxiety.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103615", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_31", - "extensionAttributes": [], - "name": "NPI - Disinhibition Frequency", - "label": "NPI - Disinhibition Frequency (C103623)", - "description": "Neuropsychiatric Inventory - Frequency of the disinhibition.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103623", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_32", - "extensionAttributes": [], - "name": "NPI - Disinhibition Severity", - "label": "NPI - Disinhibition Severity (C103624)", - "description": "Neuropsychiatric Inventory - Severity of the disinhibition.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103624", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_33", - "extensionAttributes": [], - "name": "NPI - Disinhibition Distress", - "label": "NPI - Disinhibition Distress (C103625)", - "description": "Neuropsychiatric Inventory - How emotionally distressing do you find this behavior?", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103625", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_34", - "extensionAttributes": [], - "name": "NPI - Disinhibition FxS Score", - "label": "NPI - Disinhibition FxS Score (C112476)", - "description": "Neuropsychiatric Inventory - Disinhibition: (frequency score x severity score).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112476", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - } - ], - "bcCategories": [], - "eligibilityCriterionItems": [], - "narrativeContentItems": [], - "abbreviations": [], - "administrableProducts": [], - "medicalDevices": [], - "productOrganizationRoles": [], - "dictionaries": [], - "conditions": [], - "notes": [], - "instanceType": "StudyVersion" - } - ], - "documentedBy": [], - "instanceType": "Study" - }, - "usdmVersion": "4.0", - "systemName": "SOA Workbench", - "systemVersion": "pi-fix-bc-props-specs-in-usdm" -} diff --git a/output/json/NCT12345678-usdm-20260716T1124.json b/output/json/NCT12345678-usdm-20260716T1124.json deleted file mode 100644 index acffcfe..0000000 --- a/output/json/NCT12345678-usdm-20260716T1124.json +++ /dev/null @@ -1,33031 +0,0 @@ -{ - "study": { - "id": "Study_3", - "extensionAttributes": [], - "name": "NCT12345678", - "description": "Patients with probable mild to moderate AD will be studied in a randomized, double-blind, parallel (3 arm), placebo-controlled trial of 26 weeks duration. The study will be conducted on an outpatient basis. Approximately 300 patients will be enrolled", - "label": "CDISC Pilot LZZT", - "versions": [ - { - "id": "StudyVersion_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_153", - "url": "http://www.cdisc.org/usdm/extensions/studyDesignSolution", - "valueExtensionClass": { - "id": "ExtensionClass_1", - "url": "http://www.cdisc.org/usdm/extensions/StudyDesignSolution", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_154", - "url": "tool-name", - "valueString": "SoA Workbench", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_155", - "url": "tool-version", - "valueString": "pi-fix-bc-props-specs-in-usdm", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_156", - "url": "usdm-creation-date", - "valueString": "20260716T11:24", - "instanceType": "ExtensionAttribute" - } - ], - "instanceType": "ExtensionClass" - }, - "instanceType": "ExtensionAttribute" - } - ], - "versionIdentifier": "1", - "rationale": "", - "studyIdentifiers": [ - { - "id": "StudyIdentifier_1", - "extensionAttributes": [], - "text": "NCT12345678", - "scopeId": "Organization_1", - "instanceType": "StudyIdentifier" - } - ], - "referenceIdentifiers": [], - "studyDesigns": [ - { - "id": "InterventionalStudyDesign_1", - "extensionAttributes": [], - "name": "H2Q-MC-LZZT", - "label": "CDISC Pilot LZZT", - "description": "Patients with probable mild to moderate AD will be studied in a randomized, double-blind, parallel (3 arm), placebo-controlled trial of 26 weeks duration. The study will be conducted on an outpatient basis. Approximately 300 patients will be enrolled", - "studyType": null, - "studyPhase": null, - "therapeuticAreas": [], - "characteristics": [], - "encounters": [ - { - "id": "Encounter_1", - "extensionAttributes": [], - "name": "SCREEN1", - "label": "Screening 1", - "description": "Screening encounter", - "type": { - "id": "Code_55", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "Encounter_2", - "scheduledAtId": "Timing_1", - "environmentalSettings": [ - { - "id": "Code_84", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_164", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_17", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_1", - "label": null, - "description": null, - "text": "Subject identifier", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_18", - "extensionAttributes": [], - "name": "ENCOUNTER_END_RULE_2", - "label": null, - "description": null, - "text": "completion of screening activities", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_2", - "extensionAttributes": [], - "name": "SCREEN2", - "label": "Screening 2", - "description": "Screening encounter - Ambulatory ECG Placement", - "type": { - "id": "Code_56", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_1", - "nextId": "Encounter_3", - "scheduledAtId": "Timing_2", - "environmentalSettings": [ - { - "id": "Code_85", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_165", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": { - "id": "TransitionRule_19", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_2", - "label": null, - "description": null, - "text": "subject leaves clinic after connection of ambulatory ECG machine", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_3", - "extensionAttributes": [], - "name": "DOSE", - "label": "Baseline", - "description": "Baseline encounter - Ambulatory ECG Removal", - "type": { - "id": "Code_57", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_2", - "nextId": "Encounter_4", - "scheduledAtId": "Timing_3", - "environmentalSettings": [ - { - "id": "Code_86", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_166", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": { - "id": "TransitionRule_20", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_3", - "label": null, - "description": null, - "text": "subject has connection of ambulatory ECG machine removed", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_21", - "extensionAttributes": [], - "name": "ENCOUNTER_END_RULE_5", - "label": null, - "description": null, - "text": "Radomized", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_4", - "extensionAttributes": [], - "name": "WEEK2", - "label": "Week 2", - "description": "Day 14", - "type": { - "id": "Code_58", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_3", - "nextId": "Encounter_5", - "scheduledAtId": "Timing_4", - "environmentalSettings": [ - { - "id": "Code_87", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_167", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_5", - "extensionAttributes": [], - "name": "WEEK4", - "label": "Week 4", - "description": "Day 28", - "type": { - "id": "Code_59", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_4", - "nextId": "Encounter_6", - "scheduledAtId": "Timing_5", - "environmentalSettings": [ - { - "id": "Code_88", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_168", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_6", - "extensionAttributes": [], - "name": "WEEK6", - "label": "Week 6", - "description": "Day 42", - "type": { - "id": "Code_60", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_5", - "nextId": "Encounter_7", - "scheduledAtId": "Timing_6", - "environmentalSettings": [ - { - "id": "Code_89", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_169", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_7", - "extensionAttributes": [], - "name": "WEEK8", - "label": "Week 8", - "description": "Day 56", - "type": { - "id": "Code_61", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_6", - "nextId": "Encounter_9", - "scheduledAtId": "Timing_7", - "environmentalSettings": [ - { - "id": "Code_90", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_170", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_9", - "extensionAttributes": [], - "name": "WEEK12", - "label": "Week 12", - "description": "Day 84", - "type": { - "id": "Code_63", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_7", - "nextId": "Encounter_11", - "scheduledAtId": "Timing_8", - "environmentalSettings": [ - { - "id": "Code_92", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_171", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_11", - "extensionAttributes": [], - "name": "WEEK16", - "label": "Week 16", - "description": "Day 112", - "type": { - "id": "Code_65", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_9", - "nextId": "Encounter_13", - "scheduledAtId": "Timing_9", - "environmentalSettings": [ - { - "id": "Code_94", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_172", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_13", - "extensionAttributes": [], - "name": "WEEK20", - "label": "Week 20", - "description": "Day 140", - "type": { - "id": "Code_67", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_11", - "nextId": "Encounter_15", - "scheduledAtId": "Timing_10", - "environmentalSettings": [ - { - "id": "Code_96", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_173", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_15", - "extensionAttributes": [], - "name": "WEEK24", - "label": "Week 24", - "description": "Day 168", - "type": { - "id": "Code_69", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_13", - "nextId": "Encounter_16", - "scheduledAtId": "Timing_11", - "environmentalSettings": [ - { - "id": "Code_98", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_174", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": null, - "notes": [], - "instanceType": "Encounter" - }, - { - "id": "Encounter_16", - "extensionAttributes": [], - "name": "WEEK26", - "label": "Week 26", - "description": "Day 182", - "type": { - "id": "Code_70", - "extensionAttributes": [], - "code": "C25716", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Visit", - "instanceType": "Code" - }, - "previousId": "Encounter_15", - "nextId": null, - "scheduledAtId": "Timing_12", - "environmentalSettings": [ - { - "id": "Code_99", - "extensionAttributes": [], - "code": "C211570", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "CLINIC", - "instanceType": "Code" - } - ], - "contactModes": [ - { - "id": "Code_175", - "extensionAttributes": [], - "code": "C175574", - "codeSystem": "/mdr/ct/packages/sdtmct-2025-09-26", - "codeSystemVersion": "2025-09-26", - "decode": "IN PERSON", - "instanceType": "Code" - } - ], - "transitionStartRule": null, - "transitionEndRule": { - "id": "TransitionRule_22", - "extensionAttributes": [], - "name": "ENCOUNTER_START_RULE_12", - "label": null, - "description": null, - "text": "End of treatment", - "instanceType": "TransitionRule" - }, - "notes": [], - "instanceType": "Encounter" - } - ], - "activities": [ - { - "id": "Activity_1", - "extensionAttributes": [], - "name": "Informed Consent", - "label": "Informed Consent", - "description": "Informed consent activity", - "previousId": null, - "nextId": "Activity_2", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_1" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_2", - "extensionAttributes": [], - "name": "Inclusion/Exclusion Criteria", - "label": "Inclusion/Exclusion Criteria", - "description": "Inclusion/Exclusion Criteria activity", - "previousId": "Activity_1", - "nextId": "Activity_3", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_2", - "BiomedicalConcept_3", - "BiomedicalConcept_4" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_3", - "extensionAttributes": [], - "name": "Patient number assigned", - "label": "Patient Number assigned", - "description": "Patient Number assigned activity", - "previousId": "Activity_2", - "nextId": "Activity_4", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_5" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_4", - "extensionAttributes": [], - "name": "Demographics", - "label": "Demographics", - "description": "Demographics activity", - "previousId": "Activity_3", - "nextId": "Activity_5", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_6", - "BiomedicalConcept_7", - "BiomedicalConcept_8", - "BiomedicalConcept_9", - "BiomedicalConcept_10" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_5", - "extensionAttributes": [], - "name": "Education", - "label": "Education", - "description": "Education activity", - "previousId": "Activity_4", - "nextId": "Activity_6", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_11", - "BiomedicalConcept_12" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_6", - "extensionAttributes": [], - "name": "Hachinski", - "label": "Hachinski", - "description": "Hachinski test", - "previousId": "Activity_5", - "nextId": "Activity_7", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_10", - "BiomedicalConceptSurrogate_11", - "BiomedicalConceptSurrogate_12", - "BiomedicalConceptSurrogate_13", - "BiomedicalConceptSurrogate_14", - "BiomedicalConceptSurrogate_15", - "BiomedicalConceptSurrogate_16", - "BiomedicalConceptSurrogate_17", - "BiomedicalConceptSurrogate_18", - "BiomedicalConceptSurrogate_9" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_7", - "extensionAttributes": [], - "name": "MMSE", - "label": "MMSE", - "description": "MMSE test", - "previousId": "Activity_6", - "nextId": "Activity_8", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_20", - "BiomedicalConceptSurrogate_21", - "BiomedicalConceptSurrogate_22", - "BiomedicalConceptSurrogate_23", - "BiomedicalConceptSurrogate_24", - "BiomedicalConceptSurrogate_25", - "BiomedicalConceptSurrogate_26" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_8", - "extensionAttributes": [], - "name": "Physical examination", - "label": "Physical examination", - "description": "Physical examination results", - "previousId": "Activity_7", - "nextId": "Activity_9", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_159", - "BiomedicalConcept_160", - "BiomedicalConcept_161" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_9", - "extensionAttributes": [], - "name": "Medical History", - "label": "Medical History", - "description": "Medical History response", - "previousId": "Activity_8", - "nextId": "Activity_10", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_14" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_10", - "extensionAttributes": [], - "name": "Habits", - "label": "Habits", - "description": "List of habits", - "previousId": "Activity_9", - "nextId": "Activity_11", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_15", - "BiomedicalConcept_16", - "BiomedicalConcept_17" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_11", - "extensionAttributes": [], - "name": "Chest X-ray", - "label": "Chest X-ray", - "description": "Chest X-ray result", - "previousId": "Activity_10", - "nextId": "Activity_12", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_18" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_12", - "extensionAttributes": [], - "name": "Apo E genotyping", - "label": "Apo E genotyping", - "description": "Apo E genotyping test", - "previousId": "Activity_11", - "nextId": "Activity_13", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_19" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_13", - "extensionAttributes": [], - "name": "Patient randomised", - "label": "Patient randomized", - "description": "Patient randomized activity", - "previousId": "Activity_12", - "nextId": "Activity_14", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_19" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_14", - "extensionAttributes": [], - "name": "Vital Signs", - "label": "Vital Signs", - "description": "Vital Signs result", - "previousId": "Activity_13", - "nextId": "Activity_15", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_20", - "BiomedicalConcept_21", - "BiomedicalConcept_22", - "BiomedicalConcept_23", - "BiomedicalConcept_24", - "BiomedicalConcept_25", - "BiomedicalConcept_26" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_15", - "extensionAttributes": [], - "name": "Ambulatory ECG placed", - "label": "Ambulatory ECG placed", - "description": "Ambulatory ECG placed activity", - "previousId": "Activity_14", - "nextId": "Activity_16", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_162" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_16", - "extensionAttributes": [], - "name": "Ambulatory ECG removed", - "label": "Ambulatory ECG removed", - "description": "Ambulatory ECG removed activity", - "previousId": "Activity_15", - "nextId": "Activity_17", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_163" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_17", - "extensionAttributes": [], - "name": "ECG", - "label": "ECG", - "description": "ECG results", - "previousId": "Activity_16", - "nextId": "Activity_18", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_27", - "BiomedicalConcept_28", - "BiomedicalConcept_29", - "BiomedicalConcept_30", - "BiomedicalConcept_31", - "BiomedicalConcept_32", - "BiomedicalConcept_33", - "BiomedicalConcept_34", - "BiomedicalConcept_35", - "BiomedicalConcept_36", - "BiomedicalConcept_37", - "BiomedicalConcept_38", - "BiomedicalConcept_39", - "BiomedicalConcept_40", - "BiomedicalConcept_41", - "BiomedicalConcept_42", - "BiomedicalConcept_43", - "BiomedicalConcept_44", - "BiomedicalConcept_45", - "BiomedicalConcept_46", - "BiomedicalConcept_47", - "BiomedicalConcept_48", - "BiomedicalConcept_49", - "BiomedicalConcept_50" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_18", - "extensionAttributes": [], - "name": "Placebo TTS Test", - "label": "Placebo TTS Test", - "description": "Placebo TTS Test results", - "previousId": "Activity_17", - "nextId": "Activity_19", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_164" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_19", - "extensionAttributes": [], - "name": "CT Scan", - "label": "CT Scan", - "description": "CT Scan results", - "previousId": "Activity_18", - "nextId": "Activity_20", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_51" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_20", - "extensionAttributes": [], - "name": "MRI", - "label": "MRI", - "description": "MRI results", - "previousId": "Activity_19", - "nextId": "Activity_21", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_52" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_21", - "extensionAttributes": [], - "name": "MRI, CT Scan", - "label": "MRI, CT Scan", - "description": "MRI, CT Scan results", - "previousId": "Activity_20", - "nextId": "Activity_22", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_165", - "BiomedicalConcept_166" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_22", - "extensionAttributes": [], - "name": "Concomitant medications", - "label": "Concomitant medications", - "description": "Concomitant medications information", - "previousId": "Activity_21", - "nextId": "Activity_23", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_54", - "BiomedicalConcept_55" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_23", - "extensionAttributes": [], - "name": "Hematology", - "label": "Hematology", - "description": "Hematology results", - "previousId": "Activity_22", - "nextId": "Activity_24", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_56", - "BiomedicalConcept_57", - "BiomedicalConcept_58", - "BiomedicalConcept_59", - "BiomedicalConcept_60", - "BiomedicalConcept_61", - "BiomedicalConcept_62", - "BiomedicalConcept_63", - "BiomedicalConcept_64", - "BiomedicalConcept_65", - "BiomedicalConcept_66", - "BiomedicalConcept_67", - "BiomedicalConcept_68", - "BiomedicalConcept_69", - "BiomedicalConcept_70", - "BiomedicalConcept_71", - "BiomedicalConcept_72", - "BiomedicalConcept_73" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_24", - "extensionAttributes": [], - "name": "Chemistry", - "label": "Chemistry", - "description": "Chemistry test results", - "previousId": "Activity_23", - "nextId": "Activity_25", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_74", - "BiomedicalConcept_75", - "BiomedicalConcept_76", - "BiomedicalConcept_77", - "BiomedicalConcept_78", - "BiomedicalConcept_79", - "BiomedicalConcept_80", - "BiomedicalConcept_81", - "BiomedicalConcept_82", - "BiomedicalConcept_83", - "BiomedicalConcept_84", - "BiomedicalConcept_85", - "BiomedicalConcept_86", - "BiomedicalConcept_87", - "BiomedicalConcept_88", - "BiomedicalConcept_89", - "BiomedicalConcept_90", - "BiomedicalConcept_91", - "BiomedicalConcept_92", - "BiomedicalConcept_93", - "BiomedicalConcept_94", - "BiomedicalConcept_95", - "BiomedicalConcept_96", - "BiomedicalConcept_97", - "BiomedicalConcept_98", - "BiomedicalConcept_99", - "BiomedicalConcept_100" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_25", - "extensionAttributes": [], - "name": "Urinalysis", - "label": "Urinalysis", - "description": "Urinalysis results", - "previousId": "Activity_24", - "nextId": "Activity_26", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_101", - "BiomedicalConcept_102", - "BiomedicalConcept_103", - "BiomedicalConcept_104", - "BiomedicalConcept_105", - "BiomedicalConcept_106", - "BiomedicalConcept_107", - "BiomedicalConcept_108", - "BiomedicalConcept_109" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_26", - "extensionAttributes": [], - "name": "Plasma Specimen (Xanomeline)", - "label": "Plasma Specimen (Xanomeline)", - "description": "Plasma Specimen (Xanomeline) results", - "previousId": "Activity_25", - "nextId": "Activity_27", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_27", - "extensionAttributes": [], - "name": "Hemoglobin A1C", - "label": "Hemoglobin A1C", - "description": "Hemoglobin A1C results", - "previousId": "Activity_26", - "nextId": "Activity_28", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_110", - "BiomedicalConcept_111" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_28", - "extensionAttributes": [], - "name": "Study Drug", - "label": "Study Drug", - "description": "Study Drug activity", - "previousId": "Activity_27", - "nextId": "Activity_29", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_112" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_29", - "extensionAttributes": [], - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "description": "TTS Acceptability Survey results", - "previousId": "Activity_28", - "nextId": "Activity_30", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_113", - "BiomedicalConcept_114", - "BiomedicalConcept_115", - "BiomedicalConcept_116", - "BiomedicalConcept_117" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_30", - "extensionAttributes": [], - "name": "ADAS-Cog", - "label": "ADAS-Cog", - "description": "ADAS-Cog results", - "previousId": "Activity_29", - "nextId": "Activity_31", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_172", - "BiomedicalConcept_173", - "BiomedicalConcept_174", - "BiomedicalConcept_175", - "BiomedicalConcept_176", - "BiomedicalConcept_177", - "BiomedicalConcept_178", - "BiomedicalConcept_179", - "BiomedicalConcept_180", - "BiomedicalConcept_181", - "BiomedicalConcept_182", - "BiomedicalConcept_183", - "BiomedicalConcept_184", - "BiomedicalConcept_185", - "BiomedicalConcept_186", - "BiomedicalConcept_187" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_31", - "extensionAttributes": [], - "name": "CIBIC+", - "label": "CIBIC+", - "description": "CIBIC+ results", - "previousId": "Activity_30", - "nextId": "Activity_32", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_27" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_32", - "extensionAttributes": [], - "name": "DAD", - "label": "DAD", - "description": "DAD results", - "previousId": "Activity_31", - "nextId": "Activity_33", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_28" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_33", - "extensionAttributes": [], - "name": "NPI-X", - "label": "NPI-X", - "description": "NPI-X results", - "previousId": "Activity_32", - "nextId": "Activity_34", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [], - "bcCategoryIds": [], - "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_29", - "BiomedicalConceptSurrogate_30", - "BiomedicalConceptSurrogate_31", - "BiomedicalConceptSurrogate_32", - "BiomedicalConceptSurrogate_33", - "BiomedicalConceptSurrogate_34" - ], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_34", - "extensionAttributes": [], - "name": "Adverse Events", - "label": "Adverse Events", - "description": "Activities to conduct if occurence of Adverse Event", - "previousId": "Activity_33", - "nextId": "Activity_35", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_134", - "BiomedicalConcept_135" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_35", - "extensionAttributes": [], - "name": "Check Adverse Events", - "label": "Check Adverse Events", - "description": "TL: Adverse Event Timeline", - "previousId": "Activity_34", - "nextId": "Activity_36", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_170", - "BiomedicalConcept_171" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_36", - "extensionAttributes": [], - "name": "Patient Summary", - "label": "Patient Summary", - "description": "Patient Summary (Study Conclusion)", - "previousId": "Activity_35", - "nextId": "Activity_37", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_136", - "BiomedicalConcept_137", - "BiomedicalConcept_138", - "BiomedicalConcept_139", - "BiomedicalConcept_140", - "BiomedicalConcept_141", - "BiomedicalConcept_142", - "BiomedicalConcept_143", - "BiomedicalConcept_144", - "BiomedicalConcept_145", - "BiomedicalConcept_146", - "BiomedicalConcept_147", - "BiomedicalConcept_148", - "BiomedicalConcept_149", - "BiomedicalConcept_150", - "BiomedicalConcept_151", - "BiomedicalConcept_152" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_37", - "extensionAttributes": [], - "name": "Supine", - "label": "Supine", - "description": "Supine", - "previousId": "Activity_36", - "nextId": "Activity_38", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_168" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_38", - "extensionAttributes": [], - "name": "Vital Signs Supine", - "label": "Vital Signs Supine", - "description": "Vital Signs Supine", - "previousId": "Activity_37", - "nextId": "Activity_39", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_153", - "BiomedicalConcept_154", - "BiomedicalConcept_155" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_39", - "extensionAttributes": [], - "name": "Stand", - "label": "Stand", - "description": "Stand", - "previousId": "Activity_38", - "nextId": "Activity_40", - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_169" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - }, - { - "id": "Activity_40", - "extensionAttributes": [], - "name": "Vital Signs Standing", - "label": "Vital Signs Standing", - "description": "Vital Signs Standing", - "previousId": "Activity_39", - "nextId": null, - "childIds": [], - "definedProcedures": [], - "biomedicalConceptIds": [ - "BiomedicalConcept_156", - "BiomedicalConcept_157", - "BiomedicalConcept_158" - ], - "bcCategoryIds": [], - "bcSurrogateIds": [], - "timelineId": null, - "notes": [], - "instanceType": "Activity" - } - ], - "arms": [ - { - "id": "StudyArm_1", - "extensionAttributes": [], - "name": "Placebo", - "label": "Placebo", - "description": "Placebo ARM", - "type": { - "id": "Code_1", - "extensionAttributes": [], - "code": "C174268", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Placebo Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_2", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - }, - { - "id": "StudyArm_2", - "extensionAttributes": [], - "name": "Xanomeline Low Dose", - "label": "Xanomeline Low Dose", - "description": "Active substance low dose", - "type": { - "id": "Code_3", - "extensionAttributes": [], - "code": "C174267", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Active Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_4", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - }, - { - "id": "StudyArm_3", - "extensionAttributes": [], - "name": "Xanomeline High Dose", - "label": "Xanomeline High Dose", - "description": "Active Substance high dose", - "type": { - "id": "Code_5", - "extensionAttributes": [], - "code": "C174267", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Active Comparator Arm", - "instanceType": "Code" - }, - "dataOriginDescription": "Data collected from subjects", - "dataOriginType": { - "id": "Code_6", - "extensionAttributes": [], - "code": "C188866", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Data Generated Within Study", - "instanceType": "Code" - }, - "populationIds": [], - "notes": [], - "instanceType": "StudyArm" - } - ], - "studyCells": [ - { - "id": "StudyCell_1", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_2", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_3", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_4", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_5", - "elementIds": [ - "StudyElement_2" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_5", - "extensionAttributes": [], - "armId": "StudyArm_1", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_7" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_11", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_12", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_4" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_13", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_5" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_14", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_5", - "elementIds": [ - "StudyElement_6" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_15", - "extensionAttributes": [], - "armId": "StudyArm_3", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_7" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_16", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_1", - "elementIds": [ - "StudyElement_1" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_17", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_3", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_18", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_4", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_19", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_5", - "elementIds": [ - "StudyElement_3" - ], - "instanceType": "StudyCell" - }, - { - "id": "StudyCell_20", - "extensionAttributes": [], - "armId": "StudyArm_2", - "epochId": "StudyEpoch_2", - "elementIds": [ - "StudyElement_7" - ], - "instanceType": "StudyCell" - } - ], - "rationale": "", - "epochs": [ - { - "id": "StudyEpoch_1", - "extensionAttributes": [], - "name": "Screening", - "label": "Screening", - "description": "Screening Epoch", - "type": { - "id": "Code_10", - "extensionAttributes": [], - "code": "C202487", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "SCREENING", - "instanceType": "Code" - }, - "previousId": null, - "nextId": "StudyEpoch_3", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_3", - "extensionAttributes": [], - "name": "Treatment 1", - "label": "Treatment 1", - "description": "Treatment 1 Epoch", - "type": { - "id": "Code_11", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_1", - "nextId": "StudyEpoch_4", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_4", - "extensionAttributes": [], - "name": "Treatment 2", - "label": "Treatment 2", - "description": "Treatment 2 Epoch", - "type": { - "id": "Code_13", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_3", - "nextId": "StudyEpoch_5", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_5", - "extensionAttributes": [], - "name": "Treatment 3", - "label": "Treatment 3", - "description": "Treatment 3 Epoch", - "type": { - "id": "Code_14", - "extensionAttributes": [], - "code": "C101526", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "TREATMENT", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_4", - "nextId": "StudyEpoch_2", - "notes": [], - "instanceType": "StudyEpoch" - }, - { - "id": "StudyEpoch_2", - "extensionAttributes": [], - "name": "Follow-up", - "label": "Follow-up", - "description": "Follow-up Epoch", - "type": { - "id": "Code_12", - "extensionAttributes": [], - "code": "C202578", - "codeSystem": "https://library.cdisc.org", - "codeSystemVersion": "sdtmct-2025-09-26", - "decode": "FOLLOW-UP", - "instanceType": "Code" - }, - "previousId": "StudyEpoch_5", - "nextId": null, - "notes": [], - "instanceType": "StudyEpoch" - } - ], - "elements": [ - { - "id": "StudyElement_1", - "extensionAttributes": [], - "name": "EL1", - "label": "Screening", - "description": "Screening Element", - "transitionStartRule": { - "id": "TransitionRule_23", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_1", - "label": null, - "description": null, - "text": "Informed consent", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_24", - "extensionAttributes": [], - "name": "ELEMENT_END_RULE_1", - "label": null, - "description": null, - "text": "Completion of all screening activities and no more than 2 weeks from informed consent", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_2", - "extensionAttributes": [], - "name": "EL2", - "label": "Placebo", - "description": "Placebo TTS (adhesive patches)", - "transitionStartRule": { - "id": "TransitionRule_27", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_2", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_3", - "extensionAttributes": [], - "name": "EL3", - "label": "Low", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "transitionStartRule": { - "id": "TransitionRule_28", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_3", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_4", - "extensionAttributes": [], - "name": "EL4", - "label": "High - Start", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "transitionStartRule": { - "id": "TransitionRule_29", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_4", - "label": null, - "description": null, - "text": "Randomized", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_5", - "extensionAttributes": [], - "name": "EL5", - "label": "High - Middle", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg + 25 cm2, 27 mg", - "transitionStartRule": { - "id": "TransitionRule_30", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_5", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose\\u00a0(from\\u00a0patches\\u00a0supplied\\u00a0at\\u00a0Visit\\u00a04)", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_6", - "extensionAttributes": [], - "name": "EL6", - "label": "High - End", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "transitionStartRule": { - "id": "TransitionRule_31", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_6", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose\\u00a0(from\\u00a0patches\\u00a0supplied\\u00a0at\\u00a0Visit\\u00a012)", - "instanceType": "TransitionRule" - }, - "transitionEndRule": null, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - }, - { - "id": "StudyElement_7", - "extensionAttributes": [], - "name": "EL7", - "label": "Follow up", - "description": "Follow up Element", - "transitionStartRule": { - "id": "TransitionRule_25", - "extensionAttributes": [], - "name": "ELEMENT_START_RULE_7", - "label": null, - "description": null, - "text": "End\\u00a0of\\u00a0last\\u00a0scheduled\\u00a0visit\\u00a0on\\u00a0study\\u00a0(including\\u00a0early\\u00a0termination)", - "instanceType": "TransitionRule" - }, - "transitionEndRule": { - "id": "TransitionRule_26", - "extensionAttributes": [], - "name": "ELEMENT_END_RULE_7", - "label": null, - "description": null, - "text": "Completion\\u00a0of\\u00a0all\\u00a0specified\\u00a0followup\\u00a0activities\\u00a0(which\\u00a0vary\\u00a0on\\u00a0a\\u00a0patient-by-patient\\u00a0basis)", - "instanceType": "TransitionRule" - }, - "studyInterventionIds": [], - "notes": [], - "instanceType": "StudyElement" - } - ], - "estimands": [ - { - "id": "Estimand_1", - "extensionAttributes": [], - "name": "Estimand 1", - "label": "Estimand 1", - "description": "Estimand 1", - "populationSummary": "Group mean changes from baseline in the primary efficacy parameters", - "analysisPopulationId": "", - "variableOfInterestId": "Endpoint_1", - "interventionIds": [ - "StudyIntervention_1" - ], - "intercurrentEvents": [ - { - "id": "IntercurrentEvent_1", - "extensionAttributes": [], - "name": "Disruption", - "label": "Disruption", - "description": "The disruption of treatment to the subject", - "text": "Temporary Treatment Interruption", - "strategy": "Treatment Policy. Continue to measure effect of treatment assignment regardless of interruption.", - "notes": [], - "instanceType": "IntercurrentEvent" - } - ], - "notes": [], - "instanceType": "Estimand" - } - ], - "indications": [ - { - "id": "Indication_1", - "extensionAttributes": [], - "name": "Indication 1", - "label": "Alzheimer's disease", - "description": "Alzheimer's disease", - "isRareDisease": false, - "codes": [ - { - "id": "Code_36968", - "extensionAttributes": [], - "code": "G30.9", - "codeSystem": "ICD-10-CM", - "codeSystemVersion": "1", - "decode": "Alzheimer's disease; unspecified", - "instanceType": "Code" - } - ], - "notes": [], - "instanceType": "Indication" - }, - { - "id": "Indication_2", - "extensionAttributes": [], - "name": "Indication 2", - "label": "Alzheimer's disease", - "description": "Alzheimer's disease", - "isRareDisease": false, - "codes": [ - { - "id": "Code_36969", - "extensionAttributes": [], - "code": "26929004", - "codeSystem": "SNOMED", - "codeSystemVersion": "2018-01-31", - "decode": "Alzheimer's disease", - "instanceType": "Code" - } - ], - "notes": [], - "instanceType": "Indication" - } - ], - "studyInterventionIds": [ - "StudyIntervention_1" - ], - "objectives": [ - { - "id": "Objective_1", - "extensionAttributes": [], - "name": "OBJ1", - "label": "Objective 1", - "description": "Main Objective", - "text": "To determine if there is a statistically significant relationship (overall Type 1 erroralpha=0.05) between the change in both the ADAS-Cog (11) and CIBIC+ scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2508", - "extensionAttributes": [], - "code": "C85826", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85826", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_1", - "extensionAttributes": [], - "name": "ENDPT1", - "label": "Endpoint 1", - "description": "ADAS-Cog Week 24 Endpoint", - "text": "Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] at Week 24", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2514", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_2", - "extensionAttributes": [], - "name": "ENDPT2", - "label": "Endpoint 2", - "description": "Clinician Week 24 impression of change", - "text": "Video-referenced Clinician\\u2019s Interview-based Impression of Change (CIBIC+) at Week 24", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2515", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_2", - "extensionAttributes": [], - "name": "OBJ2", - "label": "Objective 2", - "description": "Safety", - "text": "To document the safety profile of the xanomeline TTS.", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2509", - "extensionAttributes": [], - "code": "C85826", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85826", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_3", - "extensionAttributes": [], - "name": "ENDPT3", - "label": "Endpoint 3", - "description": "Adverse events", - "text": "Adverse events", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2516", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_4", - "extensionAttributes": [], - "name": "ENDPT4", - "label": "Endpoint 4", - "description": "Vital Signs", - "text": "Vital signs (weight, standing and supine blood pressure, heart rate)", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2517", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_5", - "extensionAttributes": [], - "name": "ENDPT5", - "label": "Endpoint 5", - "description": "Baseline", - "text": "The change from baseline laboratory value will be calculated as the difference between the baseline lab value and the endpoint value (i.e., the value at the specified visit) or the end of treatment observation\", \"text\": \"Laboratory evaluations (Change from Baseline)", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2518", - "extensionAttributes": [], - "code": "C94496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C94496", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_3", - "extensionAttributes": [], - "name": "OBJ3", - "label": "Objective 3", - "description": "Behaviour", - "text": "To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2510", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_6", - "extensionAttributes": [], - "name": "ENDPT6", - "label": "Endpoint 6", - "description": "Cognitive Scale", - "text": "Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] at Weeks 8 and 16", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2519", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_7", - "extensionAttributes": [], - "name": "ENDPT7", - "label": "Endpoint 7", - "description": "Clinician impression at Week8 and Week16", - "text": "Video-referenced Clinician\\u2019s Interview-based Impression of Change (CIBIC+) at Weeks 8 and 16", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2520", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - }, - { - "id": "Endpoint_8", - "extensionAttributes": [], - "name": "ENDPT8", - "label": "Endpoint 8", - "description": "NPI-X", - "text": "Mean Revised Neuropsychiatric Inventory (NPI-X) from Week 4 to Week 24", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2521", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_4", - "extensionAttributes": [], - "name": "OBJ4", - "label": "Objective 4", - "description": "Improvements", - "text": "To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas (see Attachment LZZT.5).", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2511", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_9", - "extensionAttributes": [], - "name": "ENDPT9", - "label": "Endpoint 9", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2522", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_5", - "extensionAttributes": [], - "name": "OBJ5", - "label": "Objective 5", - "description": "Improvements", - "text": "To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer's Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment (see Attachment LZZT.2).", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2512", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_10", - "extensionAttributes": [], - "name": "ENDPT10", - "label": "Endpoint 10", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2523", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - }, - { - "id": "Objective_6", - "extensionAttributes": [], - "name": "OBJ6", - "label": "Objective 6", - "description": "Response", - "text": "To assess the treatment response as a function of Apo E genotype.", - "dictionaryId": null, - "notes": [], - "level": { - "id": "Code_2513", - "extensionAttributes": [], - "code": "C85827", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C85827", - "instanceType": "Code" - }, - "endpoints": [ - { - "id": "Endpoint_11", - "extensionAttributes": [], - "name": "ENDPT11", - "label": "Endpoint 11", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "dictionaryId": null, - "notes": [], - "purpose": "", - "level": { - "id": "Code_2524", - "extensionAttributes": [], - "code": "C139173", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "C139173", - "instanceType": "Code" - }, - "instanceType": "Endpoint" - } - ], - "instanceType": "Objective" - } - ], - "population": { - "id": "StudyDesignPopulation_1", - "extensionAttributes": [], - "name": "Population_1", - "label": null, - "description": null, - "includesHealthySubjects": false, - "plannedEnrollmentNumber": null, - "plannedCompletionNumber": null, - "plannedSex": [], - "criterionIds": [], - "plannedAge": null, - "notes": [], - "cohorts": [], - "instanceType": "StudyDesignPopulation" - }, - "scheduleTimelines": [ - { - "id": "ScheduleTimeline_1", - "extensionAttributes": [], - "name": "Main Timeline", - "label": "Main Timeline", - "description": "This is the main timeline for the study design", - "mainTimeline": true, - "entryCondition": "Potential subject identified", - "entryId": "ScheduledActivityInstance_1", - "exits": [], - "timings": [ - { - "id": "Timing_1", - "extensionAttributes": [], - "name": "TIM1", - "label": "Screening", - "description": "Screening Timing", - "type": { - "id": "Code_20", - "extensionAttributes": [], - "code": "C201357", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Before", - "instanceType": "Code" - }, - "value": "-P2W", - "valueLabel": "2 Weeks Before Dose", - "relativeToFrom": { - "id": "Code_27", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_1", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_2", - "extensionAttributes": [], - "name": "TIM2", - "label": "Pre-dose", - "description": "Pre-dose Timing", - "type": { - "id": "Code_22", - "extensionAttributes": [], - "code": "C201357", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Before", - "instanceType": "Code" - }, - "value": "-P2D", - "valueLabel": "2 Days Before Dose", - "relativeToFrom": { - "id": "Code_28", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_2", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "PT4H", - "windowUpper": "PT0H", - "windowLabel": "-4..0 hours", - "instanceType": "Timing" - }, - { - "id": "Timing_3", - "extensionAttributes": [], - "name": "TIM3", - "label": "Dosing", - "description": "Dosing Anchor", - "type": { - "id": "Code_18", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "P1D", - "valueLabel": "1 Day", - "relativeToFrom": { - "id": "Code_19", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_3", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_4", - "extensionAttributes": [], - "name": "TIM4", - "label": "Week 2", - "description": "Week 2 timing", - "type": { - "id": "Code_29", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_25", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_4", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_5", - "extensionAttributes": [], - "name": "TIM5", - "label": "Week 4", - "description": "Week 4 Timing", - "type": { - "id": "Code_30", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P4W", - "valueLabel": "4 Weeks", - "relativeToFrom": { - "id": "Code_31", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_5", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_6", - "extensionAttributes": [], - "name": "TIM6", - "label": "Week 6", - "description": "Week 6 Timing", - "type": { - "id": "Code_32", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P6W", - "valueLabel": "6 Weeks", - "relativeToFrom": { - "id": "Code_33", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_6", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_7", - "extensionAttributes": [], - "name": "TIM7", - "label": "Week 8", - "description": "Week 8 Timing", - "type": { - "id": "Code_34", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P8W", - "valueLabel": "8 Weeks", - "relativeToFrom": { - "id": "Code_35", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_7", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_8", - "extensionAttributes": [], - "name": "TIM9", - "label": "Week 12", - "description": "Week 12 Timing", - "type": { - "id": "Code_36", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P12W", - "valueLabel": "12 Weeks", - "relativeToFrom": { - "id": "Code_37", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_19", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_9", - "extensionAttributes": [], - "name": "TIM11", - "label": "Week 16", - "description": "Week 16 Timing", - "type": { - "id": "Code_38", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P16W", - "valueLabel": "16 Weeks", - "relativeToFrom": { - "id": "Code_39", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_21", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_10", - "extensionAttributes": [], - "name": "TIM13", - "label": "Week 20", - "description": "Week 20 Timing", - "type": { - "id": "Code_40", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P20W", - "valueLabel": "20 Weeks", - "relativeToFrom": { - "id": "Code_41", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_23", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_11", - "extensionAttributes": [], - "name": "TIM15", - "label": "Week 24", - "description": "Week 24 Timing", - "type": { - "id": "Code_42", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P24W", - "valueLabel": "24 Weeks", - "relativeToFrom": { - "id": "Code_43", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_25", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P4D", - "windowUpper": "P4D", - "windowLabel": "-4..4 days", - "instanceType": "Timing" - }, - { - "id": "Timing_12", - "extensionAttributes": [], - "name": "TIM16", - "label": "Week 26", - "description": "Week 26 Timing", - "type": { - "id": "Code_44", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P26W", - "valueLabel": "26 Weeks", - "relativeToFrom": { - "id": "Code_45", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_26", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_3", - "windowLower": "P3D", - "windowUpper": "P3D", - "windowLabel": "-3..3 days", - "instanceType": "Timing" - }, - { - "id": "Timing_13", - "extensionAttributes": [], - "name": "TIM8", - "label": "Week 8 Home", - "description": "Week 8 Home Timing", - "type": { - "id": "Code_46", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_47", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_8", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_7", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_14", - "extensionAttributes": [], - "name": "TIM10", - "label": "Week 12 Home", - "description": "Week 12 Home Timing", - "type": { - "id": "Code_48", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_49", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_20", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_19", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_15", - "extensionAttributes": [], - "name": "TIM12", - "label": "Week 16 Home", - "description": "Week 16 Home Timing", - "type": { - "id": "Code_50", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_51", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_22", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_21", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_16", - "extensionAttributes": [], - "name": "TIM14", - "label": "Week 20 Home", - "description": "Week 20 Home Timing", - "type": { - "id": "Code_52", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "P2W", - "valueLabel": "2 Weeks", - "relativeToFrom": { - "id": "Code_53", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_24", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_23", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_1", - "extensionAttributes": [], - "name": "SCREEN1", - "label": "Screen 1", - "description": "Screen 1 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_2", - "epochId": "StudyEpoch_1", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_1", - "Activity_2", - "Activity_3", - "Activity_4", - "Activity_5", - "Activity_6", - "Activity_7", - "Activity_8", - "Activity_9", - "Activity_10", - "Activity_11", - "Activity_14", - "Activity_17", - "Activity_18", - "Activity_19", - "Activity_20", - "Activity_21", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_25", - "Activity_27", - "Activity_31", - "Activity_32", - "Activity_30", - "Activity_33" - ], - "encounterId": "Encounter_1" - }, - { - "id": "ScheduledActivityInstance_2", - "extensionAttributes": [], - "name": "SCREEN2", - "label": "Screen 2", - "description": "Screen 2 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_3", - "epochId": "StudyEpoch_1", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_15", - "Activity_33" - ], - "encounterId": "Encounter_2" - }, - { - "id": "ScheduledActivityInstance_3", - "extensionAttributes": [], - "name": "DOSE", - "label": "Dose", - "description": "Dose Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_4", - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_13", - "Activity_14", - "Activity_16", - "Activity_22", - "Activity_28", - "Activity_26", - "Activity_30", - "Activity_31", - "Activity_32", - "Activity_33" - ], - "encounterId": "Encounter_3" - }, - { - "id": "ScheduledActivityInstance_4", - "extensionAttributes": [], - "name": "WEEK2", - "label": "Week 2", - "description": "Week 2 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_5", - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_12", - "Activity_14", - "Activity_22", - "Activity_23", - "Activity_25", - "Activity_26", - "Activity_28", - "Activity_17", - "Activity_24", - "Activity_33" - ], - "encounterId": "Encounter_4" - }, - { - "id": "ScheduledActivityInstance_5", - "extensionAttributes": [], - "name": "WEEK4", - "label": "Week 4", - "description": "Week 4 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_6", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_26", - "Activity_28", - "Activity_33" - ], - "encounterId": "Encounter_5" - }, - { - "id": "ScheduledActivityInstance_6", - "extensionAttributes": [], - "name": "WEEK6", - "label": "Week 6", - "description": "Week 6 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_7", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_26", - "Activity_28", - "Activity_33" - ], - "encounterId": "Encounter_6" - }, - { - "id": "ScheduledActivityInstance_7", - "extensionAttributes": [], - "name": "WEEK8", - "label": "Week 8", - "description": "Week 8 Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_8", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_31", - "Activity_31", - "Activity_32", - "Activity_32", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_7" - }, - { - "id": "ScheduledActivityInstance_8", - "extensionAttributes": [], - "name": "WEEK8N", - "label": "Week 8 NPI", - "description": "Week 8 NPI Activity Instance", - "defaultConditionId": "ScheduledActivityInstance_19", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_31", - "Activity_31", - "Activity_32", - "Activity_32", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_7" - }, - { - "id": "ScheduledActivityInstance_19", - "extensionAttributes": [], - "name": "WEEK12", - "label": "Week 12", - "description": "Week 12", - "defaultConditionId": "ScheduledActivityInstance_20", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_25", - "Activity_25", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_9" - }, - { - "id": "ScheduledActivityInstance_20", - "extensionAttributes": [], - "name": "WEEK12N", - "label": "Week 12 NPI", - "description": "Week 12 NPI", - "defaultConditionId": "ScheduledActivityInstance_21", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_25", - "Activity_25", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_9" - }, - { - "id": "ScheduledActivityInstance_21", - "extensionAttributes": [], - "name": "WEEK16", - "label": "Week 16", - "description": "Week 16", - "defaultConditionId": "ScheduledActivityInstance_22", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_32", - "Activity_32", - "Activity_31", - "Activity_31", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_11" - }, - { - "id": "ScheduledActivityInstance_22", - "extensionAttributes": [], - "name": "WEEK16N", - "label": "Week 16 NPI", - "description": "Week 16 NPI", - "defaultConditionId": "ScheduledActivityInstance_23", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_28", - "Activity_28", - "Activity_30", - "Activity_30", - "Activity_32", - "Activity_32", - "Activity_31", - "Activity_31", - "Activity_33", - "Activity_33" - ], - "encounterId": "Encounter_11" - }, - { - "id": "ScheduledActivityInstance_23", - "extensionAttributes": [], - "name": "WEEK20", - "label": "Week 20", - "description": "Week 20", - "defaultConditionId": "ScheduledActivityInstance_24", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_13" - }, - { - "id": "ScheduledActivityInstance_24", - "extensionAttributes": [], - "name": "WEEK20N", - "label": "Week 20 NPI", - "description": "Week 20 NPI", - "defaultConditionId": "ScheduledActivityInstance_25", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_33", - "Activity_14", - "Activity_14", - "Activity_17", - "Activity_17", - "Activity_22", - "Activity_22", - "Activity_23", - "Activity_23", - "Activity_24", - "Activity_24", - "Activity_26", - "Activity_26", - "Activity_28", - "Activity_28" - ], - "encounterId": "Encounter_13" - }, - { - "id": "ScheduledActivityInstance_25", - "extensionAttributes": [], - "name": "WEEK24", - "label": "Week 24", - "description": "Week 24", - "defaultConditionId": "ScheduledActivityInstance_26", - "epochId": "StudyEpoch_5", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_25", - "Activity_28", - "Activity_30", - "Activity_32", - "Activity_31" - ], - "encounterId": "Encounter_15" - }, - { - "id": "ScheduledActivityInstance_26", - "extensionAttributes": [], - "name": "WEEK26", - "label": "Week 26", - "description": "Week 26", - "defaultConditionId": null, - "epochId": "StudyEpoch_2", - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [ - "Activity_33", - "Activity_14", - "Activity_17", - "Activity_22", - "Activity_23", - "Activity_24", - "Activity_28", - "Activity_29" - ], - "encounterId": "Encounter_16" - }, - { - "id": "ScheduledDecisionInstance_1", - "extensionAttributes": [], - "name": "testDecisionInstance", - "label": "testDecisionInstance", - "description": "testDecisionInstance", - "defaultConditionId": null, - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [ - { - "id": "Condition_1", - "extensionAttributes": [], - "condition": "is not null", - "conditionTargetId": "ScheduledActivityInstance_3", - "instanceType": "Condition" - } - ] - }, - { - "id": "ScheduledDecisionInstance_2", - "extensionAttributes": [], - "name": "test_2", - "label": "test_2", - "description": "test_2", - "defaultConditionId": "blahblahblah", - "epochId": "StudyEpoch_4", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [] - }, - { - "id": "ScheduledDecisionInstance_3", - "extensionAttributes": [], - "name": "test3", - "label": "test3", - "description": "test3", - "defaultConditionId": "ScheduledActivityInstance_11", - "epochId": "StudyEpoch_3", - "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [] - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - }, - { - "id": "ScheduleTimeline_6", - "extensionAttributes": [], - "name": "Adverse Event Timeline", - "label": "Adverse Event Timeline", - "description": "This is the adverse event timeline", - "mainTimeline": false, - "entryCondition": "Subject suffers an adverse event", - "entryId": "ScheduledActivityInstance_11", - "exits": [], - "timings": [ - { - "id": "Timing_17", - "extensionAttributes": [], - "name": "TIM17", - "label": "Adverse Event", - "description": "Adverse Event Timing", - "type": { - "id": "Code_105", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "P1D", - "valueLabel": "1 Day", - "relativeToFrom": { - "id": "Code_106", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_11", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_11", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_11", - "extensionAttributes": [], - "name": "AE", - "label": "Adverse Event", - "description": "Occurrence of Adverse Event", - "defaultConditionId": null, - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - }, - { - "id": "ScheduleTimeline_7", - "extensionAttributes": [], - "name": "Early Termination Timeline", - "label": "Early Termination Timeline", - "description": "This is the early termination processing", - "mainTimeline": false, - "entryCondition": "Subject terminates the study early", - "entryId": "ScheduledActivityInstance_12", - "exits": [], - "timings": [ - { - "id": "Timing_18", - "extensionAttributes": [], - "name": "TIM18", - "label": "Early Termination", - "description": "Early Termination Timing", - "type": { - "id": "Code_107", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "P1D", - "valueLabel": "1 Day", - "relativeToFrom": { - "id": "Code_108", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_12", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_12", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_12", - "extensionAttributes": [], - "name": "ET", - "label": "Early Termination", - "description": "Early Termination", - "defaultConditionId": null, - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - }, - { - "id": "ScheduleTimeline_8", - "extensionAttributes": [], - "name": "Vital Sign Blood Pressure Timeline", - "label": "Vital Sign Blood Pressure Timeline", - "description": "BP Profile", - "mainTimeline": false, - "entryCondition": "Automatic execution", - "entryId": "ScheduledActivityInstance_13", - "exits": [], - "timings": [ - { - "id": "Timing_19", - "extensionAttributes": [], - "name": "TIM19", - "label": "Supine", - "description": "VS Supine", - "type": { - "id": "Code_109", - "extensionAttributes": [], - "code": "C201358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Fixed Reference", - "instanceType": "Code" - }, - "value": "PT0M", - "valueLabel": "0 mins", - "relativeToFrom": { - "id": "Code_110", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_13", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_13", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_20", - "extensionAttributes": [], - "name": "TIM20", - "label": "VS while supine", - "description": "VS while supine", - "type": { - "id": "Code_111", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT5M", - "valueLabel": "5 mins", - "relativeToFrom": { - "id": "Code_112", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_14", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_13", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_21", - "extensionAttributes": [], - "name": "TIM21", - "label": "Standing", - "description": "VS Standing", - "type": { - "id": "Code_113", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT0M", - "valueLabel": "0 mins", - "relativeToFrom": { - "id": "Code_114", - "extensionAttributes": [], - "code": "C201353", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "End to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_15", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_14", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_22", - "extensionAttributes": [], - "name": "TIM22", - "label": "VS while standing", - "description": "VS while standing", - "type": { - "id": "Code_115", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT1M", - "valueLabel": "1 min", - "relativeToFrom": { - "id": "Code_116", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_16", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_15", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_23", - "extensionAttributes": [], - "name": "TIM23", - "label": "Standing", - "description": "VS Standing", - "type": { - "id": "Code_117", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT0M", - "valueLabel": "0 min", - "relativeToFrom": { - "id": "Code_118", - "extensionAttributes": [], - "code": "C201353", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "End to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_17", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_16", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - }, - { - "id": "Timing_24", - "extensionAttributes": [], - "name": "TIM24", - "label": "VS while standing", - "description": "VS while standing", - "type": { - "id": "Code_119", - "extensionAttributes": [], - "code": "C201356", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "After", - "instanceType": "Code" - }, - "value": "PT2M", - "valueLabel": "2 min", - "relativeToFrom": { - "id": "Code_120", - "extensionAttributes": [], - "code": "C201355", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Start to Start", - "instanceType": "Code" - }, - "relativeFromScheduledInstanceId": "ScheduledActivityInstance_18", - "relativeToScheduledInstanceId": "ScheduledActivityInstance_17", - "windowLower": null, - "windowUpper": null, - "windowLabel": null, - "instanceType": "Timing" - } - ], - "instances": [ - { - "id": "ScheduledActivityInstance_13", - "extensionAttributes": [], - "name": "VS_5MIN", - "label": "5 minute supine", - "description": "VS 5 minute supine", - "defaultConditionId": "ScheduledActivityInstance_14", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_14", - "extensionAttributes": [], - "name": "VS_SUPINE", - "label": "Vital signs supine", - "description": "VS Vital signs supine", - "defaultConditionId": "ScheduledActivityInstance_15", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_15", - "extensionAttributes": [], - "name": "VS_1MIN", - "label": "1 minute standing", - "description": "VS 1 minute standing", - "defaultConditionId": "ScheduledActivityInstance_16", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_16", - "extensionAttributes": [], - "name": "VS_STAND1", - "label": "Vital signs after 1 min standing", - "description": "VS Vital signs after 1 min standing", - "defaultConditionId": "ScheduledActivityInstance_17", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_17", - "extensionAttributes": [], - "name": "VS_2MIN", - "label": "2 minute standing", - "description": "VS 2 minute standing", - "defaultConditionId": "ScheduledActivityInstance_18", - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - }, - { - "id": "ScheduledActivityInstance_18", - "extensionAttributes": [], - "name": "VS_STAND3", - "label": "Vital signs after 3 min standing", - "description": "VS Vital signs after 3 min standing", - "defaultConditionId": null, - "epochId": null, - "instanceType": "ScheduledActivityInstance", - "timelineId": null, - "timelineExitId": null, - "activityIds": [], - "encounterId": null - } - ], - "plannedDuration": null, - "instanceType": "ScheduleTimeline" - } - ], - "biospecimenRetentions": [], - "documentVersionIds": [], - "eligibilityCriteria": [], - "analysisPopulations": [], - "notes": [], - "subTypes": [], - "model": { - "id": "Code_StudyDesignModel", - "extensionAttributes": [], - "code": "", - "codeSystem": "", - "codeSystemVersion": "", - "decode": "", - "instanceType": "Code" - }, - "intentTypes": [], - "blindingSchema": null, - "instanceType": "InterventionalStudyDesign" - } - ], - "titles": [ - { - "id": "StudyTitle_1", - "extensionAttributes": [], - "text": "LZZT - Pilot", - "type": { - "id": "Code_27557", - "extensionAttributes": [], - "code": "C207646", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Study Acronym", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - }, - { - "id": "StudyTitle_2", - "extensionAttributes": [], - "text": "Xanomeline (LY246708)", - "type": { - "id": "Code_27601", - "extensionAttributes": [], - "code": "C207615", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Brief Study Title", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - }, - { - "id": "StudyTitle_3", - "extensionAttributes": [], - "text": "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease", - "type": { - "id": "Code_27813", - "extensionAttributes": [], - "code": "C207616", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Official Study Title", - "instanceType": "Code" - }, - "instanceType": "StudyTitle" - } - ], - "documentVersionIds": [], - "dateValues": [], - "amendments": [ - { - "id": "StudyAmendment_1", - "extensionAttributes": [], - "notes": [], - "name": "AMEND_1", - "label": "Amendment 1", - "description": "First amendment", - "number": "1", - "summary": "Updated inclusion criteria", - "primaryReason": { - "id": "StudyAmendmentReason_1", - "extensionAttributes": [], - "code": { - "id": "Code_2525", - "extensionAttributes": [], - "code": "C207605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "IRB/IEC Feedback", - "instanceType": "Code" - }, - "otherReason": null, - "instanceType": "StudyAmendmentReason" - }, - "secondaryReasons": [ - { - "id": "StudyAmendmentReason_2", - "extensionAttributes": [], - "code": { - "id": "Code_2526", - "extensionAttributes": [], - "code": "C17649", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "OTHER", - "instanceType": "Code" - }, - "otherReason": "Fix typographical errors", - "instanceType": "StudyAmendmentReason" - } - ], - "changes": [ - { - "id": "StudyChange_2", - "extensionAttributes": [], - "name": "AMEND_CHG_1", - "label": "Change 1", - "description": "Typographical errors lead to ambiguity when interpreting Inclusion Criteria", - "summary": "Fixed inclusion criteria text", - "rationale": "Subject safety", - "changedSections": [ - { - "id": "DocumentContentReference_2", - "extensionAttributes": [], - "sectionNumber": "1.5", - "sectionTitle": "Header 1.5", - "appliesToId": "StudyDefinitionDocument_1", - "instanceType": "DocumentContentReference" - } - ], - "instanceType": "StudyChange" - } - ], - "impacts": [ - { - "id": "StudyAmendmentImpact_1", - "extensionAttributes": [], - "notes": [], - "type": { - "id": "Code_2527", - "extensionAttributes": [], - "code": "C215665", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Study Subject Safety", - "instanceType": "Code" - }, - "text": "Enhance subject safety", - "isSubstantial": false, - "instanceType": "StudyAmendmentImpact" - } - ], - "geographicScopes": [ - { - "id": "GeographicScope_1", - "extensionAttributes": [], - "type": { - "id": "Code_12462", - "extensionAttributes": [], - "code": "C68846", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Global", - "instanceType": "Code" - }, - "code": null, - "instanceType": "GeographicScope" - }, - { - "id": "GeographicScope_5", - "extensionAttributes": [], - "type": { - "id": "Code_20010", - "extensionAttributes": [], - "code": "C41129", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Region", - "instanceType": "Code" - }, - "code": { - "id": "AliasCode_20011", - "extensionAttributes": [], - "standardCode": { - "id": "Code_20011", - "extensionAttributes": [], - "code": "150", - "codeSystem": "UN M49", - "codeSystemVersion": "2026", - "decode": "Europe", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "GeographicScope" - } - ], - "enrollments": [ - { - "id": "SubjectEnrollment_1", - "extensionAttributes": [], - "name": "Enrollment 1", - "label": null, - "description": null, - "quantity": { - "id": "SubjectEnrollment_1_Qty", - "extensionAttributes": [], - "value": 15.0, - "unit": null, - "instanceType": "Quantity" - }, - "forGeographicScope": { - "id": "GeographicScope_5", - "extensionAttributes": [], - "type": { - "id": "Code_20010", - "extensionAttributes": [], - "code": "C41129", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Region", - "instanceType": "Code" - }, - "code": { - "id": "AliasCode_20011", - "extensionAttributes": [], - "standardCode": { - "id": "Code_20011", - "extensionAttributes": [], - "code": "150", - "codeSystem": "UN M49", - "codeSystemVersion": "2026", - "decode": "Europe", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "GeographicScope" - }, - "forStudyCohortId": null, - "forStudySiteId": null, - "instanceType": "SubjectEnrollment" - } - ], - "dateValues": [ - { - "id": "GovernanceDate_1", - "extensionAttributes": [], - "name": "Protocol Approval", - "label": null, - "description": null, - "type": { - "id": "Code_13051", - "extensionAttributes": [], - "code": "C215663", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Effective Date", - "instanceType": "Code" - }, - "dateValue": "2006-06-01", - "geographicScopes": [ - { - "id": "GeographicScope_1", - "extensionAttributes": [], - "type": { - "id": "Code_12462", - "extensionAttributes": [], - "code": "C68846", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Global", - "instanceType": "Code" - }, - "code": null, - "instanceType": "GeographicScope" - } - ], - "instanceType": "GovernanceDate" - } - ], - "instanceType": "StudyAmendment" - } - ], - "organizations": [ - { - "id": "Organization_1", - "extensionAttributes": [], - "name": "LILLY", - "label": "Eli Lilly", - "identifier": "00-642-1325", - "identifierScheme": "DUNS", - "type": { - "id": "Code_28637", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_1", - "extensionAttributes": [], - "text": "Lilly Corporate Ctr, Indianapolis, , IN, 4628, United States of America", - "lines": [ - "Lilly Corporate Ctr" - ], - "city": "Indianapolis", - "district": null, - "state": "IN", - "postalCode": "4628", - "country": { - "id": "Code_28638", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_2", - "extensionAttributes": [], - "name": "CT-GOV", - "label": "ClinicalTrials.gov", - "identifier": "CT-GOV", - "identifierScheme": "USGOV", - "type": { - "id": "Code_28639", - "extensionAttributes": [], - "code": "C142578", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Independent Data Monitoring Committee", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_2", - "extensionAttributes": [], - "text": "National Library of Medicine, Bethesda, 8600 Rockville Pike, MD, 20894, United States of America", - "lines": [ - "National Library of Medicine" - ], - "city": "Bethesda", - "district": "8600 Rockville Pike", - "state": "MD", - "postalCode": "20894", - "country": { - "id": "Code_28640", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - }, - { - "id": "Organization_3", - "extensionAttributes": [], - "name": "MLM Medical Labs", - "label": "Central Labu", - "identifier": "", - "identifierScheme": "", - "type": { - "id": "Code_39641", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "legalAddress": { - "id": "Address_3", - "extensionAttributes": [], - "text": null, - "lines": [], - "city": null, - "district": null, - "state": null, - "postalCode": null, - "country": { - "id": "Code_39642", - "extensionAttributes": [], - "code": "840", - "codeSystem": "ISO 3166 1 Numeric Code", - "codeSystemVersion": "2026", - "decode": "United States of America", - "instanceType": "Code" - }, - "instanceType": "Address" - }, - "managedSites": [], - "instanceType": "Organization" - } - ], - "roles": [ - { - "id": "StudyRole_1", - "extensionAttributes": [], - "name": "Role 1", - "label": "Sponsor", - "description": "Study Sponsor", - "code": { - "id": "Code_35642", - "extensionAttributes": [], - "code": "C70793", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Clinical Study Sponsor", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_1" - ], - "appliesToIds": [], - "assignedPersons": [], - "masking": { - "id": "Masking_1", - "extensionAttributes": [], - "text": "Masked", - "isMasked": true, - "instanceType": "Masking" - }, - "notes": [], - "instanceType": "StudyRole" - }, - { - "id": "StudyRole_3", - "extensionAttributes": [], - "name": "Laboratory Contact", - "label": "Lab Primary Contact", - "description": "The primary person to contact at the Central Lab", - "code": { - "id": "Code_40467", - "extensionAttributes": [], - "code": "C37984", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Laboratory", - "instanceType": "Code" - }, - "organizationIds": [ - "Organization_3" - ], - "appliesToIds": [], - "assignedPersons": [ - { - "id": "Person_2", - "extensionAttributes": [], - "name": "John Smith", - "label": null, - "description": null, - "personName": { - "id": "PersonName_2", - "extensionAttributes": [], - "text": null, - "familyName": "Smith", - "givenNames": [ - "John" - ], - "prefixes": [ - "Dr." - ], - "suffixes": [ - "PhD" - ], - "instanceType": "PersonName" - }, - "jobTitle": "", - "instanceType": "AssignedPerson" - } - ], - "masking": null, - "notes": [], - "instanceType": "StudyRole" - } - ], - "studyInterventions": [ - { - "id": "StudyIntervention_1", - "extensionAttributes": [], - "name": "XINONILINE", - "label": "Xinomiline", - "description": "Xinomiline", - "role": { - "id": "Code_36026", - "extensionAttributes": [], - "code": "C41161", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Experimental Intervention", - "instanceType": "Code" - }, - "type": { - "id": "Code_36027", - "extensionAttributes": [], - "code": "C1909", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Pharmacologic Substance", - "instanceType": "Code" - }, - "minimumResponseDuration": { - "id": "Quantity_1", - "extensionAttributes": [], - "value": 1.0, - "unit": { - "id": "AliasCode_30645", - "extensionAttributes": [], - "standardCode": { - "id": "Code_36028", - "extensionAttributes": [], - "code": "C25301", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-27", - "decode": "Day", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "Quantity" - }, - "codes": [ - { - "id": "Code_36144", - "extensionAttributes": [], - "code": "XIN", - "codeSystem": "SPONSOR", - "codeSystemVersion": "12", - "decode": "XIN", - "instanceType": "Code" - } - ], - "administrations": [], - "notes": [], - "instanceType": "StudyIntervention" - } - ], - "businessTherapeuticAreas": [], - "biomedicalConcepts": [ - { - "id": "BiomedicalConcept_1", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_126", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Informed Consent", - "label": null, - "synonyms": [ - "Informed Consent Obtained" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16735", - "properties": [ - { - "id": "BiomedicalConceptProperty_1", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3021", - "instanceType": "ResponseCode", - "name": "INFORMED CONSENT OBTAINED", - "label": "INFORMED CONSENT OBTAINED", - "isEnabled": true, - "code": { - "id": "Code_42410", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_37997", - "standardCode": { - "id": "Code_45284", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_2", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_37998", - "standardCode": { - "id": "Code_45285", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_3", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_37999", - "standardCode": { - "id": "Code_45286", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3151", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3361", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Informed Consent", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_2", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_127", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/INCL01", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Inclusion Criteria", - "label": "Inclusion Criteria", - "synonyms": [ - "Inclusion" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25532", - "properties": [ - { - "id": "BiomedicalConceptProperty_4", - "extensionAttributes": [], - "name": "TIVERS", - "label": "TIVERS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38000", - "standardCode": { - "id": "Code_45287", - "extensionAttributes": [], - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_5", - "extensionAttributes": [], - "name": "IEORRES", - "label": "IEORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38001", - "standardCode": { - "id": "Code_45288", - "extensionAttributes": [], - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_6", - "extensionAttributes": [], - "name": "IEDTC", - "label": "IEDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38002", - "standardCode": { - "id": "Code_45289", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24523", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28641", - "extensionAttributes": [], - "code": "C25532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Inclusion Criteria", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_3", - "extensionAttributes": [], - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "synonyms": [ - "Inclusion Exclusion Criteria Yes No Indicator", - "IEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83063", - "properties": [ - { - "id": "BiomedicalConceptProperty_7", - "extensionAttributes": [], - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38003", - "standardCode": { - "id": "Code_45290", - "extensionAttributes": [], - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_8", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38004", - "standardCode": { - "id": "Code_45291", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_31819", - "extensionAttributes": [], - "standardCode": { - "id": "Code_38143", - "extensionAttributes": [], - "code": "C83063", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_4", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_1", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EXCL01", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Exclusion Criteria", - "label": "Exclusion Criteria", - "synonyms": [ - "Exclusion" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25370", - "properties": [ - { - "id": "BiomedicalConceptProperty_9", - "extensionAttributes": [], - "name": "TIVERS", - "label": "TIVERS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_2841", - "instanceType": "ResponseCode", - "name": "INFORMED CONSENT OBTAINED", - "label": "INFORMED CONSENT OBTAINED", - "isEnabled": true, - "code": { - "id": "Code_40605", - "extensionAttributes": [], - "code": "C16735", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38005", - "standardCode": { - "id": "Code_45292", - "extensionAttributes": [], - "code": "C83444", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_10", - "extensionAttributes": [], - "name": "IEORRES", - "label": "IEORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38006", - "standardCode": { - "id": "Code_45293", - "extensionAttributes": [], - "code": "C181043", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Findings Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_11", - "extensionAttributes": [], - "name": "IEDTC", - "label": "IEDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38007", - "standardCode": { - "id": "Code_45294", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3153", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3363", - "extensionAttributes": [], - "code": "C25370", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Exclusion Criteria", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_5", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_2", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RAND", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Subject is Randomized", - "label": "Subject is Randomized", - "synonyms": [ - "Randomized" - ], - "reference": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "id": "BiomedicalConceptProperty_12", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3022", - "instanceType": "ResponseCode", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "isEnabled": true, - "code": { - "id": "Code_45298", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38010", - "standardCode": { - "id": "Code_45297", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_13", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38012", - "standardCode": { - "id": "Code_45299", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_14", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38013", - "standardCode": { - "id": "Code_45300", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3160", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3370", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_6", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_125", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RACE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Race", - "label": "Race", - "synonyms": [ - "Racial Group" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17049", - "properties": [ - { - "id": "BiomedicalConceptProperty_15", - "extensionAttributes": [], - "name": "RACE", - "label": "RACE", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38014", - "standardCode": { - "id": "Code_45301", - "extensionAttributes": [], - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Race", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_16", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38015", - "standardCode": { - "id": "Code_45302", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_31820", - "extensionAttributes": [], - "standardCode": { - "id": "Code_38144", - "extensionAttributes": [], - "code": "C17049", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Race", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_7", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_3", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ETHNIC", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ethnic Group", - "label": "Ethnic Group", - "synonyms": [ - "Ethnicity", - "Ethnic Origin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16564", - "properties": [ - { - "id": "BiomedicalConceptProperty_17", - "extensionAttributes": [], - "name": "ETHNIC", - "label": "ETHNIC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38016", - "standardCode": { - "id": "Code_45303", - "extensionAttributes": [], - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ethnic Group", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_18", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38017", - "standardCode": { - "id": "Code_45304", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_31821", - "extensionAttributes": [], - "standardCode": { - "id": "Code_38145", - "extensionAttributes": [], - "code": "C16564", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Ethnic Group", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_8", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_4", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AGE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Subject Age", - "label": "Subject Age", - "synonyms": [ - "Age" - ], - "reference": "/mdr/bc/biomedicalconcepts/C69260", - "properties": [ - { - "id": "BiomedicalConceptProperty_19", - "extensionAttributes": [], - "name": "AGE", - "label": "AGE", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38018", - "standardCode": { - "id": "Code_45305", - "extensionAttributes": [], - "code": "C170981", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Numeric Age for Data Tabulation", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_20", - "extensionAttributes": [], - "name": "AGEU", - "label": "AGEU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38019", - "standardCode": { - "id": "Code_45306", - "extensionAttributes": [], - "code": "C50400", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Age Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_21", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38020", - "standardCode": { - "id": "Code_45307", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24524", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28642", - "extensionAttributes": [], - "code": "C69260", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Subject Age", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_9", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_5", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BRTHDTC", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Birth Date and Time", - "label": "Birth Date and Time", - "synonyms": [ - "BRTHDTC", - "Date/Time of Birth" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83217", - "properties": [ - { - "id": "BiomedicalConceptProperty_22", - "extensionAttributes": [], - "name": "BRTHDTC", - "label": "BRTHDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38021", - "standardCode": { - "id": "Code_45308", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_23", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38022", - "standardCode": { - "id": "Code_45309", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3155", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3365", - "extensionAttributes": [], - "code": "C83217", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Birth Date and Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_10", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_6", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SEX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sex", - "label": null, - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C28421", - "properties": [ - { - "id": "BiomedicalConceptProperty_24", - "extensionAttributes": [], - "name": "SEX", - "label": "SEX", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38023", - "standardCode": { - "id": "Code_45310", - "extensionAttributes": [], - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_25", - "extensionAttributes": [], - "name": "DMDTC", - "label": "DMDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38024", - "standardCode": { - "id": "Code_45311", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24525", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28643", - "extensionAttributes": [], - "code": "C28421", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-04-01", - "decode": "Sex", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_11", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_7", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EDULEVEL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Education Level", - "label": "Education Level", - "synonyms": [ - "EDULEVEL", - "Education", - "Education Level", - "Education Level Completed", - "education_level", - "Educational Attainment", - "Educational Level", - "Level of Education Attained" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17953", - "properties": [ - { - "id": "BiomedicalConceptProperty_26", - "extensionAttributes": [], - "name": "SCORRES", - "label": "SCORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38025", - "standardCode": { - "id": "Code_45312", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_27", - "extensionAttributes": [], - "name": "SCDTC", - "label": "SCDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38026", - "standardCode": { - "id": "Code_45313", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24526", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28644", - "extensionAttributes": [], - "code": "C17953", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Education Level", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_12", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_8", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EDUYRNUM", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Number of Years of Education", - "label": "Number of Years of Education", - "synonyms": [ - "EDUYRNUM", - "Number of Years of Education" - ], - "reference": "/mdr/bc/biomedicalconcepts/C122393", - "properties": [ - { - "id": "BiomedicalConceptProperty_28", - "extensionAttributes": [], - "name": "SCORRES", - "label": "SCORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38027", - "standardCode": { - "id": "Code_45314", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_29", - "extensionAttributes": [], - "name": "SCDTC", - "label": "SCDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38028", - "standardCode": { - "id": "Code_45315", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24527", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28645", - "extensionAttributes": [], - "code": "C122393", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Number of Years of Education", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_14", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_123", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MEDHISTFREE", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_124", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MHALZHEIMERS", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_128", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MHVISUALHALLUCINATIONS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Solicited Medical History", - "label": "Solicited Medical History", - "synonyms": [ - "Medical History", - "Medical History Collection" - ], - "reference": "/mdr/bc/biomedicalconcepts/C200145", - "properties": [ - { - "id": "BiomedicalConceptProperty_30", - "extensionAttributes": [], - "name": "MHTERM", - "label": "MHTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38029", - "standardCode": { - "id": "Code_45316", - "extensionAttributes": [], - "code": "C83118", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Reported Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_31", - "extensionAttributes": [], - "name": "MHDECOD", - "label": "MHDECOD", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38030", - "standardCode": { - "id": "Code_45317", - "extensionAttributes": [], - "code": "C83346", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_32", - "extensionAttributes": [], - "name": "MHSTDTC", - "label": "MHSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38031", - "standardCode": { - "id": "Code_45318", - "extensionAttributes": [], - "code": "C83338", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_33", - "extensionAttributes": [], - "name": "MHENDTC", - "label": "MHENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38032", - "standardCode": { - "id": "Code_45319", - "extensionAttributes": [], - "code": "C83330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Medical History Event End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_34", - "extensionAttributes": [], - "name": "MHENRF", - "label": "MHENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38033", - "standardCode": { - "id": "Code_45320", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_35", - "extensionAttributes": [], - "name": "MHENRTPT", - "label": "MHENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38034", - "standardCode": { - "id": "Code_45321", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_36", - "extensionAttributes": [], - "name": "MHENTPT", - "label": "MHENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38035", - "standardCode": { - "id": "Code_45322", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3156", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3366", - "extensionAttributes": [], - "code": "C200145", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Medical History", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_15", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_134", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALCOHOLHX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alcohol Use History", - "label": "Alcohol Use History", - "synonyms": [ - "Alcohol History", - "Alcohol Use" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81229", - "properties": [ - { - "id": "BiomedicalConceptProperty_37", - "extensionAttributes": [], - "name": "SUTRT", - "label": "SUTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38036", - "standardCode": { - "id": "Code_45323", - "extensionAttributes": [], - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_38", - "extensionAttributes": [], - "name": "SUPRESP", - "label": "SUPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38037", - "standardCode": { - "id": "Code_45324", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_39", - "extensionAttributes": [], - "name": "SUOCCUR", - "label": "SUOCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38038", - "standardCode": { - "id": "Code_45325", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_40", - "extensionAttributes": [], - "name": "SUDOSE", - "label": "SUDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38039", - "standardCode": { - "id": "Code_45326", - "extensionAttributes": [], - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_41", - "extensionAttributes": [], - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38040", - "standardCode": { - "id": "Code_45327", - "extensionAttributes": [], - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_42", - "extensionAttributes": [], - "name": "SUDOSU", - "label": "SUDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38041", - "standardCode": { - "id": "Code_45328", - "extensionAttributes": [], - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_43", - "extensionAttributes": [], - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38042", - "standardCode": { - "id": "Code_45329", - "extensionAttributes": [], - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_44", - "extensionAttributes": [], - "name": "SUSTDTC", - "label": "SUSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38043", - "standardCode": { - "id": "Code_45330", - "extensionAttributes": [], - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_45", - "extensionAttributes": [], - "name": "SUENDTC", - "label": "SUENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38044", - "standardCode": { - "id": "Code_45331", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_46", - "extensionAttributes": [], - "name": "SUSTRF", - "label": "SUSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38045", - "standardCode": { - "id": "Code_45332", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_47", - "extensionAttributes": [], - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38046", - "standardCode": { - "id": "Code_45333", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_48", - "extensionAttributes": [], - "name": "SUSTTPT", - "label": "SUSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38047", - "standardCode": { - "id": "Code_45334", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_49", - "extensionAttributes": [], - "name": "SUENRF", - "label": "SUENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38048", - "standardCode": { - "id": "Code_45335", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_50", - "extensionAttributes": [], - "name": "SUENRTPT", - "label": "SUENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38049", - "standardCode": { - "id": "Code_45336", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_51", - "extensionAttributes": [], - "name": "SUENTPT", - "label": "SUENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38050", - "standardCode": { - "id": "Code_45337", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24528", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28646", - "extensionAttributes": [], - "code": "C81229", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alcohol Use History", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_16", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_135", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CAFFEINEHX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Caffeine Use History", - "label": "Caffeine Use History", - "synonyms": [ - "Caffeine History", - "Caffeine Use" - ], - "reference": "/mdr/bc/biomedicalconcepts/C201990", - "properties": [ - { - "id": "BiomedicalConceptProperty_52", - "extensionAttributes": [], - "name": "SUTRT", - "label": "SUTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38051", - "standardCode": { - "id": "Code_45338", - "extensionAttributes": [], - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_53", - "extensionAttributes": [], - "name": "SUPRESP", - "label": "SUPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38052", - "standardCode": { - "id": "Code_45339", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_54", - "extensionAttributes": [], - "name": "SUOCCUR", - "label": "SUOCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38053", - "standardCode": { - "id": "Code_45340", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_55", - "extensionAttributes": [], - "name": "SUDOSE", - "label": "SUDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38054", - "standardCode": { - "id": "Code_45341", - "extensionAttributes": [], - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_56", - "extensionAttributes": [], - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38055", - "standardCode": { - "id": "Code_45342", - "extensionAttributes": [], - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_57", - "extensionAttributes": [], - "name": "SUDOSU", - "label": "SUDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38056", - "standardCode": { - "id": "Code_45343", - "extensionAttributes": [], - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_58", - "extensionAttributes": [], - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38057", - "standardCode": { - "id": "Code_45344", - "extensionAttributes": [], - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_59", - "extensionAttributes": [], - "name": "SUSTDTC", - "label": "SUSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38058", - "standardCode": { - "id": "Code_45345", - "extensionAttributes": [], - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_60", - "extensionAttributes": [], - "name": "SUENDTC", - "label": "SUENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38059", - "standardCode": { - "id": "Code_45346", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_61", - "extensionAttributes": [], - "name": "SUSTRF", - "label": "SUSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38060", - "standardCode": { - "id": "Code_45347", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_62", - "extensionAttributes": [], - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38061", - "standardCode": { - "id": "Code_45348", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_63", - "extensionAttributes": [], - "name": "SUSTTPT", - "label": "SUSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38062", - "standardCode": { - "id": "Code_45349", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_64", - "extensionAttributes": [], - "name": "SUENRF", - "label": "SUENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38063", - "standardCode": { - "id": "Code_45350", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_65", - "extensionAttributes": [], - "name": "SUENRTPT", - "label": "SUENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38064", - "standardCode": { - "id": "Code_45351", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_66", - "extensionAttributes": [], - "name": "SUENTPT", - "label": "SUENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38065", - "standardCode": { - "id": "Code_45352", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3157", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3367", - "extensionAttributes": [], - "code": "C201990", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Caffeine Use History", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_17", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_130", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CIGARHX", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_131", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CIGARETTEHX", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_132", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PIPEHX", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_133", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TOBACCOHX", - "instanceType": "ExtensionAttribute" - } - ], - "name": "History of Tobacco Use", - "label": "History of Tobacco Use", - "synonyms": [ - "Tobacco Use", - "Tobacco Use History" - ], - "reference": "/mdr/bc/biomedicalconcepts/C181760", - "properties": [ - { - "id": "BiomedicalConceptProperty_67", - "extensionAttributes": [], - "name": "SUTRT", - "label": "SUTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38066", - "standardCode": { - "id": "Code_45353", - "extensionAttributes": [], - "code": "C83092", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Reported Name", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_68", - "extensionAttributes": [], - "name": "SUPRESP", - "label": "SUPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38067", - "standardCode": { - "id": "Code_45354", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_69", - "extensionAttributes": [], - "name": "SUOCCUR", - "label": "SUOCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38068", - "standardCode": { - "id": "Code_45355", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_70", - "extensionAttributes": [], - "name": "SUDOSE", - "label": "SUDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38069", - "standardCode": { - "id": "Code_45356", - "extensionAttributes": [], - "code": "C83416", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_71", - "extensionAttributes": [], - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38070", - "standardCode": { - "id": "Code_45357", - "extensionAttributes": [], - "code": "C83041", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_72", - "extensionAttributes": [], - "name": "SUDOSU", - "label": "SUDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38071", - "standardCode": { - "id": "Code_45358", - "extensionAttributes": [], - "code": "C83038", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_73", - "extensionAttributes": [], - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38072", - "standardCode": { - "id": "Code_45359", - "extensionAttributes": [], - "code": "C83044", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_74", - "extensionAttributes": [], - "name": "SUSTDTC", - "label": "SUSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38073", - "standardCode": { - "id": "Code_45360", - "extensionAttributes": [], - "code": "C83431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_75", - "extensionAttributes": [], - "name": "SUENDTC", - "label": "SUENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38074", - "standardCode": { - "id": "Code_45361", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_76", - "extensionAttributes": [], - "name": "SUDUR", - "label": "SUDUR", - "isRequired": false, - "isEnabled": true, - "datatype": "durationDatetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38075", - "standardCode": { - "id": "Code_45362", - "extensionAttributes": [], - "code": "C83419", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Substance Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_77", - "extensionAttributes": [], - "name": "SUSTRF", - "label": "SUSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38076", - "standardCode": { - "id": "Code_45363", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_78", - "extensionAttributes": [], - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38077", - "standardCode": { - "id": "Code_45364", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_79", - "extensionAttributes": [], - "name": "SUSTTPT", - "label": "SUSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38078", - "standardCode": { - "id": "Code_45365", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_80", - "extensionAttributes": [], - "name": "SUENRF", - "label": "SUENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38079", - "standardCode": { - "id": "Code_45366", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_81", - "extensionAttributes": [], - "name": "SUENRTPT", - "label": "SUENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38080", - "standardCode": { - "id": "Code_45367", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_82", - "extensionAttributes": [], - "name": "SUENTPT", - "label": "SUENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38081", - "standardCode": { - "id": "Code_45368", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3158", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3368", - "extensionAttributes": [], - "code": "C181760", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "History of Tobacco Use", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_18", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_136", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/XRAY", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_137", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/XRAYCHEST", - "instanceType": "ExtensionAttribute" - } - ], - "name": "X-Ray Imaging", - "label": "X-Ray Imaging", - "synonyms": [ - "Conventional X-Ray", - "Medical Imaging", - "X-Ray", - "Static X-Ray" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38101", - "properties": [ - { - "id": "BiomedicalConceptProperty_83", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38082", - "standardCode": { - "id": "Code_45369", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_84", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3023", - "instanceType": "ResponseCode", - "name": "X-RAY", - "label": "X-RAY", - "isEnabled": true, - "code": { - "id": "Code_45371", - "extensionAttributes": [], - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "X-RAY", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38083", - "standardCode": { - "id": "Code_45370", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_85", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38085", - "standardCode": { - "id": "Code_45372", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_86", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38086", - "standardCode": { - "id": "Code_45373", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_87", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38087", - "standardCode": { - "id": "Code_45374", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_88", - "extensionAttributes": [], - "name": "PRLAT", - "label": "PRLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38088", - "standardCode": { - "id": "Code_45375", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_89", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38089", - "standardCode": { - "id": "Code_45376", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_90", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38090", - "standardCode": { - "id": "Code_45377", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_38008", - "extensionAttributes": [], - "standardCode": { - "id": "Code_45295", - "extensionAttributes": [], - "code": "C38101", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "X-Ray Imaging", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_19", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_138", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RAND", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Subject is Randomized", - "label": null, - "synonyms": [ - "Randomized" - ], - "reference": "/mdr/bc/biomedicalconcepts/C114209", - "properties": [ - { - "id": "BiomedicalConceptProperty_91", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3024", - "instanceType": "ResponseCode", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "isEnabled": true, - "code": { - "id": "Code_45379", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "RANDOMIZED", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38091", - "standardCode": { - "id": "Code_45378", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_92", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38093", - "standardCode": { - "id": "Code_45380", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_93", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38094", - "standardCode": { - "id": "Code_45381", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3160", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3370", - "extensionAttributes": [], - "code": "C114209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Subject is Randomized", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_20", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_9", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TEMP", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_145", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/TEMP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Temperature", - "label": "Body Temperature", - "synonyms": [ - "Temperature" - ], - "reference": "/mdr/bc/biomedicalconcepts/C174446", - "properties": [ - { - "id": "BiomedicalConceptProperty_94", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38095", - "standardCode": { - "id": "Code_45382", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_95", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38096", - "standardCode": { - "id": "Code_45383", - "extensionAttributes": [], - "code": "C44276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Temperature", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_96", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38097", - "standardCode": { - "id": "Code_45384", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_97", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38098", - "standardCode": { - "id": "Code_45385", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2640", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2850", - "extensionAttributes": [], - "code": "C174446", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_21", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_10", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WEIGHT", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_146", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/WEIGHT_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Weight", - "label": "Body Weight", - "synonyms": [ - "WEIGHT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81328", - "properties": [ - { - "id": "BiomedicalConceptProperty_98", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38099", - "standardCode": { - "id": "Code_45386", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_99", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38100", - "standardCode": { - "id": "Code_45387", - "extensionAttributes": [], - "code": "C48208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Weight", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_100", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38101", - "standardCode": { - "id": "Code_45388", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3161", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3371", - "extensionAttributes": [], - "code": "C81328", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Weight", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_22", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_11", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HEIGHT", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_147", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/HEIGHT_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Height", - "label": "Body Height", - "synonyms": [ - "HEIGHT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C164634", - "properties": [ - { - "id": "BiomedicalConceptProperty_101", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38102", - "standardCode": { - "id": "Code_45389", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_102", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38103", - "standardCode": { - "id": "Code_45390", - "extensionAttributes": [], - "code": "C168688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Height", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_103", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38104", - "standardCode": { - "id": "Code_45391", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24529", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28647", - "extensionAttributes": [], - "code": "C164634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Height", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_23", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_12", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PULSE", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_148", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/PULSE_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Pulse Rate", - "label": "Pulse Rate", - "synonyms": [ - "Pulse" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49676", - "properties": [ - { - "id": "BiomedicalConceptProperty_104", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38105", - "standardCode": { - "id": "Code_45392", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_105", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3025", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_45394", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38106", - "standardCode": { - "id": "Code_45393", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_106", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38108", - "standardCode": { - "id": "Code_45395", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_107", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38109", - "standardCode": { - "id": "Code_45396", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_108", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38110", - "standardCode": { - "id": "Code_45397", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_109", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38111", - "standardCode": { - "id": "Code_45398", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2664", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2874", - "extensionAttributes": [], - "code": "C49676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_24", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_13", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RESP", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_149", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/RESP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Respiratory Rate", - "label": "Respiratory Rate", - "synonyms": [ - "RESP", - "RESPRATE" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49678", - "properties": [ - { - "id": "BiomedicalConceptProperty_110", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38112", - "standardCode": { - "id": "Code_45399", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_111", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3026", - "instanceType": "ResponseCode", - "name": "breaths/min", - "label": "breaths/min", - "isEnabled": true, - "code": { - "id": "Code_45401", - "extensionAttributes": [], - "code": "C49674", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "breaths/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38113", - "standardCode": { - "id": "Code_45400", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_112", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38115", - "standardCode": { - "id": "Code_45402", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2680", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2890", - "extensionAttributes": [], - "code": "C49678", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "", - "decode": "VSTESTCD", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_25", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_14", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BMI", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_150", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/BMI_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Body Mass Index", - "label": "Body Mass Index", - "synonyms": [ - "BMI", - "Quetelet Index" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16358", - "properties": [ - { - "id": "BiomedicalConceptProperty_113", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38116", - "standardCode": { - "id": "Code_45403", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_114", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38117", - "standardCode": { - "id": "Code_45404", - "extensionAttributes": [], - "code": "C42575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Density", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_115", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38118", - "standardCode": { - "id": "Code_45405", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24530", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28648", - "extensionAttributes": [], - "code": "C16358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Body Mass Index", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_26", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_151", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/DIABP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - }, - { - "id": "ExtensionAttribute_152", - "url": "http://www.cdisc.org/usdm/extensions/specializations/crf", - "valueString": "/mdr/specializations/crf/specializations/SYSBP_DENORMALIZED", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Blood Pressure", - "label": "Blood Pressure", - "synonyms": [ - "BP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C54706", - "properties": [], - "code": { - "id": "AliasCode_3162", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3372", - "extensionAttributes": [], - "code": "C54706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_27", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_15", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGINTP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Electrocardiogram Analysis", - "label": "Electrocardiogram Analysis", - "synonyms": [ - "ECG Analysis", - "EKG Analysis", - "Electrocardiogram Interpretation", - "ECG Interpretation", - "EKG Interpretation" - ], - "reference": "/mdr/bc/biomedicalconcepts/C181655", - "properties": [ - { - "id": "BiomedicalConceptProperty_116", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38119", - "standardCode": { - "id": "Code_45406", - "extensionAttributes": [], - "code": "C125009", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinical Interpretation", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_117", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38120", - "standardCode": { - "id": "Code_45407", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_118", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38121", - "standardCode": { - "id": "Code_45408", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_119", - "extensionAttributes": [], - "name": "EGCLSIG", - "label": "EGCLSIG", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38122", - "standardCode": { - "id": "Code_45409", - "extensionAttributes": [], - "code": "C93532", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Clinically Significant Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_120", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38123", - "standardCode": { - "id": "Code_45410", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24531", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28649", - "extensionAttributes": [], - "code": "C181655", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Electrocardiogram Analysis", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_28", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_16", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AVCOND", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Atrioventricular Conduction ECG Assessment", - "label": "Atrioventricular Conduction ECG Assessment", - "synonyms": [ - "AVCOND", - "Atrioventricular Conduction" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111131", - "properties": [ - { - "id": "BiomedicalConceptProperty_121", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38124", - "standardCode": { - "id": "Code_45411", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_122", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38125", - "standardCode": { - "id": "Code_45412", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_123", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38126", - "standardCode": { - "id": "Code_45413", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_124", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38127", - "standardCode": { - "id": "Code_45414", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_125", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38128", - "standardCode": { - "id": "Code_45415", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24532", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28650", - "extensionAttributes": [], - "code": "C111131", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Atrioventricular Conduction ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_29", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_17", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AXISVOLT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Axis and Voltage ECG Assessment", - "label": "Axis and Voltage ECG Assessment", - "synonyms": [ - "AXISVOLT", - "Axis and Voltage" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111132", - "properties": [ - { - "id": "BiomedicalConceptProperty_126", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38129", - "standardCode": { - "id": "Code_45416", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_127", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38130", - "standardCode": { - "id": "Code_45417", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_128", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38131", - "standardCode": { - "id": "Code_45418", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_129", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38132", - "standardCode": { - "id": "Code_45419", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_130", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38133", - "standardCode": { - "id": "Code_45420", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24533", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28651", - "extensionAttributes": [], - "code": "C111132", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Axis and Voltage ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_30", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_18", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHYPTENL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Chamber Hypertrophy or Enlargement ECG Assessment", - "label": "Chamber Hypertrophy or Enlargement ECG Assessment", - "synonyms": [ - "CHYPTENL", - "Chamber Hypertrophy or Enlargement" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111155", - "properties": [ - { - "id": "BiomedicalConceptProperty_131", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38134", - "standardCode": { - "id": "Code_45421", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_132", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38135", - "standardCode": { - "id": "Code_45422", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_133", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38136", - "standardCode": { - "id": "Code_45423", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_134", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38137", - "standardCode": { - "id": "Code_45424", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_135", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38138", - "standardCode": { - "id": "Code_45425", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24534", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28652", - "extensionAttributes": [], - "code": "C111155", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Chamber Hypertrophy or Enlargement ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_31", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_19", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TECHQUAL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECG Technical Quality", - "label": "ECG Technical Quality", - "synonyms": [ - "TECHQUAL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117807", - "properties": [ - { - "id": "BiomedicalConceptProperty_136", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38139", - "standardCode": { - "id": "Code_45426", - "extensionAttributes": [], - "code": "C114120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ECG Recording Quality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_137", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38140", - "standardCode": { - "id": "Code_45427", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_138", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38141", - "standardCode": { - "id": "Code_45428", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_139", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38142", - "standardCode": { - "id": "Code_45429", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24535", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28653", - "extensionAttributes": [], - "code": "C117807", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "ECG Technical Quality", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_32", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_20", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/IVTIACD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Intraventricular and Intraatrial Conduction ECG Assessment", - "label": "Intraventricular and Intraatrial Conduction ECG Assessment", - "synonyms": [ - "IVTIACD", - "Intraventricular-Intraatrial Conduction" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111238", - "properties": [ - { - "id": "BiomedicalConceptProperty_140", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38143", - "standardCode": { - "id": "Code_45430", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_141", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38144", - "standardCode": { - "id": "Code_45431", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_142", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38145", - "standardCode": { - "id": "Code_45432", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_143", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38146", - "standardCode": { - "id": "Code_45433", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_144", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38147", - "standardCode": { - "id": "Code_45434", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24536", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28654", - "extensionAttributes": [], - "code": "C111238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Intraventricular and Intraatrial Conduction ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_33", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_21", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MI", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Myocardial Infarction ECG Assessment", - "label": "Myocardial Infarction ECG Assessment", - "synonyms": [ - "MI", - "Myocardial Infarction" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111280", - "properties": [ - { - "id": "BiomedicalConceptProperty_145", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38148", - "standardCode": { - "id": "Code_45435", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_146", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38149", - "standardCode": { - "id": "Code_45436", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_147", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38150", - "standardCode": { - "id": "Code_45437", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_148", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38151", - "standardCode": { - "id": "Code_45438", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24537", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28655", - "extensionAttributes": [], - "code": "C111280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Myocardial Infarction ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_34", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_22", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PACEMAKR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Pacemaker ECG Assessment", - "label": "Pacemaker ECG Assessment", - "synonyms": [ - "PACEMAKR", - "Pacemaker" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111285", - "properties": [ - { - "id": "BiomedicalConceptProperty_149", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38152", - "standardCode": { - "id": "Code_45439", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_150", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38153", - "standardCode": { - "id": "Code_45440", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_151", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38154", - "standardCode": { - "id": "Code_45441", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_152", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38155", - "standardCode": { - "id": "Code_45442", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_153", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38156", - "standardCode": { - "id": "Code_45443", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24538", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28656", - "extensionAttributes": [], - "code": "C111285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Pacemaker ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_35", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_23", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RHYNOS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Rhythm Not Otherwise Specified ECG Assessment", - "label": "Rhythm Not Otherwise Specified ECG Assessment", - "synonyms": [ - "RHYNOS", - "Rhythm Not Otherwise Specified" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111307", - "properties": [ - { - "id": "BiomedicalConceptProperty_154", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38157", - "standardCode": { - "id": "Code_45444", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_155", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38158", - "standardCode": { - "id": "Code_45445", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_156", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38159", - "standardCode": { - "id": "Code_45446", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_157", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38160", - "standardCode": { - "id": "Code_45447", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_158", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38161", - "standardCode": { - "id": "Code_45448", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24539", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28657", - "extensionAttributes": [], - "code": "C111307", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Rhythm Not Otherwise Specified ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_36", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_24", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/STSTWUW", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ST Segment, T wave, and U wave ECG Assessment", - "label": "ST Segment, T wave, and U wave ECG Assessment", - "synonyms": [ - "STSTWUW", - "ST Segment, T wave, and U wave" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111363", - "properties": [ - { - "id": "BiomedicalConceptProperty_159", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38162", - "standardCode": { - "id": "Code_45449", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_160", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38163", - "standardCode": { - "id": "Code_45450", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_161", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38164", - "standardCode": { - "id": "Code_45451", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_162", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38165", - "standardCode": { - "id": "Code_45452", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_163", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38166", - "standardCode": { - "id": "Code_45453", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24540", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28658", - "extensionAttributes": [], - "code": "C111363", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "ST Segment, T wave, and U wave ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_37", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_25", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SNRARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "label": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "synonyms": [ - "SNRARRY", - "Sinus Node Rhythms and Arrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111312", - "properties": [ - { - "id": "BiomedicalConceptProperty_164", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38167", - "standardCode": { - "id": "Code_45454", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_165", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38168", - "standardCode": { - "id": "Code_45455", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_166", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38169", - "standardCode": { - "id": "Code_45456", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_167", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38170", - "standardCode": { - "id": "Code_45457", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_168", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38171", - "standardCode": { - "id": "Code_45458", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24541", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28659", - "extensionAttributes": [], - "code": "C111312", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_38", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_26", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPRARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Supraventricular Arrhythmia ECG Assessment", - "label": "Supraventricular Arrhythmia ECG Assessment", - "synonyms": [ - "SPRARRY", - "Supraventricular Arrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111320", - "properties": [ - { - "id": "BiomedicalConceptProperty_169", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38172", - "standardCode": { - "id": "Code_45459", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_170", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38173", - "standardCode": { - "id": "Code_45460", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_171", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38174", - "standardCode": { - "id": "Code_45461", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_172", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38175", - "standardCode": { - "id": "Code_45462", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_173", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38176", - "standardCode": { - "id": "Code_45463", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24542", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28660", - "extensionAttributes": [], - "code": "C111320", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Arrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_39", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_27", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPRTARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Supraventricular Tachyarrhythmia ECG Assessment", - "label": "Supraventricular Tachyarrhythmia ECG Assessment", - "synonyms": [ - "SPRTARRY", - "Supraventricular Tachyarrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111321", - "properties": [ - { - "id": "BiomedicalConceptProperty_174", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38177", - "standardCode": { - "id": "Code_45464", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_175", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38178", - "standardCode": { - "id": "Code_45465", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_176", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38179", - "standardCode": { - "id": "Code_45466", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_177", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38180", - "standardCode": { - "id": "Code_45467", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_178", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38181", - "standardCode": { - "id": "Code_45468", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24543", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28661", - "extensionAttributes": [], - "code": "C111321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Supraventricular Tachyarrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_40", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_28", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PRAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate PR Interval", - "label": "Aggregate PR Interval", - "synonyms": [ - "PR Interval Aggregate", - "PQ Interval Aggregate", - "PRAG", - "PQAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117773", - "properties": [ - { - "id": "BiomedicalConceptProperty_179", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38182", - "standardCode": { - "id": "Code_45469", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_180", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38183", - "standardCode": { - "id": "Code_45470", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_181", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38184", - "standardCode": { - "id": "Code_45471", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_182", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38185", - "standardCode": { - "id": "Code_45472", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_183", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38186", - "standardCode": { - "id": "Code_45473", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_184", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38187", - "standardCode": { - "id": "Code_45474", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_185", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38188", - "standardCode": { - "id": "Code_45475", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24544", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28662", - "extensionAttributes": [], - "code": "C117773", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate PR Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_41", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_29", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QRSAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QRS Duration", - "label": "Aggregate QRS Duration", - "synonyms": [ - "QRS Aggregate Duration", - "QRSAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117779", - "properties": [ - { - "id": "BiomedicalConceptProperty_186", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38189", - "standardCode": { - "id": "Code_45476", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_187", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38190", - "standardCode": { - "id": "Code_45477", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_188", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38191", - "standardCode": { - "id": "Code_45478", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_189", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38192", - "standardCode": { - "id": "Code_45479", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_190", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38193", - "standardCode": { - "id": "Code_45480", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_191", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38194", - "standardCode": { - "id": "Code_45481", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_192", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38195", - "standardCode": { - "id": "Code_45482", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24545", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28663", - "extensionAttributes": [], - "code": "C117779", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QRS Duration", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_42", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_30", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QT Interval", - "label": "Aggregate QT Interval", - "synonyms": [ - "QT Interval Aggregate", - "QTAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117783", - "properties": [ - { - "id": "BiomedicalConceptProperty_193", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38196", - "standardCode": { - "id": "Code_45483", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_194", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38197", - "standardCode": { - "id": "Code_45484", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_195", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38198", - "standardCode": { - "id": "Code_45485", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_196", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38199", - "standardCode": { - "id": "Code_45486", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_197", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38200", - "standardCode": { - "id": "Code_45487", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_198", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38201", - "standardCode": { - "id": "Code_45488", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_199", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38202", - "standardCode": { - "id": "Code_45489", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24546", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28664", - "extensionAttributes": [], - "code": "C117783", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QT Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_43", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_31", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCBAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QTCB Interval", - "label": "Aggregate QTCB Interval", - "synonyms": [ - "QTCB Interval Aggregate", - "QTCBAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117784", - "properties": [ - { - "id": "BiomedicalConceptProperty_200", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38203", - "standardCode": { - "id": "Code_45490", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_201", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38204", - "standardCode": { - "id": "Code_45491", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_202", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38205", - "standardCode": { - "id": "Code_45492", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_203", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38206", - "standardCode": { - "id": "Code_45493", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_204", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38207", - "standardCode": { - "id": "Code_45494", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_205", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38208", - "standardCode": { - "id": "Code_45495", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_206", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38209", - "standardCode": { - "id": "Code_45496", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24547", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28665", - "extensionAttributes": [], - "code": "C117784", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCB Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_44", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_32", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCFAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate QTCF Interval", - "label": "Aggregate QTCF Interval", - "synonyms": [ - "QTCF Interval Aggregate", - "QTCFAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117786", - "properties": [ - { - "id": "BiomedicalConceptProperty_207", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38210", - "standardCode": { - "id": "Code_45497", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_208", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38211", - "standardCode": { - "id": "Code_45498", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_209", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38212", - "standardCode": { - "id": "Code_45499", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_210", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38213", - "standardCode": { - "id": "Code_45500", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_211", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38214", - "standardCode": { - "id": "Code_45501", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_212", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38215", - "standardCode": { - "id": "Code_45502", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_213", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38216", - "standardCode": { - "id": "Code_45503", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24548", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28666", - "extensionAttributes": [], - "code": "C117786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Aggregate QTCF Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_45", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_33", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RRAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aggregate RR Interval", - "label": "Aggregate RR Interval", - "synonyms": [ - "RR Interval Aggregate", - "RRAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117791", - "properties": [ - { - "id": "BiomedicalConceptProperty_214", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38217", - "standardCode": { - "id": "Code_45504", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_215", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38218", - "standardCode": { - "id": "Code_45505", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_216", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38219", - "standardCode": { - "id": "Code_45506", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_217", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38220", - "standardCode": { - "id": "Code_45507", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_218", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38221", - "standardCode": { - "id": "Code_45508", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_219", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38222", - "standardCode": { - "id": "Code_45509", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_220", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38223", - "standardCode": { - "id": "Code_45510", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24549", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28667", - "extensionAttributes": [], - "code": "C117791", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Aggregate RR Interval", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_46", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_34", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGHRMN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Mean Heart Rate by Electrocardiogram", - "label": "Mean Heart Rate by Electrocardiogram", - "synonyms": [ - "ECG Mean Heart Rate", - "EKG Mean Heart Rate", - "EGHRMN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C119259", - "properties": [ - { - "id": "BiomedicalConceptProperty_221", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38224", - "standardCode": { - "id": "Code_45511", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_222", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3027", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_45513", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38225", - "standardCode": { - "id": "Code_45512", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_223", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38227", - "standardCode": { - "id": "Code_45514", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_224", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38228", - "standardCode": { - "id": "Code_45515", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_225", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38229", - "standardCode": { - "id": "Code_45516", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_226", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38230", - "standardCode": { - "id": "Code_45517", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24550", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28668", - "extensionAttributes": [], - "code": "C119259", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Mean Heart Rate by Electrocardiogram", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_47", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_35", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QRS_AXIS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "QRS Axis", - "label": "QRS Axis", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C118165", - "properties": [ - { - "id": "BiomedicalConceptProperty_227", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38231", - "standardCode": { - "id": "Code_45518", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_228", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3028", - "instanceType": "ResponseCode", - "name": "deg", - "label": "deg", - "isEnabled": true, - "code": { - "id": "Code_45520", - "extensionAttributes": [], - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "deg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38232", - "standardCode": { - "id": "Code_45519", - "extensionAttributes": [], - "code": "C68667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Degree Unit of Plane Angle", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_229", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38234", - "standardCode": { - "id": "Code_45521", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_230", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38235", - "standardCode": { - "id": "Code_45522", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_231", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38236", - "standardCode": { - "id": "Code_45523", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_232", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38237", - "standardCode": { - "id": "Code_45524", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24551", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28669", - "extensionAttributes": [], - "code": "C118165", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QRS Axis", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_48", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_36", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/QTCUNSAG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "QTc Correction Method Unspecified, Aggregate", - "label": "QTc Correction Method Unspecified, Aggregate", - "synonyms": [ - "QTCUNSAG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C174285", - "properties": [ - { - "id": "BiomedicalConceptProperty_233", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38238", - "standardCode": { - "id": "Code_45525", - "extensionAttributes": [], - "code": "C25330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Duration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_234", - "extensionAttributes": [], - "name": "EGORRESU", - "label": "EGORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38239", - "standardCode": { - "id": "Code_45526", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_235", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38240", - "standardCode": { - "id": "Code_45527", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_236", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38241", - "standardCode": { - "id": "Code_45528", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_237", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38242", - "standardCode": { - "id": "Code_45529", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_238", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38243", - "standardCode": { - "id": "Code_45530", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_239", - "extensionAttributes": [], - "name": "EGENDTC", - "label": "EGENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38244", - "standardCode": { - "id": "Code_45531", - "extensionAttributes": [], - "code": "C82516", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24552", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28670", - "extensionAttributes": [], - "code": "C174285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "QTc Correction Method Unspecified, Aggregate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_49", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_37", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VTARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ventricular Arrhythmia ECG Assessment", - "label": "Ventricular Arrhythmia ECG Assessment", - "synonyms": [ - "VTARRY", - "Ventricular Arrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111330", - "properties": [ - { - "id": "BiomedicalConceptProperty_240", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38245", - "standardCode": { - "id": "Code_45532", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_241", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38246", - "standardCode": { - "id": "Code_45533", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_242", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38247", - "standardCode": { - "id": "Code_45534", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_243", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38248", - "standardCode": { - "id": "Code_45535", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_244", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38249", - "standardCode": { - "id": "Code_45536", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24553", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28671", - "extensionAttributes": [], - "code": "C111330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Arrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_50", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_38", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VTTARRY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ventricular Tachyarrhythmia ECG Assessment", - "label": "Ventricular Tachyarrhythmia ECG Assessment", - "synonyms": [ - "VTTARRY", - "Ventricular Tachyarrhythmias" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111331", - "properties": [ - { - "id": "BiomedicalConceptProperty_245", - "extensionAttributes": [], - "name": "EGORRES", - "label": "EGORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38250", - "standardCode": { - "id": "Code_45537", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_246", - "extensionAttributes": [], - "name": "EGPOS", - "label": "EGPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38251", - "standardCode": { - "id": "Code_45538", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_247", - "extensionAttributes": [], - "name": "EGMETHOD", - "label": "EGMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38252", - "standardCode": { - "id": "Code_45539", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_248", - "extensionAttributes": [], - "name": "EGEVAL", - "label": "EGEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38253", - "standardCode": { - "id": "Code_45540", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_249", - "extensionAttributes": [], - "name": "EGDTC", - "label": "EGDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38254", - "standardCode": { - "id": "Code_45541", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24554", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28672", - "extensionAttributes": [], - "code": "C111331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-17", - "decode": "Ventricular Tachyarrhythmia ECG Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_51", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_39", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CTSCANCHEST", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Computed Tomography", - "label": "Computed Tomography", - "synonyms": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "id": "BiomedicalConceptProperty_250", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38255", - "standardCode": { - "id": "Code_45542", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_251", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3029", - "instanceType": "ResponseCode", - "name": "CT SCAN", - "label": "CT SCAN", - "isEnabled": true, - "code": { - "id": "Code_45544", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "CT SCAN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38256", - "standardCode": { - "id": "Code_45543", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_252", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38258", - "standardCode": { - "id": "Code_45545", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_253", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38259", - "standardCode": { - "id": "Code_45546", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_254", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3030", - "instanceType": "ResponseCode", - "name": "CHEST", - "label": "CHEST", - "isEnabled": true, - "code": { - "id": "Code_45548", - "extensionAttributes": [], - "code": "C25389", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "CHEST", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38260", - "standardCode": { - "id": "Code_45547", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_255", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38262", - "standardCode": { - "id": "Code_45549", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_256", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38263", - "standardCode": { - "id": "Code_45550", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-07-14", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_28017", - "extensionAttributes": [], - "standardCode": { - "id": "Code_32135", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_52", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_40", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MRIBRAIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "synonyms": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "id": "BiomedicalConceptProperty_257", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38264", - "standardCode": { - "id": "Code_45551", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_258", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3031", - "instanceType": "ResponseCode", - "name": "MRI", - "label": "MRI", - "isEnabled": true, - "code": { - "id": "Code_45553", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38265", - "standardCode": { - "id": "Code_45552", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_259", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38267", - "standardCode": { - "id": "Code_45554", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_260", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38268", - "standardCode": { - "id": "Code_45555", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_261", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3032", - "instanceType": "ResponseCode", - "name": "BRAIN", - "label": "BRAIN", - "isEnabled": true, - "code": { - "id": "Code_45557", - "extensionAttributes": [], - "code": "C12439", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "BRAIN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38269", - "standardCode": { - "id": "Code_45556", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_262", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38271", - "standardCode": { - "id": "Code_45558", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_263", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38272", - "standardCode": { - "id": "Code_45559", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_15783", - "extensionAttributes": [], - "standardCode": { - "id": "Code_16598", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_54", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "synonyms": [ - "CMYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83056", - "properties": [ - { - "id": "BiomedicalConceptProperty_264", - "extensionAttributes": [], - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38273", - "standardCode": { - "id": "Code_45560", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_265", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38274", - "standardCode": { - "id": "Code_45561", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24555", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28673", - "extensionAttributes": [], - "code": "C83056", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_55", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_41", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CMFREE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "synonyms": [ - "Concomitant Medication" - ], - "reference": "/mdr/bc/biomedicalconcepts/C53630", - "properties": [ - { - "id": "BiomedicalConceptProperty_266", - "extensionAttributes": [], - "name": "CMTRT", - "label": "CMTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38275", - "standardCode": { - "id": "Code_45562", - "extensionAttributes": [], - "code": "C70902", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Agent", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_267", - "extensionAttributes": [], - "name": "CMDECOD", - "label": "CMDECOD", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38276", - "standardCode": { - "id": "Code_45563", - "extensionAttributes": [], - "code": "C83345", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_268", - "extensionAttributes": [], - "name": "CMCLAS", - "label": "CMCLAS", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38277", - "standardCode": { - "id": "Code_45564", - "extensionAttributes": [], - "code": "C83219", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Class", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_269", - "extensionAttributes": [], - "name": "CMINDC", - "label": "CMINDC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38278", - "standardCode": { - "id": "Code_45565", - "extensionAttributes": [], - "code": "C83085", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Indication", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_270", - "extensionAttributes": [], - "name": "CMDOSE", - "label": "CMDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38279", - "standardCode": { - "id": "Code_45566", - "extensionAttributes": [], - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_271", - "extensionAttributes": [], - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38280", - "standardCode": { - "id": "Code_45567", - "extensionAttributes": [], - "code": "C83221", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_272", - "extensionAttributes": [], - "name": "CMDOSU", - "label": "CMDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38281", - "standardCode": { - "id": "Code_45568", - "extensionAttributes": [], - "code": "C83034", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_273", - "extensionAttributes": [], - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38282", - "standardCode": { - "id": "Code_45569", - "extensionAttributes": [], - "code": "C83110", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Form", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_274", - "extensionAttributes": [], - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38283", - "standardCode": { - "id": "Code_45570", - "extensionAttributes": [], - "code": "C83042", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_275", - "extensionAttributes": [], - "name": "CMROUTE", - "label": "CMROUTE", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38284", - "standardCode": { - "id": "Code_45571", - "extensionAttributes": [], - "code": "C83120", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Route of Administration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_276", - "extensionAttributes": [], - "name": "CMSTDTC", - "label": "CMSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38285", - "standardCode": { - "id": "Code_45572", - "extensionAttributes": [], - "code": "C83235", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_277", - "extensionAttributes": [], - "name": "CMENDTC", - "label": "CMENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38286", - "standardCode": { - "id": "Code_45573", - "extensionAttributes": [], - "code": "C83225", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_278", - "extensionAttributes": [], - "name": "CMSTRF", - "label": "CMSTRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38287", - "standardCode": { - "id": "Code_45574", - "extensionAttributes": [], - "code": "C82559", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_279", - "extensionAttributes": [], - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38288", - "standardCode": { - "id": "Code_45575", - "extensionAttributes": [], - "code": "C82560", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Start Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_280", - "extensionAttributes": [], - "name": "CMSTTPT", - "label": "CMSTTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38289", - "standardCode": { - "id": "Code_45576", - "extensionAttributes": [], - "code": "C82575", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference Start Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_281", - "extensionAttributes": [], - "name": "CMENRF", - "label": "CMENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38290", - "standardCode": { - "id": "Code_45577", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_282", - "extensionAttributes": [], - "name": "CMENRTPT", - "label": "CMENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38291", - "standardCode": { - "id": "Code_45578", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_283", - "extensionAttributes": [], - "name": "CMENTPT", - "label": "CMENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38292", - "standardCode": { - "id": "Code_45579", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24556", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28674", - "extensionAttributes": [], - "code": "C53630", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Concomitant Therapy", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_56", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_42", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HGBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hemoglobin Measurement", - "label": "Hemoglobin Measurement", - "synonyms": [ - "Hemoglobin", - "HGB" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64848", - "properties": [ - { - "id": "BiomedicalConceptProperty_284", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38293", - "standardCode": { - "id": "Code_45580", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_285", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38294", - "standardCode": { - "id": "Code_45581", - "extensionAttributes": [], - "code": "C64571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_286", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3033", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45583", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38295", - "standardCode": { - "id": "Code_45582", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_287", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38297", - "standardCode": { - "id": "Code_45584", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_288", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38298", - "standardCode": { - "id": "Code_45585", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24557", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28675", - "extensionAttributes": [], - "code": "C64848", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_57", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_43", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HCTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hematocrit Measurement", - "label": "Hematocrit Measurement", - "synonyms": [ - "Hematocrit", - "Packed Cell Volume", - "PCV", - "Erythrocyte Volume Fraction", - "EVF" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64796", - "properties": [ - { - "id": "BiomedicalConceptProperty_289", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38299", - "standardCode": { - "id": "Code_45586", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_290", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38300", - "standardCode": { - "id": "Code_45587", - "extensionAttributes": [], - "code": "C69174", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume Fraction", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_291", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3034", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45589", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38301", - "standardCode": { - "id": "Code_45588", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_292", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38303", - "standardCode": { - "id": "Code_45590", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_293", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38304", - "standardCode": { - "id": "Code_45591", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24558", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28676", - "extensionAttributes": [], - "code": "C64796", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hematocrit Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_58", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_44", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/RBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "synonyms": [ - "RBC", - "Red Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51946", - "properties": [ - { - "id": "BiomedicalConceptProperty_294", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38305", - "standardCode": { - "id": "Code_45592", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_295", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38306", - "standardCode": { - "id": "Code_45593", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_296", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3035", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45595", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38307", - "standardCode": { - "id": "Code_45594", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_297", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38309", - "standardCode": { - "id": "Code_45596", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_298", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38310", - "standardCode": { - "id": "Code_45597", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24559", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28677", - "extensionAttributes": [], - "code": "C51946", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Erythrocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_59", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_45", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MCH", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Mean Corpuscular Hemoglobin", - "label": "Erythrocyte Mean Corpuscular Hemoglobin", - "synonyms": [ - "RBC Mean Corpuscular Hemoglobin", - "MCH" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64797", - "properties": [ - { - "id": "BiomedicalConceptProperty_299", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38311", - "standardCode": { - "id": "Code_45598", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_300", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38312", - "standardCode": { - "id": "Code_45599", - "extensionAttributes": [], - "code": "C25709", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Measure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_301", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3036", - "instanceType": "ResponseCode", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "isEnabled": true, - "code": { - "id": "Code_45601", - "extensionAttributes": [], - "code": "C12521", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ERYTHROCYTES", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38313", - "standardCode": { - "id": "Code_45600", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_302", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38315", - "standardCode": { - "id": "Code_45602", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_303", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38316", - "standardCode": { - "id": "Code_45603", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24560", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28678", - "extensionAttributes": [], - "code": "C64797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Hemoglobin", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_60", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_46", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MCV", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Erythrocyte Mean Corpuscular Volume", - "label": "Erythrocyte Mean Corpuscular Volume", - "synonyms": [ - "RBC Mean Corpuscular Volume", - "MCV" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64799", - "properties": [ - { - "id": "BiomedicalConceptProperty_304", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38317", - "standardCode": { - "id": "Code_45604", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_305", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3037", - "instanceType": "ResponseCode", - "name": "fL", - "label": "fL", - "isEnabled": true, - "code": { - "id": "Code_45606", - "extensionAttributes": [], - "code": "C64780", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "fL", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38318", - "standardCode": { - "id": "Code_45605", - "extensionAttributes": [], - "code": "C44279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Volume", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_306", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3038", - "instanceType": "ResponseCode", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "isEnabled": true, - "code": { - "id": "Code_45608", - "extensionAttributes": [], - "code": "C12521", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "ERYTHROCYTES", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38320", - "standardCode": { - "id": "Code_45607", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_307", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38322", - "standardCode": { - "id": "Code_45609", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_308", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38323", - "standardCode": { - "id": "Code_45610", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24561", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28679", - "extensionAttributes": [], - "code": "C64799", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Volume", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_61", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_47", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/WBCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "synonyms": [ - "WBC", - "White Blood Cells" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51948", - "properties": [ - { - "id": "BiomedicalConceptProperty_309", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38324", - "standardCode": { - "id": "Code_45611", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_310", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38325", - "standardCode": { - "id": "Code_45612", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_311", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3039", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45614", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38326", - "standardCode": { - "id": "Code_45613", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_312", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38328", - "standardCode": { - "id": "Code_45615", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_313", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38329", - "standardCode": { - "id": "Code_45616", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24562", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28680", - "extensionAttributes": [], - "code": "C51948", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Leukocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_62", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_48", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTSGBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Segmented Neutrophil Count", - "label": "Segmented Neutrophil Count", - "synonyms": [ - "Segmented Neutrophils", - "NEUTSG" - ], - "reference": "/mdr/bc/biomedicalconcepts/C81997", - "properties": [ - { - "id": "BiomedicalConceptProperty_314", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38330", - "standardCode": { - "id": "Code_45617", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_315", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3040", - "instanceType": "ResponseCode", - "name": "10^9/L", - "label": "10^9/L", - "isEnabled": true, - "code": { - "id": "Code_45619", - "extensionAttributes": [], - "code": "C67255", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^9/L", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38331", - "standardCode": { - "id": "Code_45618", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_316", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3041", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45621", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38333", - "standardCode": { - "id": "Code_45620", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_317", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38335", - "standardCode": { - "id": "Code_45622", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_318", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38336", - "standardCode": { - "id": "Code_45623", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24563", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28681", - "extensionAttributes": [], - "code": "C81997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Segmented Neutrophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_63", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_49", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Neutrophil Band Form Count", - "label": "Neutrophil Band Form Count", - "synonyms": [ - "Neutrophil Bands", - "Bands", - "NEUTB" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64830", - "properties": [ - { - "id": "BiomedicalConceptProperty_319", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38337", - "standardCode": { - "id": "Code_45624", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_320", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3042", - "instanceType": "ResponseCode", - "name": "10^6/L", - "label": "10^6/L", - "isEnabled": true, - "code": { - "id": "Code_45626", - "extensionAttributes": [], - "code": "C67452", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^6/L", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38338", - "standardCode": { - "id": "Code_45625", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_321", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3043", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45628", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38340", - "standardCode": { - "id": "Code_45627", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_322", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38342", - "standardCode": { - "id": "Code_45629", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_323", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38343", - "standardCode": { - "id": "Code_45630", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24564", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28682", - "extensionAttributes": [], - "code": "C64830", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Neutrophil Band Form Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_64", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_50", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NEUTBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Absolute Neutrophil Count", - "label": "Absolute Neutrophil Count", - "synonyms": [ - "Neutrophils", - "Total Neutrophil Count", - "NEUT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C63321", - "properties": [ - { - "id": "BiomedicalConceptProperty_324", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38344", - "standardCode": { - "id": "Code_45631", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_325", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3044", - "instanceType": "ResponseCode", - "name": "10^9/L", - "label": "10^9/L", - "isEnabled": true, - "code": { - "id": "Code_45633", - "extensionAttributes": [], - "code": "C67255", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "10^9/L", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38345", - "standardCode": { - "id": "Code_45632", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_326", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3045", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45635", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38347", - "standardCode": { - "id": "Code_45634", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_327", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38349", - "standardCode": { - "id": "Code_45636", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_328", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38350", - "standardCode": { - "id": "Code_45637", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24565", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28683", - "extensionAttributes": [], - "code": "C63321", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Neutrophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_65", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_51", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MONOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Monocyte Count", - "label": "Monocyte Count", - "synonyms": [ - "Monocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64823", - "properties": [ - { - "id": "BiomedicalConceptProperty_329", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38351", - "standardCode": { - "id": "Code_45638", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_330", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38352", - "standardCode": { - "id": "Code_45639", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_331", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3046", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45641", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38353", - "standardCode": { - "id": "Code_45640", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_332", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38355", - "standardCode": { - "id": "Code_45642", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_333", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38356", - "standardCode": { - "id": "Code_45643", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24566", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28684", - "extensionAttributes": [], - "code": "C64823", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Monocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_66", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_52", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EOSBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Eosinophil Count", - "label": "Eosinophil Count", - "synonyms": [ - "Eosinophils" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64550", - "properties": [ - { - "id": "BiomedicalConceptProperty_334", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38357", - "standardCode": { - "id": "Code_45644", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_335", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38358", - "standardCode": { - "id": "Code_45645", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_336", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3047", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45647", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38359", - "standardCode": { - "id": "Code_45646", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_337", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38361", - "standardCode": { - "id": "Code_45648", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_338", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38362", - "standardCode": { - "id": "Code_45649", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24567", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28685", - "extensionAttributes": [], - "code": "C64550", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Eosinophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_67", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_53", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BASOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Absolute Basophil Count", - "label": "Absolute Basophil Count", - "synonyms": [ - "Basophils", - "Total Basophil Count" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64470", - "properties": [ - { - "id": "BiomedicalConceptProperty_339", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38363", - "standardCode": { - "id": "Code_45650", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_340", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38364", - "standardCode": { - "id": "Code_45651", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_341", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3048", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45653", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38365", - "standardCode": { - "id": "Code_45652", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_342", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38367", - "standardCode": { - "id": "Code_45654", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_343", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38368", - "standardCode": { - "id": "Code_45655", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3354", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3564", - "extensionAttributes": [], - "code": "C64470", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Absolute Basophil Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_68", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_54", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PLATBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Platelet Count", - "label": "Platelet Count", - "synonyms": [ - "Thrombocytes", - "Platelets", - "Anucleated Thrombocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C51951", - "properties": [ - { - "id": "BiomedicalConceptProperty_344", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38369", - "standardCode": { - "id": "Code_45656", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_345", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38370", - "standardCode": { - "id": "Code_45657", - "extensionAttributes": [], - "code": "C67391", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Number Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_346", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3049", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45659", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38371", - "standardCode": { - "id": "Code_45658", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_347", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38373", - "standardCode": { - "id": "Code_45660", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_348", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38374", - "standardCode": { - "id": "Code_45661", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24568", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28686", - "extensionAttributes": [], - "code": "C51951", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Platelet Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_69", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_55", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MICROCYBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Microcyte Count", - "label": "Microcyte Count", - "synonyms": [ - "Microcytes", - "MICROCY" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64822", - "properties": [ - { - "id": "BiomedicalConceptProperty_349", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38375", - "standardCode": { - "id": "Code_45662", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_350", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3050", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45664", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38376", - "standardCode": { - "id": "Code_45663", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_351", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38378", - "standardCode": { - "id": "Code_45665", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_352", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38379", - "standardCode": { - "id": "Code_45666", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24569", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28687", - "extensionAttributes": [], - "code": "C64822", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Microcyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_70", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_56", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MACROCYBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Macrocyte Count", - "label": "Macrocyte Count", - "synonyms": [ - "Macrocytes", - "MACROCY" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64821", - "properties": [ - { - "id": "BiomedicalConceptProperty_353", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38380", - "standardCode": { - "id": "Code_45667", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_354", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3051", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45669", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38381", - "standardCode": { - "id": "Code_45668", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_355", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38383", - "standardCode": { - "id": "Code_45670", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_356", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38384", - "standardCode": { - "id": "Code_45671", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24570", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28688", - "extensionAttributes": [], - "code": "C64821", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Macrocyte Count", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_71", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_57", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ANISOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Anisocyte Measurement", - "label": "Anisocyte Measurement", - "synonyms": [ - "Anisocytes", - "Anisocytosis", - "ANISO" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74797", - "properties": [ - { - "id": "BiomedicalConceptProperty_357", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38385", - "standardCode": { - "id": "Code_45672", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_358", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3052", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45674", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38386", - "standardCode": { - "id": "Code_45673", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_359", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38388", - "standardCode": { - "id": "Code_45675", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_360", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38389", - "standardCode": { - "id": "Code_45676", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24571", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28689", - "extensionAttributes": [], - "code": "C74797", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anisocyte Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_72", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_58", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/POIKILOBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Poikilocyte Measurement", - "label": "Poikilocyte Measurement", - "synonyms": [ - "POIKILO", - "Poikilocytes" - ], - "reference": "/mdr/bc/biomedicalconcepts/C79602", - "properties": [ - { - "id": "BiomedicalConceptProperty_361", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38390", - "standardCode": { - "id": "Code_45677", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_362", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3053", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45679", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38391", - "standardCode": { - "id": "Code_45678", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_363", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38393", - "standardCode": { - "id": "Code_45680", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_364", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38394", - "standardCode": { - "id": "Code_45681", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24572", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28690", - "extensionAttributes": [], - "code": "C79602", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Poikilocyte Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_73", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_59", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/POLYCHRBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Polychromasia", - "label": "Polychromasia", - "synonyms": [ - "POLYCHR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64803", - "properties": [ - { - "id": "BiomedicalConceptProperty_365", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38395", - "standardCode": { - "id": "Code_45682", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_366", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3054", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45684", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38396", - "standardCode": { - "id": "Code_45683", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_367", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38398", - "standardCode": { - "id": "Code_45685", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_368", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38399", - "standardCode": { - "id": "Code_45686", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24573", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28691", - "extensionAttributes": [], - "code": "C64803", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Polychromasia", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_74", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_60", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "synonyms": [ - "ALT", - "SGPT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64433", - "properties": [ - { - "id": "BiomedicalConceptProperty_369", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38400", - "standardCode": { - "id": "Code_45687", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_370", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38401", - "standardCode": { - "id": "Code_45688", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_371", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3055", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45690", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38402", - "standardCode": { - "id": "Code_45689", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_372", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38404", - "standardCode": { - "id": "Code_45691", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_373", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38405", - "standardCode": { - "id": "Code_45692", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24574", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28692", - "extensionAttributes": [], - "code": "C64433", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_75", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_61", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "synonyms": [ - "Albumin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64431", - "properties": [ - { - "id": "BiomedicalConceptProperty_374", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38406", - "standardCode": { - "id": "Code_45693", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_375", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38407", - "standardCode": { - "id": "Code_45694", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_376", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3056", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45696", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38408", - "standardCode": { - "id": "Code_45695", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_377", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38410", - "standardCode": { - "id": "Code_45697", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_378", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38411", - "standardCode": { - "id": "Code_45698", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24575", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28693", - "extensionAttributes": [], - "code": "C64431", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Albumin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_76", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_62", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "synonyms": [ - "Alkaline Phosphatase" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64432", - "properties": [ - { - "id": "BiomedicalConceptProperty_379", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38412", - "standardCode": { - "id": "Code_45699", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_380", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38413", - "standardCode": { - "id": "Code_45700", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_381", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3057", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45702", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38414", - "standardCode": { - "id": "Code_45701", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_382", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38416", - "standardCode": { - "id": "Code_45703", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_383", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38417", - "standardCode": { - "id": "Code_45704", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24576", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28694", - "extensionAttributes": [], - "code": "C64432", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_77", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_63", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "synonyms": [ - "AST", - "SGOT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64467", - "properties": [ - { - "id": "BiomedicalConceptProperty_384", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38418", - "standardCode": { - "id": "Code_45705", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_385", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38419", - "standardCode": { - "id": "Code_45706", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_386", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3058", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45708", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38420", - "standardCode": { - "id": "Code_45707", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_387", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38422", - "standardCode": { - "id": "Code_45709", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_388", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38423", - "standardCode": { - "id": "Code_45710", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24577", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28695", - "extensionAttributes": [], - "code": "C64467", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_78", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_64", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "synonyms": [ - "Creatinine" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64547", - "properties": [ - { - "id": "BiomedicalConceptProperty_389", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38424", - "standardCode": { - "id": "Code_45711", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_390", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38425", - "standardCode": { - "id": "Code_45712", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_391", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3059", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45714", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38426", - "standardCode": { - "id": "Code_45713", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_392", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38428", - "standardCode": { - "id": "Code_45715", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_393", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38429", - "standardCode": { - "id": "Code_45716", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3355", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3565", - "extensionAttributes": [], - "code": "C64547", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Creatinine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_79", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_65", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/KBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "synonyms": [ - "Potassium", - "K" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64853", - "properties": [ - { - "id": "BiomedicalConceptProperty_394", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38430", - "standardCode": { - "id": "Code_45717", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_395", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38431", - "standardCode": { - "id": "Code_45718", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_396", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3060", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45720", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38432", - "standardCode": { - "id": "Code_45719", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_397", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38434", - "standardCode": { - "id": "Code_45721", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_398", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38435", - "standardCode": { - "id": "Code_45722", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24578", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28696", - "extensionAttributes": [], - "code": "C64853", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Potassium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_80", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_66", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "synonyms": [ - "Sodium", - "NA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64809", - "properties": [ - { - "id": "BiomedicalConceptProperty_399", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38436", - "standardCode": { - "id": "Code_45723", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_400", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38437", - "standardCode": { - "id": "Code_45724", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_401", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3061", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45726", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38438", - "standardCode": { - "id": "Code_45725", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_402", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38440", - "standardCode": { - "id": "Code_45727", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_403", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38441", - "standardCode": { - "id": "Code_45728", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24579", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28697", - "extensionAttributes": [], - "code": "C64809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Sodium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_81", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_67", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "synonyms": [ - "Urea Nitrogen" - ], - "reference": "/mdr/bc/biomedicalconcepts/C125949", - "properties": [ - { - "id": "BiomedicalConceptProperty_404", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38442", - "standardCode": { - "id": "Code_45729", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_405", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38443", - "standardCode": { - "id": "Code_45730", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_406", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3062", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45732", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38444", - "standardCode": { - "id": "Code_45731", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_407", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38446", - "standardCode": { - "id": "Code_45733", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_408", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38447", - "standardCode": { - "id": "Code_45734", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24580", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28698", - "extensionAttributes": [], - "code": "C125949", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urea Nitrogen Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_82", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_68", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BICARBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Bicarbonate Measurement", - "label": "Bicarbonate Measurement", - "synonyms": [ - "Bicarbonate", - "HCO3" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74667", - "properties": [ - { - "id": "BiomedicalConceptProperty_419", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38460", - "standardCode": { - "id": "Code_45747", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_420", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38461", - "standardCode": { - "id": "Code_45748", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_421", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3065", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45750", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38462", - "standardCode": { - "id": "Code_45749", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_422", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38464", - "standardCode": { - "id": "Code_45751", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_423", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38465", - "standardCode": { - "id": "Code_45752", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24581", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28699", - "extensionAttributes": [], - "code": "C74667", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Bicarbonate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_83", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_69", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CLBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "synonyms": [ - "Chloride", - "CL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64495", - "properties": [ - { - "id": "BiomedicalConceptProperty_429", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38472", - "standardCode": { - "id": "Code_45759", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_430", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38473", - "standardCode": { - "id": "Code_45760", - "extensionAttributes": [], - "code": "C64567", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Molarity Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_431", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3067", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45762", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38474", - "standardCode": { - "id": "Code_45761", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_432", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38476", - "standardCode": { - "id": "Code_45763", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_433", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38477", - "standardCode": { - "id": "Code_45764", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24582", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28700", - "extensionAttributes": [], - "code": "C64495", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Chloride Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_84", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_70", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "synonyms": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "id": "BiomedicalConceptProperty_439", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38484", - "standardCode": { - "id": "Code_45771", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_440", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38485", - "standardCode": { - "id": "Code_45772", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_441", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3069", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45774", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38486", - "standardCode": { - "id": "Code_45773", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_442", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38488", - "standardCode": { - "id": "Code_45775", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_443", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38489", - "standardCode": { - "id": "Code_45776", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24583", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28701", - "extensionAttributes": [], - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_85", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_71", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GGTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Gamma Glutamyl Transpeptidase Measurement", - "label": "Gamma Glutamyl Transpeptidase Measurement", - "synonyms": [ - "Gamma Glutamyl Transferase", - "GGT", - "GGTP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64847", - "properties": [ - { - "id": "BiomedicalConceptProperty_449", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38496", - "standardCode": { - "id": "Code_45783", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_450", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38497", - "standardCode": { - "id": "Code_45784", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_451", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3071", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45786", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38498", - "standardCode": { - "id": "Code_45785", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_452", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38500", - "standardCode": { - "id": "Code_45787", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_453", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38501", - "standardCode": { - "id": "Code_45788", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_37996", - "extensionAttributes": [], - "standardCode": { - "id": "Code_45283", - "extensionAttributes": [], - "code": "C64847", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Gamma Glutamyl Transpeptidase Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_86", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_72", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/URATESERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urate Measurement", - "label": "Urate Measurement", - "synonyms": [ - "Urate", - "Uric Acid" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64814", - "properties": [ - { - "id": "BiomedicalConceptProperty_459", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38508", - "standardCode": { - "id": "Code_45795", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_460", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38509", - "standardCode": { - "id": "Code_45796", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_461", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3073", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45798", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38510", - "standardCode": { - "id": "Code_45797", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_462", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38512", - "standardCode": { - "id": "Code_45799", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_463", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38513", - "standardCode": { - "id": "Code_45800", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24584", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28702", - "extensionAttributes": [], - "code": "C64814", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_87", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_73", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHOSSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Phosphate Measurement", - "label": "Phosphate Measurement", - "synonyms": [ - "Phosphorus", - "Phosphate" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64857", - "properties": [ - { - "id": "BiomedicalConceptProperty_469", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38520", - "standardCode": { - "id": "Code_45807", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_470", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38521", - "standardCode": { - "id": "Code_45808", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_471", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3075", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45810", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38522", - "standardCode": { - "id": "Code_45809", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_472", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38524", - "standardCode": { - "id": "Code_45811", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_473", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38525", - "standardCode": { - "id": "Code_45812", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24585", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28703", - "extensionAttributes": [], - "code": "C64857", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Phosphate Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_88", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_74", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CABLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "synonyms": [ - "Calcium", - "CA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64488", - "properties": [ - { - "id": "BiomedicalConceptProperty_480", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38533", - "standardCode": { - "id": "Code_45820", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_481", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38534", - "standardCode": { - "id": "Code_45821", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_482", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3077", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45823", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38535", - "standardCode": { - "id": "Code_45822", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_483", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38537", - "standardCode": { - "id": "Code_45824", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_484", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38538", - "standardCode": { - "id": "Code_45825", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24586", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28704", - "extensionAttributes": [], - "code": "C64488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Calcium Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_89", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_75", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "synonyms": [ - "Glucose" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "id": "BiomedicalConceptProperty_495", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38551", - "standardCode": { - "id": "Code_45838", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_496", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38552", - "standardCode": { - "id": "Code_45839", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_497", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3080", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45841", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38553", - "standardCode": { - "id": "Code_45840", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_498", - "extensionAttributes": [], - "name": "LBMETHOD", - "label": "LBMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38555", - "standardCode": { - "id": "Code_45842", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_499", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38556", - "standardCode": { - "id": "Code_45843", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_500", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38557", - "standardCode": { - "id": "Code_45844", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24587", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28705", - "extensionAttributes": [], - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_90", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_76", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "synonyms": [ - "Protein" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "id": "BiomedicalConceptProperty_506", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38564", - "standardCode": { - "id": "Code_45851", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_507", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38565", - "standardCode": { - "id": "Code_45852", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_508", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3082", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45854", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38566", - "standardCode": { - "id": "Code_45853", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_509", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38568", - "standardCode": { - "id": "Code_45855", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_510", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38569", - "standardCode": { - "id": "Code_45856", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24588", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28706", - "extensionAttributes": [], - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_91", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_77", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "synonyms": [ - "CHOL", - "Cholesterol", - "Total Cholesterol" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105586", - "properties": [ - { - "id": "BiomedicalConceptProperty_516", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38576", - "standardCode": { - "id": "Code_45863", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_517", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38577", - "standardCode": { - "id": "Code_45864", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_518", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3084", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45866", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38578", - "standardCode": { - "id": "Code_45865", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_519", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38580", - "standardCode": { - "id": "Code_45867", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_520", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38581", - "standardCode": { - "id": "Code_45868", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24589", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28707", - "extensionAttributes": [], - "code": "C105586", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Cholesterol Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_92", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_78", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T3UPSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Triiodothyronine Uptake Measurement", - "label": "Triiodothyronine Uptake Measurement", - "synonyms": [ - "T3UP", - "T3U", - "Triiodothyronine Resin Uptake" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74748", - "properties": [ - { - "id": "BiomedicalConceptProperty_526", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38588", - "standardCode": { - "id": "Code_45875", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_527", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38589", - "standardCode": { - "id": "Code_45876", - "extensionAttributes": [], - "code": "C48570", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Percent Unit", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_528", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3086", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45878", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38590", - "standardCode": { - "id": "Code_45877", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_529", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38592", - "standardCode": { - "id": "Code_45879", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_530", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38593", - "standardCode": { - "id": "Code_45880", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24590", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28708", - "extensionAttributes": [], - "code": "C74748", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Uptake Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_93", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_79", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T3SERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Triiodothyronine Measurement", - "label": "Triiodothyronine Measurement", - "synonyms": [ - "T3", - "Total T3" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74747", - "properties": [ - { - "id": "BiomedicalConceptProperty_535", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38599", - "standardCode": { - "id": "Code_45886", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_536", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38600", - "standardCode": { - "id": "Code_45887", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_537", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3088", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45889", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38601", - "standardCode": { - "id": "Code_45888", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_538", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38603", - "standardCode": { - "id": "Code_45890", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_539", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38604", - "standardCode": { - "id": "Code_45891", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24591", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28709", - "extensionAttributes": [], - "code": "C74747", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Triiodothyronine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_94", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_80", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T4FRSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Free Thyroxine Measurement", - "label": "Free Thyroxine Measurement", - "synonyms": [ - "Free T4", - "T4FR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74786", - "properties": [ - { - "id": "BiomedicalConceptProperty_545", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38611", - "standardCode": { - "id": "Code_45898", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_546", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38612", - "standardCode": { - "id": "Code_45899", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_547", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3090", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45901", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38613", - "standardCode": { - "id": "Code_45900", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_548", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38615", - "standardCode": { - "id": "Code_45902", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_549", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38616", - "standardCode": { - "id": "Code_45903", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24592", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28710", - "extensionAttributes": [], - "code": "C74786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_95", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_81", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/T4FRIDXSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Free Thyroxine Index", - "label": "Free Thyroxine Index", - "synonyms": [ - "T4FRIDX" - ], - "reference": "/mdr/bc/biomedicalconcepts/C170598", - "properties": [ - { - "id": "BiomedicalConceptProperty_555", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38623", - "standardCode": { - "id": "Code_45910", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_556", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3092", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_45912", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38624", - "standardCode": { - "id": "Code_45911", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_557", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38626", - "standardCode": { - "id": "Code_45913", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_558", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38627", - "standardCode": { - "id": "Code_45914", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24593", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28711", - "extensionAttributes": [], - "code": "C170598", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Free Thyroxine Index", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_96", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_82", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TSHBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Thyrotropin Measurement", - "label": "Thyrotropin Measurement", - "synonyms": [ - "TSH", - "Thyrotropin" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64813", - "properties": [ - { - "id": "BiomedicalConceptProperty_564", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38634", - "standardCode": { - "id": "Code_45921", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_565", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38635", - "standardCode": { - "id": "Code_45922", - "extensionAttributes": [], - "code": "C67365", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_566", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3094", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45924", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38636", - "standardCode": { - "id": "Code_45923", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_567", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38638", - "standardCode": { - "id": "Code_45925", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_568", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38639", - "standardCode": { - "id": "Code_45926", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24594", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28712", - "extensionAttributes": [], - "code": "C64813", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Thyrotropin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_97", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_83", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VITB9BLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Folic Acid Measurement", - "label": "Folic Acid Measurement", - "synonyms": [ - "Folate", - "Folic Acid", - "Vitamin B9", - "VITB9" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74676", - "properties": [ - { - "id": "BiomedicalConceptProperty_574", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38647", - "standardCode": { - "id": "Code_45934", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_575", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38648", - "standardCode": { - "id": "Code_45935", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_576", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3097", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45937", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38649", - "standardCode": { - "id": "Code_45936", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_577", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38651", - "standardCode": { - "id": "Code_45938", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_578", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38652", - "standardCode": { - "id": "Code_45939", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3218", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3428", - "extensionAttributes": [], - "code": "C74676", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Folic Acid Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_98", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_84", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/VITB12BLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Vitamin B12 Measurement", - "label": "Vitamin B12 Measurement", - "synonyms": [ - "Cobalamin", - "Vitamin B12", - "VITB12" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64817", - "properties": [ - { - "id": "BiomedicalConceptProperty_584", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38660", - "standardCode": { - "id": "Code_45947", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_585", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38661", - "standardCode": { - "id": "Code_45948", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_586", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3100", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_45950", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38662", - "standardCode": { - "id": "Code_45949", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_587", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38664", - "standardCode": { - "id": "Code_45951", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_588", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38665", - "standardCode": { - "id": "Code_45952", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24595", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28713", - "extensionAttributes": [], - "code": "C64817", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Vitamin B12 Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_99", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_85", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TPLAB", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Treponema pallidum Antibody Measurement", - "label": "Treponema pallidum Antibody Measurement", - "synonyms": [ - "TPLAB", - "Treponema pallidum Antibody", - "Syphilis Antibody" - ], - "reference": "/mdr/bc/biomedicalconcepts/C132388", - "properties": [ - { - "id": "BiomedicalConceptProperty_592", - "extensionAttributes": [], - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3102", - "instanceType": "ResponseCode", - "name": "DETECTION", - "label": "DETECTION", - "isEnabled": true, - "code": { - "id": "Code_45958", - "extensionAttributes": [], - "code": "C174330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "DETECTION", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38670", - "standardCode": { - "id": "Code_45957", - "extensionAttributes": [], - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_593", - "extensionAttributes": [], - "name": "MBORRES", - "label": "MBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38672", - "standardCode": { - "id": "Code_45959", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_594", - "extensionAttributes": [], - "name": "MBSPEC", - "label": "MBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3103", - "instanceType": "ResponseCode", - "name": "SERUM", - "label": "SERUM", - "isEnabled": true, - "code": { - "id": "Code_45961", - "extensionAttributes": [], - "code": "C13325", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38673", - "standardCode": { - "id": "Code_45960", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_595", - "extensionAttributes": [], - "name": "MBMETHOD", - "label": "MBMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38675", - "standardCode": { - "id": "Code_45962", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_596", - "extensionAttributes": [], - "name": "MBDTC", - "label": "MBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38676", - "standardCode": { - "id": "Code_45963", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24596", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28714", - "extensionAttributes": [], - "code": "C132388", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum Antibody Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_100", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_86", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/TPADNA", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Treponema pallidum DNA Measurement", - "label": "Treponema pallidum DNA Measurement", - "synonyms": [ - "TPADNA", - "Syphilis DNA" - ], - "reference": "/mdr/bc/biomedicalconcepts/C198341", - "properties": [ - { - "id": "BiomedicalConceptProperty_606", - "extensionAttributes": [], - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3106", - "instanceType": "ResponseCode", - "name": "DETECTION", - "label": "DETECTION", - "isEnabled": true, - "code": { - "id": "Code_45976", - "extensionAttributes": [], - "code": "C174330", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "DETECTION", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38688", - "standardCode": { - "id": "Code_45975", - "extensionAttributes": [], - "code": "C117062", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Measurement, Test or Examination Detail", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_607", - "extensionAttributes": [], - "name": "MBORRES", - "label": "MBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38690", - "standardCode": { - "id": "Code_45977", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_608", - "extensionAttributes": [], - "name": "MBSPEC", - "label": "MBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38691", - "standardCode": { - "id": "Code_45978", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_609", - "extensionAttributes": [], - "name": "MBMETHOD", - "label": "MBMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3107", - "instanceType": "ResponseCode", - "name": "LINE PROBE ASSAY", - "label": "LINE PROBE ASSAY", - "isEnabled": true, - "code": { - "id": "Code_45980", - "extensionAttributes": [], - "code": "C102656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "LINE PROBE ASSAY", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38692", - "standardCode": { - "id": "Code_45979", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_610", - "extensionAttributes": [], - "name": "MBDTC", - "label": "MBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38694", - "standardCode": { - "id": "Code_45981", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24597", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28715", - "extensionAttributes": [], - "code": "C198341", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Treponema pallidum DNA Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_101", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_87", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/COLORURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Color Assessment", - "label": "Color Assessment", - "synonyms": [ - "COLOR", - "Color" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64546", - "properties": [ - { - "id": "BiomedicalConceptProperty_616", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38701", - "standardCode": { - "id": "Code_45988", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_617", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3109", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_45990", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38702", - "standardCode": { - "id": "Code_45989", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_618", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38704", - "standardCode": { - "id": "Code_45991", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24598", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28716", - "extensionAttributes": [], - "code": "C64546", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Color Assessment", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_102", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_88", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Specific Gravity", - "label": "Specific Gravity", - "synonyms": [ - "SPGRAV" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64832", - "properties": [ - { - "id": "BiomedicalConceptProperty_629", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38717", - "standardCode": { - "id": "Code_46004", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_630", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3112", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_46006", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38718", - "standardCode": { - "id": "Code_46005", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_631", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38720", - "standardCode": { - "id": "Code_46007", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_632", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38721", - "standardCode": { - "id": "Code_46008", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3219", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3429", - "extensionAttributes": [], - "code": "C64832", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Specific Gravity", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_103", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_89", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Protein Measurement", - "label": null, - "synonyms": [ - "Protein" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64858", - "properties": [ - { - "id": "BiomedicalConceptProperty_633", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38722", - "standardCode": { - "id": "Code_46009", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_634", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38723", - "standardCode": { - "id": "Code_46010", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_635", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3113", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_46012", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38724", - "standardCode": { - "id": "Code_46011", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_636", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38726", - "standardCode": { - "id": "Code_46013", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_637", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38727", - "standardCode": { - "id": "Code_46014", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24588", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28706", - "extensionAttributes": [], - "code": "C64858", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Protein Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_104", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_144", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Glucose Measurement", - "label": null, - "synonyms": [ - "Glucose" - ], - "reference": "/mdr/bc/biomedicalconcepts/C105585", - "properties": [ - { - "id": "BiomedicalConceptProperty_643", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38734", - "standardCode": { - "id": "Code_46021", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_644", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38735", - "standardCode": { - "id": "Code_46022", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_645", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3115", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_46024", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38736", - "standardCode": { - "id": "Code_46023", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_646", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38738", - "standardCode": { - "id": "Code_46025", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_647", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38739", - "standardCode": { - "id": "Code_46026", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24587", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28705", - "extensionAttributes": [], - "code": "C105585", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Glucose Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_105", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_91", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/KETONESURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Ketone Measurement", - "label": "Ketone Measurement", - "synonyms": [ - "Ketones" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64854", - "properties": [ - { - "id": "BiomedicalConceptProperty_652", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38745", - "standardCode": { - "id": "Code_46032", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_653", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38746", - "standardCode": { - "id": "Code_46033", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_654", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3117", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_46035", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38747", - "standardCode": { - "id": "Code_46034", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_655", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38749", - "standardCode": { - "id": "Code_46036", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_656", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38750", - "standardCode": { - "id": "Code_46037", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24599", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28717", - "extensionAttributes": [], - "code": "C64854", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Ketone Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_106", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_92", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Total Bilirubin Measurement", - "label": null, - "synonyms": [ - "Bilirubin", - "Total Bilirubin Level" - ], - "reference": "/mdr/bc/biomedicalconcepts/C38037", - "properties": [ - { - "id": "BiomedicalConceptProperty_657", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38751", - "standardCode": { - "id": "Code_46038", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_658", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38752", - "standardCode": { - "id": "Code_46039", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_659", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3118", - "instanceType": "ResponseCode", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "isEnabled": true, - "code": { - "id": "Code_46041", - "extensionAttributes": [], - "code": "C105706", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SERUM OR PLASMA", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38753", - "standardCode": { - "id": "Code_46040", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_660", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38755", - "standardCode": { - "id": "Code_46042", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_661", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38756", - "standardCode": { - "id": "Code_46043", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24583", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28701", - "extensionAttributes": [], - "code": "C38037", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Total Bilirubin Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_107", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_93", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/UROBILURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Urobilinogen Measurement", - "label": "Urobilinogen Measurement", - "synonyms": [ - "Urobilinogen", - "UROBIL" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64816", - "properties": [ - { - "id": "BiomedicalConceptProperty_667", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38763", - "standardCode": { - "id": "Code_46050", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_668", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38764", - "standardCode": { - "id": "Code_46051", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_669", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3120", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_46053", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38765", - "standardCode": { - "id": "Code_46052", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_670", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38767", - "standardCode": { - "id": "Code_46054", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_671", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38768", - "standardCode": { - "id": "Code_46055", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24600", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28718", - "extensionAttributes": [], - "code": "C64816", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Urobilinogen Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_108", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_94", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/OCCBLDSTOOL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Occult Blood Measurement", - "label": "Occult Blood Measurement", - "synonyms": [ - "Occult Blood", - "OCCBLD" - ], - "reference": "/mdr/bc/biomedicalconcepts/C74686", - "properties": [ - { - "id": "BiomedicalConceptProperty_676", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38774", - "standardCode": { - "id": "Code_46061", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_677", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3122", - "instanceType": "ResponseCode", - "name": "STOOL", - "label": "STOOL", - "isEnabled": true, - "code": { - "id": "Code_46063", - "extensionAttributes": [], - "code": "C13234", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "STOOL", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38775", - "standardCode": { - "id": "Code_46062", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_678", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38777", - "standardCode": { - "id": "Code_46064", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_679", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38778", - "standardCode": { - "id": "Code_46065", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3356", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3566", - "extensionAttributes": [], - "code": "C74686", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Occult Blood Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_109", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_95", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/NITRITEURIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Nitrite Measurement", - "label": "Nitrite Measurement", - "synonyms": [ - "NITRITE" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64810", - "properties": [ - { - "id": "BiomedicalConceptProperty_684", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38784", - "standardCode": { - "id": "Code_46071", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_685", - "extensionAttributes": [], - "name": "LBORRESU", - "label": "LBORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38785", - "standardCode": { - "id": "Code_46072", - "extensionAttributes": [], - "code": "C48207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Concentration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_686", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3124", - "instanceType": "ResponseCode", - "name": "URINE", - "label": "URINE", - "isEnabled": true, - "code": { - "id": "Code_46074", - "extensionAttributes": [], - "code": "C13283", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "URINE", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38786", - "standardCode": { - "id": "Code_46073", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_687", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38788", - "standardCode": { - "id": "Code_46075", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_688", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38789", - "standardCode": { - "id": "Code_46076", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_3357", - "extensionAttributes": [], - "standardCode": { - "id": "Code_3567", - "extensionAttributes": [], - "code": "C64810", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Nitrite Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_110", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_96", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HBA1CBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hemoglobin A1C Measurement", - "label": "Hemoglobin A1C Measurement", - "synonyms": [ - "Hemoglobin A1C", - "HBA1C", - "Glycosylated Hemoglobin A1C" - ], - "reference": "/mdr/bc/biomedicalconcepts/C64849", - "properties": [ - { - "id": "BiomedicalConceptProperty_703", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38804", - "standardCode": { - "id": "Code_46091", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_704", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3125", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_46093", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38805", - "standardCode": { - "id": "Code_46092", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_705", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38807", - "standardCode": { - "id": "Code_46094", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_706", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38808", - "standardCode": { - "id": "Code_46095", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24601", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28719", - "extensionAttributes": [], - "code": "C64849", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Hemoglobin A1C Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_111", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_97", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HBA1CHGBBLD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "label": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "synonyms": [ - "Hemoglobin A1C/Hemoglobin", - "HBA1CHGB" - ], - "reference": "/mdr/bc/biomedicalconcepts/C111207", - "properties": [ - { - "id": "BiomedicalConceptProperty_713", - "extensionAttributes": [], - "name": "LBORRES", - "label": "LBORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_38816", - "standardCode": { - "id": "Code_46103", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_714", - "extensionAttributes": [], - "name": "LBSPEC", - "label": "LBSPEC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3127", - "instanceType": "ResponseCode", - "name": "BLOOD", - "label": "BLOOD", - "isEnabled": true, - "code": { - "id": "Code_46105", - "extensionAttributes": [], - "code": "C12434", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "BLOOD", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38817", - "standardCode": { - "id": "Code_46104", - "extensionAttributes": [], - "code": "C70713", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Biospecimen Type", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_715", - "extensionAttributes": [], - "name": "LBFAST", - "label": "LBFAST", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_38819", - "standardCode": { - "id": "Code_46106", - "extensionAttributes": [], - "code": "C93566", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Fasting Status Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_716", - "extensionAttributes": [], - "name": "LBDTC", - "label": "LBDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38820", - "standardCode": { - "id": "Code_46107", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24602", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28720", - "extensionAttributes": [], - "code": "C111207", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_112", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_98", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EXPOSCOLL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Exposure as Collected Domain", - "label": "Exposure as Collected Domain", - "synonyms": [ - "EC", - "Exposure as Collected" - ], - "reference": "/mdr/bc/biomedicalconcepts/C117466", - "properties": [ - { - "id": "BiomedicalConceptProperty_720", - "extensionAttributes": [], - "name": "ECTRT", - "label": "ECTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38825", - "standardCode": { - "id": "Code_46112", - "extensionAttributes": [], - "code": "C117473", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Name of Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_721", - "extensionAttributes": [], - "name": "ECREFID", - "label": "ECREFID", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38826", - "standardCode": { - "id": "Code_46113", - "extensionAttributes": [], - "code": "C117469", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Reference Identifier", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_722", - "extensionAttributes": [], - "name": "ECDOSE", - "label": "ECDOSE", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38827", - "standardCode": { - "id": "Code_46114", - "extensionAttributes": [], - "code": "C117479", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_723", - "extensionAttributes": [], - "name": "ECDOSTXT", - "label": "ECDOSTXT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38828", - "standardCode": { - "id": "Code_46115", - "extensionAttributes": [], - "code": "C117480", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_724", - "extensionAttributes": [], - "name": "ECDOSU", - "label": "ECDOSU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38829", - "standardCode": { - "id": "Code_46116", - "extensionAttributes": [], - "code": "C117481", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Units", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_725", - "extensionAttributes": [], - "name": "ECDOSFRM", - "label": "ECDOSFRM", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38830", - "standardCode": { - "id": "Code_46117", - "extensionAttributes": [], - "code": "C117482", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dose Form", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_726", - "extensionAttributes": [], - "name": "ECDOSFRQ", - "label": "ECDOSFRQ", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38831", - "standardCode": { - "id": "Code_46118", - "extensionAttributes": [], - "code": "C117483", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Dosing Frequency per Interval", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_727", - "extensionAttributes": [], - "name": "ECDOSRGM", - "label": "ECDOSRGM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38832", - "standardCode": { - "id": "Code_46119", - "extensionAttributes": [], - "code": "C117485", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Intended Dose Regimen", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_728", - "extensionAttributes": [], - "name": "ECROUTE", - "label": "ECROUTE", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38833", - "standardCode": { - "id": "Code_46120", - "extensionAttributes": [], - "code": "C117486", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Route of Administration", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_729", - "extensionAttributes": [], - "name": "ECLOC", - "label": "ECLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38834", - "standardCode": { - "id": "Code_46121", - "extensionAttributes": [], - "code": "C117488", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Location", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_730", - "extensionAttributes": [], - "name": "ECLAT", - "label": "ECLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38835", - "standardCode": { - "id": "Code_46122", - "extensionAttributes": [], - "code": "C117489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_731", - "extensionAttributes": [], - "name": "ECDIR", - "label": "ECDIR", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38836", - "standardCode": { - "id": "Code_46123", - "extensionAttributes": [], - "code": "C117490", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Directionality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_732", - "extensionAttributes": [], - "name": "ECSTDTC", - "label": "ECSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38837", - "standardCode": { - "id": "Code_46124", - "extensionAttributes": [], - "code": "C117496", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected Start Date and Time of Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_733", - "extensionAttributes": [], - "name": "ECENDTC", - "label": "ECENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38838", - "standardCode": { - "id": "Code_46125", - "extensionAttributes": [], - "code": "C117497", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Exposure as Collected End Date and Time of Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24603", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28721", - "extensionAttributes": [], - "code": "C117466", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-10-03", - "decode": "Exposure as Collected Domain", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_113", - "extensionAttributes": [], - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "id": "BiomedicalConceptProperty_734", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38839", - "standardCode": { - "id": "Code_46126", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_735", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38840", - "standardCode": { - "id": "Code_46127", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_736", - "extensionAttributes": [], - "name": "Test Occurrence", - "label": "Test Occurrence", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38841", - "standardCode": { - "id": "Code_46128", - "extensionAttributes": [], - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24604", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28722", - "extensionAttributes": [], - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_114", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_99", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYACCEPTABILITY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Acceptability", - "label": "TTS Acceptability Survey - Patch Acceptability", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT4", - "properties": [ - { - "id": "BiomedicalConceptProperty_740", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38846", - "standardCode": { - "id": "Code_46133", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_741", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38847", - "standardCode": { - "id": "Code_46134", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_742", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3130", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_46136", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38848", - "standardCode": { - "id": "Code_46135", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24605", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28723", - "extensionAttributes": [], - "code": "NEW_LZZT4", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Acceptability", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_115", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_100", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYAPPEARANCE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Appearance", - "label": "TTS Acceptability Survey - Patch Appearance", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT1", - "properties": [ - { - "id": "BiomedicalConceptProperty_748", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38856", - "standardCode": { - "id": "Code_46143", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_749", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38857", - "standardCode": { - "id": "Code_46144", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_750", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3132", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_46146", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38858", - "standardCode": { - "id": "Code_46145", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24606", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28724", - "extensionAttributes": [], - "code": "NEW_LZZT1", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Appearance", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_116", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_101", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYDURABILITY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Durability", - "label": "TTS Acceptability Survey - Patch Durability", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT3", - "properties": [ - { - "id": "BiomedicalConceptProperty_777", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38886", - "standardCode": { - "id": "Code_46173", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_778", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38887", - "standardCode": { - "id": "Code_46174", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_779", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3133", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_46176", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38888", - "standardCode": { - "id": "Code_46175", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24607", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28725", - "extensionAttributes": [], - "code": "NEW_LZZT3", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Durability", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_117", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_102", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYSIZE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "TTS Acceptability Survey - Patch Size", - "label": "TTS Acceptability Survey - Patch Size", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT2", - "properties": [ - { - "id": "BiomedicalConceptProperty_780", - "extensionAttributes": [], - "name": "QSORRES", - "label": "QSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38890", - "standardCode": { - "id": "Code_46177", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_781", - "extensionAttributes": [], - "name": "QSDTC", - "label": "QSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38891", - "standardCode": { - "id": "Code_46178", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_782", - "extensionAttributes": [], - "name": "QSEVAL", - "label": "QSEVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3134", - "instanceType": "ResponseCode", - "name": "CAREGIVER", - "label": "CAREGIVER", - "isEnabled": true, - "code": { - "id": "Code_46180", - "extensionAttributes": [], - "code": "C17445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CAREGIVER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38892", - "standardCode": { - "id": "Code_46179", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24608", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28726", - "extensionAttributes": [], - "code": "NEW_LZZT2", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Size", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_134", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "synonyms": [ - "AEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "id": "BiomedicalConceptProperty_783", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38894", - "standardCode": { - "id": "Code_46181", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_784", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38895", - "standardCode": { - "id": "Code_46182", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24609", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28727", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_135", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_103", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/AE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Solicited Adverse Event", - "label": "Solicited Adverse Event", - "synonyms": [ - "Adverse Event" - ], - "reference": "/mdr/bc/biomedicalconcepts/C179175", - "properties": [ - { - "id": "BiomedicalConceptProperty_785", - "extensionAttributes": [], - "name": "AETERM", - "label": "AETERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38896", - "standardCode": { - "id": "Code_46183", - "extensionAttributes": [], - "code": "C78541", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Verbatim Description", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_786", - "extensionAttributes": [], - "name": "AEDECOD", - "label": "AEDECOD", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38897", - "standardCode": { - "id": "Code_46184", - "extensionAttributes": [], - "code": "C83344", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Dictionary Derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_787", - "extensionAttributes": [], - "name": "AELOC", - "label": "AELOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38898", - "standardCode": { - "id": "Code_46185", - "extensionAttributes": [], - "code": "C83205", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Location", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_788", - "extensionAttributes": [], - "name": "AESEV", - "label": "AESEV", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38899", - "standardCode": { - "id": "Code_46186", - "extensionAttributes": [], - "code": "C53253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Severity of Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_789", - "extensionAttributes": [], - "name": "AESER", - "label": "AESER", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38900", - "standardCode": { - "id": "Code_46187", - "extensionAttributes": [], - "code": "C53252", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Seriousness of Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_790", - "extensionAttributes": [], - "name": "AEACN", - "label": "AEACN", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38901", - "standardCode": { - "id": "Code_46188", - "extensionAttributes": [], - "code": "C83013", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Action Taken with Study Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_791", - "extensionAttributes": [], - "name": "AEACNOTH", - "label": "AEACNOTH", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38902", - "standardCode": { - "id": "Code_46189", - "extensionAttributes": [], - "code": "C83109", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Other Actions taken in Response to Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_792", - "extensionAttributes": [], - "name": "AEREL", - "label": "AEREL", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38903", - "standardCode": { - "id": "Code_46190", - "extensionAttributes": [], - "code": "C41358", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Attribution to Product or Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_793", - "extensionAttributes": [], - "name": "AERELNST", - "label": "AERELNST", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38904", - "standardCode": { - "id": "Code_46191", - "extensionAttributes": [], - "code": "C83210", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Relationship to Non Study Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_794", - "extensionAttributes": [], - "name": "AEPATT", - "label": "AEPATT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38905", - "standardCode": { - "id": "Code_46192", - "extensionAttributes": [], - "code": "C83208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Pattern", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_795", - "extensionAttributes": [], - "name": "AEOUT", - "label": "AEOUT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38906", - "standardCode": { - "id": "Code_46193", - "extensionAttributes": [], - "code": "C49489", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Outcome", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_796", - "extensionAttributes": [], - "name": "AESCAN", - "label": "AESCAN", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38907", - "standardCode": { - "id": "Code_46194", - "extensionAttributes": [], - "code": "C83211", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Involves Cancer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_797", - "extensionAttributes": [], - "name": "AESCONG", - "label": "AESCONG", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38908", - "standardCode": { - "id": "Code_46195", - "extensionAttributes": [], - "code": "C83117", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_798", - "extensionAttributes": [], - "name": "AESDISAB", - "label": "AESDISAB", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38909", - "standardCode": { - "id": "Code_46196", - "extensionAttributes": [], - "code": "C113380", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Disabling Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_799", - "extensionAttributes": [], - "name": "AESDTH", - "label": "AESDTH", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38910", - "standardCode": { - "id": "Code_46197", - "extensionAttributes": [], - "code": "C48275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Death Related to Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_800", - "extensionAttributes": [], - "name": "AESHOSP", - "label": "AESHOSP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38911", - "standardCode": { - "id": "Code_46198", - "extensionAttributes": [], - "code": "C83052", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event associated with Hospitalization", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_801", - "extensionAttributes": [], - "name": "AESLIFE", - "label": "AESLIFE", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38912", - "standardCode": { - "id": "Code_46199", - "extensionAttributes": [], - "code": "C84266", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Life Threatening Adverse Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_802", - "extensionAttributes": [], - "name": "AESOD", - "label": "AESOD", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38913", - "standardCode": { - "id": "Code_46200", - "extensionAttributes": [], - "code": "C83214", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Occurred with Overdose", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_803", - "extensionAttributes": [], - "name": "AESMIE", - "label": "AESMIE", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38914", - "standardCode": { - "id": "Code_46201", - "extensionAttributes": [], - "code": "C83053", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Associated with Serious Medical Event", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_804", - "extensionAttributes": [], - "name": "AECONTRT", - "label": "AECONTRT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38915", - "standardCode": { - "id": "Code_46202", - "extensionAttributes": [], - "code": "C83199", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Concomitant Treatment", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_805", - "extensionAttributes": [], - "name": "AETOXGR", - "label": "AETOXGR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38916", - "standardCode": { - "id": "Code_46203", - "extensionAttributes": [], - "code": "C78605", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Toxicity Grade", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_806", - "extensionAttributes": [], - "name": "AESTDTC", - "label": "AESTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38917", - "standardCode": { - "id": "Code_46204", - "extensionAttributes": [], - "code": "C83215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_807", - "extensionAttributes": [], - "name": "AEENDTC", - "label": "AEENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38918", - "standardCode": { - "id": "Code_46205", - "extensionAttributes": [], - "code": "C83201", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event End Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_808", - "extensionAttributes": [], - "name": "AEENRF", - "label": "AEENRF", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38919", - "standardCode": { - "id": "Code_46206", - "extensionAttributes": [], - "code": "C82557", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Period", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_809", - "extensionAttributes": [], - "name": "AEENRTPT", - "label": "AEENRTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38920", - "standardCode": { - "id": "Code_46207", - "extensionAttributes": [], - "code": "C82558", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "End Relative to Reference Time Point", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_810", - "extensionAttributes": [], - "name": "AEENTPT", - "label": "AEENTPT", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38921", - "standardCode": { - "id": "Code_46208", - "extensionAttributes": [], - "code": "C82574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Reference End Time Point End", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24610", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28728", - "extensionAttributes": [], - "code": "C179175", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Solicited Adverse Event", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_136", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_104", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTCOMP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Complete", - "label": "Complete", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C25250", - "properties": [], - "code": { - "id": "AliasCode_24611", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28729", - "extensionAttributes": [], - "code": "C25250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Complete [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_137", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_105", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/FAILCONT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Failure To Meet Continuation Criteria", - "label": "Failure To Meet Continuation Criteria", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C139236", - "properties": [], - "code": { - "id": "AliasCode_24612", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28730", - "extensionAttributes": [], - "code": "C139236", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Failure To Meet Continuation Criteria [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_138", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_106", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DEAD", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Dead", - "label": "Dead", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C28554", - "properties": [], - "code": { - "id": "AliasCode_24613", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28731", - "extensionAttributes": [], - "code": "C28554", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Dead [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_139", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_107", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/LACKEFFICACY", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Lack of Efficacy", - "label": "Lack of Efficacy", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C48226", - "properties": [], - "code": { - "id": "AliasCode_24614", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28732", - "extensionAttributes": [], - "code": "C48226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lack of Efficacy [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_140", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_108", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/LTFUP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Lost To Follow-Up", - "label": "Lost To Follow-Up", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C48227", - "properties": [], - "code": { - "id": "AliasCode_24615", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28733", - "extensionAttributes": [], - "code": "C48227", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Lost To Follow-Up [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_141", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_109", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "code": { - "id": "AliasCode_24616", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28734", - "extensionAttributes": [], - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_142", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_110", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PHYDECISION", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Physician Decision", - "label": "Physician Decision", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C48250", - "properties": [], - "code": { - "id": "AliasCode_24617", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28735", - "extensionAttributes": [], - "code": "C48250", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Physician Decision [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_143", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_111", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SUBJPREG", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Pregnant Subject", - "label": "Pregnant Subject", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C191656", - "properties": [], - "code": { - "id": "AliasCode_24618", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28736", - "extensionAttributes": [], - "code": "C191656", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Pregnant Subject [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_144", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_112", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROGDISEASE", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Progressive Disease", - "label": "Progressive Disease", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C35571", - "properties": [], - "code": { - "id": "AliasCode_24619", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28737", - "extensionAttributes": [], - "code": "C35571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Progressive Disease [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_145", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_113", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/PROTDEV", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Protocol Deviation", - "label": "Protocol Deviation", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C50996", - "properties": [], - "code": { - "id": "AliasCode_1747", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1937", - "extensionAttributes": [], - "code": "C50996", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Protocol Deviation", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_146", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_114", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SITETRANSFER", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Study Site Transfer", - "label": "Study Site Transfer", - "synonyms": [ - "Site Transfer", - "Study Subject Site Transfer" - ], - "reference": "/mdr/bc/biomedicalconcepts/C186208", - "properties": [ - { - "id": "BiomedicalConceptProperty_811", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3135", - "instanceType": "ResponseCode", - "name": "SITE TRANSFER", - "label": "SITE TRANSFER", - "isEnabled": true, - "code": { - "id": "Code_46210", - "extensionAttributes": [], - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "SITE TRANSFER", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38922", - "standardCode": { - "id": "Code_46209", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_812", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38924", - "standardCode": { - "id": "Code_46211", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_813", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38925", - "standardCode": { - "id": "Code_46212", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1753", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1943", - "extensionAttributes": [], - "code": "C186208", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Site Transfer", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_147", - "extensionAttributes": [], - "name": "Study Terminated By Sponsor", - "label": "Study Terminated By Sponsor", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C49632", - "properties": [], - "code": { - "id": "AliasCode_1758", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1948", - "extensionAttributes": [], - "code": "C49632", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Study Terminated By Sponsor", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_148", - "extensionAttributes": [], - "name": "Subject Removed at Sponsor Request", - "label": "Subject Removed at Sponsor Request", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C161410", - "properties": [], - "code": { - "id": "AliasCode_29205", - "extensionAttributes": [], - "standardCode": { - "id": "Code_33323", - "extensionAttributes": [], - "code": "C161410", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Subject Removed at Sponsor Request [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_149", - "extensionAttributes": [], - "name": "Trial Screen Failure", - "label": "Trial Screen Failure", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C49628", - "properties": [], - "code": { - "id": "AliasCode_1760", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1950", - "extensionAttributes": [], - "code": "C49628", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Screen Failure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_150", - "extensionAttributes": [], - "name": "Trial Site Terminated by Sponsor", - "label": "Trial Site Terminated by Sponsor", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C106576", - "properties": [], - "code": { - "id": "AliasCode_1761", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1951", - "extensionAttributes": [], - "code": "C106576", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Trial Site Terminated by Sponsor", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_151", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_115", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SUBJWITHDRAW", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Withdrawal by Subject", - "label": "Withdrawal by Subject", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C49634", - "properties": [], - "code": { - "id": "AliasCode_1762", - "extensionAttributes": [], - "standardCode": { - "id": "Code_1952", - "extensionAttributes": [], - "code": "C49634", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Withdrawal by Subject", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_152", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_116", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CONSWDRL", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Withdrawal of Consent From Protocol-Specified Activity", - "label": "Withdrawal of Consent From Protocol-Specified Activity", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C170610", - "properties": [ - { - "id": "BiomedicalConceptProperty_823", - "extensionAttributes": [], - "name": "DSDECOD", - "label": "DSDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3138", - "instanceType": "ResponseCode", - "name": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "label": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "isEnabled": true, - "code": { - "id": "Code_46225", - "extensionAttributes": [], - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38937", - "standardCode": { - "id": "Code_46224", - "extensionAttributes": [], - "code": "C82977", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Dictionary-derived Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_824", - "extensionAttributes": [], - "name": "DSTERM", - "label": "DSTERM", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_38939", - "standardCode": { - "id": "Code_46226", - "extensionAttributes": [], - "code": "C82571", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Event Term", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_825", - "extensionAttributes": [], - "name": "DSSTDTC", - "label": "DSSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38940", - "standardCode": { - "id": "Code_46227", - "extensionAttributes": [], - "code": "C82517", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Start Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_38009", - "extensionAttributes": [], - "standardCode": { - "id": "Code_45296", - "extensionAttributes": [], - "code": "C170610", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2023-12-12", - "decode": "Withdrawal of Consent From Protocol-Specified Activity", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_153", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_117", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "synonyms": [ - "SYSBP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "id": "BiomedicalConceptProperty_832", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38948", - "standardCode": { - "id": "Code_46235", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_833", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3140", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_46237", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38949", - "standardCode": { - "id": "Code_46236", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_834", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38951", - "standardCode": { - "id": "Code_46238", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_835", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38952", - "standardCode": { - "id": "Code_46239", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_836", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38953", - "standardCode": { - "id": "Code_46240", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_837", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38954", - "standardCode": { - "id": "Code_46241", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1834", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2024", - "extensionAttributes": [], - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_154", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_118", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "synonyms": [ - "DIABP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "id": "BiomedicalConceptProperty_862", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_38983", - "standardCode": { - "id": "Code_46270", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_863", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3145", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_46272", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_38984", - "standardCode": { - "id": "Code_46271", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_864", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38986", - "standardCode": { - "id": "Code_46273", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_865", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38987", - "standardCode": { - "id": "Code_46274", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_866", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_38988", - "standardCode": { - "id": "Code_46275", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_867", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_38989", - "standardCode": { - "id": "Code_46276", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_26219", - "extensionAttributes": [], - "standardCode": { - "id": "Code_30337", - "extensionAttributes": [], - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_155", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_119", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Heart Rate", - "label": "Heart Rate", - "synonyms": [ - "HR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "id": "BiomedicalConceptProperty_880", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39002", - "standardCode": { - "id": "Code_46289", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_881", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3146", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_46291", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39003", - "standardCode": { - "id": "Code_46290", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_882", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39005", - "standardCode": { - "id": "Code_46292", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_883", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39006", - "standardCode": { - "id": "Code_46293", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_884", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39007", - "standardCode": { - "id": "Code_46294", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_885", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39008", - "standardCode": { - "id": "Code_46295", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1833", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2023", - "extensionAttributes": [], - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_156", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_120", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "synonyms": [ - "SYSBP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25298", - "properties": [ - { - "id": "BiomedicalConceptProperty_886", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39009", - "standardCode": { - "id": "Code_46296", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_887", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3147", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_46298", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39010", - "standardCode": { - "id": "Code_46297", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_888", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39012", - "standardCode": { - "id": "Code_46299", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_889", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39013", - "standardCode": { - "id": "Code_46300", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_890", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39014", - "standardCode": { - "id": "Code_46301", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_891", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39015", - "standardCode": { - "id": "Code_46302", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1834", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2024", - "extensionAttributes": [], - "code": "C25298", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Systolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_157", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_121", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/DIABP", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "synonyms": [ - "DIABP" - ], - "reference": "/mdr/bc/biomedicalconcepts/C25299", - "properties": [ - { - "id": "BiomedicalConceptProperty_892", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39016", - "standardCode": { - "id": "Code_46303", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_893", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3148", - "instanceType": "ResponseCode", - "name": "mmHg", - "label": "mmHg", - "isEnabled": true, - "code": { - "id": "Code_46305", - "extensionAttributes": [], - "code": "C49670", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "mmHg", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39017", - "standardCode": { - "id": "Code_46304", - "extensionAttributes": [], - "code": "C49669", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Pressure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_894", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39019", - "standardCode": { - "id": "Code_46306", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_895", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39020", - "standardCode": { - "id": "Code_46307", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_896", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39021", - "standardCode": { - "id": "Code_46308", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_897", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39022", - "standardCode": { - "id": "Code_46309", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_26219", - "extensionAttributes": [], - "standardCode": { - "id": "Code_30337", - "extensionAttributes": [], - "code": "C25299", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Diastolic Blood Pressure", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_158", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_122", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/HR", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Heart Rate", - "label": "Heart Rate", - "synonyms": [ - "HR" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49677", - "properties": [ - { - "id": "BiomedicalConceptProperty_898", - "extensionAttributes": [], - "name": "VSORRES", - "label": "VSORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39023", - "standardCode": { - "id": "Code_46310", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_899", - "extensionAttributes": [], - "name": "VSORRESU", - "label": "VSORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3149", - "instanceType": "ResponseCode", - "name": "beats/min", - "label": "beats/min", - "isEnabled": true, - "code": { - "id": "Code_46312", - "extensionAttributes": [], - "code": "C49673", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "beats/min", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39024", - "standardCode": { - "id": "Code_46311", - "extensionAttributes": [], - "code": "C73688", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Count per Minute", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_900", - "extensionAttributes": [], - "name": "VSPOS", - "label": "VSPOS", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39026", - "standardCode": { - "id": "Code_46313", - "extensionAttributes": [], - "code": "C62164", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Body Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_901", - "extensionAttributes": [], - "name": "VSLOC", - "label": "VSLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39027", - "standardCode": { - "id": "Code_46314", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_902", - "extensionAttributes": [], - "name": "VSLAT", - "label": "VSLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39028", - "standardCode": { - "id": "Code_46315", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_903", - "extensionAttributes": [], - "name": "VSDTC", - "label": "VSDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39029", - "standardCode": { - "id": "Code_46316", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_1833", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2023", - "extensionAttributes": [], - "code": "C49677", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-12-16", - "decode": "Heart Rate", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_159", - "extensionAttributes": [], - "name": "Isometric Muscle Strength", - "label": "Isometric Muscle Strength", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C138967", - "properties": [], - "code": { - "id": "AliasCode_2312", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2502", - "extensionAttributes": [], - "code": "C138967", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Isometric Muscle Strength", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_160", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_129", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/SMMASS", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Skeletal Muscle Mass Measurement", - "label": "Skeletal Muscle Mass Measurement", - "synonyms": [ - "SMMASS", - "Skeletal Muscle Mass" - ], - "reference": "/mdr/bc/biomedicalconcepts/C178017", - "properties": [ - { - "id": "BiomedicalConceptProperty_920", - "extensionAttributes": [], - "name": "MKORRES", - "label": "MKORRES", - "isRequired": false, - "isEnabled": true, - "datatype": "float", - "responseCodes": [], - "code": { - "id": "AliasCode_39050", - "standardCode": { - "id": "Code_46337", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_921", - "extensionAttributes": [], - "name": "MKORRESU", - "label": "MKORRESU", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39051", - "standardCode": { - "id": "Code_46338", - "extensionAttributes": [], - "code": "C42579", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Unit of Mass", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_922", - "extensionAttributes": [], - "name": "MKLOC", - "label": "MKLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39052", - "standardCode": { - "id": "Code_46339", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_923", - "extensionAttributes": [], - "name": "MKLAT", - "label": "MKLAT", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39053", - "standardCode": { - "id": "Code_46340", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_924", - "extensionAttributes": [], - "name": "MKMETHOD", - "label": "MKMETHOD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39054", - "standardCode": { - "id": "Code_46341", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_925", - "extensionAttributes": [], - "name": "MKDTC", - "label": "MKDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39055", - "standardCode": { - "id": "Code_46342", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2313", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2503", - "extensionAttributes": [], - "code": "C178017", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Skeletal Muscle Mass Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_161", - "extensionAttributes": [], - "name": "Muscle Endurance Measurement", - "label": "Muscle Endurance Measurement", - "synonyms": [ - "ENDURM", - "Muscle Endurance" - ], - "reference": "/mdr/bc/biomedicalconcepts/C181501", - "properties": [ - { - "id": "BiomedicalConceptProperty_933", - "extensionAttributes": [], - "name": "Observation Result", - "label": "Observation Result", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_39064", - "standardCode": { - "id": "Code_46351", - "extensionAttributes": [], - "code": "C70856", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Observation Result", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_934", - "extensionAttributes": [], - "name": "Unit of Time", - "label": "Unit of Time", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39065", - "standardCode": { - "id": "Code_46352", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_935", - "extensionAttributes": [], - "name": "Anatomic Site", - "label": "Anatomic Site", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39066", - "standardCode": { - "id": "Code_46353", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_936", - "extensionAttributes": [], - "name": "Laterality", - "label": "Laterality", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39067", - "standardCode": { - "id": "Code_46354", - "extensionAttributes": [], - "code": "C25185", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Laterality", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_937", - "extensionAttributes": [], - "name": "Test Method", - "label": "Test Method", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39068", - "standardCode": { - "id": "Code_46355", - "extensionAttributes": [], - "code": "C82535", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Test Method", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_938", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39069", - "standardCode": { - "id": "Code_46356", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24620", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28738", - "extensionAttributes": [], - "code": "C181501", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Muscle Endurance Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_162", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_139", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGCTMON", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "synonyms": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "reference": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "id": "BiomedicalConceptProperty_949", - "extensionAttributes": [], - "name": "TSPARMCD", - "label": "TSPARMCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3155", - "instanceType": "ResponseCode", - "name": "EGCTMON", - "label": "EGCTMON", - "isEnabled": true, - "code": { - "id": "Code_46368", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "EGCTMON", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39080", - "standardCode": { - "id": "Code_46367", - "extensionAttributes": [], - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_950", - "extensionAttributes": [], - "name": "TSPARM", - "label": "TSPARM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3156", - "instanceType": "ResponseCode", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "isEnabled": true, - "code": { - "id": "Code_46370", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39082", - "standardCode": { - "id": "Code_46369", - "extensionAttributes": [], - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_951", - "extensionAttributes": [], - "name": "TSVAL", - "label": "TSVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_39084", - "standardCode": { - "id": "Code_46371", - "extensionAttributes": [], - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_952", - "extensionAttributes": [], - "name": "TSVALCD", - "label": "TSVALCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39085", - "standardCode": { - "id": "Code_46372", - "extensionAttributes": [], - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_953", - "extensionAttributes": [], - "name": "TSVCDREF", - "label": "TSVCDREF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39086", - "standardCode": { - "id": "Code_46373", - "extensionAttributes": [], - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_954", - "extensionAttributes": [], - "name": "TSVCDVER", - "label": "TSVCDVER", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39087", - "standardCode": { - "id": "Code_46374", - "extensionAttributes": [], - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2311", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2501", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_164", - "extensionAttributes": [], - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/NEW_LZZT", - "properties": [ - { - "id": "BiomedicalConceptProperty_955", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39088", - "standardCode": { - "id": "Code_46375", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_956", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39089", - "standardCode": { - "id": "Code_46376", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_957", - "extensionAttributes": [], - "name": "Test Occurrence", - "label": "Test Occurrence", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39090", - "standardCode": { - "id": "Code_46377", - "extensionAttributes": [], - "code": "C82525", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "Test Occurrence", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24604", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28722", - "extensionAttributes": [], - "code": "NEW_LZZT", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-23", - "decode": "TTS Acceptability Survey", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_165", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_141", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/MRIBRAIN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "synonyms": [ - "Magnetic Resonance", - "MRI", - "MRI Scan", - "NMR", - "NMR Imaging" - ], - "reference": "/mdr/bc/biomedicalconcepts/C16809", - "properties": [ - { - "id": "BiomedicalConceptProperty_974", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39107", - "standardCode": { - "id": "Code_46394", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_975", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3157", - "instanceType": "ResponseCode", - "name": "MRI", - "label": "MRI", - "isEnabled": true, - "code": { - "id": "Code_46396", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39108", - "standardCode": { - "id": "Code_46395", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_976", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39110", - "standardCode": { - "id": "Code_46397", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_977", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39111", - "standardCode": { - "id": "Code_46398", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_978", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3158", - "instanceType": "ResponseCode", - "name": "BRAIN", - "label": "BRAIN", - "isEnabled": true, - "code": { - "id": "Code_46400", - "extensionAttributes": [], - "code": "C12439", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "BRAIN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39112", - "standardCode": { - "id": "Code_46399", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_979", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39114", - "standardCode": { - "id": "Code_46401", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_980", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39115", - "standardCode": { - "id": "Code_46402", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_15783", - "extensionAttributes": [], - "standardCode": { - "id": "Code_16598", - "extensionAttributes": [], - "code": "C16809", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "MRI", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_166", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_142", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/CTSCAN", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Computed Tomography", - "label": "Computed Tomography", - "synonyms": [ - "CAT Scan", - "Computed Axial Tomography", - "Computed Tomography", - "Computerized Tomography", - "CT" - ], - "reference": "/mdr/bc/biomedicalconcepts/C17204", - "properties": [ - { - "id": "BiomedicalConceptProperty_997", - "extensionAttributes": [], - "name": "PRTRT", - "label": "PRTRT", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39132", - "standardCode": { - "id": "Code_46419", - "extensionAttributes": [], - "code": "C117511", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Reported Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_998", - "extensionAttributes": [], - "name": "PRDECOD", - "label": "PRDECOD", - "isRequired": true, - "isEnabled": true, - "datatype": "text", - "responseCodes": [ - { - "id": "ResponseCode_3159", - "instanceType": "ResponseCode", - "name": "CT SCAN", - "label": "CT SCAN", - "isEnabled": true, - "code": { - "id": "Code_46421", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39133", - "standardCode": { - "id": "Code_46420", - "extensionAttributes": [], - "code": "C117512", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Standardized Name of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_999", - "extensionAttributes": [], - "name": "PRPRESP", - "label": "PRPRESP", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39135", - "standardCode": { - "id": "Code_46422", - "extensionAttributes": [], - "code": "C171000", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1000", - "extensionAttributes": [], - "name": "PROCCUR", - "label": "PROCCUR", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39136", - "standardCode": { - "id": "Code_46423", - "extensionAttributes": [], - "code": "C127786", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Occurrence Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1001", - "extensionAttributes": [], - "name": "PRLOC", - "label": "PRLOC", - "isRequired": false, - "isEnabled": true, - "datatype": "text", - "responseCodes": [], - "code": { - "id": "AliasCode_39137", - "standardCode": { - "id": "Code_46424", - "extensionAttributes": [], - "code": "C13717", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Anatomic Site", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1002", - "extensionAttributes": [], - "name": "PRSTDTC", - "label": "PRSTDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39138", - "standardCode": { - "id": "Code_46425", - "extensionAttributes": [], - "code": "C117529", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "Start Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1003", - "extensionAttributes": [], - "name": "PRENDTC", - "label": "PRENDTC", - "isRequired": false, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39139", - "standardCode": { - "id": "Code_46426", - "extensionAttributes": [], - "code": "C117530", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "End Date and Time of Procedure", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_28017", - "extensionAttributes": [], - "standardCode": { - "id": "Code_32135", - "extensionAttributes": [], - "code": "C17204", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-05-26", - "decode": "CT SCAN", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_168", - "extensionAttributes": [], - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "synonyms": [ - "Vital Signs", - "VS" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "code": { - "id": "AliasCode_24621", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28739", - "extensionAttributes": [], - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_169", - "extensionAttributes": [], - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "synonyms": [ - "Vital Signs", - "VS" - ], - "reference": "/mdr/bc/biomedicalconcepts/C49672", - "properties": [], - "code": { - "id": "AliasCode_24621", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28739", - "extensionAttributes": [], - "code": "C49672", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2024-12-16", - "decode": "Vital Signs Measurement", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_170", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_143", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "instanceType": "ExtensionAttribute" - } - ], - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "synonyms": [], - "reference": "/mdr/bc/biomedicalconcepts/C41331", - "properties": [], - "code": { - "id": "AliasCode_24616", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28734", - "extensionAttributes": [], - "code": "C41331", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2026-03-31", - "decode": "Adverse Event [RETIRED]", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_171", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "synonyms": [ - "AEYN" - ], - "reference": "/mdr/bc/biomedicalconcepts/C83347", - "properties": [ - { - "id": "BiomedicalConceptProperty_1012", - "extensionAttributes": [], - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39148", - "standardCode": { - "id": "Code_46435", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1013", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39149", - "standardCode": { - "id": "Code_46436", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24609", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28727", - "extensionAttributes": [], - "code": "C83347", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Adverse Event Yes No Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_172", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Word Recall Average Score", - "label": "CDISC ADAS-Cog - Word Recall Average Score", - "synonyms": [ - "ADCRL", - "Word Recall", - "CDISC ADAS-Cog - Word Recall Average Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100177", - "properties": [ - { - "id": "BiomedicalConceptProperty_1022", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39158", - "standardCode": { - "id": "Code_46445", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1023", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_39159", - "standardCode": { - "id": "Code_46446", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1024", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39160", - "standardCode": { - "id": "Code_46447", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1025", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39161", - "standardCode": { - "id": "Code_46448", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1026", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39162", - "standardCode": { - "id": "Code_46449", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1027", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_39163", - "standardCode": { - "id": "Code_46450", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1028", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39164", - "standardCode": { - "id": "Code_46451", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1029", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39165", - "standardCode": { - "id": "Code_46452", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24622", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28740", - "extensionAttributes": [], - "code": "C100177", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recall Average Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_173", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "label": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "synonyms": [ - "ADCOF", - "Naming Objects and Fingers", - "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100191", - "properties": [ - { - "id": "BiomedicalConceptProperty_1030", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39166", - "standardCode": { - "id": "Code_46453", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1031", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39167", - "standardCode": { - "id": "Code_46454", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1032", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39168", - "standardCode": { - "id": "Code_46455", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1033", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39169", - "standardCode": { - "id": "Code_46456", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1034", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39170", - "standardCode": { - "id": "Code_46457", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1035", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39171", - "standardCode": { - "id": "Code_46458", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1036", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39172", - "standardCode": { - "id": "Code_46459", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1037", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39173", - "standardCode": { - "id": "Code_46460", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27242", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31360", - "extensionAttributes": [], - "code": "C100191", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_174", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Commands Summary Score", - "label": "CDISC ADAS-Cog - Commands Summary Score", - "synonyms": [ - "ADCCMD", - "Commands", - "CDISC ADAS-Cog - Commands Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100209", - "properties": [ - { - "id": "BiomedicalConceptProperty_1046", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39182", - "standardCode": { - "id": "Code_46469", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1047", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39183", - "standardCode": { - "id": "Code_46470", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1048", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39184", - "standardCode": { - "id": "Code_46471", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1049", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39185", - "standardCode": { - "id": "Code_46472", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1050", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39186", - "standardCode": { - "id": "Code_46473", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1051", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39187", - "standardCode": { - "id": "Code_46474", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1052", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39188", - "standardCode": { - "id": "Code_46475", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1053", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39189", - "standardCode": { - "id": "Code_46476", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24623", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28741", - "extensionAttributes": [], - "code": "C100209", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Commands Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_175", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "label": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "synonyms": [ - "ADCDRL", - "Delayed Word Recall", - "CDISC ADAS-Cog - Delayed Word Recall Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100215", - "properties": [ - { - "id": "BiomedicalConceptProperty_1062", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39198", - "standardCode": { - "id": "Code_46485", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1063", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39199", - "standardCode": { - "id": "Code_46486", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1064", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39200", - "standardCode": { - "id": "Code_46487", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1065", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39201", - "standardCode": { - "id": "Code_46488", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1066", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39202", - "standardCode": { - "id": "Code_46489", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1067", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39203", - "standardCode": { - "id": "Code_46490", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1068", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39204", - "standardCode": { - "id": "Code_46491", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1069", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39205", - "standardCode": { - "id": "Code_46492", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27243", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31361", - "extensionAttributes": [], - "code": "C100215", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_176", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "label": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "synonyms": [ - "ADCCP", - "Constructional Praxis", - "CDISC ADAS-Cog - Constructional Praxis Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100226", - "properties": [ - { - "id": "BiomedicalConceptProperty_1078", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39214", - "standardCode": { - "id": "Code_46501", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1079", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39215", - "standardCode": { - "id": "Code_46502", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1080", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39216", - "standardCode": { - "id": "Code_46503", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1081", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39217", - "standardCode": { - "id": "Code_46504", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1082", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39218", - "standardCode": { - "id": "Code_46505", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1083", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39219", - "standardCode": { - "id": "Code_46506", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1084", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39220", - "standardCode": { - "id": "Code_46507", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1085", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39221", - "standardCode": { - "id": "Code_46508", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27244", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31362", - "extensionAttributes": [], - "code": "C100226", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_177", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "label": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "synonyms": [ - "ADCIP", - "Ideational Praxis", - "CDISC ADAS-Cog - Ideational Praxis Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100232", - "properties": [ - { - "id": "BiomedicalConceptProperty_1094", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39230", - "standardCode": { - "id": "Code_46517", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1095", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39231", - "standardCode": { - "id": "Code_46518", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1096", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39232", - "standardCode": { - "id": "Code_46519", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1097", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39233", - "standardCode": { - "id": "Code_46520", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1098", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39234", - "standardCode": { - "id": "Code_46521", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1099", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39235", - "standardCode": { - "id": "Code_46522", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1100", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39236", - "standardCode": { - "id": "Code_46523", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1101", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39237", - "standardCode": { - "id": "Code_46524", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24624", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28742", - "extensionAttributes": [], - "code": "C100232", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_178", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Orientation Summary Score", - "label": "CDISC ADAS-Cog - Orientation Summary Score", - "synonyms": [ - "ADCOR", - "Orientation", - "CDISC ADAS-Cog - Orientation Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100238", - "properties": [ - { - "id": "BiomedicalConceptProperty_1110", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39246", - "standardCode": { - "id": "Code_46533", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1111", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39247", - "standardCode": { - "id": "Code_46534", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1112", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39248", - "standardCode": { - "id": "Code_46535", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1113", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39249", - "standardCode": { - "id": "Code_46536", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1114", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39250", - "standardCode": { - "id": "Code_46537", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1115", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39251", - "standardCode": { - "id": "Code_46538", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1116", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39252", - "standardCode": { - "id": "Code_46539", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1117", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39253", - "standardCode": { - "id": "Code_46540", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_27245", - "extensionAttributes": [], - "standardCode": { - "id": "Code_31363", - "extensionAttributes": [], - "code": "C100238", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Orientation Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_179", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Word Recognition Summary Score", - "label": "CDISC ADAS-Cog - Word Recognition Summary Score", - "synonyms": [ - "ADCRG", - "Word Recognition", - "CDISC ADAS-Cog - Word Recognition Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100247", - "properties": [ - { - "id": "BiomedicalConceptProperty_1126", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_39262", - "standardCode": { - "id": "Code_46549", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1127", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39263", - "standardCode": { - "id": "Code_46550", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1128", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39264", - "standardCode": { - "id": "Code_46551", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1129", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39265", - "standardCode": { - "id": "Code_46552", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1130", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39266", - "standardCode": { - "id": "Code_46553", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1131", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39267", - "standardCode": { - "id": "Code_46554", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1132", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "decimal", - "responseCodes": [], - "code": { - "id": "AliasCode_39268", - "standardCode": { - "id": "Code_46555", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1133", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39269", - "standardCode": { - "id": "Code_46556", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24625", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28743", - "extensionAttributes": [], - "code": "C100247", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recognition Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_180", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Remembering Test Instructions", - "label": "CDISC ADAS-Cog - Remembering Test Instructions", - "synonyms": [ - "ADCRI", - "Remembering Test Instructions", - "CDISC ADAS-Cog - Remembering Test Instructions" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100275", - "properties": [ - { - "id": "BiomedicalConceptProperty_1142", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39278", - "standardCode": { - "id": "Code_46565", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1143", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39279", - "standardCode": { - "id": "Code_46566", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1144", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39280", - "standardCode": { - "id": "Code_46567", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1145", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39281", - "standardCode": { - "id": "Code_46568", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1146", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39282", - "standardCode": { - "id": "Code_46569", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1147", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39283", - "standardCode": { - "id": "Code_46570", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1148", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39284", - "standardCode": { - "id": "Code_46571", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1149", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39285", - "standardCode": { - "id": "Code_46572", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24626", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28744", - "extensionAttributes": [], - "code": "C100275", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Remembering Test Instructions", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_181", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Spoken Language Ability", - "label": "CDISC ADAS-Cog - Spoken Language Ability", - "synonyms": [ - "ADCSL", - "Spoken Language Ability", - "CDISC ADAS-Cog - Spoken Language Ability" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100276", - "properties": [ - { - "id": "BiomedicalConceptProperty_1167", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39303", - "standardCode": { - "id": "Code_46590", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1168", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39304", - "standardCode": { - "id": "Code_46591", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1169", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39305", - "standardCode": { - "id": "Code_46592", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1170", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39306", - "standardCode": { - "id": "Code_46593", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1171", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39307", - "standardCode": { - "id": "Code_46594", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1172", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39308", - "standardCode": { - "id": "Code_46595", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1173", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39309", - "standardCode": { - "id": "Code_46596", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1174", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39310", - "standardCode": { - "id": "Code_46597", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24627", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28745", - "extensionAttributes": [], - "code": "C100276", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Spoken Language Ability", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_182", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "label": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "synonyms": [ - "ADCDIF", - "Word Finding Difficulty in Spont Speech", - "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100277", - "properties": [ - { - "id": "BiomedicalConceptProperty_1181", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39319", - "standardCode": { - "id": "Code_46606", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1182", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39320", - "standardCode": { - "id": "Code_46607", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1183", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39321", - "standardCode": { - "id": "Code_46608", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1184", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39322", - "standardCode": { - "id": "Code_46609", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1185", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39323", - "standardCode": { - "id": "Code_46610", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1186", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39324", - "standardCode": { - "id": "Code_46611", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1187", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39325", - "standardCode": { - "id": "Code_46612", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1188", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39326", - "standardCode": { - "id": "Code_46613", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24628", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28746", - "extensionAttributes": [], - "code": "C100277", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_183", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Comprehension", - "label": "CDISC ADAS-Cog - Comprehension", - "synonyms": [ - "ADCCMP", - "Comprehension", - "CDISC ADAS-Cog - Comprehension" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100278", - "properties": [ - { - "id": "BiomedicalConceptProperty_1189", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39327", - "standardCode": { - "id": "Code_46614", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1190", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39328", - "standardCode": { - "id": "Code_46615", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1191", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39329", - "standardCode": { - "id": "Code_46616", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1192", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39330", - "standardCode": { - "id": "Code_46617", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1193", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39331", - "standardCode": { - "id": "Code_46618", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1194", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39332", - "standardCode": { - "id": "Code_46619", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1195", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39333", - "standardCode": { - "id": "Code_46620", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1196", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39334", - "standardCode": { - "id": "Code_46621", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24629", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28747", - "extensionAttributes": [], - "code": "C100278", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Comprehension", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_184", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Concentration/Distractibility", - "label": "CDISC ADAS-Cog - Concentration/Distractibility", - "synonyms": [ - "ADCCON", - "Concentration/Distractibility", - "CDISC ADAS-Cog - Concentration/Distractibility" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100279", - "properties": [ - { - "id": "BiomedicalConceptProperty_1197", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39335", - "standardCode": { - "id": "Code_46622", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1198", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39336", - "standardCode": { - "id": "Code_46623", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1199", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39337", - "standardCode": { - "id": "Code_46624", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1200", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39338", - "standardCode": { - "id": "Code_46625", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1201", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39339", - "standardCode": { - "id": "Code_46626", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1202", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39340", - "standardCode": { - "id": "Code_46627", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1203", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39341", - "standardCode": { - "id": "Code_46628", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1204", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39342", - "standardCode": { - "id": "Code_46629", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24630", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28748", - "extensionAttributes": [], - "code": "C100279", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Concentration/Distractibility", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_185", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "label": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "synonyms": [ - "ADCNC", - "Number Cancellation", - "CDISC ADAS-Cog - Number Cancellation Summary Score" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100280", - "properties": [ - { - "id": "BiomedicalConceptProperty_1205", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39343", - "standardCode": { - "id": "Code_46630", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1206", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39344", - "standardCode": { - "id": "Code_46631", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1207", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39345", - "standardCode": { - "id": "Code_46632", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1208", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39346", - "standardCode": { - "id": "Code_46633", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1209", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39347", - "standardCode": { - "id": "Code_46634", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1210", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39348", - "standardCode": { - "id": "Code_46635", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1211", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39349", - "standardCode": { - "id": "Code_46636", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1212", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39350", - "standardCode": { - "id": "Code_46637", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24631", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28749", - "extensionAttributes": [], - "code": "C100280", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_186", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "label": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "synonyms": [ - "ADCMZ01", - "Executive Function Maze: Errors", - "CDISC ADAS-Cog - Executive Function Maze: Errors" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100285", - "properties": [ - { - "id": "BiomedicalConceptProperty_1213", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39351", - "standardCode": { - "id": "Code_46638", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1214", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39352", - "standardCode": { - "id": "Code_46639", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1215", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39353", - "standardCode": { - "id": "Code_46640", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1216", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39354", - "standardCode": { - "id": "Code_46641", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1217", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39355", - "standardCode": { - "id": "Code_46642", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1218", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39356", - "standardCode": { - "id": "Code_46643", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1219", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39357", - "standardCode": { - "id": "Code_46644", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1220", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39358", - "standardCode": { - "id": "Code_46645", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24632", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28750", - "extensionAttributes": [], - "code": "C100285", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_187", - "extensionAttributes": [], - "name": "CDISC ADAS-Cog - Executive Function Maze: Time", - "label": "CDISC ADAS-Cog - Executive Function Maze: Time", - "synonyms": [ - "ADCMZ02", - "Executive Function Maze: Time", - "CDISC ADAS-Cog - Executive Function Maze: Time" - ], - "reference": "/mdr/bc/biomedicalconcepts/C100286", - "properties": [ - { - "id": "BiomedicalConceptProperty_1221", - "extensionAttributes": [], - "name": "Ordinal Position", - "label": "Ordinal Position", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39359", - "standardCode": { - "id": "Code_46646", - "extensionAttributes": [], - "code": "C46126", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Ordinal Position", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1222", - "extensionAttributes": [], - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "isRequired": true, - "isEnabled": true, - "datatype": "integer", - "responseCodes": [], - "code": { - "id": "AliasCode_39360", - "standardCode": { - "id": "Code_46647", - "extensionAttributes": [], - "code": "C91106", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Clinical or Research Assessment Answer", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1223", - "extensionAttributes": [], - "name": "Unit of Time", - "label": "Unit of Time", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39361", - "standardCode": { - "id": "Code_46648", - "extensionAttributes": [], - "code": "C42574", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Unit of Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1224", - "extensionAttributes": [], - "name": "Category", - "label": "Category", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39362", - "standardCode": { - "id": "Code_46649", - "extensionAttributes": [], - "code": "C25372", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Category", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1225", - "extensionAttributes": [], - "name": "Subcategory", - "label": "Subcategory", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39363", - "standardCode": { - "id": "Code_46650", - "extensionAttributes": [], - "code": "C25692", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Subcategory", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1226", - "extensionAttributes": [], - "name": "Completion Status", - "label": "Completion Status", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39364", - "standardCode": { - "id": "Code_46651", - "extensionAttributes": [], - "code": "C41202", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Completion Status", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1227", - "extensionAttributes": [], - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39365", - "standardCode": { - "id": "Code_46652", - "extensionAttributes": [], - "code": "C82556", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Not-Done Reason", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1228", - "extensionAttributes": [], - "name": "Evaluator", - "label": "Evaluator", - "isRequired": true, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39366", - "standardCode": { - "id": "Code_46653", - "extensionAttributes": [], - "code": "C51824", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Evaluator", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1229", - "extensionAttributes": [], - "name": "Collection Date Time", - "label": "Collection Date Time", - "isRequired": true, - "isEnabled": true, - "datatype": "datetime", - "responseCodes": [], - "code": { - "id": "AliasCode_39367", - "standardCode": { - "id": "Code_46654", - "extensionAttributes": [], - "code": "C82515", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "Collection Date Time", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_24633", - "extensionAttributes": [], - "standardCode": { - "id": "Code_28751", - "extensionAttributes": [], - "code": "C100286", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Time", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - }, - { - "id": "BiomedicalConcept_163", - "extensionAttributes": [ - { - "id": "ExtensionAttribute_140", - "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm", - "valueString": "/mdr/specializations/sdtm/datasetspecializations/EGCTMON", - "instanceType": "ExtensionAttribute" - } - ], - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "synonyms": [ - "ECG Continuous Monitoring", - "EGCTMON" - ], - "reference": "/mdr/bc/biomedicalconcepts/C119561", - "properties": [ - { - "id": "BiomedicalConceptProperty_1230", - "extensionAttributes": [], - "name": "TSPARMCD", - "label": "TSPARMCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3160", - "instanceType": "ResponseCode", - "name": "EGCTMON", - "label": "EGCTMON", - "isEnabled": true, - "code": { - "id": "Code_46656", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "EGCTMON", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39368", - "standardCode": { - "id": "Code_46655", - "extensionAttributes": [], - "code": "C83445", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1231", - "extensionAttributes": [], - "name": "TSPARM", - "label": "TSPARM", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [ - { - "id": "ResponseCode_3161", - "instanceType": "ResponseCode", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "isEnabled": true, - "code": { - "id": "Code_46658", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring", - "instanceType": "Code" - } - } - ], - "code": { - "id": "AliasCode_39370", - "standardCode": { - "id": "Code_46657", - "extensionAttributes": [], - "code": "C49691", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1232", - "extensionAttributes": [], - "name": "TSVAL", - "label": "TSVAL", - "isRequired": false, - "isEnabled": true, - "datatype": "boolean", - "responseCodes": [], - "code": { - "id": "AliasCode_39372", - "standardCode": { - "id": "Code_46659", - "extensionAttributes": [], - "code": "C83447", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1233", - "extensionAttributes": [], - "name": "TSVALCD", - "label": "TSVALCD", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39373", - "standardCode": { - "id": "Code_46660", - "extensionAttributes": [], - "code": "C117458", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Value Code", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1234", - "extensionAttributes": [], - "name": "TSVCDREF", - "label": "TSVCDREF", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39374", - "standardCode": { - "id": "Code_46661", - "extensionAttributes": [], - "code": "C117460", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - }, - { - "id": "BiomedicalConceptProperty_1235", - "extensionAttributes": [], - "name": "TSVCDVER", - "label": "TSVCDVER", - "isRequired": false, - "isEnabled": true, - "datatype": "string", - "responseCodes": [], - "code": { - "id": "AliasCode_39375", - "standardCode": { - "id": "Code_46662", - "extensionAttributes": [], - "code": "C117461", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology", - "instanceType": "Code" - }, - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConceptProperty" - } - ], - "code": { - "id": "AliasCode_2311", - "extensionAttributes": [], - "standardCode": { - "id": "Code_2501", - "extensionAttributes": [], - "code": "C119561", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "notes": [], - "instanceType": "BiomedicalConcept" - } - ], - "bcSurrogates": [ - { - "id": "BiomedicalConceptSurrogate_9", - "extensionAttributes": [], - "name": "MHIS-NACC / MHIS01", - "label": "Modified Hachinski Ischemic Scale (C112523)", - "description": "Modified Hachinski Ischemic Scale-NACC Version Questionnaire", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112523", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_10", - "extensionAttributes": [], - "name": "MHIS0101", - "label": "Abrupt Onset (C112618)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Abrupt onset (re: cognitive status).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112618", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_11", - "extensionAttributes": [], - "name": "MHIS0102", - "label": "Stepwise Deterioration (C112619)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Stepwise deterioration (re: cognitive status).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112619", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_12", - "extensionAttributes": [], - "name": "MHIS0103", - "label": "Emotional Incontinence (C112620)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Emotional incontinence.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112620", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_13", - "extensionAttributes": [], - "name": "MHIS0104", - "label": "History or Presence of Hypertension (C112621)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - History or presence of hypertension.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112621", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_14", - "extensionAttributes": [], - "name": "MHIS0105", - "label": "History of Stroke (C112622)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - History of stroke.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112622", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_15", - "extensionAttributes": [], - "name": "MHIS0106", - "label": "Focal Neurological Symptoms (C112623)", - "description": "MHIS-NACC - Focal Neurological Symptoms", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112623", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_16", - "extensionAttributes": [], - "name": "MHIS0107", - "label": "Focal Neurological Signs (C112624)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Focal neurological signs.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112624", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_17", - "extensionAttributes": [], - "name": "MHIS0108", - "label": "Somatic Complaints (C112813)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Somatic complaints.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112813", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_18", - "extensionAttributes": [], - "name": "MHIS0109", - "label": "Total Score (C112625)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Sum all circled answers for a total score.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112625", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_19", - "extensionAttributes": [], - "name": "APOE Gene", - "label": "APOE Gene (C84468)", - "description": "This gene is involved in lipid transport and metabolism.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C84468", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_20", - "extensionAttributes": [], - "name": "Mini-Mental Status Exam", - "label": "Mini-Mental Status Exam (C74982)", - "description": "Mini-Mental State Examination (MMSE) (MMSE Copyright 1975, 1998, 2001 by MiniMental, LLC All rights reserved. Published 2001 by Psychological Assessment Resources, Inc. May not be reproduced in whole or in part in any form or by any means without written permission of Psychological Assessment Resources, Inc.).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C74982", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_21", - "extensionAttributes": [], - "name": "MMSE - Question 1", - "label": "MMSE - Question 1 (C100542)", - "description": "The Mini-Mental State Examination (MMSE) Question 1.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100542", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_22", - "extensionAttributes": [], - "name": "MMSE - Question 2", - "label": "MMSE - Question 2 (C100548)", - "description": "The Mini-Mental State Examination (MMSE) Question 2.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100548", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_23", - "extensionAttributes": [], - "name": "MMSE - Question 3", - "label": "MMSE - Question 3 (C100554)", - "description": "The Mini-Mental State Examination (MMSE) Question 3.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100554", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_24", - "extensionAttributes": [], - "name": "MMSE - Question 4", - "label": "MMSE - Question 4 (C100558)", - "description": "The Mini-Mental State Examination (MMSE) Question 4.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100558", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_25", - "extensionAttributes": [], - "name": "MMSE - Question 6", - "label": "MMSE - Question 6 (C100575)", - "description": "The Mini-Mental State Examination (MMSE) Question 6.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100575", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_26", - "extensionAttributes": [], - "name": "MMSE Functional Test Question", - "label": "MMSE Functional Test Question (C100118)", - "description": "A question associated with the MMSE functional test.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100118", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_27", - "extensionAttributes": [], - "name": "ADCS-CGIC", - "label": "ADCS-CGIC Questionnaire Question (C103490)", - "description": "A question associated with the ADCS-CGIC questionnaire.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103490", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_28", - "extensionAttributes": [], - "name": "DAD", - "label": "Disability Assessment for Dementia Questionnaire (C105165)", - "description": "Disability Assessment for Dementia (DAD) (copyright 1994 by L. Gauthier I. Gelinas. All rights reserved.).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C105165", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_29", - "extensionAttributes": [], - "name": "NPI - NPI Total Distress Score", - "label": "NPI - NPI Total Distress Score (C112482)", - "description": "Neuropsychiatric Inventory - Sub-total of distress score.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112482", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_30", - "extensionAttributes": [], - "name": "NPI - Anxiety Severity", - "label": "NPI - Anxiety Severity (C103615)", - "description": "Neuropsychiatric Inventory - Severity of the anxiety.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103615", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_31", - "extensionAttributes": [], - "name": "NPI - Disinhibition Frequency", - "label": "NPI - Disinhibition Frequency (C103623)", - "description": "Neuropsychiatric Inventory - Frequency of the disinhibition.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103623", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_32", - "extensionAttributes": [], - "name": "NPI - Disinhibition Severity", - "label": "NPI - Disinhibition Severity (C103624)", - "description": "Neuropsychiatric Inventory - Severity of the disinhibition.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103624", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_33", - "extensionAttributes": [], - "name": "NPI - Disinhibition Distress", - "label": "NPI - Disinhibition Distress (C103625)", - "description": "Neuropsychiatric Inventory - How emotionally distressing do you find this behavior?", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103625", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - }, - { - "id": "BiomedicalConceptSurrogate_34", - "extensionAttributes": [], - "name": "NPI - Disinhibition FxS Score", - "label": "NPI - Disinhibition FxS Score (C112476)", - "description": "Neuropsychiatric Inventory - Disinhibition: (frequency score x severity score).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112476", - "notes": [], - "instanceType": "BiomedicalConceptSurrogate" - } - ], - "bcCategories": [], - "eligibilityCriterionItems": [], - "narrativeContentItems": [], - "abbreviations": [], - "administrableProducts": [], - "medicalDevices": [], - "productOrganizationRoles": [], - "dictionaries": [], - "conditions": [], - "notes": [], - "instanceType": "StudyVersion" - } - ], - "documentedBy": [], - "instanceType": "Study" - }, - "usdmVersion": "4.0", - "systemName": "SOA Workbench", - "systemVersion": "pi-fix-bc-props-specs-in-usdm" -} From d8140d7f59c5f8cca66ee2426d5adc15698488ca Mon Sep 17 00:00:00 2001 From: pendingintent <3921919+pendingintent@users.noreply.github.com> Date: Thu, 13 Aug 2026 09:31:41 -0400 Subject: [PATCH 2/4] Fix claude-review workflow missing id-token permission The claude-code-action requires id-token: write to fetch an OIDC token for GitHub App authentication; without it the action failed on every PR with "Could not fetch an OIDC token." --- .github/workflows/claude-review.yml | 3 ++- 1 file changed, 2 insertions(+), 1 deletion(-) diff --git a/.github/workflows/claude-review.yml b/.github/workflows/claude-review.yml index ec39cf3..6057d30 100644 --- a/.github/workflows/claude-review.yml +++ b/.github/workflows/claude-review.yml @@ -8,6 +8,7 @@ on: permissions: contents: read pull-requests: write + id-token: write jobs: claude-review: @@ -16,7 +17,7 @@ jobs: - name: Checkout uses: actions/checkout@v4 with: - fetch-depth: 0 # Full history needed for diff analysis + fetch-depth: 0 # Full history needed for diff analysis - name: Claude Code claude-review uses: anthropics/claude-code-action@v1 From eedae5a8e99b848731f3e3a63bf4e796488ce669 Mon Sep 17 00:00:00 2001 From: pendingintent <3921919+pendingintent@users.noreply.github.com> Date: Thu, 13 Aug 2026 09:38:38 -0400 Subject: [PATCH 3/4] Added export of the PrE0102 study for import into SoA Workbench. --- .../pilot-LZZT-soa-bundle-20260612T0950.json | 49217 ---------------- output/exports/PrE0102.soa-bundle.json | 24609 ++++++++ 2 files changed, 24609 insertions(+), 49217 deletions(-) delete mode 100644 output/backup/pilot-LZZT-soa-bundle-20260612T0950.json create mode 100644 output/exports/PrE0102.soa-bundle.json diff --git a/output/backup/pilot-LZZT-soa-bundle-20260612T0950.json b/output/backup/pilot-LZZT-soa-bundle-20260612T0950.json deleted file mode 100644 index 747acf5..0000000 --- a/output/backup/pilot-LZZT-soa-bundle-20260612T0950.json +++ /dev/null @@ -1,49217 +0,0 @@ -{ - "format_version": "1.0", - "exported_at": "2026-06-12T13:50:29.975900+00:00", - "soa": { - "name": "Darren", - "study_id": "H2Q-MC-LZZT", - "study_label": "Alzheimer Study", - "study_description": "Patients with probable mild to moderate AD will be studied in a randomized, double-blind, parallel (3 arm), placebo-controlled trial of 26 weeks duration. The study will be conducted on an outpatient basis. Approximately 300 patients will be enrolled" - }, - "code": [ - { - "id": 1, - "soa_id": 3, - "code_uid": "Code_1", - "code": "C174268", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Placebo Comparator Arm" - }, - { - "id": 2, - "soa_id": 3, - "code_uid": "Code_2", - "code": "C188866", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Data Generated Within Study" - }, - { - "id": 3, - "soa_id": 3, - "code_uid": "Code_3", - "code": "C174267", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Active Comparator Arm" - }, - { - "id": 4, - "soa_id": 3, - "code_uid": "Code_4", - "code": "C188866", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Data Generated Within Study" - }, - { - "id": 5, - "soa_id": 3, - "code_uid": "Code_5", - "code": "C174267", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Active Comparator Arm" - }, - { - "id": 6, - "soa_id": 3, - "code_uid": "Code_6", - "code": "C188866", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Data Generated Within Study" - }, - { - "id": 7, - "soa_id": 3, - "code_uid": "Code_7", - "code": "C42872", - "code_system": "/mdr/ct/packages/sdtmct-2025-09-26", - "code_system_version": "2025-09-26", - "decode": "WASHOUT" - }, - { - "id": 8, - "soa_id": 3, - "code_uid": "Code_8", - "code": "C42872", - "code_system": "/mdr/ct/packages/sdtmct-2025-09-26", - "code_system_version": "2025-09-26", - "decode": "WASHOUT" - }, - { - "id": 9, - "soa_id": 3, - "code_uid": "Code_9", - "code": "C125938", - "code_system": "/mdr/ct/packages/sdtmct-2025-09-26", - "code_system_version": "2025-09-26", - "decode": "BASELINE" - }, - { - "id": 10, - "soa_id": 3, - "code_uid": "Code_10", - "code": "C202487", - "code_system": "/mdr/ct/packages/sdtmct-2025-09-26", - "code_system_version": "2025-09-26", - "decode": "SCREENING" - }, - { - "id": 11, - "soa_id": 3, - "code_uid": "Code_11", - "code": "C101526", - "code_system": "/mdr/ct/packages/sdtmct-2025-09-26", - "code_system_version": "2025-09-26", - "decode": "TREATMENT" - }, - { - "id": 12, - "soa_id": 3, - "code_uid": "Code_12", - "code": "C202578", - "code_system": "/mdr/ct/packages/sdtmct-2025-09-26", - "code_system_version": "2025-09-26", - "decode": "FOLLOW-UP" - }, - { - "id": 13, - "soa_id": 3, - "code_uid": "Code_13", - "code": "C101526", - "code_system": "/mdr/ct/packages/sdtmct-2025-09-26", - "code_system_version": "2025-09-26", - "decode": "TREATMENT" - }, - { - "id": 14, - "soa_id": 3, - "code_uid": "Code_14", - "code": "C101526", - "code_system": "/mdr/ct/packages/sdtmct-2025-09-26", - "code_system_version": "2025-09-26", - "decode": "TREATMENT" - }, - { - "id": 15, - "soa_id": 3, - "code_uid": "Code_15", - "code": "C201357", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Before" - }, - { - "id": 16, - "soa_id": 3, - "code_uid": "Code_16", - "code": "C201357", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Before" - }, - { - "id": 17, - "soa_id": 3, - "code_uid": "Code_17", - "code": "C201358", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Fixed Reference" - }, - { - "id": 18, - "soa_id": 3, - "code_uid": "Code_18", - "code": "C201358", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Fixed Reference" - }, - { - "id": 19, - "soa_id": 3, - "code_uid": "Code_19", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 20, - "soa_id": 3, - "code_uid": "Code_20", - "code": "C201357", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Before" - }, - { - "id": 21, - "soa_id": 3, - "code_uid": "Code_21", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 22, - "soa_id": 3, - "code_uid": "Code_22", - "code": "C201357", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Before" - }, - { - "id": 23, - "soa_id": 3, - "code_uid": "Code_23", - "code": "C201354", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to End" - }, - { - "id": 24, - "soa_id": 3, - "code_uid": "Code_24", - "code": "C201352", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "End to End" - }, - { - "id": 25, - "soa_id": 3, - "code_uid": "Code_25", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 26, - "soa_id": 3, - "code_uid": "Code_26", - "code": "C201357", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Before" - }, - { - "id": 27, - "soa_id": 3, - "code_uid": "Code_27", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 28, - "soa_id": 3, - "code_uid": "Code_28", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 29, - "soa_id": 3, - "code_uid": "Code_29", - "code": "C201356", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "After" - }, - { - "id": 30, - "soa_id": 3, - "code_uid": "Code_30", - "code": "C201356", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "After" - }, - { - "id": 31, - "soa_id": 3, - "code_uid": "Code_31", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 32, - "soa_id": 3, - "code_uid": "Code_32", - "code": "C201356", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "After" - }, - { - "id": 33, - "soa_id": 3, - "code_uid": "Code_33", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 34, - "soa_id": 3, - "code_uid": "Code_34", - "code": "C201356", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "After" - }, - { - "id": 35, - "soa_id": 3, - "code_uid": "Code_35", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 36, - "soa_id": 3, - "code_uid": "Code_36", - "code": "C201356", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "After" - }, - { - "id": 37, - "soa_id": 3, - "code_uid": "Code_37", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 39, - "soa_id": 3, - "code_uid": "Code_39", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 40, - "soa_id": 3, - "code_uid": "Code_40", - "code": "C201356", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "After" - }, - { - "id": 41, - "soa_id": 3, - "code_uid": "Code_41", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 42, - "soa_id": 3, - "code_uid": "Code_42", - "code": "C201356", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "After" - }, - { - "id": 43, - "soa_id": 3, - "code_uid": "Code_43", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 44, - "soa_id": 3, - "code_uid": "Code_44", - "code": "C201356", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "After" - }, - { - "id": 45, - "soa_id": 3, - "code_uid": "Code_45", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 46, - "soa_id": 3, - "code_uid": "Code_46", - "code": "C201356", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "After" - }, - { - "id": 47, - "soa_id": 3, - "code_uid": "Code_47", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 48, - "soa_id": 3, - "code_uid": "Code_48", - "code": "C201356", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "After" - }, - { - "id": 49, - "soa_id": 3, - "code_uid": "Code_49", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 53, - "soa_id": 3, - "code_uid": "Code_53", - "code": "C201355", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Start to Start" - }, - { - "id": 54, - "soa_id": 3, - "code_uid": "Code_54", - "code": "C25716", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Visit" - }, - { - "id": 60, - "soa_id": 3, - "code_uid": "Code_60", - "code": "C25716", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Visit" - }, - { - "id": 67, - "soa_id": 3, - "code_uid": "Code_67", - "code": "C25716", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Visit" - }, - { - "id": 69, - "soa_id": 3, - "code_uid": "Code_69", - "code": "C25716", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Visit" - }, - { - "id": 72, - "soa_id": 3, - "code_uid": "Code_72", - "code": "C25716", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Visit" - }, - { - "id": 152, - "soa_id": 3, - "code_uid": "Code_152", - "code": "C25170", - "code_system": "/mdr/ct/packages/sdtmct-2025-09-26", - "code_system_version": "2025-09-26", - "decode": "E-MAIL" - }, - { - "id": 153, - "soa_id": 3, - "code_uid": "Code_153", - "code": "C177933", - "code_system": "/mdr/ct/packages/sdtmct-2025-09-26", - "code_system_version": "2025-09-26", - "decode": "IVRS" - }, - { - "id": 190, - "soa_id": 3, - "code_uid": "Code_190", - "code": "C165830", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Real World Data" - }, - { - "id": 2391, - "soa_id": 3, - "code_uid": "Code_1937", - "code": "C50996", - "code_system": "/mdr/bc/packages/2023-12-12/biomedicalconcepts", - "code_system_version": "2023-12-12", - "decode": "Protocol Deviation" - }, - { - "id": 2397, - "soa_id": 3, - "code_uid": "Code_1943", - "code": "C186208", - "code_system": "/mdr/bc/packages/2023-12-12/biomedicalconcepts", - "code_system_version": "2023-12-12", - "decode": "Study Site Transfer" - }, - { - "id": 2402, - "soa_id": 3, - "code_uid": "Code_1948", - "code": "C49632", - "code_system": "/mdr/bc/packages/2023-12-12/biomedicalconcepts", - "code_system_version": "2023-12-12", - "decode": "Study Terminated By Sponsor" - }, - { - "id": 2404, - "soa_id": 3, - "code_uid": "Code_1950", - "code": "C49628", - "code_system": "/mdr/bc/packages/2023-12-12/biomedicalconcepts", - "code_system_version": "2023-12-12", - "decode": "Trial Screen Failure" - }, - { - "id": 2405, - "soa_id": 3, - "code_uid": "Code_1951", - "code": "C106576", - "code_system": "/mdr/bc/packages/2023-12-12/biomedicalconcepts", - "code_system_version": "2023-12-12", - "decode": "Trial Site Terminated by Sponsor" - }, - { - "id": 2406, - "soa_id": 3, - "code_uid": "Code_1952", - "code": "C49634", - "code_system": "/mdr/bc/packages/2023-12-12/biomedicalconcepts", - "code_system_version": "2023-12-12", - "decode": "Withdrawal by Subject" - }, - { - "id": 2477, - "soa_id": 3, - "code_uid": "Code_2023", - "code": "C49677", - "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", - "code_system_version": "2025-12-16", - "decode": "Heart Rate" - }, - { - "id": 2489, - "soa_id": 3, - "code_uid": "Code_2024", - "code": "C25298", - "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", - "code_system_version": "2025-12-16", - "decode": "Systolic Blood Pressure" - }, - { - "id": 3432, - "soa_id": 3, - "code_uid": "Code_2125", - "code": "C100242", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Orientation: Year" - }, - { - "id": 3434, - "soa_id": 3, - "code_uid": "Code_2127", - "code": "C100244", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Orientation: Season" - }, - { - "id": 3435, - "soa_id": 3, - "code_uid": "Code_2128", - "code": "C100245", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Orientation: Place" - }, - { - "id": 4172, - "soa_id": 3, - "code_uid": "Code_2501", - "code": "C119561", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "ECG Continuous Monitoring Indicator" - }, - { - "id": 4205, - "soa_id": 3, - "code_uid": "Code_2502", - "code": "C138967", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Isometric Muscle Strength" - }, - { - "id": 4206, - "soa_id": 3, - "code_uid": "Code_2503", - "code": "C178017", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Skeletal Muscle Mass Measurement" - }, - { - "id": 21332, - "soa_id": 3, - "code_uid": "Code_2850", - "code": "C174446", - "code_system": "http://www.cdisc.org", - "code_system_version": "", - "decode": "VSTESTCD" - }, - { - "id": 21356, - "soa_id": 3, - "code_uid": "Code_2874", - "code": "C49676", - "code_system": "http://www.cdisc.org", - "code_system_version": "", - "decode": "VSTESTCD" - }, - { - "id": 21372, - "soa_id": 3, - "code_uid": "Code_2890", - "code": "C49678", - "code_system": "http://www.cdisc.org", - "code_system_version": "", - "decode": "VSTESTCD" - }, - { - "id": 21843, - "soa_id": 3, - "code_uid": "Code_3361", - "code": "C16735", - "code_system": "/mdr/bc/packages/2023-12-12/biomedicalconcepts", - "code_system_version": "2023-12-12", - "decode": "Informed Consent" - }, - { - "id": 21845, - "soa_id": 3, - "code_uid": "Code_3363", - "code": "C25370", - "code_system": "/mdr/bc/packages/2024-12-16/biomedicalconcepts", - "code_system_version": "2024-12-16", - "decode": "Exclusion Criteria" - }, - { - "id": 21847, - "soa_id": 3, - "code_uid": "Code_3365", - "code": "C83217", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Birth Date and Time" - }, - { - "id": 21848, - "soa_id": 3, - "code_uid": "Code_3366", - "code": "C200145", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Solicited Medical History" - }, - { - "id": 21849, - "soa_id": 3, - "code_uid": "Code_3367", - "code": "C201990", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Caffeine Use History" - }, - { - "id": 21850, - "soa_id": 3, - "code_uid": "Code_3368", - "code": "C181760", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "History of Tobacco Use" - }, - { - "id": 21852, - "soa_id": 3, - "code_uid": "Code_3370", - "code": "C114209", - "code_system": "/mdr/bc/packages/2023-12-12/biomedicalconcepts", - "code_system_version": "2023-12-12", - "decode": "Subject is Randomized" - }, - { - "id": 21853, - "soa_id": 3, - "code_uid": "Code_3371", - "code": "C81328", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Body Weight" - }, - { - "id": 21854, - "soa_id": 3, - "code_uid": "Code_3372", - "code": "C54706", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Blood Pressure" - }, - { - "id": 26409, - "soa_id": 3, - "code_uid": "Code_3428", - "code": "C74676", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Folic Acid Measurement" - }, - { - "id": 26410, - "soa_id": 3, - "code_uid": "Code_3429", - "code": "C64832", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Specific Gravity" - }, - { - "id": 31367, - "soa_id": 3, - "code_uid": "Code_3564", - "code": "C64470", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Absolute Basophil Count" - }, - { - "id": 31368, - "soa_id": 3, - "code_uid": "Code_3565", - "code": "C64547", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Creatinine Measurement" - }, - { - "id": 31369, - "soa_id": 3, - "code_uid": "Code_3566", - "code": "C74686", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Occult Blood Measurement" - }, - { - "id": 31370, - "soa_id": 3, - "code_uid": "Code_3567", - "code": "C64810", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Nitrite Measurement" - }, - { - "id": 39354, - "soa_id": 3, - "code_uid": "Code_5992", - "code": "C64847", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Gamma Glutamyl Transpeptidase Measurement" - }, - { - "id": 40254, - "soa_id": 3, - "code_uid": "Code_6157", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Observation Result" - }, - { - "id": 40255, - "soa_id": 3, - "code_uid": "Code_6158", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Body Position" - }, - { - "id": 40257, - "soa_id": 3, - "code_uid": "Code_6160", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Evaluator" - }, - { - "id": 40258, - "soa_id": 3, - "code_uid": "Code_6161", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Collection Date Time" - }, - { - "id": 41089, - "soa_id": 3, - "code_uid": "Code_6606", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Observation Result" - }, - { - "id": 41090, - "soa_id": 3, - "code_uid": "Code_6607", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Unit of Concentration" - }, - { - "id": 41093, - "soa_id": 3, - "code_uid": "Code_6610", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Fasting Status Indicator" - }, - { - "id": 41094, - "soa_id": 3, - "code_uid": "Code_6611", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Collection Date Time" - }, - { - "id": 45606, - "soa_id": 3, - "code_uid": "Code_8947", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "SERUM OR PLASMA" - }, - { - "id": 48480, - "soa_id": 3, - "code_uid": "Code_10138", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "BLOOD" - }, - { - "id": 49389, - "soa_id": 3, - "code_uid": "Code_11043", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "EGCTMON" - }, - { - "id": 49391, - "soa_id": 3, - "code_uid": "Code_11045", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "ECG Continuous Monitoring" - }, - { - "id": 49401, - "soa_id": 3, - "code_uid": "Code_11055", - "code": "C16809", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "MRI" - }, - { - "id": 53505, - "soa_id": 3, - "code_uid": "Code_12460", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "CAREGIVER" - }, - { - "id": 53509, - "soa_id": 3, - "code_uid": "Code_12465", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "CAREGIVER" - }, - { - "id": 75416, - "soa_id": 3, - "code_uid": "Code_13702", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Observation Result" - }, - { - "id": 75417, - "soa_id": 3, - "code_uid": "Code_13703", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Unit of Concentration" - }, - { - "id": 75418, - "soa_id": 3, - "code_uid": "Code_13704", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Biospecimen Type" - }, - { - "id": 75419, - "soa_id": 3, - "code_uid": "Code_13705", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "URINE" - }, - { - "id": 75420, - "soa_id": 3, - "code_uid": "Code_13706", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Fasting Status Indicator" - }, - { - "id": 75421, - "soa_id": 3, - "code_uid": "Code_13707", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Collection Date Time" - }, - { - "id": 75597, - "soa_id": 3, - "code_uid": "Code_13807", - "code": "C186208", - "code_system": "http://www.cdisc.org", - "code_system_version": "2023-12-12", - "decode": "SITE TRANSFER" - }, - { - "id": 78051, - "soa_id": 3, - "code_uid": "Code_14734", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "EGCTMON" - }, - { - "id": 81163, - "soa_id": 3, - "code_uid": "Code_15549", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Observation Result" - }, - { - "id": 81164, - "soa_id": 3, - "code_uid": "Code_15550", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Unit of Concentration" - }, - { - "id": 81165, - "soa_id": 3, - "code_uid": "Code_15551", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Biospecimen Type" - }, - { - "id": 81166, - "soa_id": 3, - "code_uid": "Code_15552", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "SERUM OR PLASMA" - }, - { - "id": 81167, - "soa_id": 3, - "code_uid": "Code_15553", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Fasting Status Indicator" - }, - { - "id": 81168, - "soa_id": 3, - "code_uid": "Code_15554", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Collection Date Time" - }, - { - "id": 81321, - "soa_id": 3, - "code_uid": "Code_15634", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Observation Result" - }, - { - "id": 81322, - "soa_id": 3, - "code_uid": "Code_15635", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Unit of Concentration" - }, - { - "id": 81323, - "soa_id": 3, - "code_uid": "Code_15636", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Biospecimen Type" - }, - { - "id": 81324, - "soa_id": 3, - "code_uid": "Code_15637", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "SERUM OR PLASMA" - }, - { - "id": 81325, - "soa_id": 3, - "code_uid": "Code_15638", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Fasting Status Indicator" - }, - { - "id": 81326, - "soa_id": 3, - "code_uid": "Code_15639", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Collection Date Time" - }, - { - "id": 82369, - "soa_id": 3, - "code_uid": "Code_16474", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Observation Result" - }, - { - "id": 82370, - "soa_id": 3, - "code_uid": "Code_16475", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Body Position" - }, - { - "id": 82371, - "soa_id": 3, - "code_uid": "Code_16476", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Test Method" - }, - { - "id": 82372, - "soa_id": 3, - "code_uid": "Code_16477", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Evaluator" - }, - { - "id": 82373, - "soa_id": 3, - "code_uid": "Code_16478", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Collection Date Time" - }, - { - "id": 82379, - "soa_id": 3, - "code_uid": "Code_16484", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Observation Result" - }, - { - "id": 82380, - "soa_id": 3, - "code_uid": "Code_16485", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Body Position" - }, - { - "id": 82381, - "soa_id": 3, - "code_uid": "Code_16486", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Test Method" - }, - { - "id": 82382, - "soa_id": 3, - "code_uid": "Code_16487", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Evaluator" - }, - { - "id": 82383, - "soa_id": 3, - "code_uid": "Code_16488", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Collection Date Time" - }, - { - "id": 82389, - "soa_id": 3, - "code_uid": "Code_16494", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Observation Result" - }, - { - "id": 82390, - "soa_id": 3, - "code_uid": "Code_16495", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Body Position" - }, - { - "id": 82391, - "soa_id": 3, - "code_uid": "Code_16496", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Test Method" - }, - { - "id": 82392, - "soa_id": 3, - "code_uid": "Code_16497", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Evaluator" - }, - { - "id": 82393, - "soa_id": 3, - "code_uid": "Code_16498", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Collection Date Time" - }, - { - "id": 82583, - "soa_id": 3, - "code_uid": "Code_16596", - "code": "C117511", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Reported Name of Procedure" - }, - { - "id": 82584, - "soa_id": 3, - "code_uid": "Code_16597", - "code": "C117512", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Standardized Name of Procedure" - }, - { - "id": 82585, - "soa_id": 3, - "code_uid": "Code_16598", - "code": "C16809", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "MRI" - }, - { - "id": 82586, - "soa_id": 3, - "code_uid": "Code_16599", - "code": "C171000", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - }, - { - "id": 82587, - "soa_id": 3, - "code_uid": "Code_16600", - "code": "C127786", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Occurrence Indicator" - }, - { - "id": 82588, - "soa_id": 3, - "code_uid": "Code_16601", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Anatomic Site" - }, - { - "id": 82589, - "soa_id": 3, - "code_uid": "Code_16602", - "code": "C12439", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "BRAIN" - }, - { - "id": 82590, - "soa_id": 3, - "code_uid": "Code_16603", - "code": "C117529", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Start Date and Time of Procedure" - }, - { - "id": 82591, - "soa_id": 3, - "code_uid": "Code_16604", - "code": "C117530", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "End Date and Time of Procedure" - }, - { - "id": 85684, - "soa_id": 3, - "code_uid": "Code_18131", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "BLOOD" - }, - { - "id": 91383, - "soa_id": 3, - "code_uid": "Code_20011", - "code": "150", - "code_system": "UN M49", - "code_system_version": "2026", - "decode": "Europe" - }, - { - "id": 94769, - "soa_id": 3, - "code_uid": "Code_20515", - "code": "C25389", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "CHEST" - }, - { - "id": 94913, - "soa_id": 3, - "code_uid": "Code_20659", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 95872, - "soa_id": 3, - "code_uid": "Code_21294", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 96618, - "soa_id": 3, - "code_uid": "Code_22040", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "EGCTMON" - }, - { - "id": 128965, - "soa_id": 3, - "code_uid": "Code_24852", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 129329, - "soa_id": 3, - "code_uid": "Code_25216", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 129531, - "soa_id": 3, - "code_uid": "Code_25414", - "code": "C186208", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SITE TRANSFER" - }, - { - "id": 134669, - "soa_id": 3, - "code_uid": "Code_27557", - "code": "C207646", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-03-27", - "decode": "Study Acronym" - }, - { - "id": 134713, - "soa_id": 3, - "code_uid": "Code_27601", - "code": "C207615", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-03-27", - "decode": "Brief Study Title" - }, - { - "id": 134975, - "soa_id": 3, - "code_uid": "Code_27813", - "code": "C207616", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-03-27", - "decode": "Official Study Title" - }, - { - "id": 140671, - "soa_id": 3, - "code_uid": "Code_28637", - "code": "C70793", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-03-27", - "decode": "Clinical Study Sponsor" - }, - { - "id": 140672, - "soa_id": 3, - "code_uid": "Code_28638", - "code": "840", - "code_system": "ISO 3166 1 Numeric Code", - "code_system_version": "2026", - "decode": "United States of America" - }, - { - "id": 140673, - "soa_id": 3, - "code_uid": "Code_28639", - "code": "C142578", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-03-27", - "decode": "Independent Data Monitoring Committee" - }, - { - "id": 140674, - "soa_id": 3, - "code_uid": "Code_28640", - "code": "840", - "code_system": "ISO 3166 1 Numeric Code", - "code_system_version": "2026", - "decode": "United States of America" - }, - { - "id": 148700, - "soa_id": 3, - "code_uid": "Code_28641", - "code": "C25532", - "code_system": "/mdr/bc/packages/2023-12-12/biomedicalconcepts", - "code_system_version": "2023-12-12", - "decode": "Inclusion Criteria" - }, - { - "id": 148701, - "soa_id": 3, - "code_uid": "Code_28642", - "code": "C69260", - "code_system": "/mdr/bc/packages/2025-04-01/biomedicalconcepts", - "code_system_version": "2025-04-01", - "decode": "Subject Age" - }, - { - "id": 148702, - "soa_id": 3, - "code_uid": "Code_28643", - "code": "C28421", - "code_system": "/mdr/bc/packages/2025-04-01/biomedicalconcepts", - "code_system_version": "2025-04-01", - "decode": "Sex" - }, - { - "id": 148703, - "soa_id": 3, - "code_uid": "Code_28644", - "code": "C17953", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "Education Level" - }, - { - "id": 148704, - "soa_id": 3, - "code_uid": "Code_28645", - "code": "C122393", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "Number of Years of Education" - }, - { - "id": 148705, - "soa_id": 3, - "code_uid": "Code_28646", - "code": "C81229", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Alcohol Use History" - }, - { - "id": 148706, - "soa_id": 3, - "code_uid": "Code_28647", - "code": "C164634", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Body Height" - }, - { - "id": 148707, - "soa_id": 3, - "code_uid": "Code_28648", - "code": "C16358", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Body Mass Index" - }, - { - "id": 148708, - "soa_id": 3, - "code_uid": "Code_28649", - "code": "C181655", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Electrocardiogram Analysis" - }, - { - "id": 148709, - "soa_id": 3, - "code_uid": "Code_28650", - "code": "C111131", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Atrioventricular Conduction ECG Assessment" - }, - { - "id": 148710, - "soa_id": 3, - "code_uid": "Code_28651", - "code": "C111132", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Axis and Voltage ECG Assessment" - }, - { - "id": 148711, - "soa_id": 3, - "code_uid": "Code_28652", - "code": "C111155", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Chamber Hypertrophy or Enlargement ECG Assessment" - }, - { - "id": 148712, - "soa_id": 3, - "code_uid": "Code_28653", - "code": "C117807", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "ECG Technical Quality" - }, - { - "id": 148713, - "soa_id": 3, - "code_uid": "Code_28654", - "code": "C111238", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Intraventricular and Intraatrial Conduction ECG Assessment" - }, - { - "id": 148714, - "soa_id": 3, - "code_uid": "Code_28655", - "code": "C111280", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Myocardial Infarction ECG Assessment" - }, - { - "id": 148715, - "soa_id": 3, - "code_uid": "Code_28656", - "code": "C111285", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Pacemaker ECG Assessment" - }, - { - "id": 148716, - "soa_id": 3, - "code_uid": "Code_28657", - "code": "C111307", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Rhythm Not Otherwise Specified ECG Assessment" - }, - { - "id": 148717, - "soa_id": 3, - "code_uid": "Code_28658", - "code": "C111363", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "ST Segment, T wave, and U wave ECG Assessment" - }, - { - "id": 148718, - "soa_id": 3, - "code_uid": "Code_28659", - "code": "C111312", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Sinus Node Rhythm and Arrhythmia ECG Assessment" - }, - { - "id": 148719, - "soa_id": 3, - "code_uid": "Code_28660", - "code": "C111320", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Supraventricular Arrhythmia ECG Assessment" - }, - { - "id": 148720, - "soa_id": 3, - "code_uid": "Code_28661", - "code": "C111321", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Supraventricular Tachyarrhythmia ECG Assessment" - }, - { - "id": 148721, - "soa_id": 3, - "code_uid": "Code_28662", - "code": "C117773", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Aggregate PR Interval" - }, - { - "id": 148722, - "soa_id": 3, - "code_uid": "Code_28663", - "code": "C117779", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Aggregate QRS Duration" - }, - { - "id": 148723, - "soa_id": 3, - "code_uid": "Code_28664", - "code": "C117783", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Aggregate QT Interval" - }, - { - "id": 148724, - "soa_id": 3, - "code_uid": "Code_28665", - "code": "C117784", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Aggregate QTCB Interval" - }, - { - "id": 148725, - "soa_id": 3, - "code_uid": "Code_28666", - "code": "C117786", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Aggregate QTCF Interval" - }, - { - "id": 148726, - "soa_id": 3, - "code_uid": "Code_28667", - "code": "C117791", - "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", - "code_system_version": "2026-05-26", - "decode": "Aggregate RR Interval" - }, - { - "id": 148727, - "soa_id": 3, - "code_uid": "Code_28668", - "code": "C119259", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Mean Heart Rate by Electrocardiogram" - }, - { - "id": 148728, - "soa_id": 3, - "code_uid": "Code_28669", - "code": "C118165", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "QRS Axis" - }, - { - "id": 148729, - "soa_id": 3, - "code_uid": "Code_28670", - "code": "C174285", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "QTc Correction Method Unspecified, Aggregate" - }, - { - "id": 148730, - "soa_id": 3, - "code_uid": "Code_28671", - "code": "C111330", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Ventricular Arrhythmia ECG Assessment" - }, - { - "id": 148731, - "soa_id": 3, - "code_uid": "Code_28672", - "code": "C111331", - "code_system": "/mdr/bc/packages/2024-12-17/biomedicalconcepts", - "code_system_version": "2024-12-17", - "decode": "Ventricular Tachyarrhythmia ECG Assessment" - }, - { - "id": 148732, - "soa_id": 3, - "code_uid": "Code_28673", - "code": "C83056", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - }, - { - "id": 148733, - "soa_id": 3, - "code_uid": "Code_28674", - "code": "C53630", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Concomitant Therapy" - }, - { - "id": 148734, - "soa_id": 3, - "code_uid": "Code_28675", - "code": "C64848", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Hemoglobin Measurement" - }, - { - "id": 148735, - "soa_id": 3, - "code_uid": "Code_28676", - "code": "C64796", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Hematocrit Measurement" - }, - { - "id": 148736, - "soa_id": 3, - "code_uid": "Code_28677", - "code": "C51946", - "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", - "code_system_version": "2025-12-16", - "decode": "Erythrocyte Count" - }, - { - "id": 148737, - "soa_id": 3, - "code_uid": "Code_28678", - "code": "C64797", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Hemoglobin" - }, - { - "id": 148738, - "soa_id": 3, - "code_uid": "Code_28679", - "code": "C64799", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Erythrocyte Mean Corpuscular Volume" - }, - { - "id": 148739, - "soa_id": 3, - "code_uid": "Code_28680", - "code": "C51948", - "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", - "code_system_version": "2025-12-16", - "decode": "Leukocyte Count" - }, - { - "id": 148740, - "soa_id": 3, - "code_uid": "Code_28681", - "code": "C81997", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Segmented Neutrophil Count" - }, - { - "id": 148741, - "soa_id": 3, - "code_uid": "Code_28682", - "code": "C64830", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Neutrophil Band Form Count" - }, - { - "id": 148742, - "soa_id": 3, - "code_uid": "Code_28683", - "code": "C63321", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Absolute Neutrophil Count" - }, - { - "id": 148743, - "soa_id": 3, - "code_uid": "Code_28684", - "code": "C64823", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Monocyte Count" - }, - { - "id": 148744, - "soa_id": 3, - "code_uid": "Code_28685", - "code": "C64550", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Eosinophil Count" - }, - { - "id": 148745, - "soa_id": 3, - "code_uid": "Code_28686", - "code": "C51951", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Platelet Count" - }, - { - "id": 148746, - "soa_id": 3, - "code_uid": "Code_28687", - "code": "C64822", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Microcyte Count" - }, - { - "id": 148747, - "soa_id": 3, - "code_uid": "Code_28688", - "code": "C64821", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Macrocyte Count" - }, - { - "id": 148748, - "soa_id": 3, - "code_uid": "Code_28689", - "code": "C74797", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Anisocyte Measurement" - }, - { - "id": 148749, - "soa_id": 3, - "code_uid": "Code_28690", - "code": "C79602", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Poikilocyte Measurement" - }, - { - "id": 148750, - "soa_id": 3, - "code_uid": "Code_28691", - "code": "C64803", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Polychromasia" - }, - { - "id": 148751, - "soa_id": 3, - "code_uid": "Code_28692", - "code": "C64433", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Alanine Aminotransferase Measurement" - }, - { - "id": 148752, - "soa_id": 3, - "code_uid": "Code_28693", - "code": "C64431", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Albumin Measurement" - }, - { - "id": 148753, - "soa_id": 3, - "code_uid": "Code_28694", - "code": "C64432", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Alkaline Phosphatase Measurement" - }, - { - "id": 148754, - "soa_id": 3, - "code_uid": "Code_28695", - "code": "C64467", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Aspartate Aminotransferase Measurement" - }, - { - "id": 148755, - "soa_id": 3, - "code_uid": "Code_28696", - "code": "C64853", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Potassium Measurement" - }, - { - "id": 148756, - "soa_id": 3, - "code_uid": "Code_28697", - "code": "C64809", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Sodium Measurement" - }, - { - "id": 148757, - "soa_id": 3, - "code_uid": "Code_28698", - "code": "C125949", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Urea Nitrogen Measurement" - }, - { - "id": 148758, - "soa_id": 3, - "code_uid": "Code_28699", - "code": "C74667", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Bicarbonate Measurement" - }, - { - "id": 148759, - "soa_id": 3, - "code_uid": "Code_28700", - "code": "C64495", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Chloride Measurement" - }, - { - "id": 148760, - "soa_id": 3, - "code_uid": "Code_28701", - "code": "C38037", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Total Bilirubin Measurement" - }, - { - "id": 148761, - "soa_id": 3, - "code_uid": "Code_28702", - "code": "C64814", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Urate Measurement" - }, - { - "id": 148762, - "soa_id": 3, - "code_uid": "Code_28703", - "code": "C64857", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Phosphate Measurement" - }, - { - "id": 148763, - "soa_id": 3, - "code_uid": "Code_28704", - "code": "C64488", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Calcium Measurement" - }, - { - "id": 148764, - "soa_id": 3, - "code_uid": "Code_28705", - "code": "C105585", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "Glucose Measurement" - }, - { - "id": 148765, - "soa_id": 3, - "code_uid": "Code_28706", - "code": "C64858", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Total Protein Measurement" - }, - { - "id": 148766, - "soa_id": 3, - "code_uid": "Code_28707", - "code": "C105586", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Cholesterol Measurement" - }, - { - "id": 148767, - "soa_id": 3, - "code_uid": "Code_28708", - "code": "C74748", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Triiodothyronine Uptake Measurement" - }, - { - "id": 148768, - "soa_id": 3, - "code_uid": "Code_28709", - "code": "C74747", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Triiodothyronine Measurement" - }, - { - "id": 148769, - "soa_id": 3, - "code_uid": "Code_28710", - "code": "C74786", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Free Thyroxine Measurement" - }, - { - "id": 148770, - "soa_id": 3, - "code_uid": "Code_28711", - "code": "C170598", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Free Thyroxine Index" - }, - { - "id": 148771, - "soa_id": 3, - "code_uid": "Code_28712", - "code": "C64813", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Thyrotropin Measurement" - }, - { - "id": 148772, - "soa_id": 3, - "code_uid": "Code_28713", - "code": "C64817", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Vitamin B12 Measurement" - }, - { - "id": 148773, - "soa_id": 3, - "code_uid": "Code_28714", - "code": "C132388", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "Treponema pallidum Antibody Measurement" - }, - { - "id": 148774, - "soa_id": 3, - "code_uid": "Code_28715", - "code": "C198341", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "Treponema pallidum DNA Measurement" - }, - { - "id": 148775, - "soa_id": 3, - "code_uid": "Code_28716", - "code": "C64546", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "Color Assessment" - }, - { - "id": 148776, - "soa_id": 3, - "code_uid": "Code_28717", - "code": "C64854", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Ketone Measurement" - }, - { - "id": 148777, - "soa_id": 3, - "code_uid": "Code_28718", - "code": "C64816", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Urobilinogen Measurement" - }, - { - "id": 148778, - "soa_id": 3, - "code_uid": "Code_28719", - "code": "C64849", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Hemoglobin A1C Measurement" - }, - { - "id": 148779, - "soa_id": 3, - "code_uid": "Code_28720", - "code": "C111207", - "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", - "code_system_version": "2026-05-26", - "decode": "Hemoglobin A1C to Hemoglobin Ratio Measurement" - }, - { - "id": 148780, - "soa_id": 3, - "code_uid": "Code_28721", - "code": "C117466", - "code_system": "/mdr/bc/packages/2023-10-03/biomedicalconcepts", - "code_system_version": "2023-10-03", - "decode": "Exposure as Collected Domain" - }, - { - "id": 148781, - "soa_id": 3, - "code_uid": "Code_28722", - "code": "NEW_LZZT", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "TTS Acceptability Survey" - }, - { - "id": 148782, - "soa_id": 3, - "code_uid": "Code_28723", - "code": "NEW_LZZT4", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Acceptability" - }, - { - "id": 148783, - "soa_id": 3, - "code_uid": "Code_28724", - "code": "NEW_LZZT1", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Appearance" - }, - { - "id": 148784, - "soa_id": 3, - "code_uid": "Code_28725", - "code": "NEW_LZZT3", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Durability" - }, - { - "id": 148785, - "soa_id": 3, - "code_uid": "Code_28726", - "code": "NEW_LZZT2", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "TTS Acceptability Survey - Patch Size" - }, - { - "id": 148786, - "soa_id": 3, - "code_uid": "Code_28727", - "code": "C83347", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - }, - { - "id": 148787, - "soa_id": 3, - "code_uid": "Code_28728", - "code": "C179175", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Solicited Adverse Event" - }, - { - "id": 148788, - "soa_id": 3, - "code_uid": "Code_28729", - "code": "C25250", - "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", - "code_system_version": "2026-03-31", - "decode": "Complete [RETIRED]" - }, - { - "id": 148789, - "soa_id": 3, - "code_uid": "Code_28730", - "code": "C139236", - "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", - "code_system_version": "2026-03-31", - "decode": "Failure To Meet Continuation Criteria [RETIRED]" - }, - { - "id": 148790, - "soa_id": 3, - "code_uid": "Code_28731", - "code": "C28554", - "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", - "code_system_version": "2026-03-31", - "decode": "Dead [RETIRED]" - }, - { - "id": 148791, - "soa_id": 3, - "code_uid": "Code_28732", - "code": "C48226", - "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", - "code_system_version": "2026-03-31", - "decode": "Lack of Efficacy [RETIRED]" - }, - { - "id": 148792, - "soa_id": 3, - "code_uid": "Code_28733", - "code": "C48227", - "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", - "code_system_version": "2026-03-31", - "decode": "Lost To Follow-Up [RETIRED]" - }, - { - "id": 148793, - "soa_id": 3, - "code_uid": "Code_28734", - "code": "C41331", - "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", - "code_system_version": "2026-03-31", - "decode": "Adverse Event [RETIRED]" - }, - { - "id": 148794, - "soa_id": 3, - "code_uid": "Code_28735", - "code": "C48250", - "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", - "code_system_version": "2026-03-31", - "decode": "Physician Decision [RETIRED]" - }, - { - "id": 148795, - "soa_id": 3, - "code_uid": "Code_28736", - "code": "C191656", - "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", - "code_system_version": "2026-03-31", - "decode": "Pregnant Subject [RETIRED]" - }, - { - "id": 148796, - "soa_id": 3, - "code_uid": "Code_28737", - "code": "C35571", - "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", - "code_system_version": "2026-03-31", - "decode": "Progressive Disease [RETIRED]" - }, - { - "id": 148821, - "soa_id": 3, - "code_uid": "Code_28738", - "code": "C181501", - "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", - "code_system_version": "2025-07-01", - "decode": "Muscle Endurance Measurement" - }, - { - "id": 148822, - "soa_id": 3, - "code_uid": "Code_28739", - "code": "C49672", - "code_system": "/mdr/bc/packages/2024-12-16/biomedicalconcepts", - "code_system_version": "2024-12-16", - "decode": "Vital Signs Measurement" - }, - { - "id": 148823, - "soa_id": 3, - "code_uid": "Code_28740", - "code": "C100177", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recall Average Score" - }, - { - "id": 148824, - "soa_id": 3, - "code_uid": "Code_28741", - "code": "C100209", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Commands Summary Score" - }, - { - "id": 148825, - "soa_id": 3, - "code_uid": "Code_28742", - "code": "C100232", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Ideational Praxis Summary Score" - }, - { - "id": 148826, - "soa_id": 3, - "code_uid": "Code_28743", - "code": "C100247", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Recognition Summary Score" - }, - { - "id": 148827, - "soa_id": 3, - "code_uid": "Code_28744", - "code": "C100275", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Remembering Test Instructions" - }, - { - "id": 148828, - "soa_id": 3, - "code_uid": "Code_28745", - "code": "C100276", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Spoken Language Ability" - }, - { - "id": 148829, - "soa_id": 3, - "code_uid": "Code_28746", - "code": "C100277", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech" - }, - { - "id": 148830, - "soa_id": 3, - "code_uid": "Code_28747", - "code": "C100278", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Comprehension" - }, - { - "id": 148831, - "soa_id": 3, - "code_uid": "Code_28748", - "code": "C100279", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Concentration/Distractibility" - }, - { - "id": 148832, - "soa_id": 3, - "code_uid": "Code_28749", - "code": "C100280", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Number Cancellation Summary Score" - }, - { - "id": 148833, - "soa_id": 3, - "code_uid": "Code_28750", - "code": "C100285", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Errors" - }, - { - "id": 148834, - "soa_id": 3, - "code_uid": "Code_28751", - "code": "C100286", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Executive Function Maze: Time" - }, - { - "id": 152008, - "soa_id": 3, - "code_uid": "Code_28951", - "code": "C114209", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "RANDOMIZED" - }, - { - "id": 152311, - "soa_id": 3, - "code_uid": "Code_29254", - "code": "C68667", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "deg" - }, - { - "id": 152446, - "soa_id": 3, - "code_uid": "Code_29389", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 152885, - "soa_id": 3, - "code_uid": "Code_29828", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 153035, - "soa_id": 3, - "code_uid": "Code_29978", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 153072, - "soa_id": 3, - "code_uid": "Code_30015", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 153144, - "soa_id": 3, - "code_uid": "Code_30087", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 153148, - "soa_id": 3, - "code_uid": "Code_30091", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 153380, - "soa_id": 3, - "code_uid": "Code_30319", - "code": "C16809", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "MRI" - }, - { - "id": 153384, - "soa_id": 3, - "code_uid": "Code_30323", - "code": "C12439", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "BRAIN" - }, - { - "id": 153397, - "soa_id": 3, - "code_uid": "Code_30336", - "code": "C17204", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CT SCAN" - }, - { - "id": 154655, - "soa_id": 3, - "code_uid": "Code_30337", - "code": "C25299", - "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", - "code_system_version": "2025-12-16", - "decode": "Diastolic Blood Pressure" - }, - { - "id": 154995, - "soa_id": 3, - "code_uid": "Code_30535", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 154996, - "soa_id": 3, - "code_uid": "Code_30536", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 154997, - "soa_id": 3, - "code_uid": "Code_30537", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 154998, - "soa_id": 3, - "code_uid": "Code_30538", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 154999, - "soa_id": 3, - "code_uid": "Code_30539", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 155005, - "soa_id": 3, - "code_uid": "Code_30545", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 155006, - "soa_id": 3, - "code_uid": "Code_30546", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 155007, - "soa_id": 3, - "code_uid": "Code_30547", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 155008, - "soa_id": 3, - "code_uid": "Code_30548", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 155009, - "soa_id": 3, - "code_uid": "Code_30549", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 155627, - "soa_id": 3, - "code_uid": "Code_30885", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 155628, - "soa_id": 3, - "code_uid": "Code_30886", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 155629, - "soa_id": 3, - "code_uid": "Code_30887", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 155630, - "soa_id": 3, - "code_uid": "Code_30888", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 155631, - "soa_id": 3, - "code_uid": "Code_30889", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 155632, - "soa_id": 3, - "code_uid": "Code_30890", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 155639, - "soa_id": 3, - "code_uid": "Code_30897", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 155640, - "soa_id": 3, - "code_uid": "Code_30898", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 155641, - "soa_id": 3, - "code_uid": "Code_30899", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 155642, - "soa_id": 3, - "code_uid": "Code_30900", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 155643, - "soa_id": 3, - "code_uid": "Code_30901", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 155644, - "soa_id": 3, - "code_uid": "Code_30902", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 155645, - "soa_id": 3, - "code_uid": "Code_30903", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 155680, - "soa_id": 3, - "code_uid": "Code_30932", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 155826, - "soa_id": 3, - "code_uid": "Code_31048", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 156109, - "soa_id": 3, - "code_uid": "Code_31239", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 156130, - "soa_id": 3, - "code_uid": "Code_31260", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 157716, - "soa_id": 3, - "code_uid": "Code_31360", - "code": "C100191", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score" - }, - { - "id": 157717, - "soa_id": 3, - "code_uid": "Code_31361", - "code": "C100215", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Delayed Word Recall Summary Score" - }, - { - "id": 157718, - "soa_id": 3, - "code_uid": "Code_31362", - "code": "C100226", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Constructional Praxis Summary Score" - }, - { - "id": 157719, - "soa_id": 3, - "code_uid": "Code_31363", - "code": "C100238", - "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", - "code_system_version": "2025-11-18", - "decode": "CDISC ADAS-Cog - Orientation Summary Score" - }, - { - "id": 158278, - "soa_id": 3, - "code_uid": "Code_31922", - "code": "C102656", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "LINE PROBE ASSAY" - }, - { - "id": 158292, - "soa_id": 3, - "code_uid": "Code_31936", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 158298, - "soa_id": 3, - "code_uid": "Code_31942", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 158491, - "soa_id": 3, - "code_uid": "Code_32135", - "code": "C17204", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CT SCAN" - }, - { - "id": 161163, - "soa_id": 3, - "code_uid": "Code_32362", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 161479, - "soa_id": 3, - "code_uid": "Code_32544", - "code": "C16809", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "MRI" - }, - { - "id": 161547, - "soa_id": 3, - "code_uid": "Code_32580", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 161583, - "soa_id": 3, - "code_uid": "Code_32597", - "code": "C64780", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "fL" - }, - { - "id": 161585, - "soa_id": 3, - "code_uid": "Code_32599", - "code": "C12521", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "ERYTHROCYTES" - }, - { - "id": 161596, - "soa_id": 3, - "code_uid": "Code_32605", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 161662, - "soa_id": 3, - "code_uid": "Code_32638", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 161685, - "soa_id": 3, - "code_uid": "Code_32650", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 161704, - "soa_id": 3, - "code_uid": "Code_32660", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 161714, - "soa_id": 3, - "code_uid": "Code_32665", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 161727, - "soa_id": 3, - "code_uid": "Code_32673", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 161728, - "soa_id": 3, - "code_uid": "Code_32674", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 161729, - "soa_id": 3, - "code_uid": "Code_32675", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 161730, - "soa_id": 3, - "code_uid": "Code_32676", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 161731, - "soa_id": 3, - "code_uid": "Code_32677", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 161749, - "soa_id": 3, - "code_uid": "Code_32689", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 161750, - "soa_id": 3, - "code_uid": "Code_32690", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 161751, - "soa_id": 3, - "code_uid": "Code_32691", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 161752, - "soa_id": 3, - "code_uid": "Code_32692", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 161753, - "soa_id": 3, - "code_uid": "Code_32693", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 161754, - "soa_id": 3, - "code_uid": "Code_32694", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 161761, - "soa_id": 3, - "code_uid": "Code_32701", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 161762, - "soa_id": 3, - "code_uid": "Code_32702", - "code": "C67365", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - }, - { - "id": 161763, - "soa_id": 3, - "code_uid": "Code_32703", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 161764, - "soa_id": 3, - "code_uid": "Code_32704", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 161765, - "soa_id": 3, - "code_uid": "Code_32705", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 161766, - "soa_id": 3, - "code_uid": "Code_32706", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 161966, - "soa_id": 3, - "code_uid": "Code_32810", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 161967, - "soa_id": 3, - "code_uid": "Code_32811", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 161968, - "soa_id": 3, - "code_uid": "Code_32812", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 161969, - "soa_id": 3, - "code_uid": "Code_32813", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 161970, - "soa_id": 3, - "code_uid": "Code_32814", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 161971, - "soa_id": 3, - "code_uid": "Code_32815", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 162009, - "soa_id": 3, - "code_uid": "Code_32836", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 162127, - "soa_id": 3, - "code_uid": "Code_32924", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 162246, - "soa_id": 3, - "code_uid": "Code_33043", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 162399, - "soa_id": 3, - "code_uid": "Code_33192", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 162406, - "soa_id": 3, - "code_uid": "Code_33199", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 164400, - "soa_id": 3, - "code_uid": "Code_33323", - "code": "C161410", - "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", - "code_system_version": "2026-03-31", - "decode": "Subject Removed at Sponsor Request [RETIRED]" - }, - { - "id": 165029, - "soa_id": 3, - "code_uid": "Code_33937", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 165068, - "soa_id": 3, - "code_uid": "Code_33976", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 165147, - "soa_id": 3, - "code_uid": "Code_34055", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 165153, - "soa_id": 3, - "code_uid": "Code_34061", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 165171, - "soa_id": 3, - "code_uid": "Code_34079", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 165189, - "soa_id": 3, - "code_uid": "Code_34097", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 165247, - "soa_id": 3, - "code_uid": "Code_34155", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 165401, - "soa_id": 3, - "code_uid": "Code_34309", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 165447, - "soa_id": 3, - "code_uid": "Code_34355", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "EGCTMON" - }, - { - "id": 165449, - "soa_id": 3, - "code_uid": "Code_34357", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "ECG Continuous Monitoring" - }, - { - "id": 168583, - "soa_id": 3, - "code_uid": "Code_35203", - "code": "C70793", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-03-27", - "decode": "Clinical Study Sponsor" - }, - { - "id": 169052, - "soa_id": 3, - "code_uid": "Code_35642", - "code": "C70793", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-03-27", - "decode": "Clinical Study Sponsor" - }, - { - "id": 177623, - "soa_id": 3, - "code_uid": "Code_36026", - "code": "C41161", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-03-27", - "decode": "Experimental Intervention" - }, - { - "id": 177624, - "soa_id": 3, - "code_uid": "Code_36027", - "code": "C1909", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-26", - "decode": "Pharmacologic Substance" - }, - { - "id": 177625, - "soa_id": 3, - "code_uid": "Code_36028", - "code": "C25301", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-03-27", - "decode": "Day" - }, - { - "id": 177741, - "soa_id": 3, - "code_uid": "Code_36144", - "code": "XIN", - "code_system": "SPONSOR", - "code_system_version": "12", - "decode": "XIN" - }, - { - "id": 192727, - "soa_id": 3, - "code_uid": "Code_36968", - "code": "G30.9", - "code_system": "ICD-10-CM", - "code_system_version": "1", - "decode": "Alzheimer's disease; unspecified" - }, - { - "id": 192728, - "soa_id": 3, - "code_uid": "Code_36969", - "code": "26929004", - "code_system": "SNOMED", - "code_system_version": "2018-01-31", - "decode": "Alzheimer's disease" - }, - { - "id": 195339, - "soa_id": 3, - "code_uid": "Code_37230", - "code": "C49674", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "breaths/min" - }, - { - "id": 195639, - "soa_id": 3, - "code_uid": "Code_37457", - "code": "C17204", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "CT SCAN" - }, - { - "id": 195643, - "soa_id": 3, - "code_uid": "Code_37461", - "code": "C25389", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "CHEST" - }, - { - "id": 195728, - "soa_id": 3, - "code_uid": "Code_37534", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 195752, - "soa_id": 3, - "code_uid": "Code_37545", - "code": "C64780", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "fL" - }, - { - "id": 195754, - "soa_id": 3, - "code_uid": "Code_37547", - "code": "C12521", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "ERYTHROCYTES" - }, - { - "id": 195820, - "soa_id": 3, - "code_uid": "Code_37580", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 195844, - "soa_id": 3, - "code_uid": "Code_37592", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 195866, - "soa_id": 3, - "code_uid": "Code_37603", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 195876, - "soa_id": 3, - "code_uid": "Code_37608", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 195886, - "soa_id": 3, - "code_uid": "Code_37613", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 195896, - "soa_id": 3, - "code_uid": "Code_37618", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 195930, - "soa_id": 3, - "code_uid": "Code_37635", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 195978, - "soa_id": 3, - "code_uid": "Code_37677", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 196026, - "soa_id": 3, - "code_uid": "Code_37725", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 196050, - "soa_id": 3, - "code_uid": "Code_37737", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 196074, - "soa_id": 3, - "code_uid": "Code_37749", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 196077, - "soa_id": 3, - "code_uid": "Code_37752", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 196078, - "soa_id": 3, - "code_uid": "Code_37753", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 196079, - "soa_id": 3, - "code_uid": "Code_37754", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 196080, - "soa_id": 3, - "code_uid": "Code_37755", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 196081, - "soa_id": 3, - "code_uid": "Code_37756", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 196082, - "soa_id": 3, - "code_uid": "Code_37757", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 196099, - "soa_id": 3, - "code_uid": "Code_37767", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 196112, - "soa_id": 3, - "code_uid": "Code_37774", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 196136, - "soa_id": 3, - "code_uid": "Code_37786", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 196148, - "soa_id": 3, - "code_uid": "Code_37792", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 196170, - "soa_id": 3, - "code_uid": "Code_37803", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 196194, - "soa_id": 3, - "code_uid": "Code_37815", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 196219, - "soa_id": 3, - "code_uid": "Code_37825", - "code": "C174330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "DETECTION" - }, - { - "id": 196237, - "soa_id": 3, - "code_uid": "Code_37836", - "code": "C102656", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "LINE PROBE ASSAY" - }, - { - "id": 196266, - "soa_id": 3, - "code_uid": "Code_37861", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 196296, - "soa_id": 3, - "code_uid": "Code_37885", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 196314, - "soa_id": 3, - "code_uid": "Code_37897", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 196336, - "soa_id": 3, - "code_uid": "Code_37908", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 196400, - "soa_id": 3, - "code_uid": "Code_37941", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 196408, - "soa_id": 3, - "code_uid": "Code_37945", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 196424, - "soa_id": 3, - "code_uid": "Code_37953", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 196494, - "soa_id": 3, - "code_uid": "Code_37987", - "code": "C170610", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY" - }, - { - "id": 196520, - "soa_id": 3, - "code_uid": "Code_37999", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 196562, - "soa_id": 3, - "code_uid": "Code_38041", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 196569, - "soa_id": 3, - "code_uid": "Code_38048", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 196634, - "soa_id": 3, - "code_uid": "Code_38113", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "EGCTMON" - }, - { - "id": 196636, - "soa_id": 3, - "code_uid": "Code_38115", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "ECG Continuous Monitoring" - }, - { - "id": 196644, - "soa_id": 3, - "code_uid": "Code_38123", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "ECG Continuous Monitoring" - }, - { - "id": 198387, - "soa_id": 3, - "code_uid": "Code_38143", - "code": "C83063", - "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", - "code_system_version": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator" - }, - { - "id": 198388, - "soa_id": 3, - "code_uid": "Code_38144", - "code": "C17049", - "code_system": "/mdr/bc/packages/2025-04-01/biomedicalconcepts", - "code_system_version": "2025-04-01", - "decode": "Race" - }, - { - "id": 198389, - "soa_id": 3, - "code_uid": "Code_38145", - "code": "C16564", - "code_system": "/mdr/bc/packages/2025-04-01/biomedicalconcepts", - "code_system_version": "2025-04-01", - "decode": "Ethnic Group" - }, - { - "id": 198677, - "soa_id": 3, - "code_uid": "Code_38408", - "code": "C68667", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "deg" - }, - { - "id": 198746, - "soa_id": 3, - "code_uid": "Code_38477", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 198758, - "soa_id": 3, - "code_uid": "Code_38489", - "code": "C12521", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "ERYTHROCYTES" - }, - { - "id": 198781, - "soa_id": 3, - "code_uid": "Code_38512", - "code": "C67452", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "10^6/L" - }, - { - "id": 198783, - "soa_id": 3, - "code_uid": "Code_38514", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 198794, - "soa_id": 3, - "code_uid": "Code_38525", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 198811, - "soa_id": 3, - "code_uid": "Code_38542", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 198830, - "soa_id": 3, - "code_uid": "Code_38561", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 198840, - "soa_id": 3, - "code_uid": "Code_38571", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 198846, - "soa_id": 3, - "code_uid": "Code_38577", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 198868, - "soa_id": 3, - "code_uid": "Code_38599", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 198895, - "soa_id": 3, - "code_uid": "Code_38626", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 198912, - "soa_id": 3, - "code_uid": "Code_38643", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 198934, - "soa_id": 3, - "code_uid": "Code_38665", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 198946, - "soa_id": 3, - "code_uid": "Code_38677", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 198991, - "soa_id": 3, - "code_uid": "Code_38722", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 199003, - "soa_id": 3, - "code_uid": "Code_38734", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 199032, - "soa_id": 3, - "code_uid": "Code_38763", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 199037, - "soa_id": 3, - "code_uid": "Code_38768", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 199065, - "soa_id": 3, - "code_uid": "Code_38796", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 199069, - "soa_id": 3, - "code_uid": "Code_38800", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 199781, - "soa_id": 3, - "code_uid": "Code_39422", - "code": "C170610", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY" - }, - { - "id": 199805, - "soa_id": 3, - "code_uid": "Code_39446", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 199858, - "soa_id": 3, - "code_uid": "Code_39499", - "code": "C12439", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "BRAIN" - }, - { - "id": 200712, - "soa_id": 3, - "code_uid": "Code_39641", - "code": "C37984", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-03-27", - "decode": "Laboratory" - }, - { - "id": 200713, - "soa_id": 3, - "code_uid": "Code_39642", - "code": "840", - "code_system": "ISO 3166 1 Numeric Code", - "code_system_version": "2026", - "decode": "United States of America" - }, - { - "id": 214296, - "soa_id": 3, - "code_uid": "Code_40467", - "code": "C37984", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-03-27", - "decode": "Laboratory" - }, - { - "id": 217740, - "soa_id": 3, - "code_uid": "Code_40605", - "code": "C16735", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED" - }, - { - "id": 217763, - "soa_id": 3, - "code_uid": "Code_40628", - "code": "C114209", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "RANDOMIZED" - }, - { - "id": 217801, - "soa_id": 3, - "code_uid": "Code_40666", - "code": "C29848", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "YEARS" - }, - { - "id": 217955, - "soa_id": 3, - "code_uid": "Code_40772", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 217966, - "soa_id": 3, - "code_uid": "Code_40779", - "code": "C49674", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "breaths/min" - }, - { - "id": 218080, - "soa_id": 3, - "code_uid": "Code_40810", - "code": "C114209", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "RANDOMIZED" - }, - { - "id": 218238, - "soa_id": 3, - "code_uid": "Code_40968", - "code": "C38101", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "X-RAY" - }, - { - "id": 218245, - "soa_id": 3, - "code_uid": "Code_40975", - "code": "C114209", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "RANDOMIZED" - }, - { - "id": 218286, - "soa_id": 3, - "code_uid": "Code_41016", - "code": "C49674", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "breaths/min" - }, - { - "id": 218517, - "soa_id": 3, - "code_uid": "Code_41247", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 218531, - "soa_id": 3, - "code_uid": "Code_41261", - "code": "C68667", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "deg" - }, - { - "id": 218585, - "soa_id": 3, - "code_uid": "Code_41315", - "code": "C17204", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "CT SCAN" - }, - { - "id": 218589, - "soa_id": 3, - "code_uid": "Code_41319", - "code": "C25389", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "CHEST" - }, - { - "id": 218612, - "soa_id": 3, - "code_uid": "Code_41342", - "code": "C16809", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "MRI" - }, - { - "id": 218616, - "soa_id": 3, - "code_uid": "Code_41346", - "code": "C12439", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "BRAIN" - }, - { - "id": 218666, - "soa_id": 3, - "code_uid": "Code_41396", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218685, - "soa_id": 3, - "code_uid": "Code_41415", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218698, - "soa_id": 3, - "code_uid": "Code_41428", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218711, - "soa_id": 3, - "code_uid": "Code_41441", - "code": "C12521", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "ERYTHROCYTES" - }, - { - "id": 218723, - "soa_id": 3, - "code_uid": "Code_41453", - "code": "C64780", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "fL" - }, - { - "id": 218725, - "soa_id": 3, - "code_uid": "Code_41455", - "code": "C12521", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "ERYTHROCYTES" - }, - { - "id": 218737, - "soa_id": 3, - "code_uid": "Code_41467", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218748, - "soa_id": 3, - "code_uid": "Code_41478", - "code": "C67255", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "10^9/L" - }, - { - "id": 218750, - "soa_id": 3, - "code_uid": "Code_41480", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218761, - "soa_id": 3, - "code_uid": "Code_41491", - "code": "C67452", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "10^6/L" - }, - { - "id": 218763, - "soa_id": 3, - "code_uid": "Code_41493", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218774, - "soa_id": 3, - "code_uid": "Code_41504", - "code": "C67255", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "10^9/L" - }, - { - "id": 218776, - "soa_id": 3, - "code_uid": "Code_41506", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218787, - "soa_id": 3, - "code_uid": "Code_41517", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218798, - "soa_id": 3, - "code_uid": "Code_41528", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218809, - "soa_id": 3, - "code_uid": "Code_41539", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218820, - "soa_id": 3, - "code_uid": "Code_41550", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218825, - "soa_id": 3, - "code_uid": "Code_41555", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218835, - "soa_id": 3, - "code_uid": "Code_41565", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218846, - "soa_id": 3, - "code_uid": "Code_41576", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218857, - "soa_id": 3, - "code_uid": "Code_41587", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218868, - "soa_id": 3, - "code_uid": "Code_41598", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218880, - "soa_id": 3, - "code_uid": "Code_41610", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 218903, - "soa_id": 3, - "code_uid": "Code_41633", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 218925, - "soa_id": 3, - "code_uid": "Code_41655", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 218937, - "soa_id": 3, - "code_uid": "Code_41667", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218949, - "soa_id": 3, - "code_uid": "Code_41679", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218961, - "soa_id": 3, - "code_uid": "Code_41691", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 218973, - "soa_id": 3, - "code_uid": "Code_41703", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218985, - "soa_id": 3, - "code_uid": "Code_41715", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 218997, - "soa_id": 3, - "code_uid": "Code_41727", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 219009, - "soa_id": 3, - "code_uid": "Code_41739", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 219022, - "soa_id": 3, - "code_uid": "Code_41752", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 219034, - "soa_id": 3, - "code_uid": "Code_41764", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 219046, - "soa_id": 3, - "code_uid": "Code_41776", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 219058, - "soa_id": 3, - "code_uid": "Code_41788", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 219077, - "soa_id": 3, - "code_uid": "Code_41807", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 219083, - "soa_id": 3, - "code_uid": "Code_41813", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 219100, - "soa_id": 3, - "code_uid": "Code_41830", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 219112, - "soa_id": 3, - "code_uid": "Code_41842", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 219128, - "soa_id": 3, - "code_uid": "Code_41858", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 219141, - "soa_id": 3, - "code_uid": "Code_41871", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 219154, - "soa_id": 3, - "code_uid": "Code_41884", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 219164, - "soa_id": 3, - "code_uid": "Code_41894", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 219185, - "soa_id": 3, - "code_uid": "Code_41915", - "code": "C174330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "DETECTION" - }, - { - "id": 219188, - "soa_id": 3, - "code_uid": "Code_41918", - "code": "C13325", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM" - }, - { - "id": 219192, - "soa_id": 3, - "code_uid": "Code_41922", - "code": "C174330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "DETECTION" - }, - { - "id": 219196, - "soa_id": 3, - "code_uid": "Code_41926", - "code": "C102656", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "LINE PROBE ASSAY" - }, - { - "id": 219212, - "soa_id": 3, - "code_uid": "Code_41942", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 219227, - "soa_id": 3, - "code_uid": "Code_41957", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 219233, - "soa_id": 3, - "code_uid": "Code_41963", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 219239, - "soa_id": 3, - "code_uid": "Code_41969", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 219251, - "soa_id": 3, - "code_uid": "Code_41981", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 219262, - "soa_id": 3, - "code_uid": "Code_41992", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 219291, - "soa_id": 3, - "code_uid": "Code_42021", - "code": "C13234", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "STOOL" - }, - { - "id": 219300, - "soa_id": 3, - "code_uid": "Code_42030", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 219317, - "soa_id": 3, - "code_uid": "Code_42047", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 219350, - "soa_id": 3, - "code_uid": "Code_42080", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 219386, - "soa_id": 3, - "code_uid": "Code_42116", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 219430, - "soa_id": 3, - "code_uid": "Code_42160", - "code": "C186208", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SITE TRANSFER" - }, - { - "id": 219481, - "soa_id": 3, - "code_uid": "Code_42211", - "code": "C170610", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY" - }, - { - "id": 219522, - "soa_id": 3, - "code_uid": "Code_42252", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 219539, - "soa_id": 3, - "code_uid": "Code_42269", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 219554, - "soa_id": 3, - "code_uid": "Code_42284", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 219561, - "soa_id": 3, - "code_uid": "Code_42291", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 219568, - "soa_id": 3, - "code_uid": "Code_42298", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 219575, - "soa_id": 3, - "code_uid": "Code_42305", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 219641, - "soa_id": 3, - "code_uid": "Code_42371", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "EGCTMON" - }, - { - "id": 219643, - "soa_id": 3, - "code_uid": "Code_42373", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "ECG Continuous Monitoring" - }, - { - "id": 219649, - "soa_id": 3, - "code_uid": "Code_42379", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "EGCTMON" - }, - { - "id": 219651, - "soa_id": 3, - "code_uid": "Code_42381", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "ECG Continuous Monitoring" - }, - { - "id": 219661, - "soa_id": 3, - "code_uid": "Code_42391", - "code": "C16809", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "MRI" - }, - { - "id": 219665, - "soa_id": 3, - "code_uid": "Code_42395", - "code": "C12439", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "BRAIN" - }, - { - "id": 219678, - "soa_id": 3, - "code_uid": "Code_42408", - "code": "C17204", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CT SCAN" - }, - { - "id": 221280, - "soa_id": 3, - "code_uid": "Code_42410", - "code": "C16735", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "INFORMED CONSENT OBTAINED" - }, - { - "id": 221292, - "soa_id": 3, - "code_uid": "Code_42422", - "code": "C114209", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "RANDOMIZED" - }, - { - "id": 221324, - "soa_id": 3, - "code_uid": "Code_42452", - "code": "C29848", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "YEARS" - }, - { - "id": 221381, - "soa_id": 3, - "code_uid": "Code_42509", - "code": "C38101", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "X-RAY" - }, - { - "id": 221388, - "soa_id": 3, - "code_uid": "Code_42516", - "code": "C114209", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "RANDOMIZED" - }, - { - "id": 221506, - "soa_id": 3, - "code_uid": "Code_42622", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 221513, - "soa_id": 3, - "code_uid": "Code_42629", - "code": "C49674", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "breaths/min" - }, - { - "id": 221625, - "soa_id": 3, - "code_uid": "Code_42741", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 221655, - "soa_id": 3, - "code_uid": "Code_42771", - "code": "C17204", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "CT SCAN" - }, - { - "id": 221659, - "soa_id": 3, - "code_uid": "Code_42775", - "code": "C25389", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "CHEST" - }, - { - "id": 221920, - "soa_id": 3, - "code_uid": "Code_43034", - "code": "C16809", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "MRI" - }, - { - "id": 221924, - "soa_id": 3, - "code_uid": "Code_43038", - "code": "C12439", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "BRAIN" - }, - { - "id": 221950, - "soa_id": 3, - "code_uid": "Code_43064", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 221961, - "soa_id": 3, - "code_uid": "Code_43075", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 221971, - "soa_id": 3, - "code_uid": "Code_43085", - "code": "C64780", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "fL" - }, - { - "id": 221973, - "soa_id": 3, - "code_uid": "Code_43087", - "code": "C12521", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "ERYTHROCYTES" - }, - { - "id": 221983, - "soa_id": 3, - "code_uid": "Code_43097", - "code": "C67255", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "10^9/L" - }, - { - "id": 221985, - "soa_id": 3, - "code_uid": "Code_43099", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 221995, - "soa_id": 3, - "code_uid": "Code_43109", - "code": "C67255", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "10^9/L" - }, - { - "id": 221997, - "soa_id": 3, - "code_uid": "Code_43111", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 222008, - "soa_id": 3, - "code_uid": "Code_43122", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 222023, - "soa_id": 3, - "code_uid": "Code_43137", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 222028, - "soa_id": 3, - "code_uid": "Code_43142", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 222033, - "soa_id": 3, - "code_uid": "Code_43147", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 222042, - "soa_id": 3, - "code_uid": "Code_43156", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 222058, - "soa_id": 3, - "code_uid": "Code_43172", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 222064, - "soa_id": 3, - "code_uid": "Code_43178", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 222070, - "soa_id": 3, - "code_uid": "Code_43184", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 222081, - "soa_id": 3, - "code_uid": "Code_43195", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 222097, - "soa_id": 3, - "code_uid": "Code_43211", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 222113, - "soa_id": 3, - "code_uid": "Code_43227", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 222135, - "soa_id": 3, - "code_uid": "Code_43249", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 222146, - "soa_id": 3, - "code_uid": "Code_43260", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 222157, - "soa_id": 3, - "code_uid": "Code_43271", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 222162, - "soa_id": 3, - "code_uid": "Code_43276", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 222173, - "soa_id": 3, - "code_uid": "Code_43287", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 222182, - "soa_id": 3, - "code_uid": "Code_43296", - "code": "C174330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "DETECTION" - }, - { - "id": 222185, - "soa_id": 3, - "code_uid": "Code_43299", - "code": "C13325", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM" - }, - { - "id": 222189, - "soa_id": 3, - "code_uid": "Code_43303", - "code": "C174330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "DETECTION" - }, - { - "id": 222193, - "soa_id": 3, - "code_uid": "Code_43307", - "code": "C102656", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "LINE PROBE ASSAY" - }, - { - "id": 222197, - "soa_id": 3, - "code_uid": "Code_43311", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 222206, - "soa_id": 3, - "code_uid": "Code_43320", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 222217, - "soa_id": 3, - "code_uid": "Code_43331", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 222223, - "soa_id": 3, - "code_uid": "Code_43337", - "code": "C105706", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SERUM OR PLASMA" - }, - { - "id": 222229, - "soa_id": 3, - "code_uid": "Code_43343", - "code": "C13283", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "URINE" - }, - { - "id": 222234, - "soa_id": 3, - "code_uid": "Code_43348", - "code": "C13234", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "STOOL" - }, - { - "id": 222248, - "soa_id": 3, - "code_uid": "Code_43362", - "code": "C12434", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "BLOOD" - }, - { - "id": 222277, - "soa_id": 3, - "code_uid": "Code_43391", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 222281, - "soa_id": 3, - "code_uid": "Code_43395", - "code": "C17445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CAREGIVER" - }, - { - "id": 222311, - "soa_id": 3, - "code_uid": "Code_43425", - "code": "C186208", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "SITE TRANSFER" - }, - { - "id": 222319, - "soa_id": 3, - "code_uid": "Code_43433", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 222332, - "soa_id": 3, - "code_uid": "Code_43446", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 222345, - "soa_id": 3, - "code_uid": "Code_43459", - "code": "C49670", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "mmHg" - }, - { - "id": 222352, - "soa_id": 3, - "code_uid": "Code_43466", - "code": "C49673", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "beats/min" - }, - { - "id": 222376, - "soa_id": 3, - "code_uid": "Code_43490", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "EGCTMON" - }, - { - "id": 222378, - "soa_id": 3, - "code_uid": "Code_43492", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "ECG Continuous Monitoring" - }, - { - "id": 222388, - "soa_id": 3, - "code_uid": "Code_43502", - "code": "C16809", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "MRI" - }, - { - "id": 222396, - "soa_id": 3, - "code_uid": "Code_43510", - "code": "C17204", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CT SCAN" - }, - { - "id": 227941, - "soa_id": 3, - "code_uid": "Code_44185", - "code": "C16809", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "MRI" - }, - { - "id": 227945, - "soa_id": 3, - "code_uid": "Code_44189", - "code": "C12439", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "BRAIN" - }, - { - "id": 227950, - "soa_id": 3, - "code_uid": "Code_44194", - "code": "C17204", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "CT SCAN" - }, - { - "id": 228088, - "soa_id": 3, - "code_uid": "Code_44332", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "EGCTMON" - }, - { - "id": 228090, - "soa_id": 3, - "code_uid": "Code_44334", - "code": "C119561", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "ECG Continuous Monitoring" - }, - { - "id": 231871, - "soa_id": 3, - "code_uid": "Code_44335", - "code": "C82977", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Dictionary-derived Term" - }, - { - "id": 231872, - "soa_id": 3, - "code_uid": "Code_44336", - "code": "C82571", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Reported Event Term" - }, - { - "id": 231873, - "soa_id": 3, - "code_uid": "Code_44337", - "code": "C82517", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Start Date Time" - }, - { - "id": 231874, - "soa_id": 3, - "code_uid": "Code_44338", - "code": "C83444", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - }, - { - "id": 231875, - "soa_id": 3, - "code_uid": "Code_44339", - "code": "C181043", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Clinical Findings Indicator" - }, - { - "id": 231876, - "soa_id": 3, - "code_uid": "Code_44340", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231877, - "soa_id": 3, - "code_uid": "Code_44341", - "code": "C83063", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-23", - "decode": "Inclusion Exclusion Criteria Yes No Indicator" - }, - { - "id": 231878, - "soa_id": 3, - "code_uid": "Code_44342", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-23", - "decode": "Collection Date Time" - }, - { - "id": 231879, - "soa_id": 3, - "code_uid": "Code_44343", - "code": "C83444", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Trial Inclusion Exclusion Criteria Version" - }, - { - "id": 231880, - "soa_id": 3, - "code_uid": "Code_44344", - "code": "C181043", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Clinical Findings Indicator" - }, - { - "id": 231881, - "soa_id": 3, - "code_uid": "Code_44345", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231882, - "soa_id": 3, - "code_uid": "Code_44346", - "code": "C82977", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Dictionary-derived Term" - }, - { - "id": 231883, - "soa_id": 3, - "code_uid": "Code_44347", - "code": "C82571", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Reported Event Term" - }, - { - "id": 231884, - "soa_id": 3, - "code_uid": "Code_44348", - "code": "C82517", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Start Date Time" - }, - { - "id": 231885, - "soa_id": 3, - "code_uid": "Code_44349", - "code": "C17049", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Race" - }, - { - "id": 231886, - "soa_id": 3, - "code_uid": "Code_44350", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231887, - "soa_id": 3, - "code_uid": "Code_44351", - "code": "C16564", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Ethnic Group" - }, - { - "id": 231888, - "soa_id": 3, - "code_uid": "Code_44352", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231889, - "soa_id": 3, - "code_uid": "Code_44353", - "code": "C170981", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Numeric Age for Data Tabulation" - }, - { - "id": 231890, - "soa_id": 3, - "code_uid": "Code_44354", - "code": "C50400", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Age Unit" - }, - { - "id": 231891, - "soa_id": 3, - "code_uid": "Code_44355", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Collection Date Time" - }, - { - "id": 231892, - "soa_id": 3, - "code_uid": "Code_44356", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Collection Date Time" - }, - { - "id": 231893, - "soa_id": 3, - "code_uid": "Code_44357", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Collection Date Time" - }, - { - "id": 231894, - "soa_id": 3, - "code_uid": "Code_44358", - "code": "C28421", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-04-01", - "decode": "Sex" - }, - { - "id": 231895, - "soa_id": 3, - "code_uid": "Code_44359", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-04-01", - "decode": "Collection Date Time" - }, - { - "id": 231896, - "soa_id": 3, - "code_uid": "Code_44360", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 231897, - "soa_id": 3, - "code_uid": "Code_44361", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231898, - "soa_id": 3, - "code_uid": "Code_44362", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 231899, - "soa_id": 3, - "code_uid": "Code_44363", - "code": "C42574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Time" - }, - { - "id": 231900, - "soa_id": 3, - "code_uid": "Code_44364", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231901, - "soa_id": 3, - "code_uid": "Code_44365", - "code": "C83118", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Medical History Reported Term" - }, - { - "id": 231902, - "soa_id": 3, - "code_uid": "Code_44366", - "code": "C83346", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Medical History Dictionary Derived Term" - }, - { - "id": 231903, - "soa_id": 3, - "code_uid": "Code_44367", - "code": "C83338", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Medical History Event Start Date Time" - }, - { - "id": 231904, - "soa_id": 3, - "code_uid": "Code_44368", - "code": "C83330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Medical History Event End Date Time" - }, - { - "id": 231905, - "soa_id": 3, - "code_uid": "Code_44369", - "code": "C82557", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "End Relative to Reference Period" - }, - { - "id": 231906, - "soa_id": 3, - "code_uid": "Code_44370", - "code": "C82558", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "End Relative to Reference Time Point" - }, - { - "id": 231907, - "soa_id": 3, - "code_uid": "Code_44371", - "code": "C82574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-12-16", - "decode": "Reference End Time Point End" - }, - { - "id": 231908, - "soa_id": 3, - "code_uid": "Code_44372", - "code": "C83092", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Reported Name" - }, - { - "id": 231909, - "soa_id": 3, - "code_uid": "Code_44373", - "code": "C171000", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - }, - { - "id": 231910, - "soa_id": 3, - "code_uid": "Code_44374", - "code": "C127786", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Occurrence Indicator" - }, - { - "id": 231911, - "soa_id": 3, - "code_uid": "Code_44375", - "code": "C83416", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose" - }, - { - "id": 231912, - "soa_id": 3, - "code_uid": "Code_44376", - "code": "C83041", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose Description" - }, - { - "id": 231913, - "soa_id": 3, - "code_uid": "Code_44377", - "code": "C83038", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose Unit" - }, - { - "id": 231914, - "soa_id": 3, - "code_uid": "Code_44378", - "code": "C83044", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose Frequency" - }, - { - "id": 231915, - "soa_id": 3, - "code_uid": "Code_44379", - "code": "C83431", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Start Date Time" - }, - { - "id": 231916, - "soa_id": 3, - "code_uid": "Code_44380", - "code": "C83419", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use End Date Time" - }, - { - "id": 231917, - "soa_id": 3, - "code_uid": "Code_44381", - "code": "C82559", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Start Relative to Reference Period" - }, - { - "id": 231918, - "soa_id": 3, - "code_uid": "Code_44382", - "code": "C82560", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - }, - { - "id": 231919, - "soa_id": 3, - "code_uid": "Code_44383", - "code": "C82575", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Reference Start Time Point" - }, - { - "id": 231920, - "soa_id": 3, - "code_uid": "Code_44384", - "code": "C82557", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "End Relative to Reference Period" - }, - { - "id": 231921, - "soa_id": 3, - "code_uid": "Code_44385", - "code": "C82558", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "End Relative to Reference Time Point" - }, - { - "id": 231922, - "soa_id": 3, - "code_uid": "Code_44386", - "code": "C82574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Reference End Time Point End" - }, - { - "id": 231923, - "soa_id": 3, - "code_uid": "Code_44387", - "code": "C83092", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Reported Name" - }, - { - "id": 231924, - "soa_id": 3, - "code_uid": "Code_44388", - "code": "C171000", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - }, - { - "id": 231925, - "soa_id": 3, - "code_uid": "Code_44389", - "code": "C127786", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Occurrence Indicator" - }, - { - "id": 231926, - "soa_id": 3, - "code_uid": "Code_44390", - "code": "C83416", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose" - }, - { - "id": 231927, - "soa_id": 3, - "code_uid": "Code_44391", - "code": "C83041", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose Description" - }, - { - "id": 231928, - "soa_id": 3, - "code_uid": "Code_44392", - "code": "C83038", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose Unit" - }, - { - "id": 231929, - "soa_id": 3, - "code_uid": "Code_44393", - "code": "C83044", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose Frequency" - }, - { - "id": 231930, - "soa_id": 3, - "code_uid": "Code_44394", - "code": "C83431", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Start Date Time" - }, - { - "id": 231931, - "soa_id": 3, - "code_uid": "Code_44395", - "code": "C83419", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use End Date Time" - }, - { - "id": 231932, - "soa_id": 3, - "code_uid": "Code_44396", - "code": "C82559", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Start Relative to Reference Period" - }, - { - "id": 231933, - "soa_id": 3, - "code_uid": "Code_44397", - "code": "C82560", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - }, - { - "id": 231934, - "soa_id": 3, - "code_uid": "Code_44398", - "code": "C82575", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Reference Start Time Point" - }, - { - "id": 231935, - "soa_id": 3, - "code_uid": "Code_44399", - "code": "C82557", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "End Relative to Reference Period" - }, - { - "id": 231936, - "soa_id": 3, - "code_uid": "Code_44400", - "code": "C82558", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "End Relative to Reference Time Point" - }, - { - "id": 231937, - "soa_id": 3, - "code_uid": "Code_44401", - "code": "C82574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Reference End Time Point End" - }, - { - "id": 231938, - "soa_id": 3, - "code_uid": "Code_44402", - "code": "C83092", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Reported Name" - }, - { - "id": 231939, - "soa_id": 3, - "code_uid": "Code_44403", - "code": "C171000", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Prespecified Event or Intervention Indicator" - }, - { - "id": 231940, - "soa_id": 3, - "code_uid": "Code_44404", - "code": "C127786", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Occurrence Indicator" - }, - { - "id": 231941, - "soa_id": 3, - "code_uid": "Code_44405", - "code": "C83416", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose" - }, - { - "id": 231942, - "soa_id": 3, - "code_uid": "Code_44406", - "code": "C83041", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose Description" - }, - { - "id": 231943, - "soa_id": 3, - "code_uid": "Code_44407", - "code": "C83038", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose Unit" - }, - { - "id": 231944, - "soa_id": 3, - "code_uid": "Code_44408", - "code": "C83044", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Dose Frequency" - }, - { - "id": 231945, - "soa_id": 3, - "code_uid": "Code_44409", - "code": "C83431", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use Start Date Time" - }, - { - "id": 231946, - "soa_id": 3, - "code_uid": "Code_44410", - "code": "C83419", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use End Date Time" - }, - { - "id": 231947, - "soa_id": 3, - "code_uid": "Code_44411", - "code": "C83419", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Substance Use End Date Time" - }, - { - "id": 231948, - "soa_id": 3, - "code_uid": "Code_44412", - "code": "C82559", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Start Relative to Reference Period" - }, - { - "id": 231949, - "soa_id": 3, - "code_uid": "Code_44413", - "code": "C82560", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - }, - { - "id": 231950, - "soa_id": 3, - "code_uid": "Code_44414", - "code": "C82575", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Reference Start Time Point" - }, - { - "id": 231951, - "soa_id": 3, - "code_uid": "Code_44415", - "code": "C82557", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "End Relative to Reference Period" - }, - { - "id": 231952, - "soa_id": 3, - "code_uid": "Code_44416", - "code": "C82558", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "End Relative to Reference Time Point" - }, - { - "id": 231953, - "soa_id": 3, - "code_uid": "Code_44417", - "code": "C82574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Reference End Time Point End" - }, - { - "id": 231954, - "soa_id": 3, - "code_uid": "Code_44418", - "code": "C117511", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Reported Name of Procedure" - }, - { - "id": 231955, - "soa_id": 3, - "code_uid": "Code_44419", - "code": "C117512", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Standardized Name of Procedure" - }, - { - "id": 231956, - "soa_id": 3, - "code_uid": "Code_44420", - "code": "C171000", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator" - }, - { - "id": 231957, - "soa_id": 3, - "code_uid": "Code_44421", - "code": "C127786", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Occurrence Indicator" - }, - { - "id": 231958, - "soa_id": 3, - "code_uid": "Code_44422", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Anatomic Site" - }, - { - "id": 231959, - "soa_id": 3, - "code_uid": "Code_44423", - "code": "C117529", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Start Date and Time of Procedure" - }, - { - "id": 231960, - "soa_id": 3, - "code_uid": "Code_44424", - "code": "C117530", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "End Date and Time of Procedure" - }, - { - "id": 231961, - "soa_id": 3, - "code_uid": "Code_44425", - "code": "C82977", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Dictionary-derived Term" - }, - { - "id": 231962, - "soa_id": 3, - "code_uid": "Code_44426", - "code": "C82571", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Reported Event Term" - }, - { - "id": 231963, - "soa_id": 3, - "code_uid": "Code_44427", - "code": "C82517", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Start Date Time" - }, - { - "id": 231964, - "soa_id": 3, - "code_uid": "Code_44428", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 231965, - "soa_id": 3, - "code_uid": "Code_44429", - "code": "C44276", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Temperature" - }, - { - "id": 231966, - "soa_id": 3, - "code_uid": "Code_44430", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Anatomic Site" - }, - { - "id": 231967, - "soa_id": 3, - "code_uid": "Code_44431", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231968, - "soa_id": 3, - "code_uid": "Code_44432", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 231969, - "soa_id": 3, - "code_uid": "Code_44433", - "code": "C48208", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Weight" - }, - { - "id": 231970, - "soa_id": 3, - "code_uid": "Code_44434", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231971, - "soa_id": 3, - "code_uid": "Code_44435", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 231972, - "soa_id": 3, - "code_uid": "Code_44436", - "code": "C168688", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Height" - }, - { - "id": 231973, - "soa_id": 3, - "code_uid": "Code_44437", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231974, - "soa_id": 3, - "code_uid": "Code_44438", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 231975, - "soa_id": 3, - "code_uid": "Code_44439", - "code": "C73688", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Count per Minute" - }, - { - "id": 231976, - "soa_id": 3, - "code_uid": "Code_44440", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 231977, - "soa_id": 3, - "code_uid": "Code_44441", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Anatomic Site" - }, - { - "id": 231978, - "soa_id": 3, - "code_uid": "Code_44442", - "code": "C25185", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Laterality" - }, - { - "id": 231979, - "soa_id": 3, - "code_uid": "Code_44443", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231980, - "soa_id": 3, - "code_uid": "Code_44444", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 231981, - "soa_id": 3, - "code_uid": "Code_44445", - "code": "C73688", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Count per Minute" - }, - { - "id": 231982, - "soa_id": 3, - "code_uid": "Code_44446", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231983, - "soa_id": 3, - "code_uid": "Code_44447", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 231984, - "soa_id": 3, - "code_uid": "Code_44448", - "code": "C42575", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Mass Density" - }, - { - "id": 231985, - "soa_id": 3, - "code_uid": "Code_44449", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231986, - "soa_id": 3, - "code_uid": "Code_44450", - "code": "C125009", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Clinical Interpretation" - }, - { - "id": 231987, - "soa_id": 3, - "code_uid": "Code_44451", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 231988, - "soa_id": 3, - "code_uid": "Code_44452", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 231989, - "soa_id": 3, - "code_uid": "Code_44453", - "code": "C93532", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Clinically Significant Indicator" - }, - { - "id": 231990, - "soa_id": 3, - "code_uid": "Code_44454", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231991, - "soa_id": 3, - "code_uid": "Code_44455", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 231992, - "soa_id": 3, - "code_uid": "Code_44456", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 231993, - "soa_id": 3, - "code_uid": "Code_44457", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 231994, - "soa_id": 3, - "code_uid": "Code_44458", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 231995, - "soa_id": 3, - "code_uid": "Code_44459", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 231996, - "soa_id": 3, - "code_uid": "Code_44460", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 231997, - "soa_id": 3, - "code_uid": "Code_44461", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 231998, - "soa_id": 3, - "code_uid": "Code_44462", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 231999, - "soa_id": 3, - "code_uid": "Code_44463", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232000, - "soa_id": 3, - "code_uid": "Code_44464", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232001, - "soa_id": 3, - "code_uid": "Code_44465", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232002, - "soa_id": 3, - "code_uid": "Code_44466", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232003, - "soa_id": 3, - "code_uid": "Code_44467", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232004, - "soa_id": 3, - "code_uid": "Code_44468", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232005, - "soa_id": 3, - "code_uid": "Code_44469", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232006, - "soa_id": 3, - "code_uid": "Code_44470", - "code": "C114120", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "ECG Recording Quality" - }, - { - "id": 232007, - "soa_id": 3, - "code_uid": "Code_44471", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232008, - "soa_id": 3, - "code_uid": "Code_44472", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232009, - "soa_id": 3, - "code_uid": "Code_44473", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232010, - "soa_id": 3, - "code_uid": "Code_44474", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232011, - "soa_id": 3, - "code_uid": "Code_44475", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232012, - "soa_id": 3, - "code_uid": "Code_44476", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232013, - "soa_id": 3, - "code_uid": "Code_44477", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232014, - "soa_id": 3, - "code_uid": "Code_44478", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232015, - "soa_id": 3, - "code_uid": "Code_44479", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232016, - "soa_id": 3, - "code_uid": "Code_44480", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232017, - "soa_id": 3, - "code_uid": "Code_44481", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232018, - "soa_id": 3, - "code_uid": "Code_44482", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232019, - "soa_id": 3, - "code_uid": "Code_44483", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232020, - "soa_id": 3, - "code_uid": "Code_44484", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232021, - "soa_id": 3, - "code_uid": "Code_44485", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232022, - "soa_id": 3, - "code_uid": "Code_44486", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232023, - "soa_id": 3, - "code_uid": "Code_44487", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232024, - "soa_id": 3, - "code_uid": "Code_44488", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232025, - "soa_id": 3, - "code_uid": "Code_44489", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232026, - "soa_id": 3, - "code_uid": "Code_44490", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232027, - "soa_id": 3, - "code_uid": "Code_44491", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232028, - "soa_id": 3, - "code_uid": "Code_44492", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232029, - "soa_id": 3, - "code_uid": "Code_44493", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232030, - "soa_id": 3, - "code_uid": "Code_44494", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232031, - "soa_id": 3, - "code_uid": "Code_44495", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232032, - "soa_id": 3, - "code_uid": "Code_44496", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232033, - "soa_id": 3, - "code_uid": "Code_44497", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232034, - "soa_id": 3, - "code_uid": "Code_44498", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232035, - "soa_id": 3, - "code_uid": "Code_44499", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232036, - "soa_id": 3, - "code_uid": "Code_44500", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232037, - "soa_id": 3, - "code_uid": "Code_44501", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232038, - "soa_id": 3, - "code_uid": "Code_44502", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232039, - "soa_id": 3, - "code_uid": "Code_44503", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232040, - "soa_id": 3, - "code_uid": "Code_44504", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232041, - "soa_id": 3, - "code_uid": "Code_44505", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232042, - "soa_id": 3, - "code_uid": "Code_44506", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232043, - "soa_id": 3, - "code_uid": "Code_44507", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232044, - "soa_id": 3, - "code_uid": "Code_44508", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232045, - "soa_id": 3, - "code_uid": "Code_44509", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232046, - "soa_id": 3, - "code_uid": "Code_44510", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232047, - "soa_id": 3, - "code_uid": "Code_44511", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232048, - "soa_id": 3, - "code_uid": "Code_44512", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232049, - "soa_id": 3, - "code_uid": "Code_44513", - "code": "C25330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Duration" - }, - { - "id": 232050, - "soa_id": 3, - "code_uid": "Code_44514", - "code": "C42574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Time" - }, - { - "id": 232051, - "soa_id": 3, - "code_uid": "Code_44515", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232052, - "soa_id": 3, - "code_uid": "Code_44516", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232053, - "soa_id": 3, - "code_uid": "Code_44517", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232054, - "soa_id": 3, - "code_uid": "Code_44518", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232055, - "soa_id": 3, - "code_uid": "Code_44519", - "code": "C82516", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation End Date Time" - }, - { - "id": 232056, - "soa_id": 3, - "code_uid": "Code_44520", - "code": "C25330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Duration" - }, - { - "id": 232057, - "soa_id": 3, - "code_uid": "Code_44521", - "code": "C42574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Time" - }, - { - "id": 232058, - "soa_id": 3, - "code_uid": "Code_44522", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232059, - "soa_id": 3, - "code_uid": "Code_44523", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232060, - "soa_id": 3, - "code_uid": "Code_44524", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232061, - "soa_id": 3, - "code_uid": "Code_44525", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232062, - "soa_id": 3, - "code_uid": "Code_44526", - "code": "C82516", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation End Date Time" - }, - { - "id": 232063, - "soa_id": 3, - "code_uid": "Code_44527", - "code": "C25330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Duration" - }, - { - "id": 232064, - "soa_id": 3, - "code_uid": "Code_44528", - "code": "C42574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Time" - }, - { - "id": 232065, - "soa_id": 3, - "code_uid": "Code_44529", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232066, - "soa_id": 3, - "code_uid": "Code_44530", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232067, - "soa_id": 3, - "code_uid": "Code_44531", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232068, - "soa_id": 3, - "code_uid": "Code_44532", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232069, - "soa_id": 3, - "code_uid": "Code_44533", - "code": "C82516", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation End Date Time" - }, - { - "id": 232070, - "soa_id": 3, - "code_uid": "Code_44534", - "code": "C25330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Duration" - }, - { - "id": 232071, - "soa_id": 3, - "code_uid": "Code_44535", - "code": "C42574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Time" - }, - { - "id": 232072, - "soa_id": 3, - "code_uid": "Code_44536", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232073, - "soa_id": 3, - "code_uid": "Code_44537", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232074, - "soa_id": 3, - "code_uid": "Code_44538", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232075, - "soa_id": 3, - "code_uid": "Code_44539", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232076, - "soa_id": 3, - "code_uid": "Code_44540", - "code": "C82516", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation End Date Time" - }, - { - "id": 232077, - "soa_id": 3, - "code_uid": "Code_44541", - "code": "C25330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Duration" - }, - { - "id": 232078, - "soa_id": 3, - "code_uid": "Code_44542", - "code": "C42574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Time" - }, - { - "id": 232079, - "soa_id": 3, - "code_uid": "Code_44543", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232080, - "soa_id": 3, - "code_uid": "Code_44544", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232081, - "soa_id": 3, - "code_uid": "Code_44545", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232082, - "soa_id": 3, - "code_uid": "Code_44546", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232083, - "soa_id": 3, - "code_uid": "Code_44547", - "code": "C82516", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation End Date Time" - }, - { - "id": 232084, - "soa_id": 3, - "code_uid": "Code_44548", - "code": "C25330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Duration" - }, - { - "id": 232085, - "soa_id": 3, - "code_uid": "Code_44549", - "code": "C42574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Time" - }, - { - "id": 232086, - "soa_id": 3, - "code_uid": "Code_44550", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232087, - "soa_id": 3, - "code_uid": "Code_44551", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232088, - "soa_id": 3, - "code_uid": "Code_44552", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232089, - "soa_id": 3, - "code_uid": "Code_44553", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232090, - "soa_id": 3, - "code_uid": "Code_44554", - "code": "C82516", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation End Date Time" - }, - { - "id": 232091, - "soa_id": 3, - "code_uid": "Code_44555", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232092, - "soa_id": 3, - "code_uid": "Code_44556", - "code": "C73688", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Count per Minute" - }, - { - "id": 232093, - "soa_id": 3, - "code_uid": "Code_44557", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232094, - "soa_id": 3, - "code_uid": "Code_44558", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232095, - "soa_id": 3, - "code_uid": "Code_44559", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232096, - "soa_id": 3, - "code_uid": "Code_44560", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232097, - "soa_id": 3, - "code_uid": "Code_44561", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232098, - "soa_id": 3, - "code_uid": "Code_44562", - "code": "C68667", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Degree Unit of Plane Angle" - }, - { - "id": 232099, - "soa_id": 3, - "code_uid": "Code_44563", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232100, - "soa_id": 3, - "code_uid": "Code_44564", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232101, - "soa_id": 3, - "code_uid": "Code_44565", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232102, - "soa_id": 3, - "code_uid": "Code_44566", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232103, - "soa_id": 3, - "code_uid": "Code_44567", - "code": "C25330", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Duration" - }, - { - "id": 232104, - "soa_id": 3, - "code_uid": "Code_44568", - "code": "C42574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Time" - }, - { - "id": 232105, - "soa_id": 3, - "code_uid": "Code_44569", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232106, - "soa_id": 3, - "code_uid": "Code_44570", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232107, - "soa_id": 3, - "code_uid": "Code_44571", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232108, - "soa_id": 3, - "code_uid": "Code_44572", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232109, - "soa_id": 3, - "code_uid": "Code_44573", - "code": "C82516", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation End Date Time" - }, - { - "id": 232110, - "soa_id": 3, - "code_uid": "Code_44574", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232111, - "soa_id": 3, - "code_uid": "Code_44575", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232112, - "soa_id": 3, - "code_uid": "Code_44576", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232113, - "soa_id": 3, - "code_uid": "Code_44577", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232114, - "soa_id": 3, - "code_uid": "Code_44578", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232115, - "soa_id": 3, - "code_uid": "Code_44579", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232116, - "soa_id": 3, - "code_uid": "Code_44580", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232117, - "soa_id": 3, - "code_uid": "Code_44581", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232118, - "soa_id": 3, - "code_uid": "Code_44582", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232119, - "soa_id": 3, - "code_uid": "Code_44583", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232120, - "soa_id": 3, - "code_uid": "Code_44584", - "code": "C117511", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Reported Name of Procedure" - }, - { - "id": 232121, - "soa_id": 3, - "code_uid": "Code_44585", - "code": "C117512", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Standardized Name of Procedure" - }, - { - "id": 232122, - "soa_id": 3, - "code_uid": "Code_44586", - "code": "C171000", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - }, - { - "id": 232123, - "soa_id": 3, - "code_uid": "Code_44587", - "code": "C127786", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Occurrence Indicator" - }, - { - "id": 232124, - "soa_id": 3, - "code_uid": "Code_44588", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Anatomic Site" - }, - { - "id": 232125, - "soa_id": 3, - "code_uid": "Code_44589", - "code": "C117529", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Start Date and Time of Procedure" - }, - { - "id": 232126, - "soa_id": 3, - "code_uid": "Code_44590", - "code": "C117530", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "End Date and Time of Procedure" - }, - { - "id": 232127, - "soa_id": 3, - "code_uid": "Code_44591", - "code": "C117511", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Reported Name of Procedure" - }, - { - "id": 232128, - "soa_id": 3, - "code_uid": "Code_44592", - "code": "C117512", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Standardized Name of Procedure" - }, - { - "id": 232129, - "soa_id": 3, - "code_uid": "Code_44593", - "code": "C171000", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - }, - { - "id": 232130, - "soa_id": 3, - "code_uid": "Code_44594", - "code": "C127786", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Occurrence Indicator" - }, - { - "id": 232131, - "soa_id": 3, - "code_uid": "Code_44595", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Anatomic Site" - }, - { - "id": 232132, - "soa_id": 3, - "code_uid": "Code_44596", - "code": "C117529", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Start Date and Time of Procedure" - }, - { - "id": 232133, - "soa_id": 3, - "code_uid": "Code_44597", - "code": "C117530", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "End Date and Time of Procedure" - }, - { - "id": 232134, - "soa_id": 3, - "code_uid": "Code_44598", - "code": "C83056", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-23", - "decode": "Concomitant Medication Yes No Indicator" - }, - { - "id": 232135, - "soa_id": 3, - "code_uid": "Code_44599", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-23", - "decode": "Collection Date Time" - }, - { - "id": 232136, - "soa_id": 3, - "code_uid": "Code_44600", - "code": "C70902", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Agent" - }, - { - "id": 232137, - "soa_id": 3, - "code_uid": "Code_44601", - "code": "C83345", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Medication Dictionary Derived Term" - }, - { - "id": 232138, - "soa_id": 3, - "code_uid": "Code_44602", - "code": "C83219", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Medication Class" - }, - { - "id": 232139, - "soa_id": 3, - "code_uid": "Code_44603", - "code": "C83085", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Medication Use Indication" - }, - { - "id": 232140, - "soa_id": 3, - "code_uid": "Code_44604", - "code": "C83221", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Medication Dose" - }, - { - "id": 232141, - "soa_id": 3, - "code_uid": "Code_44605", - "code": "C83221", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Medication Dose" - }, - { - "id": 232142, - "soa_id": 3, - "code_uid": "Code_44606", - "code": "C83034", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Medication Dose Unit" - }, - { - "id": 232143, - "soa_id": 3, - "code_uid": "Code_44607", - "code": "C83110", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Medication Dose Form" - }, - { - "id": 232144, - "soa_id": 3, - "code_uid": "Code_44608", - "code": "C83042", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Medication Dose Frequency" - }, - { - "id": 232145, - "soa_id": 3, - "code_uid": "Code_44609", - "code": "C83120", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Medication Route of Administration" - }, - { - "id": 232146, - "soa_id": 3, - "code_uid": "Code_44610", - "code": "C83235", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Medication Use Start Date Time" - }, - { - "id": 232147, - "soa_id": 3, - "code_uid": "Code_44611", - "code": "C83225", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Concomitant Medication Use End Date Time" - }, - { - "id": 232148, - "soa_id": 3, - "code_uid": "Code_44612", - "code": "C82559", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Start Relative to Reference Period" - }, - { - "id": 232149, - "soa_id": 3, - "code_uid": "Code_44613", - "code": "C82560", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Start Relative to Reference Time Point" - }, - { - "id": 232150, - "soa_id": 3, - "code_uid": "Code_44614", - "code": "C82575", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Reference Start Time Point" - }, - { - "id": 232151, - "soa_id": 3, - "code_uid": "Code_44615", - "code": "C82557", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "End Relative to Reference Period" - }, - { - "id": 232152, - "soa_id": 3, - "code_uid": "Code_44616", - "code": "C82558", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "End Relative to Reference Time Point" - }, - { - "id": 232153, - "soa_id": 3, - "code_uid": "Code_44617", - "code": "C82574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Reference End Time Point End" - }, - { - "id": 232154, - "soa_id": 3, - "code_uid": "Code_44618", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232155, - "soa_id": 3, - "code_uid": "Code_44619", - "code": "C64571", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Mass Concentration" - }, - { - "id": 232156, - "soa_id": 3, - "code_uid": "Code_44620", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232157, - "soa_id": 3, - "code_uid": "Code_44621", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232158, - "soa_id": 3, - "code_uid": "Code_44622", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232159, - "soa_id": 3, - "code_uid": "Code_44623", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232160, - "soa_id": 3, - "code_uid": "Code_44624", - "code": "C69174", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Volume Fraction" - }, - { - "id": 232161, - "soa_id": 3, - "code_uid": "Code_44625", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232162, - "soa_id": 3, - "code_uid": "Code_44626", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232163, - "soa_id": 3, - "code_uid": "Code_44627", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232164, - "soa_id": 3, - "code_uid": "Code_44628", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232165, - "soa_id": 3, - "code_uid": "Code_44629", - "code": "C67391", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Number Concentration" - }, - { - "id": 232166, - "soa_id": 3, - "code_uid": "Code_44630", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232167, - "soa_id": 3, - "code_uid": "Code_44631", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232168, - "soa_id": 3, - "code_uid": "Code_44632", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232169, - "soa_id": 3, - "code_uid": "Code_44633", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232170, - "soa_id": 3, - "code_uid": "Code_44634", - "code": "C25709", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Measure" - }, - { - "id": 232171, - "soa_id": 3, - "code_uid": "Code_44635", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232172, - "soa_id": 3, - "code_uid": "Code_44636", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232173, - "soa_id": 3, - "code_uid": "Code_44637", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232174, - "soa_id": 3, - "code_uid": "Code_44638", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232175, - "soa_id": 3, - "code_uid": "Code_44639", - "code": "C44279", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Volume" - }, - { - "id": 232176, - "soa_id": 3, - "code_uid": "Code_44640", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232177, - "soa_id": 3, - "code_uid": "Code_44641", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232178, - "soa_id": 3, - "code_uid": "Code_44642", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232179, - "soa_id": 3, - "code_uid": "Code_44643", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232180, - "soa_id": 3, - "code_uid": "Code_44644", - "code": "C67391", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Number Concentration" - }, - { - "id": 232181, - "soa_id": 3, - "code_uid": "Code_44645", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232182, - "soa_id": 3, - "code_uid": "Code_44646", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232183, - "soa_id": 3, - "code_uid": "Code_44647", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232184, - "soa_id": 3, - "code_uid": "Code_44648", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232185, - "soa_id": 3, - "code_uid": "Code_44649", - "code": "C67391", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Number Concentration" - }, - { - "id": 232186, - "soa_id": 3, - "code_uid": "Code_44650", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232187, - "soa_id": 3, - "code_uid": "Code_44651", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232188, - "soa_id": 3, - "code_uid": "Code_44652", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232189, - "soa_id": 3, - "code_uid": "Code_44653", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232190, - "soa_id": 3, - "code_uid": "Code_44654", - "code": "C67391", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Number Concentration" - }, - { - "id": 232191, - "soa_id": 3, - "code_uid": "Code_44655", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232192, - "soa_id": 3, - "code_uid": "Code_44656", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232193, - "soa_id": 3, - "code_uid": "Code_44657", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232194, - "soa_id": 3, - "code_uid": "Code_44658", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232195, - "soa_id": 3, - "code_uid": "Code_44659", - "code": "C67391", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Number Concentration" - }, - { - "id": 232196, - "soa_id": 3, - "code_uid": "Code_44660", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232197, - "soa_id": 3, - "code_uid": "Code_44661", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232198, - "soa_id": 3, - "code_uid": "Code_44662", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232199, - "soa_id": 3, - "code_uid": "Code_44663", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232200, - "soa_id": 3, - "code_uid": "Code_44664", - "code": "C67391", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Number Concentration" - }, - { - "id": 232201, - "soa_id": 3, - "code_uid": "Code_44665", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232202, - "soa_id": 3, - "code_uid": "Code_44666", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232203, - "soa_id": 3, - "code_uid": "Code_44667", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232204, - "soa_id": 3, - "code_uid": "Code_44668", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232205, - "soa_id": 3, - "code_uid": "Code_44669", - "code": "C67391", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Number Concentration" - }, - { - "id": 232206, - "soa_id": 3, - "code_uid": "Code_44670", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232207, - "soa_id": 3, - "code_uid": "Code_44671", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232208, - "soa_id": 3, - "code_uid": "Code_44672", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232209, - "soa_id": 3, - "code_uid": "Code_44673", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232210, - "soa_id": 3, - "code_uid": "Code_44674", - "code": "C67391", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Number Concentration" - }, - { - "id": 232211, - "soa_id": 3, - "code_uid": "Code_44675", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232212, - "soa_id": 3, - "code_uid": "Code_44676", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232213, - "soa_id": 3, - "code_uid": "Code_44677", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232214, - "soa_id": 3, - "code_uid": "Code_44678", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232215, - "soa_id": 3, - "code_uid": "Code_44679", - "code": "C67391", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Number Concentration" - }, - { - "id": 232216, - "soa_id": 3, - "code_uid": "Code_44680", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232217, - "soa_id": 3, - "code_uid": "Code_44681", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232218, - "soa_id": 3, - "code_uid": "Code_44682", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232219, - "soa_id": 3, - "code_uid": "Code_44683", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232220, - "soa_id": 3, - "code_uid": "Code_44684", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232221, - "soa_id": 3, - "code_uid": "Code_44685", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232222, - "soa_id": 3, - "code_uid": "Code_44686", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232223, - "soa_id": 3, - "code_uid": "Code_44687", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232224, - "soa_id": 3, - "code_uid": "Code_44688", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232225, - "soa_id": 3, - "code_uid": "Code_44689", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232226, - "soa_id": 3, - "code_uid": "Code_44690", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232227, - "soa_id": 3, - "code_uid": "Code_44691", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232228, - "soa_id": 3, - "code_uid": "Code_44692", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232229, - "soa_id": 3, - "code_uid": "Code_44693", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232230, - "soa_id": 3, - "code_uid": "Code_44694", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232231, - "soa_id": 3, - "code_uid": "Code_44695", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232232, - "soa_id": 3, - "code_uid": "Code_44696", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232233, - "soa_id": 3, - "code_uid": "Code_44697", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232234, - "soa_id": 3, - "code_uid": "Code_44698", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232235, - "soa_id": 3, - "code_uid": "Code_44699", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232236, - "soa_id": 3, - "code_uid": "Code_44700", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232237, - "soa_id": 3, - "code_uid": "Code_44701", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232238, - "soa_id": 3, - "code_uid": "Code_44702", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232239, - "soa_id": 3, - "code_uid": "Code_44703", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232240, - "soa_id": 3, - "code_uid": "Code_44704", - "code": "C67365", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - }, - { - "id": 232241, - "soa_id": 3, - "code_uid": "Code_44705", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232242, - "soa_id": 3, - "code_uid": "Code_44706", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232243, - "soa_id": 3, - "code_uid": "Code_44707", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232244, - "soa_id": 3, - "code_uid": "Code_44708", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232245, - "soa_id": 3, - "code_uid": "Code_44709", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232246, - "soa_id": 3, - "code_uid": "Code_44710", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232247, - "soa_id": 3, - "code_uid": "Code_44711", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232248, - "soa_id": 3, - "code_uid": "Code_44712", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232249, - "soa_id": 3, - "code_uid": "Code_44713", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232250, - "soa_id": 3, - "code_uid": "Code_44714", - "code": "C67365", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - }, - { - "id": 232251, - "soa_id": 3, - "code_uid": "Code_44715", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232252, - "soa_id": 3, - "code_uid": "Code_44716", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232253, - "soa_id": 3, - "code_uid": "Code_44717", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232254, - "soa_id": 3, - "code_uid": "Code_44718", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232255, - "soa_id": 3, - "code_uid": "Code_44719", - "code": "C67365", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - }, - { - "id": 232256, - "soa_id": 3, - "code_uid": "Code_44720", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232257, - "soa_id": 3, - "code_uid": "Code_44721", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232258, - "soa_id": 3, - "code_uid": "Code_44722", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232259, - "soa_id": 3, - "code_uid": "Code_44723", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232260, - "soa_id": 3, - "code_uid": "Code_44724", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232261, - "soa_id": 3, - "code_uid": "Code_44725", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232262, - "soa_id": 3, - "code_uid": "Code_44726", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232263, - "soa_id": 3, - "code_uid": "Code_44727", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232264, - "soa_id": 3, - "code_uid": "Code_44728", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232265, - "soa_id": 3, - "code_uid": "Code_44729", - "code": "C64567", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Molarity Unit" - }, - { - "id": 232266, - "soa_id": 3, - "code_uid": "Code_44730", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232267, - "soa_id": 3, - "code_uid": "Code_44731", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232268, - "soa_id": 3, - "code_uid": "Code_44732", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232269, - "soa_id": 3, - "code_uid": "Code_44733", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232270, - "soa_id": 3, - "code_uid": "Code_44734", - "code": "C64567", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Molarity Unit" - }, - { - "id": 232271, - "soa_id": 3, - "code_uid": "Code_44735", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232272, - "soa_id": 3, - "code_uid": "Code_44736", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232273, - "soa_id": 3, - "code_uid": "Code_44737", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232274, - "soa_id": 3, - "code_uid": "Code_44738", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232275, - "soa_id": 3, - "code_uid": "Code_44739", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232276, - "soa_id": 3, - "code_uid": "Code_44740", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232277, - "soa_id": 3, - "code_uid": "Code_44741", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232278, - "soa_id": 3, - "code_uid": "Code_44742", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232279, - "soa_id": 3, - "code_uid": "Code_44743", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232280, - "soa_id": 3, - "code_uid": "Code_44744", - "code": "C64567", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Molarity Unit" - }, - { - "id": 232281, - "soa_id": 3, - "code_uid": "Code_44745", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232282, - "soa_id": 3, - "code_uid": "Code_44746", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232283, - "soa_id": 3, - "code_uid": "Code_44747", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232284, - "soa_id": 3, - "code_uid": "Code_44748", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232285, - "soa_id": 3, - "code_uid": "Code_44749", - "code": "C64567", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Molarity Unit" - }, - { - "id": 232286, - "soa_id": 3, - "code_uid": "Code_44750", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232287, - "soa_id": 3, - "code_uid": "Code_44751", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232288, - "soa_id": 3, - "code_uid": "Code_44752", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232289, - "soa_id": 3, - "code_uid": "Code_44753", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232290, - "soa_id": 3, - "code_uid": "Code_44754", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232291, - "soa_id": 3, - "code_uid": "Code_44755", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232292, - "soa_id": 3, - "code_uid": "Code_44756", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232293, - "soa_id": 3, - "code_uid": "Code_44757", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232294, - "soa_id": 3, - "code_uid": "Code_44758", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232295, - "soa_id": 3, - "code_uid": "Code_44759", - "code": "C67365", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - }, - { - "id": 232296, - "soa_id": 3, - "code_uid": "Code_44760", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232297, - "soa_id": 3, - "code_uid": "Code_44761", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232298, - "soa_id": 3, - "code_uid": "Code_44762", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232299, - "soa_id": 3, - "code_uid": "Code_44763", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232300, - "soa_id": 3, - "code_uid": "Code_44764", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232301, - "soa_id": 3, - "code_uid": "Code_44765", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232302, - "soa_id": 3, - "code_uid": "Code_44766", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232303, - "soa_id": 3, - "code_uid": "Code_44767", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232304, - "soa_id": 3, - "code_uid": "Code_44768", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232305, - "soa_id": 3, - "code_uid": "Code_44769", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232306, - "soa_id": 3, - "code_uid": "Code_44770", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232307, - "soa_id": 3, - "code_uid": "Code_44771", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232308, - "soa_id": 3, - "code_uid": "Code_44772", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232309, - "soa_id": 3, - "code_uid": "Code_44773", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232310, - "soa_id": 3, - "code_uid": "Code_44774", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232311, - "soa_id": 3, - "code_uid": "Code_44775", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232312, - "soa_id": 3, - "code_uid": "Code_44776", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232313, - "soa_id": 3, - "code_uid": "Code_44777", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232314, - "soa_id": 3, - "code_uid": "Code_44778", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232315, - "soa_id": 3, - "code_uid": "Code_44779", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232316, - "soa_id": 3, - "code_uid": "Code_44780", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232317, - "soa_id": 3, - "code_uid": "Code_44781", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232318, - "soa_id": 3, - "code_uid": "Code_44782", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232319, - "soa_id": 3, - "code_uid": "Code_44783", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232320, - "soa_id": 3, - "code_uid": "Code_44784", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232321, - "soa_id": 3, - "code_uid": "Code_44785", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232322, - "soa_id": 3, - "code_uid": "Code_44786", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232323, - "soa_id": 3, - "code_uid": "Code_44787", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232324, - "soa_id": 3, - "code_uid": "Code_44788", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232325, - "soa_id": 3, - "code_uid": "Code_44789", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232326, - "soa_id": 3, - "code_uid": "Code_44790", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232327, - "soa_id": 3, - "code_uid": "Code_44791", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232328, - "soa_id": 3, - "code_uid": "Code_44792", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232329, - "soa_id": 3, - "code_uid": "Code_44793", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232330, - "soa_id": 3, - "code_uid": "Code_44794", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232331, - "soa_id": 3, - "code_uid": "Code_44795", - "code": "C48570", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Percent Unit" - }, - { - "id": 232332, - "soa_id": 3, - "code_uid": "Code_44796", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232333, - "soa_id": 3, - "code_uid": "Code_44797", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232334, - "soa_id": 3, - "code_uid": "Code_44798", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232335, - "soa_id": 3, - "code_uid": "Code_44799", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232336, - "soa_id": 3, - "code_uid": "Code_44800", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232337, - "soa_id": 3, - "code_uid": "Code_44801", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232338, - "soa_id": 3, - "code_uid": "Code_44802", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232339, - "soa_id": 3, - "code_uid": "Code_44803", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232340, - "soa_id": 3, - "code_uid": "Code_44804", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232341, - "soa_id": 3, - "code_uid": "Code_44805", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232342, - "soa_id": 3, - "code_uid": "Code_44806", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232343, - "soa_id": 3, - "code_uid": "Code_44807", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232344, - "soa_id": 3, - "code_uid": "Code_44808", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232345, - "soa_id": 3, - "code_uid": "Code_44809", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232346, - "soa_id": 3, - "code_uid": "Code_44810", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232347, - "soa_id": 3, - "code_uid": "Code_44811", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232348, - "soa_id": 3, - "code_uid": "Code_44812", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232349, - "soa_id": 3, - "code_uid": "Code_44813", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232350, - "soa_id": 3, - "code_uid": "Code_44814", - "code": "C67365", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Catalytic Activity Concentration" - }, - { - "id": 232351, - "soa_id": 3, - "code_uid": "Code_44815", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232352, - "soa_id": 3, - "code_uid": "Code_44816", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232353, - "soa_id": 3, - "code_uid": "Code_44817", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232354, - "soa_id": 3, - "code_uid": "Code_44818", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232355, - "soa_id": 3, - "code_uid": "Code_44819", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232356, - "soa_id": 3, - "code_uid": "Code_44820", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232357, - "soa_id": 3, - "code_uid": "Code_44821", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232358, - "soa_id": 3, - "code_uid": "Code_44822", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232359, - "soa_id": 3, - "code_uid": "Code_44823", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232360, - "soa_id": 3, - "code_uid": "Code_44824", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232361, - "soa_id": 3, - "code_uid": "Code_44825", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232362, - "soa_id": 3, - "code_uid": "Code_44826", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232363, - "soa_id": 3, - "code_uid": "Code_44827", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232364, - "soa_id": 3, - "code_uid": "Code_44828", - "code": "C117062", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - }, - { - "id": 232365, - "soa_id": 3, - "code_uid": "Code_44829", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232366, - "soa_id": 3, - "code_uid": "Code_44830", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232367, - "soa_id": 3, - "code_uid": "Code_44831", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232368, - "soa_id": 3, - "code_uid": "Code_44832", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232369, - "soa_id": 3, - "code_uid": "Code_44833", - "code": "C117062", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Measurement, Test or Examination Detail" - }, - { - "id": 232370, - "soa_id": 3, - "code_uid": "Code_44834", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232371, - "soa_id": 3, - "code_uid": "Code_44835", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232372, - "soa_id": 3, - "code_uid": "Code_44836", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232373, - "soa_id": 3, - "code_uid": "Code_44837", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232374, - "soa_id": 3, - "code_uid": "Code_44838", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232375, - "soa_id": 3, - "code_uid": "Code_44839", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232376, - "soa_id": 3, - "code_uid": "Code_44840", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232377, - "soa_id": 3, - "code_uid": "Code_44841", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232378, - "soa_id": 3, - "code_uid": "Code_44842", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232379, - "soa_id": 3, - "code_uid": "Code_44843", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232380, - "soa_id": 3, - "code_uid": "Code_44844", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232381, - "soa_id": 3, - "code_uid": "Code_44845", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232382, - "soa_id": 3, - "code_uid": "Code_44846", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232383, - "soa_id": 3, - "code_uid": "Code_44847", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232384, - "soa_id": 3, - "code_uid": "Code_44848", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232385, - "soa_id": 3, - "code_uid": "Code_44849", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232386, - "soa_id": 3, - "code_uid": "Code_44850", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232387, - "soa_id": 3, - "code_uid": "Code_44851", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232388, - "soa_id": 3, - "code_uid": "Code_44852", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232389, - "soa_id": 3, - "code_uid": "Code_44853", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232390, - "soa_id": 3, - "code_uid": "Code_44854", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232391, - "soa_id": 3, - "code_uid": "Code_44855", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232392, - "soa_id": 3, - "code_uid": "Code_44856", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232393, - "soa_id": 3, - "code_uid": "Code_44857", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232394, - "soa_id": 3, - "code_uid": "Code_44858", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232395, - "soa_id": 3, - "code_uid": "Code_44859", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232396, - "soa_id": 3, - "code_uid": "Code_44860", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232397, - "soa_id": 3, - "code_uid": "Code_44861", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232398, - "soa_id": 3, - "code_uid": "Code_44862", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232399, - "soa_id": 3, - "code_uid": "Code_44863", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232400, - "soa_id": 3, - "code_uid": "Code_44864", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232401, - "soa_id": 3, - "code_uid": "Code_44865", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232402, - "soa_id": 3, - "code_uid": "Code_44866", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232403, - "soa_id": 3, - "code_uid": "Code_44867", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232404, - "soa_id": 3, - "code_uid": "Code_44868", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232405, - "soa_id": 3, - "code_uid": "Code_44869", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232406, - "soa_id": 3, - "code_uid": "Code_44870", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232407, - "soa_id": 3, - "code_uid": "Code_44871", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232408, - "soa_id": 3, - "code_uid": "Code_44872", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232409, - "soa_id": 3, - "code_uid": "Code_44873", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232410, - "soa_id": 3, - "code_uid": "Code_44874", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232411, - "soa_id": 3, - "code_uid": "Code_44875", - "code": "C48207", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Concentration" - }, - { - "id": 232412, - "soa_id": 3, - "code_uid": "Code_44876", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232413, - "soa_id": 3, - "code_uid": "Code_44877", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232414, - "soa_id": 3, - "code_uid": "Code_44878", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232415, - "soa_id": 3, - "code_uid": "Code_44879", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232416, - "soa_id": 3, - "code_uid": "Code_44880", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232417, - "soa_id": 3, - "code_uid": "Code_44881", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232418, - "soa_id": 3, - "code_uid": "Code_44882", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232419, - "soa_id": 3, - "code_uid": "Code_44883", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232420, - "soa_id": 3, - "code_uid": "Code_44884", - "code": "C70713", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Biospecimen Type" - }, - { - "id": 232421, - "soa_id": 3, - "code_uid": "Code_44885", - "code": "C93566", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Fasting Status Indicator" - }, - { - "id": 232422, - "soa_id": 3, - "code_uid": "Code_44886", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232423, - "soa_id": 3, - "code_uid": "Code_44887", - "code": "C117473", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Name of Treatment" - }, - { - "id": 232424, - "soa_id": 3, - "code_uid": "Code_44888", - "code": "C117469", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Reference Identifier" - }, - { - "id": 232425, - "soa_id": 3, - "code_uid": "Code_44889", - "code": "C117479", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Dose" - }, - { - "id": 232426, - "soa_id": 3, - "code_uid": "Code_44890", - "code": "C117480", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Dose Description" - }, - { - "id": 232427, - "soa_id": 3, - "code_uid": "Code_44891", - "code": "C117481", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Dose Units" - }, - { - "id": 232428, - "soa_id": 3, - "code_uid": "Code_44892", - "code": "C117482", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Dose Form" - }, - { - "id": 232429, - "soa_id": 3, - "code_uid": "Code_44893", - "code": "C117483", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Dosing Frequency per Interval" - }, - { - "id": 232430, - "soa_id": 3, - "code_uid": "Code_44894", - "code": "C117485", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Intended Dose Regimen" - }, - { - "id": 232431, - "soa_id": 3, - "code_uid": "Code_44895", - "code": "C117486", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Route of Administration" - }, - { - "id": 232432, - "soa_id": 3, - "code_uid": "Code_44896", - "code": "C117488", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Location" - }, - { - "id": 232433, - "soa_id": 3, - "code_uid": "Code_44897", - "code": "C117489", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Laterality" - }, - { - "id": 232434, - "soa_id": 3, - "code_uid": "Code_44898", - "code": "C117490", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Directionality" - }, - { - "id": 232435, - "soa_id": 3, - "code_uid": "Code_44899", - "code": "C117496", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected Start Date and Time of Treatment" - }, - { - "id": 232436, - "soa_id": 3, - "code_uid": "Code_44900", - "code": "C117497", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Exposure as Collected End Date and Time of Treatment" - }, - { - "id": 232437, - "soa_id": 3, - "code_uid": "Code_44901", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-23", - "decode": "Category" - }, - { - "id": 232438, - "soa_id": 3, - "code_uid": "Code_44902", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-23", - "decode": "Collection Date Time" - }, - { - "id": 232439, - "soa_id": 3, - "code_uid": "Code_44903", - "code": "C82525", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-23", - "decode": "Test Occurrence" - }, - { - "id": 232440, - "soa_id": 3, - "code_uid": "Code_44904", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Ordinal Position" - }, - { - "id": 232441, - "soa_id": 3, - "code_uid": "Code_44905", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232442, - "soa_id": 3, - "code_uid": "Code_44906", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232443, - "soa_id": 3, - "code_uid": "Code_44907", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Ordinal Position" - }, - { - "id": 232444, - "soa_id": 3, - "code_uid": "Code_44908", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232445, - "soa_id": 3, - "code_uid": "Code_44909", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232446, - "soa_id": 3, - "code_uid": "Code_44910", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Ordinal Position" - }, - { - "id": 232447, - "soa_id": 3, - "code_uid": "Code_44911", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232448, - "soa_id": 3, - "code_uid": "Code_44912", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232449, - "soa_id": 3, - "code_uid": "Code_44913", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Ordinal Position" - }, - { - "id": 232450, - "soa_id": 3, - "code_uid": "Code_44914", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232451, - "soa_id": 3, - "code_uid": "Code_44915", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Evaluator" - }, - { - "id": 232452, - "soa_id": 3, - "code_uid": "Code_44916", - "code": "C83347", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - }, - { - "id": 232453, - "soa_id": 3, - "code_uid": "Code_44917", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Collection Date Time" - }, - { - "id": 232454, - "soa_id": 3, - "code_uid": "Code_44918", - "code": "C78541", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Verbatim Description" - }, - { - "id": 232455, - "soa_id": 3, - "code_uid": "Code_44919", - "code": "C83344", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Dictionary Derived Term" - }, - { - "id": 232456, - "soa_id": 3, - "code_uid": "Code_44920", - "code": "C83205", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Location" - }, - { - "id": 232457, - "soa_id": 3, - "code_uid": "Code_44921", - "code": "C53253", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Severity of Adverse Event" - }, - { - "id": 232458, - "soa_id": 3, - "code_uid": "Code_44922", - "code": "C53252", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Seriousness of Adverse Event" - }, - { - "id": 232459, - "soa_id": 3, - "code_uid": "Code_44923", - "code": "C83013", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Action Taken with Study Treatment" - }, - { - "id": 232460, - "soa_id": 3, - "code_uid": "Code_44924", - "code": "C83109", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Other Actions taken in Response to Adverse Event" - }, - { - "id": 232461, - "soa_id": 3, - "code_uid": "Code_44925", - "code": "C41358", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Attribution to Product or Procedure" - }, - { - "id": 232462, - "soa_id": 3, - "code_uid": "Code_44926", - "code": "C83210", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Relationship to Non Study Treatment" - }, - { - "id": 232463, - "soa_id": 3, - "code_uid": "Code_44927", - "code": "C83208", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Pattern" - }, - { - "id": 232464, - "soa_id": 3, - "code_uid": "Code_44928", - "code": "C49489", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Outcome" - }, - { - "id": 232465, - "soa_id": 3, - "code_uid": "Code_44929", - "code": "C83211", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Involves Cancer" - }, - { - "id": 232466, - "soa_id": 3, - "code_uid": "Code_44930", - "code": "C83117", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Seriousness Due to Congenital Anomaly" - }, - { - "id": 232467, - "soa_id": 3, - "code_uid": "Code_44931", - "code": "C113380", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Disabling Adverse Event" - }, - { - "id": 232468, - "soa_id": 3, - "code_uid": "Code_44932", - "code": "C48275", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Death Related to Adverse Event" - }, - { - "id": 232469, - "soa_id": 3, - "code_uid": "Code_44933", - "code": "C83052", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event associated with Hospitalization" - }, - { - "id": 232470, - "soa_id": 3, - "code_uid": "Code_44934", - "code": "C84266", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Life Threatening Adverse Event" - }, - { - "id": 232471, - "soa_id": 3, - "code_uid": "Code_44935", - "code": "C83214", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Occurred with Overdose" - }, - { - "id": 232472, - "soa_id": 3, - "code_uid": "Code_44936", - "code": "C83053", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Associated with Serious Medical Event" - }, - { - "id": 232473, - "soa_id": 3, - "code_uid": "Code_44937", - "code": "C83199", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Concomitant Treatment" - }, - { - "id": 232474, - "soa_id": 3, - "code_uid": "Code_44938", - "code": "C78605", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Toxicity Grade" - }, - { - "id": 232475, - "soa_id": 3, - "code_uid": "Code_44939", - "code": "C83215", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Start Date Time" - }, - { - "id": 232476, - "soa_id": 3, - "code_uid": "Code_44940", - "code": "C83201", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event End Date Time" - }, - { - "id": 232477, - "soa_id": 3, - "code_uid": "Code_44941", - "code": "C82557", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "End Relative to Reference Period" - }, - { - "id": 232478, - "soa_id": 3, - "code_uid": "Code_44942", - "code": "C82558", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "End Relative to Reference Time Point" - }, - { - "id": 232479, - "soa_id": 3, - "code_uid": "Code_44943", - "code": "C82574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Reference End Time Point End" - }, - { - "id": 232480, - "soa_id": 3, - "code_uid": "Code_44944", - "code": "C82977", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Dictionary-derived Term" - }, - { - "id": 232481, - "soa_id": 3, - "code_uid": "Code_44945", - "code": "C82571", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Reported Event Term" - }, - { - "id": 232482, - "soa_id": 3, - "code_uid": "Code_44946", - "code": "C82517", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Start Date Time" - }, - { - "id": 232483, - "soa_id": 3, - "code_uid": "Code_44947", - "code": "C82977", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Dictionary-derived Term" - }, - { - "id": 232484, - "soa_id": 3, - "code_uid": "Code_44948", - "code": "C82571", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Reported Event Term" - }, - { - "id": 232485, - "soa_id": 3, - "code_uid": "Code_44949", - "code": "C82517", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Start Date Time" - }, - { - "id": 232486, - "soa_id": 3, - "code_uid": "Code_44950", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232487, - "soa_id": 3, - "code_uid": "Code_44951", - "code": "C49669", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Pressure" - }, - { - "id": 232488, - "soa_id": 3, - "code_uid": "Code_44952", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232489, - "soa_id": 3, - "code_uid": "Code_44953", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Anatomic Site" - }, - { - "id": 232490, - "soa_id": 3, - "code_uid": "Code_44954", - "code": "C25185", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Laterality" - }, - { - "id": 232491, - "soa_id": 3, - "code_uid": "Code_44955", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232492, - "soa_id": 3, - "code_uid": "Code_44956", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232493, - "soa_id": 3, - "code_uid": "Code_44957", - "code": "C49669", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Pressure" - }, - { - "id": 232494, - "soa_id": 3, - "code_uid": "Code_44958", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232495, - "soa_id": 3, - "code_uid": "Code_44959", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Anatomic Site" - }, - { - "id": 232496, - "soa_id": 3, - "code_uid": "Code_44960", - "code": "C25185", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Laterality" - }, - { - "id": 232497, - "soa_id": 3, - "code_uid": "Code_44961", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232498, - "soa_id": 3, - "code_uid": "Code_44962", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232499, - "soa_id": 3, - "code_uid": "Code_44963", - "code": "C73688", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Count per Minute" - }, - { - "id": 232500, - "soa_id": 3, - "code_uid": "Code_44964", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232501, - "soa_id": 3, - "code_uid": "Code_44965", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Anatomic Site" - }, - { - "id": 232502, - "soa_id": 3, - "code_uid": "Code_44966", - "code": "C25185", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Laterality" - }, - { - "id": 232503, - "soa_id": 3, - "code_uid": "Code_44967", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232504, - "soa_id": 3, - "code_uid": "Code_44968", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232505, - "soa_id": 3, - "code_uid": "Code_44969", - "code": "C49669", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Pressure" - }, - { - "id": 232506, - "soa_id": 3, - "code_uid": "Code_44970", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232507, - "soa_id": 3, - "code_uid": "Code_44971", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Anatomic Site" - }, - { - "id": 232508, - "soa_id": 3, - "code_uid": "Code_44972", - "code": "C25185", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Laterality" - }, - { - "id": 232509, - "soa_id": 3, - "code_uid": "Code_44973", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232510, - "soa_id": 3, - "code_uid": "Code_44974", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232511, - "soa_id": 3, - "code_uid": "Code_44975", - "code": "C49669", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Pressure" - }, - { - "id": 232512, - "soa_id": 3, - "code_uid": "Code_44976", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232513, - "soa_id": 3, - "code_uid": "Code_44977", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Anatomic Site" - }, - { - "id": 232514, - "soa_id": 3, - "code_uid": "Code_44978", - "code": "C25185", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Laterality" - }, - { - "id": 232515, - "soa_id": 3, - "code_uid": "Code_44979", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232516, - "soa_id": 3, - "code_uid": "Code_44980", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232517, - "soa_id": 3, - "code_uid": "Code_44981", - "code": "C73688", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Count per Minute" - }, - { - "id": 232518, - "soa_id": 3, - "code_uid": "Code_44982", - "code": "C62164", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Body Position" - }, - { - "id": 232519, - "soa_id": 3, - "code_uid": "Code_44983", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Anatomic Site" - }, - { - "id": 232520, - "soa_id": 3, - "code_uid": "Code_44984", - "code": "C25185", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Laterality" - }, - { - "id": 232521, - "soa_id": 3, - "code_uid": "Code_44985", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232522, - "soa_id": 3, - "code_uid": "Code_44986", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Observation Result" - }, - { - "id": 232523, - "soa_id": 3, - "code_uid": "Code_44987", - "code": "C42579", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Unit of Mass" - }, - { - "id": 232524, - "soa_id": 3, - "code_uid": "Code_44988", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Anatomic Site" - }, - { - "id": 232525, - "soa_id": 3, - "code_uid": "Code_44989", - "code": "C25185", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Laterality" - }, - { - "id": 232526, - "soa_id": 3, - "code_uid": "Code_44990", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Test Method" - }, - { - "id": 232527, - "soa_id": 3, - "code_uid": "Code_44991", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Collection Date Time" - }, - { - "id": 232528, - "soa_id": 3, - "code_uid": "Code_44992", - "code": "C70856", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Observation Result" - }, - { - "id": 232529, - "soa_id": 3, - "code_uid": "Code_44993", - "code": "C42574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Unit of Time" - }, - { - "id": 232530, - "soa_id": 3, - "code_uid": "Code_44994", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Anatomic Site" - }, - { - "id": 232531, - "soa_id": 3, - "code_uid": "Code_44995", - "code": "C25185", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Laterality" - }, - { - "id": 232532, - "soa_id": 3, - "code_uid": "Code_44996", - "code": "C82535", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Test Method" - }, - { - "id": 232533, - "soa_id": 3, - "code_uid": "Code_44997", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Collection Date Time" - }, - { - "id": 232534, - "soa_id": 3, - "code_uid": "Code_44998", - "code": "C83445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter Code" - }, - { - "id": 232535, - "soa_id": 3, - "code_uid": "Code_44999", - "code": "C49691", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter" - }, - { - "id": 232536, - "soa_id": 3, - "code_uid": "Code_45000", - "code": "C83447", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter Value" - }, - { - "id": 232537, - "soa_id": 3, - "code_uid": "Code_45001", - "code": "C117458", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - }, - { - "id": 232538, - "soa_id": 3, - "code_uid": "Code_45002", - "code": "C117460", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - }, - { - "id": 232539, - "soa_id": 3, - "code_uid": "Code_45003", - "code": "C117461", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - }, - { - "id": 232540, - "soa_id": 3, - "code_uid": "Code_45004", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-23", - "decode": "Category" - }, - { - "id": 232541, - "soa_id": 3, - "code_uid": "Code_45005", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-23", - "decode": "Collection Date Time" - }, - { - "id": 232542, - "soa_id": 3, - "code_uid": "Code_45006", - "code": "C82525", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-09-23", - "decode": "Test Occurrence" - }, - { - "id": 232543, - "soa_id": 3, - "code_uid": "Code_45007", - "code": "C117511", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Reported Name of Procedure" - }, - { - "id": 232544, - "soa_id": 3, - "code_uid": "Code_45008", - "code": "C117512", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Standardized Name of Procedure" - }, - { - "id": 232545, - "soa_id": 3, - "code_uid": "Code_45009", - "code": "C171000", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Prespecified Event or Intervention Indicator" - }, - { - "id": 232546, - "soa_id": 3, - "code_uid": "Code_45010", - "code": "C127786", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Occurrence Indicator" - }, - { - "id": 232547, - "soa_id": 3, - "code_uid": "Code_45011", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Anatomic Site" - }, - { - "id": 232548, - "soa_id": 3, - "code_uid": "Code_45012", - "code": "C117529", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "Start Date and Time of Procedure" - }, - { - "id": 232549, - "soa_id": 3, - "code_uid": "Code_45013", - "code": "C117530", - "code_system": "http://www.cdisc.org", - "code_system_version": "2024-12-16", - "decode": "End Date and Time of Procedure" - }, - { - "id": 232550, - "soa_id": 3, - "code_uid": "Code_45014", - "code": "C117511", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Reported Name of Procedure" - }, - { - "id": 232551, - "soa_id": 3, - "code_uid": "Code_45015", - "code": "C117512", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Standardized Name of Procedure" - }, - { - "id": 232552, - "soa_id": 3, - "code_uid": "Code_45016", - "code": "C171000", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Prespecified Event or Intervention Indicator" - }, - { - "id": 232553, - "soa_id": 3, - "code_uid": "Code_45017", - "code": "C127786", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Occurrence Indicator" - }, - { - "id": 232554, - "soa_id": 3, - "code_uid": "Code_45018", - "code": "C13717", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Anatomic Site" - }, - { - "id": 232555, - "soa_id": 3, - "code_uid": "Code_45019", - "code": "C117529", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "Start Date and Time of Procedure" - }, - { - "id": 232556, - "soa_id": 3, - "code_uid": "Code_45020", - "code": "C117530", - "code_system": "http://www.cdisc.org", - "code_system_version": "2026-05-26", - "decode": "End Date and Time of Procedure" - }, - { - "id": 232557, - "soa_id": 3, - "code_uid": "Code_45021", - "code": "C83347", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Adverse Event Yes No Indicator" - }, - { - "id": 232558, - "soa_id": 3, - "code_uid": "Code_45022", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Collection Date Time" - }, - { - "id": 232559, - "soa_id": 3, - "code_uid": "Code_45023", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232560, - "soa_id": 3, - "code_uid": "Code_45024", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232561, - "soa_id": 3, - "code_uid": "Code_45025", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232562, - "soa_id": 3, - "code_uid": "Code_45026", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232563, - "soa_id": 3, - "code_uid": "Code_45027", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232564, - "soa_id": 3, - "code_uid": "Code_45028", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232565, - "soa_id": 3, - "code_uid": "Code_45029", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232566, - "soa_id": 3, - "code_uid": "Code_45030", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232567, - "soa_id": 3, - "code_uid": "Code_45031", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232568, - "soa_id": 3, - "code_uid": "Code_45032", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232569, - "soa_id": 3, - "code_uid": "Code_45033", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232570, - "soa_id": 3, - "code_uid": "Code_45034", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232571, - "soa_id": 3, - "code_uid": "Code_45035", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232572, - "soa_id": 3, - "code_uid": "Code_45036", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232573, - "soa_id": 3, - "code_uid": "Code_45037", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232574, - "soa_id": 3, - "code_uid": "Code_45038", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232575, - "soa_id": 3, - "code_uid": "Code_45039", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232576, - "soa_id": 3, - "code_uid": "Code_45040", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232577, - "soa_id": 3, - "code_uid": "Code_45041", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232578, - "soa_id": 3, - "code_uid": "Code_45042", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232579, - "soa_id": 3, - "code_uid": "Code_45043", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232580, - "soa_id": 3, - "code_uid": "Code_45044", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232581, - "soa_id": 3, - "code_uid": "Code_45045", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232582, - "soa_id": 3, - "code_uid": "Code_45046", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232583, - "soa_id": 3, - "code_uid": "Code_45047", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232584, - "soa_id": 3, - "code_uid": "Code_45048", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232585, - "soa_id": 3, - "code_uid": "Code_45049", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232586, - "soa_id": 3, - "code_uid": "Code_45050", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232587, - "soa_id": 3, - "code_uid": "Code_45051", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232588, - "soa_id": 3, - "code_uid": "Code_45052", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232589, - "soa_id": 3, - "code_uid": "Code_45053", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232590, - "soa_id": 3, - "code_uid": "Code_45054", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232591, - "soa_id": 3, - "code_uid": "Code_45055", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232592, - "soa_id": 3, - "code_uid": "Code_45056", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232593, - "soa_id": 3, - "code_uid": "Code_45057", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232594, - "soa_id": 3, - "code_uid": "Code_45058", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232595, - "soa_id": 3, - "code_uid": "Code_45059", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232596, - "soa_id": 3, - "code_uid": "Code_45060", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232597, - "soa_id": 3, - "code_uid": "Code_45061", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232598, - "soa_id": 3, - "code_uid": "Code_45062", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232599, - "soa_id": 3, - "code_uid": "Code_45063", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232600, - "soa_id": 3, - "code_uid": "Code_45064", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232601, - "soa_id": 3, - "code_uid": "Code_45065", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232602, - "soa_id": 3, - "code_uid": "Code_45066", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232603, - "soa_id": 3, - "code_uid": "Code_45067", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232604, - "soa_id": 3, - "code_uid": "Code_45068", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232605, - "soa_id": 3, - "code_uid": "Code_45069", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232606, - "soa_id": 3, - "code_uid": "Code_45070", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232607, - "soa_id": 3, - "code_uid": "Code_45071", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232608, - "soa_id": 3, - "code_uid": "Code_45072", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232609, - "soa_id": 3, - "code_uid": "Code_45073", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232610, - "soa_id": 3, - "code_uid": "Code_45074", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232611, - "soa_id": 3, - "code_uid": "Code_45075", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232612, - "soa_id": 3, - "code_uid": "Code_45076", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232613, - "soa_id": 3, - "code_uid": "Code_45077", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232614, - "soa_id": 3, - "code_uid": "Code_45078", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232615, - "soa_id": 3, - "code_uid": "Code_45079", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232616, - "soa_id": 3, - "code_uid": "Code_45080", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232617, - "soa_id": 3, - "code_uid": "Code_45081", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232618, - "soa_id": 3, - "code_uid": "Code_45082", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232619, - "soa_id": 3, - "code_uid": "Code_45083", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232620, - "soa_id": 3, - "code_uid": "Code_45084", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232621, - "soa_id": 3, - "code_uid": "Code_45085", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232622, - "soa_id": 3, - "code_uid": "Code_45086", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232623, - "soa_id": 3, - "code_uid": "Code_45087", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232624, - "soa_id": 3, - "code_uid": "Code_45088", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232625, - "soa_id": 3, - "code_uid": "Code_45089", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232626, - "soa_id": 3, - "code_uid": "Code_45090", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232627, - "soa_id": 3, - "code_uid": "Code_45091", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232628, - "soa_id": 3, - "code_uid": "Code_45092", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232629, - "soa_id": 3, - "code_uid": "Code_45093", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232630, - "soa_id": 3, - "code_uid": "Code_45094", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232631, - "soa_id": 3, - "code_uid": "Code_45095", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232632, - "soa_id": 3, - "code_uid": "Code_45096", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232633, - "soa_id": 3, - "code_uid": "Code_45097", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232634, - "soa_id": 3, - "code_uid": "Code_45098", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232635, - "soa_id": 3, - "code_uid": "Code_45099", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232636, - "soa_id": 3, - "code_uid": "Code_45100", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232637, - "soa_id": 3, - "code_uid": "Code_45101", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232638, - "soa_id": 3, - "code_uid": "Code_45102", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232639, - "soa_id": 3, - "code_uid": "Code_45103", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232640, - "soa_id": 3, - "code_uid": "Code_45104", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232641, - "soa_id": 3, - "code_uid": "Code_45105", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232642, - "soa_id": 3, - "code_uid": "Code_45106", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232643, - "soa_id": 3, - "code_uid": "Code_45107", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232644, - "soa_id": 3, - "code_uid": "Code_45108", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232645, - "soa_id": 3, - "code_uid": "Code_45109", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232646, - "soa_id": 3, - "code_uid": "Code_45110", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232647, - "soa_id": 3, - "code_uid": "Code_45111", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232648, - "soa_id": 3, - "code_uid": "Code_45112", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232649, - "soa_id": 3, - "code_uid": "Code_45113", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232650, - "soa_id": 3, - "code_uid": "Code_45114", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232651, - "soa_id": 3, - "code_uid": "Code_45115", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232652, - "soa_id": 3, - "code_uid": "Code_45116", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232653, - "soa_id": 3, - "code_uid": "Code_45117", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232654, - "soa_id": 3, - "code_uid": "Code_45118", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232655, - "soa_id": 3, - "code_uid": "Code_45119", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232656, - "soa_id": 3, - "code_uid": "Code_45120", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232657, - "soa_id": 3, - "code_uid": "Code_45121", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232658, - "soa_id": 3, - "code_uid": "Code_45122", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232659, - "soa_id": 3, - "code_uid": "Code_45123", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232660, - "soa_id": 3, - "code_uid": "Code_45124", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232661, - "soa_id": 3, - "code_uid": "Code_45125", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232662, - "soa_id": 3, - "code_uid": "Code_45126", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232663, - "soa_id": 3, - "code_uid": "Code_45127", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232664, - "soa_id": 3, - "code_uid": "Code_45128", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232665, - "soa_id": 3, - "code_uid": "Code_45129", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232666, - "soa_id": 3, - "code_uid": "Code_45130", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232667, - "soa_id": 3, - "code_uid": "Code_45131", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232668, - "soa_id": 3, - "code_uid": "Code_45132", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232669, - "soa_id": 3, - "code_uid": "Code_45133", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232670, - "soa_id": 3, - "code_uid": "Code_45134", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232671, - "soa_id": 3, - "code_uid": "Code_45135", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232672, - "soa_id": 3, - "code_uid": "Code_45136", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232673, - "soa_id": 3, - "code_uid": "Code_45137", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232674, - "soa_id": 3, - "code_uid": "Code_45138", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232675, - "soa_id": 3, - "code_uid": "Code_45139", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232676, - "soa_id": 3, - "code_uid": "Code_45140", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232677, - "soa_id": 3, - "code_uid": "Code_45141", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232678, - "soa_id": 3, - "code_uid": "Code_45142", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232679, - "soa_id": 3, - "code_uid": "Code_45143", - "code": "C46126", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Ordinal Position" - }, - { - "id": 232680, - "soa_id": 3, - "code_uid": "Code_45144", - "code": "C91106", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Clinical or Research Assessment Answer" - }, - { - "id": 232681, - "soa_id": 3, - "code_uid": "Code_45145", - "code": "C42574", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Unit of Time" - }, - { - "id": 232682, - "soa_id": 3, - "code_uid": "Code_45146", - "code": "C25372", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Category" - }, - { - "id": 232683, - "soa_id": 3, - "code_uid": "Code_45147", - "code": "C25692", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Subcategory" - }, - { - "id": 232684, - "soa_id": 3, - "code_uid": "Code_45148", - "code": "C41202", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Completion Status" - }, - { - "id": 232685, - "soa_id": 3, - "code_uid": "Code_45149", - "code": "C82556", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Not-Done Reason" - }, - { - "id": 232686, - "soa_id": 3, - "code_uid": "Code_45150", - "code": "C51824", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Evaluator" - }, - { - "id": 232687, - "soa_id": 3, - "code_uid": "Code_45151", - "code": "C82515", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-11-18", - "decode": "Collection Date Time" - }, - { - "id": 232688, - "soa_id": 3, - "code_uid": "Code_45152", - "code": "C83445", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter Code" - }, - { - "id": 232689, - "soa_id": 3, - "code_uid": "Code_45153", - "code": "C49691", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter" - }, - { - "id": 232690, - "soa_id": 3, - "code_uid": "Code_45154", - "code": "C83447", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter Value" - }, - { - "id": 232691, - "soa_id": 3, - "code_uid": "Code_45155", - "code": "C117458", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter Value Code" - }, - { - "id": 232692, - "soa_id": 3, - "code_uid": "Code_45156", - "code": "C117460", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter Name of the Reference Terminology" - }, - { - "id": 232693, - "soa_id": 3, - "code_uid": "Code_45157", - "code": "C117461", - "code_system": "http://www.cdisc.org", - "code_system_version": "2025-07-01", - "decode": "Trial Summary Parameter Version of the Reference Terminology" - } - ], - "alias_code": [ - { - "id": 520, - "soa_id": 3, - "alias_code_uid": "AliasCode_313", - "standard_code": "Code_503" - }, - { - "id": 541, - "soa_id": 3, - "alias_code_uid": "AliasCode_334", - "standard_code": "Code_524" - }, - { - "id": 570, - "soa_id": 3, - "alias_code_uid": "AliasCode_363", - "standard_code": "Code_553" - }, - { - "id": 659, - "soa_id": 3, - "alias_code_uid": "AliasCode_452", - "standard_code": "Code_642" - }, - { - "id": 757, - "soa_id": 3, - "alias_code_uid": "AliasCode_550", - "standard_code": "Code_740" - }, - { - "id": 767, - "soa_id": 3, - "alias_code_uid": "AliasCode_560", - "standard_code": "Code_750" - }, - { - "id": 797, - "soa_id": 3, - "alias_code_uid": "AliasCode_590", - "standard_code": "Code_780" - }, - { - "id": 807, - "soa_id": 3, - "alias_code_uid": "AliasCode_600", - "standard_code": "Code_790" - }, - { - "id": 855, - "soa_id": 3, - "alias_code_uid": "AliasCode_648", - "standard_code": "Code_838" - }, - { - "id": 869, - "soa_id": 3, - "alias_code_uid": "AliasCode_662", - "standard_code": "Code_852" - }, - { - "id": 883, - "soa_id": 3, - "alias_code_uid": "AliasCode_676", - "standard_code": "Code_866" - }, - { - "id": 897, - "soa_id": 3, - "alias_code_uid": "AliasCode_690", - "standard_code": "Code_880" - }, - { - "id": 911, - "soa_id": 3, - "alias_code_uid": "AliasCode_704", - "standard_code": "Code_894" - }, - { - "id": 924, - "soa_id": 3, - "alias_code_uid": "AliasCode_717", - "standard_code": "Code_907" - }, - { - "id": 937, - "soa_id": 3, - "alias_code_uid": "AliasCode_730", - "standard_code": "Code_920" - }, - { - "id": 951, - "soa_id": 3, - "alias_code_uid": "AliasCode_744", - "standard_code": "Code_934" - }, - { - "id": 961, - "soa_id": 3, - "alias_code_uid": "AliasCode_754", - "standard_code": "Code_944" - }, - { - "id": 971, - "soa_id": 3, - "alias_code_uid": "AliasCode_764", - "standard_code": "Code_954" - }, - { - "id": 981, - "soa_id": 3, - "alias_code_uid": "AliasCode_774", - "standard_code": "Code_964" - }, - { - "id": 993, - "soa_id": 3, - "alias_code_uid": "AliasCode_786", - "standard_code": "Code_976" - }, - { - "id": 1390, - "soa_id": 3, - "alias_code_uid": "AliasCode_1183", - "standard_code": "Code_1373" - }, - { - "id": 1521, - "soa_id": 3, - "alias_code_uid": "AliasCode_1314", - "standard_code": "Code_1504" - }, - { - "id": 1627, - "soa_id": 3, - "alias_code_uid": "AliasCode_1420", - "standard_code": "Code_1610" - }, - { - "id": 1689, - "soa_id": 3, - "alias_code_uid": "AliasCode_1482", - "standard_code": "Code_1672" - }, - { - "id": 1702, - "soa_id": 3, - "alias_code_uid": "AliasCode_1495", - "standard_code": "Code_1685" - }, - { - "id": 1715, - "soa_id": 3, - "alias_code_uid": "AliasCode_1508", - "standard_code": "Code_1698" - }, - { - "id": 1735, - "soa_id": 3, - "alias_code_uid": "AliasCode_1528", - "standard_code": "Code_1718" - }, - { - "id": 1736, - "soa_id": 3, - "alias_code_uid": "AliasCode_1529", - "standard_code": "Code_1719" - }, - { - "id": 1737, - "soa_id": 3, - "alias_code_uid": "AliasCode_1530", - "standard_code": "Code_1720" - }, - { - "id": 1738, - "soa_id": 3, - "alias_code_uid": "AliasCode_1531", - "standard_code": "Code_1721" - }, - { - "id": 1739, - "soa_id": 3, - "alias_code_uid": "AliasCode_1532", - "standard_code": "Code_1722" - }, - { - "id": 1858, - "soa_id": 3, - "alias_code_uid": "AliasCode_1651", - "standard_code": "Code_1841" - }, - { - "id": 1859, - "soa_id": 3, - "alias_code_uid": "AliasCode_1652", - "standard_code": "Code_1842" - }, - { - "id": 1900, - "soa_id": 3, - "alias_code_uid": "AliasCode_1693", - "standard_code": "Code_1883" - }, - { - "id": 1906, - "soa_id": 3, - "alias_code_uid": "AliasCode_1699", - "standard_code": "Code_1889" - }, - { - "id": 1912, - "soa_id": 3, - "alias_code_uid": "AliasCode_1705", - "standard_code": "Code_1895" - }, - { - "id": 1918, - "soa_id": 3, - "alias_code_uid": "AliasCode_1711", - "standard_code": "Code_1901" - }, - { - "id": 1924, - "soa_id": 3, - "alias_code_uid": "AliasCode_1717", - "standard_code": "Code_1907" - }, - { - "id": 1930, - "soa_id": 3, - "alias_code_uid": "AliasCode_1723", - "standard_code": "Code_1913" - }, - { - "id": 1936, - "soa_id": 3, - "alias_code_uid": "AliasCode_1729", - "standard_code": "Code_1919" - }, - { - "id": 1942, - "soa_id": 3, - "alias_code_uid": "AliasCode_1735", - "standard_code": "Code_1925" - }, - { - "id": 1948, - "soa_id": 3, - "alias_code_uid": "AliasCode_1741", - "standard_code": "Code_1931" - }, - { - "id": 1954, - "soa_id": 3, - "alias_code_uid": "AliasCode_1747", - "standard_code": "Code_1937" - }, - { - "id": 1960, - "soa_id": 3, - "alias_code_uid": "AliasCode_1753", - "standard_code": "Code_1943" - }, - { - "id": 1965, - "soa_id": 3, - "alias_code_uid": "AliasCode_1758", - "standard_code": "Code_1948" - }, - { - "id": 1966, - "soa_id": 3, - "alias_code_uid": "AliasCode_1759", - "standard_code": "Code_1949" - }, - { - "id": 1967, - "soa_id": 3, - "alias_code_uid": "AliasCode_1760", - "standard_code": "Code_1950" - }, - { - "id": 1968, - "soa_id": 3, - "alias_code_uid": "AliasCode_1761", - "standard_code": "Code_1951" - }, - { - "id": 1969, - "soa_id": 3, - "alias_code_uid": "AliasCode_1762", - "standard_code": "Code_1952" - }, - { - "id": 1975, - "soa_id": 3, - "alias_code_uid": "AliasCode_1768", - "standard_code": "Code_1958" - }, - { - "id": 1980, - "soa_id": 3, - "alias_code_uid": "AliasCode_1773", - "standard_code": "Code_1963" - }, - { - "id": 1992, - "soa_id": 3, - "alias_code_uid": "AliasCode_1785", - "standard_code": "Code_1975" - }, - { - "id": 2004, - "soa_id": 3, - "alias_code_uid": "AliasCode_1797", - "standard_code": "Code_1987" - }, - { - "id": 2016, - "soa_id": 3, - "alias_code_uid": "AliasCode_1809", - "standard_code": "Code_1999" - }, - { - "id": 2028, - "soa_id": 3, - "alias_code_uid": "AliasCode_1821", - "standard_code": "Code_2011" - }, - { - "id": 2040, - "soa_id": 3, - "alias_code_uid": "AliasCode_1833", - "standard_code": "Code_2023" - }, - { - "id": 2052, - "soa_id": 3, - "alias_code_uid": "AliasCode_1834", - "standard_code": "Code_2024" - }, - { - "id": 2064, - "soa_id": 3, - "alias_code_uid": "AliasCode_1846", - "standard_code": "Code_2036" - }, - { - "id": 2076, - "soa_id": 3, - "alias_code_uid": "AliasCode_1858", - "standard_code": "Code_2048" - }, - { - "id": 2934, - "soa_id": 3, - "alias_code_uid": "AliasCode_1874", - "standard_code": "Code_2064" - }, - { - "id": 2944, - "soa_id": 3, - "alias_code_uid": "AliasCode_1884", - "standard_code": "Code_2074" - }, - { - "id": 2959, - "soa_id": 3, - "alias_code_uid": "AliasCode_1899", - "standard_code": "Code_2089" - }, - { - "id": 2960, - "soa_id": 3, - "alias_code_uid": "AliasCode_1900", - "standard_code": "Code_2090" - }, - { - "id": 2961, - "soa_id": 3, - "alias_code_uid": "AliasCode_1901", - "standard_code": "Code_2091" - }, - { - "id": 2962, - "soa_id": 3, - "alias_code_uid": "AliasCode_1902", - "standard_code": "Code_2092" - }, - { - "id": 2963, - "soa_id": 3, - "alias_code_uid": "AliasCode_1903", - "standard_code": "Code_2093" - }, - { - "id": 2964, - "soa_id": 3, - "alias_code_uid": "AliasCode_1904", - "standard_code": "Code_2094" - }, - { - "id": 2965, - "soa_id": 3, - "alias_code_uid": "AliasCode_1905", - "standard_code": "Code_2095" - }, - { - "id": 2966, - "soa_id": 3, - "alias_code_uid": "AliasCode_1906", - "standard_code": "Code_2096" - }, - { - "id": 2967, - "soa_id": 3, - "alias_code_uid": "AliasCode_1907", - "standard_code": "Code_2097" - }, - { - "id": 2968, - "soa_id": 3, - "alias_code_uid": "AliasCode_1908", - "standard_code": "Code_2098" - }, - { - "id": 2969, - "soa_id": 3, - "alias_code_uid": "AliasCode_1909", - "standard_code": "Code_2099" - }, - { - "id": 2970, - "soa_id": 3, - "alias_code_uid": "AliasCode_1910", - "standard_code": "Code_2100" - }, - { - "id": 2971, - "soa_id": 3, - "alias_code_uid": "AliasCode_1911", - "standard_code": "Code_2101" - }, - { - "id": 2972, - "soa_id": 3, - "alias_code_uid": "AliasCode_1912", - "standard_code": "Code_2102" - }, - { - "id": 2973, - "soa_id": 3, - "alias_code_uid": "AliasCode_1913", - "standard_code": "Code_2103" - }, - { - "id": 2974, - "soa_id": 3, - "alias_code_uid": "AliasCode_1914", - "standard_code": "Code_2104" - }, - { - "id": 2975, - "soa_id": 3, - "alias_code_uid": "AliasCode_1915", - "standard_code": "Code_2105" - }, - { - "id": 2976, - "soa_id": 3, - "alias_code_uid": "AliasCode_1916", - "standard_code": "Code_2106" - }, - { - "id": 2977, - "soa_id": 3, - "alias_code_uid": "AliasCode_1917", - "standard_code": "Code_2107" - }, - { - "id": 2978, - "soa_id": 3, - "alias_code_uid": "AliasCode_1918", - "standard_code": "Code_2108" - }, - { - "id": 2979, - "soa_id": 3, - "alias_code_uid": "AliasCode_1919", - "standard_code": "Code_2109" - }, - { - "id": 2980, - "soa_id": 3, - "alias_code_uid": "AliasCode_1920", - "standard_code": "Code_2110" - }, - { - "id": 2981, - "soa_id": 3, - "alias_code_uid": "AliasCode_1921", - "standard_code": "Code_2111" - }, - { - "id": 2982, - "soa_id": 3, - "alias_code_uid": "AliasCode_1922", - "standard_code": "Code_2112" - }, - { - "id": 2983, - "soa_id": 3, - "alias_code_uid": "AliasCode_1923", - "standard_code": "Code_2113" - }, - { - "id": 2984, - "soa_id": 3, - "alias_code_uid": "AliasCode_1924", - "standard_code": "Code_2114" - }, - { - "id": 2985, - "soa_id": 3, - "alias_code_uid": "AliasCode_1925", - "standard_code": "Code_2115" - }, - { - "id": 2986, - "soa_id": 3, - "alias_code_uid": "AliasCode_1926", - "standard_code": "Code_2116" - }, - { - "id": 2987, - "soa_id": 3, - "alias_code_uid": "AliasCode_1927", - "standard_code": "Code_2117" - }, - { - "id": 2988, - "soa_id": 3, - "alias_code_uid": "AliasCode_1928", - "standard_code": "Code_2118" - }, - { - "id": 2989, - "soa_id": 3, - "alias_code_uid": "AliasCode_1929", - "standard_code": "Code_2119" - }, - { - "id": 2990, - "soa_id": 3, - "alias_code_uid": "AliasCode_1930", - "standard_code": "Code_2120" - }, - { - "id": 2991, - "soa_id": 3, - "alias_code_uid": "AliasCode_1931", - "standard_code": "Code_2121" - }, - { - "id": 2992, - "soa_id": 3, - "alias_code_uid": "AliasCode_1932", - "standard_code": "Code_2122" - }, - { - "id": 2993, - "soa_id": 3, - "alias_code_uid": "AliasCode_1933", - "standard_code": "Code_2123" - }, - { - "id": 2994, - "soa_id": 3, - "alias_code_uid": "AliasCode_1934", - "standard_code": "Code_2124" - }, - { - "id": 2995, - "soa_id": 3, - "alias_code_uid": "AliasCode_1935", - "standard_code": "Code_2125" - }, - { - "id": 2996, - "soa_id": 3, - "alias_code_uid": "AliasCode_1936", - "standard_code": "Code_2126" - }, - { - "id": 2997, - "soa_id": 3, - "alias_code_uid": "AliasCode_1937", - "standard_code": "Code_2127" - }, - { - "id": 2998, - "soa_id": 3, - "alias_code_uid": "AliasCode_1938", - "standard_code": "Code_2128" - }, - { - "id": 2999, - "soa_id": 3, - "alias_code_uid": "AliasCode_1939", - "standard_code": "Code_2129" - }, - { - "id": 3000, - "soa_id": 3, - "alias_code_uid": "AliasCode_1940", - "standard_code": "Code_2130" - }, - { - "id": 3001, - "soa_id": 3, - "alias_code_uid": "AliasCode_1941", - "standard_code": "Code_2131" - }, - { - "id": 3002, - "soa_id": 3, - "alias_code_uid": "AliasCode_1942", - "standard_code": "Code_2132" - }, - { - "id": 3003, - "soa_id": 3, - "alias_code_uid": "AliasCode_1943", - "standard_code": "Code_2133" - }, - { - "id": 3004, - "soa_id": 3, - "alias_code_uid": "AliasCode_1944", - "standard_code": "Code_2134" - }, - { - "id": 3005, - "soa_id": 3, - "alias_code_uid": "AliasCode_1945", - "standard_code": "Code_2135" - }, - { - "id": 3006, - "soa_id": 3, - "alias_code_uid": "AliasCode_1946", - "standard_code": "Code_2136" - }, - { - "id": 3007, - "soa_id": 3, - "alias_code_uid": "AliasCode_1947", - "standard_code": "Code_2137" - }, - { - "id": 3008, - "soa_id": 3, - "alias_code_uid": "AliasCode_1948", - "standard_code": "Code_2138" - }, - { - "id": 3009, - "soa_id": 3, - "alias_code_uid": "AliasCode_1949", - "standard_code": "Code_2139" - }, - { - "id": 3010, - "soa_id": 3, - "alias_code_uid": "AliasCode_1950", - "standard_code": "Code_2140" - }, - { - "id": 3011, - "soa_id": 3, - "alias_code_uid": "AliasCode_1951", - "standard_code": "Code_2141" - }, - { - "id": 3012, - "soa_id": 3, - "alias_code_uid": "AliasCode_1952", - "standard_code": "Code_2142" - }, - { - "id": 3013, - "soa_id": 3, - "alias_code_uid": "AliasCode_1953", - "standard_code": "Code_2143" - }, - { - "id": 3014, - "soa_id": 3, - "alias_code_uid": "AliasCode_1954", - "standard_code": "Code_2144" - }, - { - "id": 3015, - "soa_id": 3, - "alias_code_uid": "AliasCode_1955", - "standard_code": "Code_2145" - }, - { - "id": 3016, - "soa_id": 3, - "alias_code_uid": "AliasCode_1956", - "standard_code": "Code_2146" - }, - { - "id": 3017, - "soa_id": 3, - "alias_code_uid": "AliasCode_1957", - "standard_code": "Code_2147" - }, - { - "id": 3018, - "soa_id": 3, - "alias_code_uid": "AliasCode_1958", - "standard_code": "Code_2148" - }, - { - "id": 3019, - "soa_id": 3, - "alias_code_uid": "AliasCode_1959", - "standard_code": "Code_2149" - }, - { - "id": 3020, - "soa_id": 3, - "alias_code_uid": "AliasCode_1960", - "standard_code": "Code_2150" - }, - { - "id": 3021, - "soa_id": 3, - "alias_code_uid": "AliasCode_1961", - "standard_code": "Code_2151" - }, - { - "id": 3022, - "soa_id": 3, - "alias_code_uid": "AliasCode_1962", - "standard_code": "Code_2152" - }, - { - "id": 3023, - "soa_id": 3, - "alias_code_uid": "AliasCode_1963", - "standard_code": "Code_2153" - }, - { - "id": 3024, - "soa_id": 3, - "alias_code_uid": "AliasCode_1964", - "standard_code": "Code_2154" - }, - { - "id": 3025, - "soa_id": 3, - "alias_code_uid": "AliasCode_1965", - "standard_code": "Code_2155" - }, - { - "id": 3026, - "soa_id": 3, - "alias_code_uid": "AliasCode_1966", - "standard_code": "Code_2156" - }, - { - "id": 3027, - "soa_id": 3, - "alias_code_uid": "AliasCode_1967", - "standard_code": "Code_2157" - }, - { - "id": 3028, - "soa_id": 3, - "alias_code_uid": "AliasCode_1968", - "standard_code": "Code_2158" - }, - { - "id": 3029, - "soa_id": 3, - "alias_code_uid": "AliasCode_1969", - "standard_code": "Code_2159" - }, - { - "id": 3030, - "soa_id": 3, - "alias_code_uid": "AliasCode_1970", - "standard_code": "Code_2160" - }, - { - "id": 3031, - "soa_id": 3, - "alias_code_uid": "AliasCode_1971", - "standard_code": "Code_2161" - }, - { - "id": 3032, - "soa_id": 3, - "alias_code_uid": "AliasCode_1972", - "standard_code": "Code_2162" - }, - { - "id": 3033, - "soa_id": 3, - "alias_code_uid": "AliasCode_1973", - "standard_code": "Code_2163" - }, - { - "id": 3034, - "soa_id": 3, - "alias_code_uid": "AliasCode_1974", - "standard_code": "Code_2164" - }, - { - "id": 3035, - "soa_id": 3, - "alias_code_uid": "AliasCode_1975", - "standard_code": "Code_2165" - }, - { - "id": 3036, - "soa_id": 3, - "alias_code_uid": "AliasCode_1976", - "standard_code": "Code_2166" - }, - { - "id": 3037, - "soa_id": 3, - "alias_code_uid": "AliasCode_1977", - "standard_code": "Code_2167" - }, - { - "id": 3038, - "soa_id": 3, - "alias_code_uid": "AliasCode_1978", - "standard_code": "Code_2168" - }, - { - "id": 3039, - "soa_id": 3, - "alias_code_uid": "AliasCode_1979", - "standard_code": "Code_2169" - }, - { - "id": 3040, - "soa_id": 3, - "alias_code_uid": "AliasCode_1980", - "standard_code": "Code_2170" - }, - { - "id": 3041, - "soa_id": 3, - "alias_code_uid": "AliasCode_1981", - "standard_code": "Code_2171" - }, - { - "id": 3735, - "soa_id": 3, - "alias_code_uid": "AliasCode_2311", - "standard_code": "Code_2501" - }, - { - "id": 3768, - "soa_id": 3, - "alias_code_uid": "AliasCode_2312", - "standard_code": "Code_2502" - }, - { - "id": 3769, - "soa_id": 3, - "alias_code_uid": "AliasCode_2313", - "standard_code": "Code_2503" - }, - { - "id": 3770, - "soa_id": 3, - "alias_code_uid": "AliasCode_2314", - "standard_code": "Code_2504" - }, - { - "id": 3772, - "soa_id": 3, - "alias_code_uid": "AliasCode_2316", - "standard_code": "Code_2506" - }, - { - "id": 3773, - "soa_id": 3, - "alias_code_uid": "AliasCode_2317", - "standard_code": "Code_2507" - }, - { - "id": 20592, - "soa_id": 3, - "alias_code_uid": "AliasCode_2337", - "standard_code": "Code_2547" - }, - { - "id": 20614, - "soa_id": 3, - "alias_code_uid": "AliasCode_2359", - "standard_code": "Code_2569" - }, - { - "id": 20621, - "soa_id": 3, - "alias_code_uid": "AliasCode_2366", - "standard_code": "Code_2576" - }, - { - "id": 20895, - "soa_id": 3, - "alias_code_uid": "AliasCode_2640", - "standard_code": "Code_2850" - }, - { - "id": 20919, - "soa_id": 3, - "alias_code_uid": "AliasCode_2664", - "standard_code": "Code_2874" - }, - { - "id": 20935, - "soa_id": 3, - "alias_code_uid": "AliasCode_2680", - "standard_code": "Code_2890" - }, - { - "id": 20938, - "soa_id": 3, - "alias_code_uid": "AliasCode_2683", - "standard_code": "Code_2893" - }, - { - "id": 21406, - "soa_id": 3, - "alias_code_uid": "AliasCode_3151", - "standard_code": "Code_3361" - }, - { - "id": 21407, - "soa_id": 3, - "alias_code_uid": "AliasCode_3152", - "standard_code": "Code_3362" - }, - { - "id": 21408, - "soa_id": 3, - "alias_code_uid": "AliasCode_3153", - "standard_code": "Code_3363" - }, - { - "id": 21409, - "soa_id": 3, - "alias_code_uid": "AliasCode_3154", - "standard_code": "Code_3364" - }, - { - "id": 21410, - "soa_id": 3, - "alias_code_uid": "AliasCode_3155", - "standard_code": "Code_3365" - }, - { - "id": 21411, - "soa_id": 3, - "alias_code_uid": "AliasCode_3156", - "standard_code": "Code_3366" - }, - { - "id": 21412, - "soa_id": 3, - "alias_code_uid": "AliasCode_3157", - "standard_code": "Code_3367" - }, - { - "id": 21413, - "soa_id": 3, - "alias_code_uid": "AliasCode_3158", - "standard_code": "Code_3368" - }, - { - "id": 21414, - "soa_id": 3, - "alias_code_uid": "AliasCode_3159", - "standard_code": "Code_3369" - }, - { - "id": 21415, - "soa_id": 3, - "alias_code_uid": "AliasCode_3160", - "standard_code": "Code_3370" - }, - { - "id": 21416, - "soa_id": 3, - "alias_code_uid": "AliasCode_3161", - "standard_code": "Code_3371" - }, - { - "id": 21417, - "soa_id": 3, - "alias_code_uid": "AliasCode_3162", - "standard_code": "Code_3372" - }, - { - "id": 21418, - "soa_id": 3, - "alias_code_uid": "AliasCode_3163", - "standard_code": "Code_3373" - }, - { - "id": 21419, - "soa_id": 3, - "alias_code_uid": "AliasCode_3164", - "standard_code": "Code_3374" - }, - { - "id": 21420, - "soa_id": 3, - "alias_code_uid": "AliasCode_3165", - "standard_code": "Code_3375" - }, - { - "id": 21421, - "soa_id": 3, - "alias_code_uid": "AliasCode_3166", - "standard_code": "Code_3376" - }, - { - "id": 21422, - "soa_id": 3, - "alias_code_uid": "AliasCode_3167", - "standard_code": "Code_3377" - }, - { - "id": 21423, - "soa_id": 3, - "alias_code_uid": "AliasCode_3168", - "standard_code": "Code_3378" - }, - { - "id": 21424, - "soa_id": 3, - "alias_code_uid": "AliasCode_3169", - "standard_code": "Code_3379" - }, - { - "id": 21425, - "soa_id": 3, - "alias_code_uid": "AliasCode_3170", - "standard_code": "Code_3380" - }, - { - "id": 21426, - "soa_id": 3, - "alias_code_uid": "AliasCode_3171", - "standard_code": "Code_3381" - }, - { - "id": 21427, - "soa_id": 3, - "alias_code_uid": "AliasCode_3172", - "standard_code": "Code_3382" - }, - { - "id": 21428, - "soa_id": 3, - "alias_code_uid": "AliasCode_3173", - "standard_code": "Code_3383" - }, - { - "id": 21429, - "soa_id": 3, - "alias_code_uid": "AliasCode_3174", - "standard_code": "Code_3384" - }, - { - "id": 21430, - "soa_id": 3, - "alias_code_uid": "AliasCode_3175", - "standard_code": "Code_3385" - }, - { - "id": 21431, - "soa_id": 3, - "alias_code_uid": "AliasCode_3176", - "standard_code": "Code_3386" - }, - { - "id": 21432, - "soa_id": 3, - "alias_code_uid": "AliasCode_3177", - "standard_code": "Code_3387" - }, - { - "id": 21433, - "soa_id": 3, - "alias_code_uid": "AliasCode_3178", - "standard_code": "Code_3388" - }, - { - "id": 21434, - "soa_id": 3, - "alias_code_uid": "AliasCode_3179", - "standard_code": "Code_3389" - }, - { - "id": 21435, - "soa_id": 3, - "alias_code_uid": "AliasCode_3180", - "standard_code": "Code_3390" - }, - { - "id": 21436, - "soa_id": 3, - "alias_code_uid": "AliasCode_3181", - "standard_code": "Code_3391" - }, - { - "id": 21437, - "soa_id": 3, - "alias_code_uid": "AliasCode_3182", - "standard_code": "Code_3392" - }, - { - "id": 21438, - "soa_id": 3, - "alias_code_uid": "AliasCode_3183", - "standard_code": "Code_3393" - }, - { - "id": 21439, - "soa_id": 3, - "alias_code_uid": "AliasCode_3184", - "standard_code": "Code_3394" - }, - { - "id": 21440, - "soa_id": 3, - "alias_code_uid": "AliasCode_3185", - "standard_code": "Code_3395" - }, - { - "id": 21441, - "soa_id": 3, - "alias_code_uid": "AliasCode_3186", - "standard_code": "Code_3396" - }, - { - "id": 21442, - "soa_id": 3, - "alias_code_uid": "AliasCode_3187", - "standard_code": "Code_3397" - }, - { - "id": 21443, - "soa_id": 3, - "alias_code_uid": "AliasCode_3188", - "standard_code": "Code_3398" - }, - { - "id": 21444, - "soa_id": 3, - "alias_code_uid": "AliasCode_3189", - "standard_code": "Code_3399" - }, - { - "id": 21445, - "soa_id": 3, - "alias_code_uid": "AliasCode_3190", - "standard_code": "Code_3400" - }, - { - "id": 21446, - "soa_id": 3, - "alias_code_uid": "AliasCode_3191", - "standard_code": "Code_3401" - }, - { - "id": 21447, - "soa_id": 3, - "alias_code_uid": "AliasCode_3192", - "standard_code": "Code_3402" - }, - { - "id": 21448, - "soa_id": 3, - "alias_code_uid": "AliasCode_3193", - "standard_code": "Code_3403" - }, - { - "id": 21449, - "soa_id": 3, - "alias_code_uid": "AliasCode_3194", - "standard_code": "Code_3404" - }, - { - "id": 21450, - "soa_id": 3, - "alias_code_uid": "AliasCode_3195", - "standard_code": "Code_3405" - }, - { - "id": 21451, - "soa_id": 3, - "alias_code_uid": "AliasCode_3196", - "standard_code": "Code_3406" - }, - { - "id": 21452, - "soa_id": 3, - "alias_code_uid": "AliasCode_3197", - "standard_code": "Code_3407" - }, - { - "id": 21453, - "soa_id": 3, - "alias_code_uid": "AliasCode_3198", - "standard_code": "Code_3408" - }, - { - "id": 21454, - "soa_id": 3, - "alias_code_uid": "AliasCode_3199", - "standard_code": "Code_3409" - }, - { - "id": 21455, - "soa_id": 3, - "alias_code_uid": "AliasCode_3200", - "standard_code": "Code_3410" - }, - { - "id": 21456, - "soa_id": 3, - "alias_code_uid": "AliasCode_3201", - "standard_code": "Code_3411" - }, - { - "id": 21457, - "soa_id": 3, - "alias_code_uid": "AliasCode_3202", - "standard_code": "Code_3412" - }, - { - "id": 21458, - "soa_id": 3, - "alias_code_uid": "AliasCode_3203", - "standard_code": "Code_3413" - }, - { - "id": 25958, - "soa_id": 3, - "alias_code_uid": "AliasCode_3204", - "standard_code": "Code_3414" - }, - { - "id": 25959, - "soa_id": 3, - "alias_code_uid": "AliasCode_3205", - "standard_code": "Code_3415" - }, - { - "id": 25960, - "soa_id": 3, - "alias_code_uid": "AliasCode_3206", - "standard_code": "Code_3416" - }, - { - "id": 25961, - "soa_id": 3, - "alias_code_uid": "AliasCode_3207", - "standard_code": "Code_3417" - }, - { - "id": 25962, - "soa_id": 3, - "alias_code_uid": "AliasCode_3208", - "standard_code": "Code_3418" - }, - { - "id": 25963, - "soa_id": 3, - "alias_code_uid": "AliasCode_3209", - "standard_code": "Code_3419" - }, - { - "id": 25964, - "soa_id": 3, - "alias_code_uid": "AliasCode_3210", - "standard_code": "Code_3420" - }, - { - "id": 25965, - "soa_id": 3, - "alias_code_uid": "AliasCode_3211", - "standard_code": "Code_3421" - }, - { - "id": 25966, - "soa_id": 3, - "alias_code_uid": "AliasCode_3212", - "standard_code": "Code_3422" - }, - { - "id": 25967, - "soa_id": 3, - "alias_code_uid": "AliasCode_3213", - "standard_code": "Code_3423" - }, - { - "id": 25968, - "soa_id": 3, - "alias_code_uid": "AliasCode_3214", - "standard_code": "Code_3424" - }, - { - "id": 25969, - "soa_id": 3, - "alias_code_uid": "AliasCode_3215", - "standard_code": "Code_3425" - }, - { - "id": 25970, - "soa_id": 3, - "alias_code_uid": "AliasCode_3216", - "standard_code": "Code_3426" - }, - { - "id": 25971, - "soa_id": 3, - "alias_code_uid": "AliasCode_3217", - "standard_code": "Code_3427" - }, - { - "id": 25972, - "soa_id": 3, - "alias_code_uid": "AliasCode_3218", - "standard_code": "Code_3428" - }, - { - "id": 25973, - "soa_id": 3, - "alias_code_uid": "AliasCode_3219", - "standard_code": "Code_3429" - }, - { - "id": 30926, - "soa_id": 3, - "alias_code_uid": "AliasCode_3354", - "standard_code": "Code_3564" - }, - { - "id": 30927, - "soa_id": 3, - "alias_code_uid": "AliasCode_3355", - "standard_code": "Code_3565" - }, - { - "id": 30928, - "soa_id": 3, - "alias_code_uid": "AliasCode_3356", - "standard_code": "Code_3566" - }, - { - "id": 30929, - "soa_id": 3, - "alias_code_uid": "AliasCode_3357", - "standard_code": "Code_3567" - }, - { - "id": 38913, - "soa_id": 3, - "alias_code_uid": "AliasCode_5782", - "standard_code": "Code_5992" - }, - { - "id": 39813, - "soa_id": 3, - "alias_code_uid": "AliasCode_5947", - "standard_code": "Code_6157" - }, - { - "id": 39814, - "soa_id": 3, - "alias_code_uid": "AliasCode_5948", - "standard_code": "Code_6158" - }, - { - "id": 39815, - "soa_id": 3, - "alias_code_uid": "AliasCode_5949", - "standard_code": "Code_6159" - }, - { - "id": 39816, - "soa_id": 3, - "alias_code_uid": "AliasCode_5950", - "standard_code": "Code_6160" - }, - { - "id": 39817, - "soa_id": 3, - "alias_code_uid": "AliasCode_5951", - "standard_code": "Code_6161" - }, - { - "id": 40648, - "soa_id": 3, - "alias_code_uid": "AliasCode_6396", - "standard_code": "Code_6606" - }, - { - "id": 40649, - "soa_id": 3, - "alias_code_uid": "AliasCode_6397", - "standard_code": "Code_6607" - }, - { - "id": 40650, - "soa_id": 3, - "alias_code_uid": "AliasCode_6398", - "standard_code": "Code_6608" - }, - { - "id": 40652, - "soa_id": 3, - "alias_code_uid": "AliasCode_6400", - "standard_code": "Code_6610" - }, - { - "id": 40653, - "soa_id": 3, - "alias_code_uid": "AliasCode_6401", - "standard_code": "Code_6611" - }, - { - "id": 45165, - "soa_id": 3, - "alias_code_uid": "AliasCode_8737", - "standard_code": "Code_8947" - }, - { - "id": 48039, - "soa_id": 3, - "alias_code_uid": "AliasCode_9928", - "standard_code": "Code_10138" - }, - { - "id": 48948, - "soa_id": 3, - "alias_code_uid": "AliasCode_10833", - "standard_code": "Code_11043" - }, - { - "id": 48950, - "soa_id": 3, - "alias_code_uid": "AliasCode_10835", - "standard_code": "Code_11045" - }, - { - "id": 48960, - "soa_id": 3, - "alias_code_uid": "AliasCode_10845", - "standard_code": "Code_11055" - }, - { - "id": 53064, - "soa_id": 3, - "alias_code_uid": "AliasCode_12250", - "standard_code": "Code_12460" - }, - { - "id": 53068, - "soa_id": 3, - "alias_code_uid": "AliasCode_12254", - "standard_code": "Code_12465" - }, - { - "id": 74975, - "soa_id": 3, - "alias_code_uid": "AliasCode_13031", - "standard_code": "Code_13702" - }, - { - "id": 74976, - "soa_id": 3, - "alias_code_uid": "AliasCode_13032", - "standard_code": "Code_13703" - }, - { - "id": 74977, - "soa_id": 3, - "alias_code_uid": "AliasCode_13033", - "standard_code": "Code_13704" - }, - { - "id": 74978, - "soa_id": 3, - "alias_code_uid": "AliasCode_13034", - "standard_code": "Code_13705" - }, - { - "id": 74979, - "soa_id": 3, - "alias_code_uid": "AliasCode_13035", - "standard_code": "Code_13706" - }, - { - "id": 74980, - "soa_id": 3, - "alias_code_uid": "AliasCode_13036", - "standard_code": "Code_13707" - }, - { - "id": 75156, - "soa_id": 3, - "alias_code_uid": "AliasCode_13136", - "standard_code": "Code_13807" - }, - { - "id": 77610, - "soa_id": 3, - "alias_code_uid": "AliasCode_14063", - "standard_code": "Code_14734" - }, - { - "id": 80722, - "soa_id": 3, - "alias_code_uid": "AliasCode_14734", - "standard_code": "Code_15549" - }, - { - "id": 80723, - "soa_id": 3, - "alias_code_uid": "AliasCode_14735", - "standard_code": "Code_15550" - }, - { - "id": 80724, - "soa_id": 3, - "alias_code_uid": "AliasCode_14736", - "standard_code": "Code_15551" - }, - { - "id": 80725, - "soa_id": 3, - "alias_code_uid": "AliasCode_14737", - "standard_code": "Code_15552" - }, - { - "id": 80726, - "soa_id": 3, - "alias_code_uid": "AliasCode_14738", - "standard_code": "Code_15553" - }, - { - "id": 80727, - "soa_id": 3, - "alias_code_uid": "AliasCode_14739", - "standard_code": "Code_15554" - }, - { - "id": 80880, - "soa_id": 3, - "alias_code_uid": "AliasCode_14819", - "standard_code": "Code_15634" - }, - { - "id": 80881, - "soa_id": 3, - "alias_code_uid": "AliasCode_14820", - "standard_code": "Code_15635" - }, - { - "id": 80882, - "soa_id": 3, - "alias_code_uid": "AliasCode_14821", - "standard_code": "Code_15636" - }, - { - "id": 80883, - "soa_id": 3, - "alias_code_uid": "AliasCode_14822", - "standard_code": "Code_15637" - }, - { - "id": 80884, - "soa_id": 3, - "alias_code_uid": "AliasCode_14823", - "standard_code": "Code_15638" - }, - { - "id": 80885, - "soa_id": 3, - "alias_code_uid": "AliasCode_14824", - "standard_code": "Code_15639" - }, - { - "id": 81928, - "soa_id": 3, - "alias_code_uid": "AliasCode_15659", - "standard_code": "Code_16474" - }, - { - "id": 81929, - "soa_id": 3, - "alias_code_uid": "AliasCode_15660", - "standard_code": "Code_16475" - }, - { - "id": 81930, - "soa_id": 3, - "alias_code_uid": "AliasCode_15661", - "standard_code": "Code_16476" - }, - { - "id": 81931, - "soa_id": 3, - "alias_code_uid": "AliasCode_15662", - "standard_code": "Code_16477" - }, - { - "id": 81932, - "soa_id": 3, - "alias_code_uid": "AliasCode_15663", - "standard_code": "Code_16478" - }, - { - "id": 81938, - "soa_id": 3, - "alias_code_uid": "AliasCode_15669", - "standard_code": "Code_16484" - }, - { - "id": 81939, - "soa_id": 3, - "alias_code_uid": "AliasCode_15670", - "standard_code": "Code_16485" - }, - { - "id": 81940, - "soa_id": 3, - "alias_code_uid": "AliasCode_15671", - "standard_code": "Code_16486" - }, - { - "id": 81941, - "soa_id": 3, - "alias_code_uid": "AliasCode_15672", - "standard_code": "Code_16487" - }, - { - "id": 81942, - "soa_id": 3, - "alias_code_uid": "AliasCode_15673", - "standard_code": "Code_16488" - }, - { - "id": 81948, - "soa_id": 3, - "alias_code_uid": "AliasCode_15679", - "standard_code": "Code_16494" - }, - { - "id": 81949, - "soa_id": 3, - "alias_code_uid": "AliasCode_15680", - "standard_code": "Code_16495" - }, - { - "id": 81950, - "soa_id": 3, - "alias_code_uid": "AliasCode_15681", - "standard_code": "Code_16496" - }, - { - "id": 81951, - "soa_id": 3, - "alias_code_uid": "AliasCode_15682", - "standard_code": "Code_16497" - }, - { - "id": 81952, - "soa_id": 3, - "alias_code_uid": "AliasCode_15683", - "standard_code": "Code_16498" - }, - { - "id": 82142, - "soa_id": 3, - "alias_code_uid": "AliasCode_15781", - "standard_code": "Code_16596" - }, - { - "id": 82143, - "soa_id": 3, - "alias_code_uid": "AliasCode_15782", - "standard_code": "Code_16597" - }, - { - "id": 82144, - "soa_id": 3, - "alias_code_uid": "AliasCode_15783", - "standard_code": "Code_16598" - }, - { - "id": 82145, - "soa_id": 3, - "alias_code_uid": "AliasCode_15784", - "standard_code": "Code_16599" - }, - { - "id": 82146, - "soa_id": 3, - "alias_code_uid": "AliasCode_15785", - "standard_code": "Code_16600" - }, - { - "id": 82147, - "soa_id": 3, - "alias_code_uid": "AliasCode_15786", - "standard_code": "Code_16601" - }, - { - "id": 82148, - "soa_id": 3, - "alias_code_uid": "AliasCode_15787", - "standard_code": "Code_16602" - }, - { - "id": 82149, - "soa_id": 3, - "alias_code_uid": "AliasCode_15788", - "standard_code": "Code_16603" - }, - { - "id": 82150, - "soa_id": 3, - "alias_code_uid": "AliasCode_15789", - "standard_code": "Code_16604" - }, - { - "id": 85243, - "soa_id": 3, - "alias_code_uid": "AliasCode_17316", - "standard_code": "Code_18131" - }, - { - "id": 94326, - "soa_id": 3, - "alias_code_uid": "AliasCode_18050", - "standard_code": "Code_20515" - }, - { - "id": 94470, - "soa_id": 3, - "alias_code_uid": "AliasCode_18194", - "standard_code": "Code_20659" - }, - { - "id": 95429, - "soa_id": 3, - "alias_code_uid": "AliasCode_18829", - "standard_code": "Code_21294" - }, - { - "id": 96175, - "soa_id": 3, - "alias_code_uid": "AliasCode_19575", - "standard_code": "Code_22040" - }, - { - "id": 128522, - "soa_id": 3, - "alias_code_uid": "AliasCode_22387", - "standard_code": "Code_24852" - }, - { - "id": 128886, - "soa_id": 3, - "alias_code_uid": "AliasCode_22751", - "standard_code": "Code_25216" - }, - { - "id": 129088, - "soa_id": 3, - "alias_code_uid": "AliasCode_22949", - "standard_code": "Code_25414" - }, - { - "id": 148250, - "soa_id": 3, - "alias_code_uid": "AliasCode_24523", - "standard_code": "Code_28641" - }, - { - "id": 148251, - "soa_id": 3, - "alias_code_uid": "AliasCode_24524", - "standard_code": "Code_28642" - }, - { - "id": 148252, - "soa_id": 3, - "alias_code_uid": "AliasCode_24525", - "standard_code": "Code_28643" - }, - { - "id": 148253, - "soa_id": 3, - "alias_code_uid": "AliasCode_24526", - "standard_code": "Code_28644" - }, - { - "id": 148254, - "soa_id": 3, - "alias_code_uid": "AliasCode_24527", - "standard_code": "Code_28645" - }, - { - "id": 148255, - "soa_id": 3, - "alias_code_uid": "AliasCode_24528", - "standard_code": "Code_28646" - }, - { - "id": 148256, - "soa_id": 3, - "alias_code_uid": "AliasCode_24529", - "standard_code": "Code_28647" - }, - { - "id": 148257, - "soa_id": 3, - "alias_code_uid": "AliasCode_24530", - "standard_code": "Code_28648" - }, - { - "id": 148258, - "soa_id": 3, - "alias_code_uid": "AliasCode_24531", - "standard_code": "Code_28649" - }, - { - "id": 148259, - "soa_id": 3, - "alias_code_uid": "AliasCode_24532", - "standard_code": "Code_28650" - }, - { - "id": 148260, - "soa_id": 3, - "alias_code_uid": "AliasCode_24533", - "standard_code": "Code_28651" - }, - { - "id": 148261, - "soa_id": 3, - "alias_code_uid": "AliasCode_24534", - "standard_code": "Code_28652" - }, - { - "id": 148262, - "soa_id": 3, - "alias_code_uid": "AliasCode_24535", - "standard_code": "Code_28653" - }, - { - "id": 148263, - "soa_id": 3, - "alias_code_uid": "AliasCode_24536", - "standard_code": "Code_28654" - }, - { - "id": 148264, - "soa_id": 3, - "alias_code_uid": "AliasCode_24537", - "standard_code": "Code_28655" - }, - { - "id": 148265, - "soa_id": 3, - "alias_code_uid": "AliasCode_24538", - "standard_code": "Code_28656" - }, - { - "id": 148266, - "soa_id": 3, - "alias_code_uid": "AliasCode_24539", - "standard_code": "Code_28657" - }, - { - "id": 148267, - "soa_id": 3, - "alias_code_uid": "AliasCode_24540", - "standard_code": "Code_28658" - }, - { - "id": 148268, - "soa_id": 3, - "alias_code_uid": "AliasCode_24541", - "standard_code": "Code_28659" - }, - { - "id": 148269, - "soa_id": 3, - "alias_code_uid": "AliasCode_24542", - "standard_code": "Code_28660" - }, - { - "id": 148270, - "soa_id": 3, - "alias_code_uid": "AliasCode_24543", - "standard_code": "Code_28661" - }, - { - "id": 148271, - "soa_id": 3, - "alias_code_uid": "AliasCode_24544", - "standard_code": "Code_28662" - }, - { - "id": 148272, - "soa_id": 3, - "alias_code_uid": "AliasCode_24545", - "standard_code": "Code_28663" - }, - { - "id": 148273, - "soa_id": 3, - "alias_code_uid": "AliasCode_24546", - "standard_code": "Code_28664" - }, - { - "id": 148274, - "soa_id": 3, - "alias_code_uid": "AliasCode_24547", - "standard_code": "Code_28665" - }, - { - "id": 148275, - "soa_id": 3, - "alias_code_uid": "AliasCode_24548", - "standard_code": "Code_28666" - }, - { - "id": 148276, - "soa_id": 3, - "alias_code_uid": "AliasCode_24549", - "standard_code": "Code_28667" - }, - { - "id": 148277, - "soa_id": 3, - "alias_code_uid": "AliasCode_24550", - "standard_code": "Code_28668" - }, - { - "id": 148278, - "soa_id": 3, - "alias_code_uid": "AliasCode_24551", - "standard_code": "Code_28669" - }, - { - "id": 148279, - "soa_id": 3, - "alias_code_uid": "AliasCode_24552", - "standard_code": "Code_28670" - }, - { - "id": 148280, - "soa_id": 3, - "alias_code_uid": "AliasCode_24553", - "standard_code": "Code_28671" - }, - { - "id": 148281, - "soa_id": 3, - "alias_code_uid": "AliasCode_24554", - "standard_code": "Code_28672" - }, - { - "id": 148282, - "soa_id": 3, - "alias_code_uid": "AliasCode_24555", - "standard_code": "Code_28673" - }, - { - "id": 148283, - "soa_id": 3, - "alias_code_uid": "AliasCode_24556", - "standard_code": "Code_28674" - }, - { - "id": 148284, - "soa_id": 3, - "alias_code_uid": "AliasCode_24557", - "standard_code": "Code_28675" - }, - { - "id": 148285, - "soa_id": 3, - "alias_code_uid": "AliasCode_24558", - "standard_code": "Code_28676" - }, - { - "id": 148286, - "soa_id": 3, - "alias_code_uid": "AliasCode_24559", - "standard_code": "Code_28677" - }, - { - "id": 148287, - "soa_id": 3, - "alias_code_uid": "AliasCode_24560", - "standard_code": "Code_28678" - }, - { - "id": 148288, - "soa_id": 3, - "alias_code_uid": "AliasCode_24561", - "standard_code": "Code_28679" - }, - { - "id": 148289, - "soa_id": 3, - "alias_code_uid": "AliasCode_24562", - "standard_code": "Code_28680" - }, - { - "id": 148290, - "soa_id": 3, - "alias_code_uid": "AliasCode_24563", - "standard_code": "Code_28681" - }, - { - "id": 148291, - "soa_id": 3, - "alias_code_uid": "AliasCode_24564", - "standard_code": "Code_28682" - }, - { - "id": 148292, - "soa_id": 3, - "alias_code_uid": "AliasCode_24565", - "standard_code": "Code_28683" - }, - { - "id": 148293, - "soa_id": 3, - "alias_code_uid": "AliasCode_24566", - "standard_code": "Code_28684" - }, - { - "id": 148294, - "soa_id": 3, - "alias_code_uid": "AliasCode_24567", - "standard_code": "Code_28685" - }, - { - "id": 148295, - "soa_id": 3, - "alias_code_uid": "AliasCode_24568", - "standard_code": "Code_28686" - }, - { - "id": 148296, - "soa_id": 3, - "alias_code_uid": "AliasCode_24569", - "standard_code": "Code_28687" - }, - { - "id": 148297, - "soa_id": 3, - "alias_code_uid": "AliasCode_24570", - "standard_code": "Code_28688" - }, - { - "id": 148298, - "soa_id": 3, - "alias_code_uid": "AliasCode_24571", - "standard_code": "Code_28689" - }, - { - "id": 148299, - "soa_id": 3, - "alias_code_uid": "AliasCode_24572", - "standard_code": "Code_28690" - }, - { - "id": 148300, - "soa_id": 3, - "alias_code_uid": "AliasCode_24573", - "standard_code": "Code_28691" - }, - { - "id": 148301, - "soa_id": 3, - "alias_code_uid": "AliasCode_24574", - "standard_code": "Code_28692" - }, - { - "id": 148302, - "soa_id": 3, - "alias_code_uid": "AliasCode_24575", - "standard_code": "Code_28693" - }, - { - "id": 148303, - "soa_id": 3, - "alias_code_uid": "AliasCode_24576", - "standard_code": "Code_28694" - }, - { - "id": 148304, - "soa_id": 3, - "alias_code_uid": "AliasCode_24577", - "standard_code": "Code_28695" - }, - { - "id": 148305, - "soa_id": 3, - "alias_code_uid": "AliasCode_24578", - "standard_code": "Code_28696" - }, - { - "id": 148306, - "soa_id": 3, - "alias_code_uid": "AliasCode_24579", - "standard_code": "Code_28697" - }, - { - "id": 148307, - "soa_id": 3, - "alias_code_uid": "AliasCode_24580", - "standard_code": "Code_28698" - }, - { - "id": 148308, - "soa_id": 3, - "alias_code_uid": "AliasCode_24581", - "standard_code": "Code_28699" - }, - { - "id": 148309, - "soa_id": 3, - "alias_code_uid": "AliasCode_24582", - "standard_code": "Code_28700" - }, - { - "id": 148310, - "soa_id": 3, - "alias_code_uid": "AliasCode_24583", - "standard_code": "Code_28701" - }, - { - "id": 148311, - "soa_id": 3, - "alias_code_uid": "AliasCode_24584", - "standard_code": "Code_28702" - }, - { - "id": 148312, - "soa_id": 3, - "alias_code_uid": "AliasCode_24585", - "standard_code": "Code_28703" - }, - { - "id": 148313, - "soa_id": 3, - "alias_code_uid": "AliasCode_24586", - "standard_code": "Code_28704" - }, - { - "id": 148314, - "soa_id": 3, - "alias_code_uid": "AliasCode_24587", - "standard_code": "Code_28705" - }, - { - "id": 148315, - "soa_id": 3, - "alias_code_uid": "AliasCode_24588", - "standard_code": "Code_28706" - }, - { - "id": 148316, - "soa_id": 3, - "alias_code_uid": "AliasCode_24589", - "standard_code": "Code_28707" - }, - { - "id": 148317, - "soa_id": 3, - "alias_code_uid": "AliasCode_24590", - "standard_code": "Code_28708" - }, - { - "id": 148318, - "soa_id": 3, - "alias_code_uid": "AliasCode_24591", - "standard_code": "Code_28709" - }, - { - "id": 148319, - "soa_id": 3, - "alias_code_uid": "AliasCode_24592", - "standard_code": "Code_28710" - }, - { - "id": 148320, - "soa_id": 3, - "alias_code_uid": "AliasCode_24593", - "standard_code": "Code_28711" - }, - { - "id": 148321, - "soa_id": 3, - "alias_code_uid": "AliasCode_24594", - "standard_code": "Code_28712" - }, - { - "id": 148322, - "soa_id": 3, - "alias_code_uid": "AliasCode_24595", - "standard_code": "Code_28713" - }, - { - "id": 148323, - "soa_id": 3, - "alias_code_uid": "AliasCode_24596", - "standard_code": "Code_28714" - }, - { - "id": 148324, - "soa_id": 3, - "alias_code_uid": "AliasCode_24597", - "standard_code": "Code_28715" - }, - { - "id": 148325, - "soa_id": 3, - "alias_code_uid": "AliasCode_24598", - "standard_code": "Code_28716" - }, - { - "id": 148326, - "soa_id": 3, - "alias_code_uid": "AliasCode_24599", - "standard_code": "Code_28717" - }, - { - "id": 148327, - "soa_id": 3, - "alias_code_uid": "AliasCode_24600", - "standard_code": "Code_28718" - }, - { - "id": 148328, - "soa_id": 3, - "alias_code_uid": "AliasCode_24601", - "standard_code": "Code_28719" - }, - { - "id": 148329, - "soa_id": 3, - "alias_code_uid": "AliasCode_24602", - "standard_code": "Code_28720" - }, - { - "id": 148330, - "soa_id": 3, - "alias_code_uid": "AliasCode_24603", - "standard_code": "Code_28721" - }, - { - "id": 148331, - "soa_id": 3, - "alias_code_uid": "AliasCode_24604", - "standard_code": "Code_28722" - }, - { - "id": 148332, - "soa_id": 3, - "alias_code_uid": "AliasCode_24605", - "standard_code": "Code_28723" - }, - { - "id": 148333, - "soa_id": 3, - "alias_code_uid": "AliasCode_24606", - "standard_code": "Code_28724" - }, - { - "id": 148334, - "soa_id": 3, - "alias_code_uid": "AliasCode_24607", - "standard_code": "Code_28725" - }, - { - "id": 148335, - "soa_id": 3, - "alias_code_uid": "AliasCode_24608", - "standard_code": "Code_28726" - }, - { - "id": 148336, - "soa_id": 3, - "alias_code_uid": "AliasCode_24609", - "standard_code": "Code_28727" - }, - { - "id": 148337, - "soa_id": 3, - "alias_code_uid": "AliasCode_24610", - "standard_code": "Code_28728" - }, - { - "id": 148338, - "soa_id": 3, - "alias_code_uid": "AliasCode_24611", - "standard_code": "Code_28729" - }, - { - "id": 148339, - "soa_id": 3, - "alias_code_uid": "AliasCode_24612", - "standard_code": "Code_28730" - }, - { - "id": 148340, - "soa_id": 3, - "alias_code_uid": "AliasCode_24613", - "standard_code": "Code_28731" - }, - { - "id": 148341, - "soa_id": 3, - "alias_code_uid": "AliasCode_24614", - "standard_code": "Code_28732" - }, - { - "id": 148342, - "soa_id": 3, - "alias_code_uid": "AliasCode_24615", - "standard_code": "Code_28733" - }, - { - "id": 148343, - "soa_id": 3, - "alias_code_uid": "AliasCode_24616", - "standard_code": "Code_28734" - }, - { - "id": 148344, - "soa_id": 3, - "alias_code_uid": "AliasCode_24617", - "standard_code": "Code_28735" - }, - { - "id": 148345, - "soa_id": 3, - "alias_code_uid": "AliasCode_24618", - "standard_code": "Code_28736" - }, - { - "id": 148346, - "soa_id": 3, - "alias_code_uid": "AliasCode_24619", - "standard_code": "Code_28737" - }, - { - "id": 148371, - "soa_id": 3, - "alias_code_uid": "AliasCode_24620", - "standard_code": "Code_28738" - }, - { - "id": 148372, - "soa_id": 3, - "alias_code_uid": "AliasCode_24621", - "standard_code": "Code_28739" - }, - { - "id": 148373, - "soa_id": 3, - "alias_code_uid": "AliasCode_24622", - "standard_code": "Code_28740" - }, - { - "id": 148374, - "soa_id": 3, - "alias_code_uid": "AliasCode_24623", - "standard_code": "Code_28741" - }, - { - "id": 148375, - "soa_id": 3, - "alias_code_uid": "AliasCode_24624", - "standard_code": "Code_28742" - }, - { - "id": 148376, - "soa_id": 3, - "alias_code_uid": "AliasCode_24625", - "standard_code": "Code_28743" - }, - { - "id": 148377, - "soa_id": 3, - "alias_code_uid": "AliasCode_24626", - "standard_code": "Code_28744" - }, - { - "id": 148378, - "soa_id": 3, - "alias_code_uid": "AliasCode_24627", - "standard_code": "Code_28745" - }, - { - "id": 148379, - "soa_id": 3, - "alias_code_uid": "AliasCode_24628", - "standard_code": "Code_28746" - }, - { - "id": 148380, - "soa_id": 3, - "alias_code_uid": "AliasCode_24629", - "standard_code": "Code_28747" - }, - { - "id": 148381, - "soa_id": 3, - "alias_code_uid": "AliasCode_24630", - "standard_code": "Code_28748" - }, - { - "id": 148382, - "soa_id": 3, - "alias_code_uid": "AliasCode_24631", - "standard_code": "Code_28749" - }, - { - "id": 148383, - "soa_id": 3, - "alias_code_uid": "AliasCode_24632", - "standard_code": "Code_28750" - }, - { - "id": 148384, - "soa_id": 3, - "alias_code_uid": "AliasCode_24633", - "standard_code": "Code_28751" - }, - { - "id": 151558, - "soa_id": 3, - "alias_code_uid": "AliasCode_24833", - "standard_code": "Code_28951" - }, - { - "id": 151861, - "soa_id": 3, - "alias_code_uid": "AliasCode_25136", - "standard_code": "Code_29254" - }, - { - "id": 151996, - "soa_id": 3, - "alias_code_uid": "AliasCode_25271", - "standard_code": "Code_29389" - }, - { - "id": 152435, - "soa_id": 3, - "alias_code_uid": "AliasCode_25710", - "standard_code": "Code_29828" - }, - { - "id": 152585, - "soa_id": 3, - "alias_code_uid": "AliasCode_25860", - "standard_code": "Code_29978" - }, - { - "id": 152622, - "soa_id": 3, - "alias_code_uid": "AliasCode_25897", - "standard_code": "Code_30015" - }, - { - "id": 152694, - "soa_id": 3, - "alias_code_uid": "AliasCode_25969", - "standard_code": "Code_30087" - }, - { - "id": 152698, - "soa_id": 3, - "alias_code_uid": "AliasCode_25973", - "standard_code": "Code_30091" - }, - { - "id": 152930, - "soa_id": 3, - "alias_code_uid": "AliasCode_26201", - "standard_code": "Code_30319" - }, - { - "id": 152934, - "soa_id": 3, - "alias_code_uid": "AliasCode_26205", - "standard_code": "Code_30323" - }, - { - "id": 152947, - "soa_id": 3, - "alias_code_uid": "AliasCode_26218", - "standard_code": "Code_30336" - }, - { - "id": 154205, - "soa_id": 3, - "alias_code_uid": "AliasCode_26219", - "standard_code": "Code_30337" - }, - { - "id": 154545, - "soa_id": 3, - "alias_code_uid": "AliasCode_26417", - "standard_code": "Code_30535" - }, - { - "id": 154546, - "soa_id": 3, - "alias_code_uid": "AliasCode_26418", - "standard_code": "Code_30536" - }, - { - "id": 154547, - "soa_id": 3, - "alias_code_uid": "AliasCode_26419", - "standard_code": "Code_30537" - }, - { - "id": 154548, - "soa_id": 3, - "alias_code_uid": "AliasCode_26420", - "standard_code": "Code_30538" - }, - { - "id": 154549, - "soa_id": 3, - "alias_code_uid": "AliasCode_26421", - "standard_code": "Code_30539" - }, - { - "id": 154555, - "soa_id": 3, - "alias_code_uid": "AliasCode_26427", - "standard_code": "Code_30545" - }, - { - "id": 154556, - "soa_id": 3, - "alias_code_uid": "AliasCode_26428", - "standard_code": "Code_30546" - }, - { - "id": 154557, - "soa_id": 3, - "alias_code_uid": "AliasCode_26429", - "standard_code": "Code_30547" - }, - { - "id": 154558, - "soa_id": 3, - "alias_code_uid": "AliasCode_26430", - "standard_code": "Code_30548" - }, - { - "id": 154559, - "soa_id": 3, - "alias_code_uid": "AliasCode_26431", - "standard_code": "Code_30549" - }, - { - "id": 155177, - "soa_id": 3, - "alias_code_uid": "AliasCode_26767", - "standard_code": "Code_30885" - }, - { - "id": 155178, - "soa_id": 3, - "alias_code_uid": "AliasCode_26768", - "standard_code": "Code_30886" - }, - { - "id": 155179, - "soa_id": 3, - "alias_code_uid": "AliasCode_26769", - "standard_code": "Code_30887" - }, - { - "id": 155180, - "soa_id": 3, - "alias_code_uid": "AliasCode_26770", - "standard_code": "Code_30888" - }, - { - "id": 155181, - "soa_id": 3, - "alias_code_uid": "AliasCode_26771", - "standard_code": "Code_30889" - }, - { - "id": 155182, - "soa_id": 3, - "alias_code_uid": "AliasCode_26772", - "standard_code": "Code_30890" - }, - { - "id": 155189, - "soa_id": 3, - "alias_code_uid": "AliasCode_26779", - "standard_code": "Code_30897" - }, - { - "id": 155190, - "soa_id": 3, - "alias_code_uid": "AliasCode_26780", - "standard_code": "Code_30898" - }, - { - "id": 155191, - "soa_id": 3, - "alias_code_uid": "AliasCode_26781", - "standard_code": "Code_30899" - }, - { - "id": 155192, - "soa_id": 3, - "alias_code_uid": "AliasCode_26782", - "standard_code": "Code_30900" - }, - { - "id": 155193, - "soa_id": 3, - "alias_code_uid": "AliasCode_26783", - "standard_code": "Code_30901" - }, - { - "id": 155194, - "soa_id": 3, - "alias_code_uid": "AliasCode_26784", - "standard_code": "Code_30902" - }, - { - "id": 155195, - "soa_id": 3, - "alias_code_uid": "AliasCode_26785", - "standard_code": "Code_30903" - }, - { - "id": 155230, - "soa_id": 3, - "alias_code_uid": "AliasCode_26814", - "standard_code": "Code_30932" - }, - { - "id": 155376, - "soa_id": 3, - "alias_code_uid": "AliasCode_26930", - "standard_code": "Code_31048" - }, - { - "id": 155659, - "soa_id": 3, - "alias_code_uid": "AliasCode_27121", - "standard_code": "Code_31239" - }, - { - "id": 155680, - "soa_id": 3, - "alias_code_uid": "AliasCode_27142", - "standard_code": "Code_31260" - }, - { - "id": 157241, - "soa_id": 3, - "alias_code_uid": "AliasCode_27242", - "standard_code": "Code_31360" - }, - { - "id": 157242, - "soa_id": 3, - "alias_code_uid": "AliasCode_27243", - "standard_code": "Code_31361" - }, - { - "id": 157243, - "soa_id": 3, - "alias_code_uid": "AliasCode_27244", - "standard_code": "Code_31362" - }, - { - "id": 157244, - "soa_id": 3, - "alias_code_uid": "AliasCode_27245", - "standard_code": "Code_31363" - }, - { - "id": 157803, - "soa_id": 3, - "alias_code_uid": "AliasCode_27804", - "standard_code": "Code_31922" - }, - { - "id": 157817, - "soa_id": 3, - "alias_code_uid": "AliasCode_27818", - "standard_code": "Code_31936" - }, - { - "id": 157823, - "soa_id": 3, - "alias_code_uid": "AliasCode_27824", - "standard_code": "Code_31942" - }, - { - "id": 158016, - "soa_id": 3, - "alias_code_uid": "AliasCode_28017", - "standard_code": "Code_32135" - }, - { - "id": 160663, - "soa_id": 3, - "alias_code_uid": "AliasCode_28244", - "standard_code": "Code_32362" - }, - { - "id": 160979, - "soa_id": 3, - "alias_code_uid": "AliasCode_28426", - "standard_code": "Code_32544" - }, - { - "id": 161047, - "soa_id": 3, - "alias_code_uid": "AliasCode_28462", - "standard_code": "Code_32580" - }, - { - "id": 161083, - "soa_id": 3, - "alias_code_uid": "AliasCode_28479", - "standard_code": "Code_32597" - }, - { - "id": 161085, - "soa_id": 3, - "alias_code_uid": "AliasCode_28481", - "standard_code": "Code_32599" - }, - { - "id": 161096, - "soa_id": 3, - "alias_code_uid": "AliasCode_28487", - "standard_code": "Code_32605" - }, - { - "id": 161162, - "soa_id": 3, - "alias_code_uid": "AliasCode_28520", - "standard_code": "Code_32638" - }, - { - "id": 161185, - "soa_id": 3, - "alias_code_uid": "AliasCode_28532", - "standard_code": "Code_32650" - }, - { - "id": 161204, - "soa_id": 3, - "alias_code_uid": "AliasCode_28542", - "standard_code": "Code_32660" - }, - { - "id": 161214, - "soa_id": 3, - "alias_code_uid": "AliasCode_28547", - "standard_code": "Code_32665" - }, - { - "id": 161227, - "soa_id": 3, - "alias_code_uid": "AliasCode_28555", - "standard_code": "Code_32673" - }, - { - "id": 161228, - "soa_id": 3, - "alias_code_uid": "AliasCode_28556", - "standard_code": "Code_32674" - }, - { - "id": 161229, - "soa_id": 3, - "alias_code_uid": "AliasCode_28557", - "standard_code": "Code_32675" - }, - { - "id": 161230, - "soa_id": 3, - "alias_code_uid": "AliasCode_28558", - "standard_code": "Code_32676" - }, - { - "id": 161231, - "soa_id": 3, - "alias_code_uid": "AliasCode_28559", - "standard_code": "Code_32677" - }, - { - "id": 161249, - "soa_id": 3, - "alias_code_uid": "AliasCode_28571", - "standard_code": "Code_32689" - }, - { - "id": 161250, - "soa_id": 3, - "alias_code_uid": "AliasCode_28572", - "standard_code": "Code_32690" - }, - { - "id": 161251, - "soa_id": 3, - "alias_code_uid": "AliasCode_28573", - "standard_code": "Code_32691" - }, - { - "id": 161252, - "soa_id": 3, - "alias_code_uid": "AliasCode_28574", - "standard_code": "Code_32692" - }, - { - "id": 161253, - "soa_id": 3, - "alias_code_uid": "AliasCode_28575", - "standard_code": "Code_32693" - }, - { - "id": 161254, - "soa_id": 3, - "alias_code_uid": "AliasCode_28576", - "standard_code": "Code_32694" - }, - { - "id": 161261, - "soa_id": 3, - "alias_code_uid": "AliasCode_28583", - "standard_code": "Code_32701" - }, - { - "id": 161262, - "soa_id": 3, - "alias_code_uid": "AliasCode_28584", - "standard_code": "Code_32702" - }, - { - "id": 161263, - "soa_id": 3, - "alias_code_uid": "AliasCode_28585", - "standard_code": "Code_32703" - }, - { - "id": 161264, - "soa_id": 3, - "alias_code_uid": "AliasCode_28586", - "standard_code": "Code_32704" - }, - { - "id": 161265, - "soa_id": 3, - "alias_code_uid": "AliasCode_28587", - "standard_code": "Code_32705" - }, - { - "id": 161266, - "soa_id": 3, - "alias_code_uid": "AliasCode_28588", - "standard_code": "Code_32706" - }, - { - "id": 161466, - "soa_id": 3, - "alias_code_uid": "AliasCode_28692", - "standard_code": "Code_32810" - }, - { - "id": 161467, - "soa_id": 3, - "alias_code_uid": "AliasCode_28693", - "standard_code": "Code_32811" - }, - { - "id": 161468, - "soa_id": 3, - "alias_code_uid": "AliasCode_28694", - "standard_code": "Code_32812" - }, - { - "id": 161469, - "soa_id": 3, - "alias_code_uid": "AliasCode_28695", - "standard_code": "Code_32813" - }, - { - "id": 161470, - "soa_id": 3, - "alias_code_uid": "AliasCode_28696", - "standard_code": "Code_32814" - }, - { - "id": 161471, - "soa_id": 3, - "alias_code_uid": "AliasCode_28697", - "standard_code": "Code_32815" - }, - { - "id": 161509, - "soa_id": 3, - "alias_code_uid": "AliasCode_28718", - "standard_code": "Code_32836" - }, - { - "id": 161627, - "soa_id": 3, - "alias_code_uid": "AliasCode_28806", - "standard_code": "Code_32924" - }, - { - "id": 161746, - "soa_id": 3, - "alias_code_uid": "AliasCode_28925", - "standard_code": "Code_33043" - }, - { - "id": 161899, - "soa_id": 3, - "alias_code_uid": "AliasCode_29074", - "standard_code": "Code_33192" - }, - { - "id": 161906, - "soa_id": 3, - "alias_code_uid": "AliasCode_29081", - "standard_code": "Code_33199" - }, - { - "id": 163875, - "soa_id": 3, - "alias_code_uid": "AliasCode_29205", - "standard_code": "Code_33323" - }, - { - "id": 164504, - "soa_id": 3, - "alias_code_uid": "AliasCode_29819", - "standard_code": "Code_33937" - }, - { - "id": 164543, - "soa_id": 3, - "alias_code_uid": "AliasCode_29858", - "standard_code": "Code_33976" - }, - { - "id": 164622, - "soa_id": 3, - "alias_code_uid": "AliasCode_29937", - "standard_code": "Code_34055" - }, - { - "id": 164628, - "soa_id": 3, - "alias_code_uid": "AliasCode_29943", - "standard_code": "Code_34061" - }, - { - "id": 164646, - "soa_id": 3, - "alias_code_uid": "AliasCode_29961", - "standard_code": "Code_34079" - }, - { - "id": 164664, - "soa_id": 3, - "alias_code_uid": "AliasCode_29979", - "standard_code": "Code_34097" - }, - { - "id": 164722, - "soa_id": 3, - "alias_code_uid": "AliasCode_30037", - "standard_code": "Code_34155" - }, - { - "id": 164876, - "soa_id": 3, - "alias_code_uid": "AliasCode_30191", - "standard_code": "Code_34309" - }, - { - "id": 164922, - "soa_id": 3, - "alias_code_uid": "AliasCode_30237", - "standard_code": "Code_34355" - }, - { - "id": 164924, - "soa_id": 3, - "alias_code_uid": "AliasCode_30239", - "standard_code": "Code_34357" - }, - { - "id": 177096, - "soa_id": 3, - "alias_code_uid": "AliasCode_30645", - "standard_code": "Code_36028" - }, - { - "id": 194801, - "soa_id": 3, - "alias_code_uid": "AliasCode_30906", - "standard_code": "Code_37230" - }, - { - "id": 195101, - "soa_id": 3, - "alias_code_uid": "AliasCode_31133", - "standard_code": "Code_37457" - }, - { - "id": 195105, - "soa_id": 3, - "alias_code_uid": "AliasCode_31137", - "standard_code": "Code_37461" - }, - { - "id": 195190, - "soa_id": 3, - "alias_code_uid": "AliasCode_31210", - "standard_code": "Code_37534" - }, - { - "id": 195214, - "soa_id": 3, - "alias_code_uid": "AliasCode_31221", - "standard_code": "Code_37545" - }, - { - "id": 195216, - "soa_id": 3, - "alias_code_uid": "AliasCode_31223", - "standard_code": "Code_37547" - }, - { - "id": 195282, - "soa_id": 3, - "alias_code_uid": "AliasCode_31256", - "standard_code": "Code_37580" - }, - { - "id": 195306, - "soa_id": 3, - "alias_code_uid": "AliasCode_31268", - "standard_code": "Code_37592" - }, - { - "id": 195328, - "soa_id": 3, - "alias_code_uid": "AliasCode_31279", - "standard_code": "Code_37603" - }, - { - "id": 195338, - "soa_id": 3, - "alias_code_uid": "AliasCode_31284", - "standard_code": "Code_37608" - }, - { - "id": 195348, - "soa_id": 3, - "alias_code_uid": "AliasCode_31289", - "standard_code": "Code_37613" - }, - { - "id": 195358, - "soa_id": 3, - "alias_code_uid": "AliasCode_31294", - "standard_code": "Code_37618" - }, - { - "id": 195392, - "soa_id": 3, - "alias_code_uid": "AliasCode_31311", - "standard_code": "Code_37635" - }, - { - "id": 195440, - "soa_id": 3, - "alias_code_uid": "AliasCode_31353", - "standard_code": "Code_37677" - }, - { - "id": 195488, - "soa_id": 3, - "alias_code_uid": "AliasCode_31401", - "standard_code": "Code_37725" - }, - { - "id": 195512, - "soa_id": 3, - "alias_code_uid": "AliasCode_31413", - "standard_code": "Code_37737" - }, - { - "id": 195536, - "soa_id": 3, - "alias_code_uid": "AliasCode_31425", - "standard_code": "Code_37749" - }, - { - "id": 195539, - "soa_id": 3, - "alias_code_uid": "AliasCode_31428", - "standard_code": "Code_37752" - }, - { - "id": 195540, - "soa_id": 3, - "alias_code_uid": "AliasCode_31429", - "standard_code": "Code_37753" - }, - { - "id": 195541, - "soa_id": 3, - "alias_code_uid": "AliasCode_31430", - "standard_code": "Code_37754" - }, - { - "id": 195542, - "soa_id": 3, - "alias_code_uid": "AliasCode_31431", - "standard_code": "Code_37755" - }, - { - "id": 195543, - "soa_id": 3, - "alias_code_uid": "AliasCode_31432", - "standard_code": "Code_37756" - }, - { - "id": 195544, - "soa_id": 3, - "alias_code_uid": "AliasCode_31433", - "standard_code": "Code_37757" - }, - { - "id": 195561, - "soa_id": 3, - "alias_code_uid": "AliasCode_31443", - "standard_code": "Code_37767" - }, - { - "id": 195574, - "soa_id": 3, - "alias_code_uid": "AliasCode_31450", - "standard_code": "Code_37774" - }, - { - "id": 195598, - "soa_id": 3, - "alias_code_uid": "AliasCode_31462", - "standard_code": "Code_37786" - }, - { - "id": 195610, - "soa_id": 3, - "alias_code_uid": "AliasCode_31468", - "standard_code": "Code_37792" - }, - { - "id": 195632, - "soa_id": 3, - "alias_code_uid": "AliasCode_31479", - "standard_code": "Code_37803" - }, - { - "id": 195656, - "soa_id": 3, - "alias_code_uid": "AliasCode_31491", - "standard_code": "Code_37815" - }, - { - "id": 195679, - "soa_id": 3, - "alias_code_uid": "AliasCode_31501", - "standard_code": "Code_37825" - }, - { - "id": 195697, - "soa_id": 3, - "alias_code_uid": "AliasCode_31512", - "standard_code": "Code_37836" - }, - { - "id": 195726, - "soa_id": 3, - "alias_code_uid": "AliasCode_31537", - "standard_code": "Code_37861" - }, - { - "id": 195756, - "soa_id": 3, - "alias_code_uid": "AliasCode_31561", - "standard_code": "Code_37885" - }, - { - "id": 195774, - "soa_id": 3, - "alias_code_uid": "AliasCode_31573", - "standard_code": "Code_37897" - }, - { - "id": 195796, - "soa_id": 3, - "alias_code_uid": "AliasCode_31584", - "standard_code": "Code_37908" - }, - { - "id": 195860, - "soa_id": 3, - "alias_code_uid": "AliasCode_31617", - "standard_code": "Code_37941" - }, - { - "id": 195868, - "soa_id": 3, - "alias_code_uid": "AliasCode_31621", - "standard_code": "Code_37945" - }, - { - "id": 195884, - "soa_id": 3, - "alias_code_uid": "AliasCode_31629", - "standard_code": "Code_37953" - }, - { - "id": 195954, - "soa_id": 3, - "alias_code_uid": "AliasCode_31663", - "standard_code": "Code_37987" - }, - { - "id": 195980, - "soa_id": 3, - "alias_code_uid": "AliasCode_31675", - "standard_code": "Code_37999" - }, - { - "id": 196022, - "soa_id": 3, - "alias_code_uid": "AliasCode_31717", - "standard_code": "Code_38041" - }, - { - "id": 196029, - "soa_id": 3, - "alias_code_uid": "AliasCode_31724", - "standard_code": "Code_38048" - }, - { - "id": 196094, - "soa_id": 3, - "alias_code_uid": "AliasCode_31789", - "standard_code": "Code_38113" - }, - { - "id": 196096, - "soa_id": 3, - "alias_code_uid": "AliasCode_31791", - "standard_code": "Code_38115" - }, - { - "id": 196104, - "soa_id": 3, - "alias_code_uid": "AliasCode_31799", - "standard_code": "Code_38123" - }, - { - "id": 197836, - "soa_id": 3, - "alias_code_uid": "AliasCode_31819", - "standard_code": "Code_38143" - }, - { - "id": 197837, - "soa_id": 3, - "alias_code_uid": "AliasCode_31820", - "standard_code": "Code_38144" - }, - { - "id": 197838, - "soa_id": 3, - "alias_code_uid": "AliasCode_31821", - "standard_code": "Code_38145" - }, - { - "id": 198126, - "soa_id": 3, - "alias_code_uid": "AliasCode_32084", - "standard_code": "Code_38408" - }, - { - "id": 198195, - "soa_id": 3, - "alias_code_uid": "AliasCode_32153", - "standard_code": "Code_38477" - }, - { - "id": 198207, - "soa_id": 3, - "alias_code_uid": "AliasCode_32165", - "standard_code": "Code_38489" - }, - { - "id": 198230, - "soa_id": 3, - "alias_code_uid": "AliasCode_32188", - "standard_code": "Code_38512" - }, - { - "id": 198232, - "soa_id": 3, - "alias_code_uid": "AliasCode_32190", - "standard_code": "Code_38514" - }, - { - "id": 198243, - "soa_id": 3, - "alias_code_uid": "AliasCode_32201", - "standard_code": "Code_38525" - }, - { - "id": 198260, - "soa_id": 3, - "alias_code_uid": "AliasCode_32218", - "standard_code": "Code_38542" - }, - { - "id": 198279, - "soa_id": 3, - "alias_code_uid": "AliasCode_32237", - "standard_code": "Code_38561" - }, - { - "id": 198289, - "soa_id": 3, - "alias_code_uid": "AliasCode_32247", - "standard_code": "Code_38571" - }, - { - "id": 198295, - "soa_id": 3, - "alias_code_uid": "AliasCode_32253", - "standard_code": "Code_38577" - }, - { - "id": 198317, - "soa_id": 3, - "alias_code_uid": "AliasCode_32275", - "standard_code": "Code_38599" - }, - { - "id": 198344, - "soa_id": 3, - "alias_code_uid": "AliasCode_32302", - "standard_code": "Code_38626" - }, - { - "id": 198361, - "soa_id": 3, - "alias_code_uid": "AliasCode_32319", - "standard_code": "Code_38643" - }, - { - "id": 198383, - "soa_id": 3, - "alias_code_uid": "AliasCode_32341", - "standard_code": "Code_38665" - }, - { - "id": 198395, - "soa_id": 3, - "alias_code_uid": "AliasCode_32353", - "standard_code": "Code_38677" - }, - { - "id": 198440, - "soa_id": 3, - "alias_code_uid": "AliasCode_32398", - "standard_code": "Code_38722" - }, - { - "id": 198452, - "soa_id": 3, - "alias_code_uid": "AliasCode_32410", - "standard_code": "Code_38734" - }, - { - "id": 198481, - "soa_id": 3, - "alias_code_uid": "AliasCode_32439", - "standard_code": "Code_38763" - }, - { - "id": 198486, - "soa_id": 3, - "alias_code_uid": "AliasCode_32444", - "standard_code": "Code_38768" - }, - { - "id": 198514, - "soa_id": 3, - "alias_code_uid": "AliasCode_32472", - "standard_code": "Code_38796" - }, - { - "id": 198518, - "soa_id": 3, - "alias_code_uid": "AliasCode_32476", - "standard_code": "Code_38800" - }, - { - "id": 199230, - "soa_id": 3, - "alias_code_uid": "AliasCode_33098", - "standard_code": "Code_39422" - }, - { - "id": 199254, - "soa_id": 3, - "alias_code_uid": "AliasCode_33122", - "standard_code": "Code_39446" - }, - { - "id": 199307, - "soa_id": 3, - "alias_code_uid": "AliasCode_33175", - "standard_code": "Code_39499" - }, - { - "id": 217179, - "soa_id": 3, - "alias_code_uid": "AliasCode_33318", - "standard_code": "Code_40605" - }, - { - "id": 217202, - "soa_id": 3, - "alias_code_uid": "AliasCode_33341", - "standard_code": "Code_40628" - }, - { - "id": 217240, - "soa_id": 3, - "alias_code_uid": "AliasCode_33379", - "standard_code": "Code_40666" - }, - { - "id": 217394, - "soa_id": 3, - "alias_code_uid": "AliasCode_33485", - "standard_code": "Code_40772" - }, - { - "id": 217405, - "soa_id": 3, - "alias_code_uid": "AliasCode_33492", - "standard_code": "Code_40779" - }, - { - "id": 217519, - "soa_id": 3, - "alias_code_uid": "AliasCode_33523", - "standard_code": "Code_40810" - }, - { - "id": 217677, - "soa_id": 3, - "alias_code_uid": "AliasCode_33681", - "standard_code": "Code_40968" - }, - { - "id": 217684, - "soa_id": 3, - "alias_code_uid": "AliasCode_33688", - "standard_code": "Code_40975" - }, - { - "id": 217725, - "soa_id": 3, - "alias_code_uid": "AliasCode_33729", - "standard_code": "Code_41016" - }, - { - "id": 217956, - "soa_id": 3, - "alias_code_uid": "AliasCode_33960", - "standard_code": "Code_41247" - }, - { - "id": 217970, - "soa_id": 3, - "alias_code_uid": "AliasCode_33974", - "standard_code": "Code_41261" - }, - { - "id": 218024, - "soa_id": 3, - "alias_code_uid": "AliasCode_34028", - "standard_code": "Code_41315" - }, - { - "id": 218028, - "soa_id": 3, - "alias_code_uid": "AliasCode_34032", - "standard_code": "Code_41319" - }, - { - "id": 218051, - "soa_id": 3, - "alias_code_uid": "AliasCode_34055", - "standard_code": "Code_41342" - }, - { - "id": 218055, - "soa_id": 3, - "alias_code_uid": "AliasCode_34059", - "standard_code": "Code_41346" - }, - { - "id": 218105, - "soa_id": 3, - "alias_code_uid": "AliasCode_34109", - "standard_code": "Code_41396" - }, - { - "id": 218124, - "soa_id": 3, - "alias_code_uid": "AliasCode_34128", - "standard_code": "Code_41415" - }, - { - "id": 218137, - "soa_id": 3, - "alias_code_uid": "AliasCode_34141", - "standard_code": "Code_41428" - }, - { - "id": 218150, - "soa_id": 3, - "alias_code_uid": "AliasCode_34154", - "standard_code": "Code_41441" - }, - { - "id": 218162, - "soa_id": 3, - "alias_code_uid": "AliasCode_34166", - "standard_code": "Code_41453" - }, - { - "id": 218164, - "soa_id": 3, - "alias_code_uid": "AliasCode_34168", - "standard_code": "Code_41455" - }, - { - "id": 218176, - "soa_id": 3, - "alias_code_uid": "AliasCode_34180", - "standard_code": "Code_41467" - }, - { - "id": 218187, - "soa_id": 3, - "alias_code_uid": "AliasCode_34191", - "standard_code": "Code_41478" - }, - { - "id": 218189, - "soa_id": 3, - "alias_code_uid": "AliasCode_34193", - "standard_code": "Code_41480" - }, - { - "id": 218200, - "soa_id": 3, - "alias_code_uid": "AliasCode_34204", - "standard_code": "Code_41491" - }, - { - "id": 218202, - "soa_id": 3, - "alias_code_uid": "AliasCode_34206", - "standard_code": "Code_41493" - }, - { - "id": 218213, - "soa_id": 3, - "alias_code_uid": "AliasCode_34217", - "standard_code": "Code_41504" - }, - { - "id": 218215, - "soa_id": 3, - "alias_code_uid": "AliasCode_34219", - "standard_code": "Code_41506" - }, - { - "id": 218226, - "soa_id": 3, - "alias_code_uid": "AliasCode_34230", - "standard_code": "Code_41517" - }, - { - "id": 218237, - "soa_id": 3, - "alias_code_uid": "AliasCode_34241", - "standard_code": "Code_41528" - }, - { - "id": 218248, - "soa_id": 3, - "alias_code_uid": "AliasCode_34252", - "standard_code": "Code_41539" - }, - { - "id": 218259, - "soa_id": 3, - "alias_code_uid": "AliasCode_34263", - "standard_code": "Code_41550" - }, - { - "id": 218264, - "soa_id": 3, - "alias_code_uid": "AliasCode_34268", - "standard_code": "Code_41555" - }, - { - "id": 218274, - "soa_id": 3, - "alias_code_uid": "AliasCode_34278", - "standard_code": "Code_41565" - }, - { - "id": 218285, - "soa_id": 3, - "alias_code_uid": "AliasCode_34289", - "standard_code": "Code_41576" - }, - { - "id": 218296, - "soa_id": 3, - "alias_code_uid": "AliasCode_34300", - "standard_code": "Code_41587" - }, - { - "id": 218307, - "soa_id": 3, - "alias_code_uid": "AliasCode_34311", - "standard_code": "Code_41598" - }, - { - "id": 218319, - "soa_id": 3, - "alias_code_uid": "AliasCode_34323", - "standard_code": "Code_41610" - }, - { - "id": 218342, - "soa_id": 3, - "alias_code_uid": "AliasCode_34346", - "standard_code": "Code_41633" - }, - { - "id": 218364, - "soa_id": 3, - "alias_code_uid": "AliasCode_34368", - "standard_code": "Code_41655" - }, - { - "id": 218376, - "soa_id": 3, - "alias_code_uid": "AliasCode_34380", - "standard_code": "Code_41667" - }, - { - "id": 218388, - "soa_id": 3, - "alias_code_uid": "AliasCode_34392", - "standard_code": "Code_41679" - }, - { - "id": 218400, - "soa_id": 3, - "alias_code_uid": "AliasCode_34404", - "standard_code": "Code_41691" - }, - { - "id": 218412, - "soa_id": 3, - "alias_code_uid": "AliasCode_34416", - "standard_code": "Code_41703" - }, - { - "id": 218424, - "soa_id": 3, - "alias_code_uid": "AliasCode_34428", - "standard_code": "Code_41715" - }, - { - "id": 218436, - "soa_id": 3, - "alias_code_uid": "AliasCode_34440", - "standard_code": "Code_41727" - }, - { - "id": 218448, - "soa_id": 3, - "alias_code_uid": "AliasCode_34452", - "standard_code": "Code_41739" - }, - { - "id": 218461, - "soa_id": 3, - "alias_code_uid": "AliasCode_34465", - "standard_code": "Code_41752" - }, - { - "id": 218473, - "soa_id": 3, - "alias_code_uid": "AliasCode_34477", - "standard_code": "Code_41764" - }, - { - "id": 218485, - "soa_id": 3, - "alias_code_uid": "AliasCode_34489", - "standard_code": "Code_41776" - }, - { - "id": 218497, - "soa_id": 3, - "alias_code_uid": "AliasCode_34501", - "standard_code": "Code_41788" - }, - { - "id": 218516, - "soa_id": 3, - "alias_code_uid": "AliasCode_34520", - "standard_code": "Code_41807" - }, - { - "id": 218522, - "soa_id": 3, - "alias_code_uid": "AliasCode_34526", - "standard_code": "Code_41813" - }, - { - "id": 218539, - "soa_id": 3, - "alias_code_uid": "AliasCode_34543", - "standard_code": "Code_41830" - }, - { - "id": 218551, - "soa_id": 3, - "alias_code_uid": "AliasCode_34555", - "standard_code": "Code_41842" - }, - { - "id": 218567, - "soa_id": 3, - "alias_code_uid": "AliasCode_34571", - "standard_code": "Code_41858" - }, - { - "id": 218580, - "soa_id": 3, - "alias_code_uid": "AliasCode_34584", - "standard_code": "Code_41871" - }, - { - "id": 218593, - "soa_id": 3, - "alias_code_uid": "AliasCode_34597", - "standard_code": "Code_41884" - }, - { - "id": 218603, - "soa_id": 3, - "alias_code_uid": "AliasCode_34607", - "standard_code": "Code_41894" - }, - { - "id": 218624, - "soa_id": 3, - "alias_code_uid": "AliasCode_34628", - "standard_code": "Code_41915" - }, - { - "id": 218627, - "soa_id": 3, - "alias_code_uid": "AliasCode_34631", - "standard_code": "Code_41918" - }, - { - "id": 218631, - "soa_id": 3, - "alias_code_uid": "AliasCode_34635", - "standard_code": "Code_41922" - }, - { - "id": 218635, - "soa_id": 3, - "alias_code_uid": "AliasCode_34639", - "standard_code": "Code_41926" - }, - { - "id": 218651, - "soa_id": 3, - "alias_code_uid": "AliasCode_34655", - "standard_code": "Code_41942" - }, - { - "id": 218666, - "soa_id": 3, - "alias_code_uid": "AliasCode_34670", - "standard_code": "Code_41957" - }, - { - "id": 218672, - "soa_id": 3, - "alias_code_uid": "AliasCode_34676", - "standard_code": "Code_41963" - }, - { - "id": 218678, - "soa_id": 3, - "alias_code_uid": "AliasCode_34682", - "standard_code": "Code_41969" - }, - { - "id": 218690, - "soa_id": 3, - "alias_code_uid": "AliasCode_34694", - "standard_code": "Code_41981" - }, - { - "id": 218701, - "soa_id": 3, - "alias_code_uid": "AliasCode_34705", - "standard_code": "Code_41992" - }, - { - "id": 218730, - "soa_id": 3, - "alias_code_uid": "AliasCode_34734", - "standard_code": "Code_42021" - }, - { - "id": 218739, - "soa_id": 3, - "alias_code_uid": "AliasCode_34743", - "standard_code": "Code_42030" - }, - { - "id": 218756, - "soa_id": 3, - "alias_code_uid": "AliasCode_34760", - "standard_code": "Code_42047" - }, - { - "id": 218789, - "soa_id": 3, - "alias_code_uid": "AliasCode_34793", - "standard_code": "Code_42080" - }, - { - "id": 218825, - "soa_id": 3, - "alias_code_uid": "AliasCode_34829", - "standard_code": "Code_42116" - }, - { - "id": 218869, - "soa_id": 3, - "alias_code_uid": "AliasCode_34873", - "standard_code": "Code_42160" - }, - { - "id": 218920, - "soa_id": 3, - "alias_code_uid": "AliasCode_34924", - "standard_code": "Code_42211" - }, - { - "id": 218961, - "soa_id": 3, - "alias_code_uid": "AliasCode_34965", - "standard_code": "Code_42252" - }, - { - "id": 218978, - "soa_id": 3, - "alias_code_uid": "AliasCode_34982", - "standard_code": "Code_42269" - }, - { - "id": 218993, - "soa_id": 3, - "alias_code_uid": "AliasCode_34997", - "standard_code": "Code_42284" - }, - { - "id": 219000, - "soa_id": 3, - "alias_code_uid": "AliasCode_35004", - "standard_code": "Code_42291" - }, - { - "id": 219007, - "soa_id": 3, - "alias_code_uid": "AliasCode_35011", - "standard_code": "Code_42298" - }, - { - "id": 219014, - "soa_id": 3, - "alias_code_uid": "AliasCode_35018", - "standard_code": "Code_42305" - }, - { - "id": 219080, - "soa_id": 3, - "alias_code_uid": "AliasCode_35084", - "standard_code": "Code_42371" - }, - { - "id": 219082, - "soa_id": 3, - "alias_code_uid": "AliasCode_35086", - "standard_code": "Code_42373" - }, - { - "id": 219088, - "soa_id": 3, - "alias_code_uid": "AliasCode_35092", - "standard_code": "Code_42379" - }, - { - "id": 219090, - "soa_id": 3, - "alias_code_uid": "AliasCode_35094", - "standard_code": "Code_42381" - }, - { - "id": 219100, - "soa_id": 3, - "alias_code_uid": "AliasCode_35104", - "standard_code": "Code_42391" - }, - { - "id": 219104, - "soa_id": 3, - "alias_code_uid": "AliasCode_35108", - "standard_code": "Code_42395" - }, - { - "id": 219117, - "soa_id": 3, - "alias_code_uid": "AliasCode_35121", - "standard_code": "Code_42408" - }, - { - "id": 220719, - "soa_id": 3, - "alias_code_uid": "AliasCode_35123", - "standard_code": "Code_42410" - }, - { - "id": 220731, - "soa_id": 3, - "alias_code_uid": "AliasCode_35135", - "standard_code": "Code_42422" - }, - { - "id": 220763, - "soa_id": 3, - "alias_code_uid": "AliasCode_35165", - "standard_code": "Code_42452" - }, - { - "id": 220820, - "soa_id": 3, - "alias_code_uid": "AliasCode_35222", - "standard_code": "Code_42509" - }, - { - "id": 220827, - "soa_id": 3, - "alias_code_uid": "AliasCode_35229", - "standard_code": "Code_42516" - }, - { - "id": 220945, - "soa_id": 3, - "alias_code_uid": "AliasCode_35335", - "standard_code": "Code_42622" - }, - { - "id": 220952, - "soa_id": 3, - "alias_code_uid": "AliasCode_35342", - "standard_code": "Code_42629" - }, - { - "id": 221064, - "soa_id": 3, - "alias_code_uid": "AliasCode_35454", - "standard_code": "Code_42741" - }, - { - "id": 221094, - "soa_id": 3, - "alias_code_uid": "AliasCode_35484", - "standard_code": "Code_42771" - }, - { - "id": 221098, - "soa_id": 3, - "alias_code_uid": "AliasCode_35488", - "standard_code": "Code_42775" - }, - { - "id": 221359, - "soa_id": 3, - "alias_code_uid": "AliasCode_35747", - "standard_code": "Code_43034" - }, - { - "id": 221363, - "soa_id": 3, - "alias_code_uid": "AliasCode_35751", - "standard_code": "Code_43038" - }, - { - "id": 221389, - "soa_id": 3, - "alias_code_uid": "AliasCode_35777", - "standard_code": "Code_43064" - }, - { - "id": 221400, - "soa_id": 3, - "alias_code_uid": "AliasCode_35788", - "standard_code": "Code_43075" - }, - { - "id": 221410, - "soa_id": 3, - "alias_code_uid": "AliasCode_35798", - "standard_code": "Code_43085" - }, - { - "id": 221412, - "soa_id": 3, - "alias_code_uid": "AliasCode_35800", - "standard_code": "Code_43087" - }, - { - "id": 221422, - "soa_id": 3, - "alias_code_uid": "AliasCode_35810", - "standard_code": "Code_43097" - }, - { - "id": 221424, - "soa_id": 3, - "alias_code_uid": "AliasCode_35812", - "standard_code": "Code_43099" - }, - { - "id": 221434, - "soa_id": 3, - "alias_code_uid": "AliasCode_35822", - "standard_code": "Code_43109" - }, - { - "id": 221436, - "soa_id": 3, - "alias_code_uid": "AliasCode_35824", - "standard_code": "Code_43111" - }, - { - "id": 221447, - "soa_id": 3, - "alias_code_uid": "AliasCode_35835", - "standard_code": "Code_43122" - }, - { - "id": 221462, - "soa_id": 3, - "alias_code_uid": "AliasCode_35850", - "standard_code": "Code_43137" - }, - { - "id": 221467, - "soa_id": 3, - "alias_code_uid": "AliasCode_35855", - "standard_code": "Code_43142" - }, - { - "id": 221472, - "soa_id": 3, - "alias_code_uid": "AliasCode_35860", - "standard_code": "Code_43147" - }, - { - "id": 221481, - "soa_id": 3, - "alias_code_uid": "AliasCode_35869", - "standard_code": "Code_43156" - }, - { - "id": 221497, - "soa_id": 3, - "alias_code_uid": "AliasCode_35885", - "standard_code": "Code_43172" - }, - { - "id": 221503, - "soa_id": 3, - "alias_code_uid": "AliasCode_35891", - "standard_code": "Code_43178" - }, - { - "id": 221509, - "soa_id": 3, - "alias_code_uid": "AliasCode_35897", - "standard_code": "Code_43184" - }, - { - "id": 221520, - "soa_id": 3, - "alias_code_uid": "AliasCode_35908", - "standard_code": "Code_43195" - }, - { - "id": 221536, - "soa_id": 3, - "alias_code_uid": "AliasCode_35924", - "standard_code": "Code_43211" - }, - { - "id": 221552, - "soa_id": 3, - "alias_code_uid": "AliasCode_35940", - "standard_code": "Code_43227" - }, - { - "id": 221574, - "soa_id": 3, - "alias_code_uid": "AliasCode_35962", - "standard_code": "Code_43249" - }, - { - "id": 221585, - "soa_id": 3, - "alias_code_uid": "AliasCode_35973", - "standard_code": "Code_43260" - }, - { - "id": 221596, - "soa_id": 3, - "alias_code_uid": "AliasCode_35984", - "standard_code": "Code_43271" - }, - { - "id": 221601, - "soa_id": 3, - "alias_code_uid": "AliasCode_35989", - "standard_code": "Code_43276" - }, - { - "id": 221612, - "soa_id": 3, - "alias_code_uid": "AliasCode_36000", - "standard_code": "Code_43287" - }, - { - "id": 221621, - "soa_id": 3, - "alias_code_uid": "AliasCode_36009", - "standard_code": "Code_43296" - }, - { - "id": 221624, - "soa_id": 3, - "alias_code_uid": "AliasCode_36012", - "standard_code": "Code_43299" - }, - { - "id": 221628, - "soa_id": 3, - "alias_code_uid": "AliasCode_36016", - "standard_code": "Code_43303" - }, - { - "id": 221632, - "soa_id": 3, - "alias_code_uid": "AliasCode_36020", - "standard_code": "Code_43307" - }, - { - "id": 221636, - "soa_id": 3, - "alias_code_uid": "AliasCode_36024", - "standard_code": "Code_43311" - }, - { - "id": 221645, - "soa_id": 3, - "alias_code_uid": "AliasCode_36033", - "standard_code": "Code_43320" - }, - { - "id": 221656, - "soa_id": 3, - "alias_code_uid": "AliasCode_36044", - "standard_code": "Code_43331" - }, - { - "id": 221662, - "soa_id": 3, - "alias_code_uid": "AliasCode_36050", - "standard_code": "Code_43337" - }, - { - "id": 221668, - "soa_id": 3, - "alias_code_uid": "AliasCode_36056", - "standard_code": "Code_43343" - }, - { - "id": 221673, - "soa_id": 3, - "alias_code_uid": "AliasCode_36061", - "standard_code": "Code_43348" - }, - { - "id": 221687, - "soa_id": 3, - "alias_code_uid": "AliasCode_36075", - "standard_code": "Code_43362" - }, - { - "id": 221716, - "soa_id": 3, - "alias_code_uid": "AliasCode_36104", - "standard_code": "Code_43391" - }, - { - "id": 221720, - "soa_id": 3, - "alias_code_uid": "AliasCode_36108", - "standard_code": "Code_43395" - }, - { - "id": 221750, - "soa_id": 3, - "alias_code_uid": "AliasCode_36138", - "standard_code": "Code_43425" - }, - { - "id": 221758, - "soa_id": 3, - "alias_code_uid": "AliasCode_36146", - "standard_code": "Code_43433" - }, - { - "id": 221771, - "soa_id": 3, - "alias_code_uid": "AliasCode_36159", - "standard_code": "Code_43446" - }, - { - "id": 221784, - "soa_id": 3, - "alias_code_uid": "AliasCode_36172", - "standard_code": "Code_43459" - }, - { - "id": 221791, - "soa_id": 3, - "alias_code_uid": "AliasCode_36179", - "standard_code": "Code_43466" - }, - { - "id": 221815, - "soa_id": 3, - "alias_code_uid": "AliasCode_36203", - "standard_code": "Code_43490" - }, - { - "id": 221817, - "soa_id": 3, - "alias_code_uid": "AliasCode_36205", - "standard_code": "Code_43492" - }, - { - "id": 221827, - "soa_id": 3, - "alias_code_uid": "AliasCode_36215", - "standard_code": "Code_43502" - }, - { - "id": 221835, - "soa_id": 3, - "alias_code_uid": "AliasCode_36223", - "standard_code": "Code_43510" - }, - { - "id": 227365, - "soa_id": 3, - "alias_code_uid": "AliasCode_36898", - "standard_code": "Code_44185" - }, - { - "id": 227369, - "soa_id": 3, - "alias_code_uid": "AliasCode_36902", - "standard_code": "Code_44189" - }, - { - "id": 227374, - "soa_id": 3, - "alias_code_uid": "AliasCode_36907", - "standard_code": "Code_44194" - }, - { - "id": 227512, - "soa_id": 3, - "alias_code_uid": "AliasCode_37045", - "standard_code": "Code_44332" - }, - { - "id": 227514, - "soa_id": 3, - "alias_code_uid": "AliasCode_37047", - "standard_code": "Code_44334" - }, - { - "id": 231295, - "soa_id": 3, - "alias_code_uid": "AliasCode_37048", - "standard_code": "Code_44335" - }, - { - "id": 231296, - "soa_id": 3, - "alias_code_uid": "AliasCode_37049", - "standard_code": "Code_44336" - }, - { - "id": 231297, - "soa_id": 3, - "alias_code_uid": "AliasCode_37050", - "standard_code": "Code_44337" - }, - { - "id": 231298, - "soa_id": 3, - "alias_code_uid": "AliasCode_37051", - "standard_code": "Code_44338" - }, - { - "id": 231299, - "soa_id": 3, - "alias_code_uid": "AliasCode_37052", - "standard_code": "Code_44339" - }, - { - "id": 231300, - "soa_id": 3, - "alias_code_uid": "AliasCode_37053", - "standard_code": "Code_44340" - }, - { - "id": 231301, - "soa_id": 3, - "alias_code_uid": "AliasCode_37054", - "standard_code": "Code_44341" - }, - { - "id": 231302, - "soa_id": 3, - "alias_code_uid": "AliasCode_37055", - "standard_code": "Code_44342" - }, - { - "id": 231303, - "soa_id": 3, - "alias_code_uid": "AliasCode_37056", - "standard_code": "Code_44343" - }, - { - "id": 231304, - "soa_id": 3, - "alias_code_uid": "AliasCode_37057", - "standard_code": "Code_44344" - }, - { - "id": 231305, - "soa_id": 3, - "alias_code_uid": "AliasCode_37058", - "standard_code": "Code_44345" - }, - { - "id": 231306, - "soa_id": 3, - "alias_code_uid": "AliasCode_37059", - "standard_code": "Code_44346" - }, - { - "id": 231307, - "soa_id": 3, - "alias_code_uid": "AliasCode_37060", - "standard_code": "Code_44347" - }, - { - "id": 231308, - "soa_id": 3, - "alias_code_uid": "AliasCode_37061", - "standard_code": "Code_44348" - }, - { - "id": 231309, - "soa_id": 3, - "alias_code_uid": "AliasCode_37062", - "standard_code": "Code_44349" - }, - { - "id": 231310, - "soa_id": 3, - "alias_code_uid": "AliasCode_37063", - "standard_code": "Code_44350" - }, - { - "id": 231311, - "soa_id": 3, - "alias_code_uid": "AliasCode_37064", - "standard_code": "Code_44351" - }, - { - "id": 231312, - "soa_id": 3, - "alias_code_uid": "AliasCode_37065", - "standard_code": "Code_44352" - }, - { - "id": 231313, - "soa_id": 3, - "alias_code_uid": "AliasCode_37066", - "standard_code": "Code_44353" - }, - { - "id": 231314, - "soa_id": 3, - "alias_code_uid": "AliasCode_37067", - "standard_code": "Code_44354" - }, - { - "id": 231315, - "soa_id": 3, - "alias_code_uid": "AliasCode_37068", - "standard_code": "Code_44355" - }, - { - "id": 231316, - "soa_id": 3, - "alias_code_uid": "AliasCode_37069", - "standard_code": "Code_44356" - }, - { - "id": 231317, - "soa_id": 3, - "alias_code_uid": "AliasCode_37070", - "standard_code": "Code_44357" - }, - { - "id": 231318, - "soa_id": 3, - "alias_code_uid": "AliasCode_37071", - "standard_code": "Code_44358" - }, - { - "id": 231319, - "soa_id": 3, - "alias_code_uid": "AliasCode_37072", - "standard_code": "Code_44359" - }, - { - "id": 231320, - "soa_id": 3, - "alias_code_uid": "AliasCode_37073", - "standard_code": "Code_44360" - }, - { - "id": 231321, - "soa_id": 3, - "alias_code_uid": "AliasCode_37074", - "standard_code": "Code_44361" - }, - { - "id": 231322, - "soa_id": 3, - "alias_code_uid": "AliasCode_37075", - "standard_code": "Code_44362" - }, - { - "id": 231323, - "soa_id": 3, - "alias_code_uid": "AliasCode_37076", - "standard_code": "Code_44363" - }, - { - "id": 231324, - "soa_id": 3, - "alias_code_uid": "AliasCode_37077", - "standard_code": "Code_44364" - }, - { - "id": 231325, - "soa_id": 3, - "alias_code_uid": "AliasCode_37078", - "standard_code": "Code_44365" - }, - { - "id": 231326, - "soa_id": 3, - "alias_code_uid": "AliasCode_37079", - "standard_code": "Code_44366" - }, - { - "id": 231327, - "soa_id": 3, - "alias_code_uid": "AliasCode_37080", - "standard_code": "Code_44367" - }, - { - "id": 231328, - "soa_id": 3, - "alias_code_uid": "AliasCode_37081", - "standard_code": "Code_44368" - }, - { - "id": 231329, - "soa_id": 3, - "alias_code_uid": "AliasCode_37082", - "standard_code": "Code_44369" - }, - { - "id": 231330, - "soa_id": 3, - "alias_code_uid": "AliasCode_37083", - "standard_code": "Code_44370" - }, - { - "id": 231331, - "soa_id": 3, - "alias_code_uid": "AliasCode_37084", - "standard_code": "Code_44371" - }, - { - "id": 231332, - "soa_id": 3, - "alias_code_uid": "AliasCode_37085", - "standard_code": "Code_44372" - }, - { - "id": 231333, - "soa_id": 3, - "alias_code_uid": "AliasCode_37086", - "standard_code": "Code_44373" - }, - { - "id": 231334, - "soa_id": 3, - "alias_code_uid": "AliasCode_37087", - "standard_code": "Code_44374" - }, - { - "id": 231335, - "soa_id": 3, - "alias_code_uid": "AliasCode_37088", - "standard_code": "Code_44375" - }, - { - "id": 231336, - "soa_id": 3, - "alias_code_uid": "AliasCode_37089", - "standard_code": "Code_44376" - }, - { - "id": 231337, - "soa_id": 3, - "alias_code_uid": "AliasCode_37090", - "standard_code": "Code_44377" - }, - { - "id": 231338, - "soa_id": 3, - "alias_code_uid": "AliasCode_37091", - "standard_code": "Code_44378" - }, - { - "id": 231339, - "soa_id": 3, - "alias_code_uid": "AliasCode_37092", - "standard_code": "Code_44379" - }, - { - "id": 231340, - "soa_id": 3, - "alias_code_uid": "AliasCode_37093", - "standard_code": "Code_44380" - }, - { - "id": 231341, - "soa_id": 3, - "alias_code_uid": "AliasCode_37094", - "standard_code": "Code_44381" - }, - { - "id": 231342, - "soa_id": 3, - "alias_code_uid": "AliasCode_37095", - "standard_code": "Code_44382" - }, - { - "id": 231343, - "soa_id": 3, - "alias_code_uid": "AliasCode_37096", - "standard_code": "Code_44383" - }, - { - "id": 231344, - "soa_id": 3, - "alias_code_uid": "AliasCode_37097", - "standard_code": "Code_44384" - }, - { - "id": 231345, - "soa_id": 3, - "alias_code_uid": "AliasCode_37098", - "standard_code": "Code_44385" - }, - { - "id": 231346, - "soa_id": 3, - "alias_code_uid": "AliasCode_37099", - "standard_code": "Code_44386" - }, - { - "id": 231347, - "soa_id": 3, - "alias_code_uid": "AliasCode_37100", - "standard_code": "Code_44387" - }, - { - "id": 231348, - "soa_id": 3, - "alias_code_uid": "AliasCode_37101", - "standard_code": "Code_44388" - }, - { - "id": 231349, - "soa_id": 3, - "alias_code_uid": "AliasCode_37102", - "standard_code": "Code_44389" - }, - { - "id": 231350, - "soa_id": 3, - "alias_code_uid": "AliasCode_37103", - "standard_code": "Code_44390" - }, - { - "id": 231351, - "soa_id": 3, - "alias_code_uid": "AliasCode_37104", - "standard_code": "Code_44391" - }, - { - "id": 231352, - "soa_id": 3, - "alias_code_uid": "AliasCode_37105", - "standard_code": "Code_44392" - }, - { - "id": 231353, - "soa_id": 3, - "alias_code_uid": "AliasCode_37106", - "standard_code": "Code_44393" - }, - { - "id": 231354, - "soa_id": 3, - "alias_code_uid": "AliasCode_37107", - "standard_code": "Code_44394" - }, - { - "id": 231355, - "soa_id": 3, - "alias_code_uid": "AliasCode_37108", - "standard_code": "Code_44395" - }, - { - "id": 231356, - "soa_id": 3, - "alias_code_uid": "AliasCode_37109", - "standard_code": "Code_44396" - }, - { - "id": 231357, - "soa_id": 3, - "alias_code_uid": "AliasCode_37110", - "standard_code": "Code_44397" - }, - { - "id": 231358, - "soa_id": 3, - "alias_code_uid": "AliasCode_37111", - "standard_code": "Code_44398" - }, - { - "id": 231359, - "soa_id": 3, - "alias_code_uid": "AliasCode_37112", - "standard_code": "Code_44399" - }, - { - "id": 231360, - "soa_id": 3, - "alias_code_uid": "AliasCode_37113", - "standard_code": "Code_44400" - }, - { - "id": 231361, - "soa_id": 3, - "alias_code_uid": "AliasCode_37114", - "standard_code": "Code_44401" - }, - { - "id": 231362, - "soa_id": 3, - "alias_code_uid": "AliasCode_37115", - "standard_code": "Code_44402" - }, - { - "id": 231363, - "soa_id": 3, - "alias_code_uid": "AliasCode_37116", - "standard_code": "Code_44403" - }, - { - "id": 231364, - "soa_id": 3, - "alias_code_uid": "AliasCode_37117", - "standard_code": "Code_44404" - }, - { - "id": 231365, - "soa_id": 3, - "alias_code_uid": "AliasCode_37118", - "standard_code": "Code_44405" - }, - { - "id": 231366, - "soa_id": 3, - "alias_code_uid": "AliasCode_37119", - "standard_code": "Code_44406" - }, - { - "id": 231367, - "soa_id": 3, - "alias_code_uid": "AliasCode_37120", - "standard_code": "Code_44407" - }, - { - "id": 231368, - "soa_id": 3, - "alias_code_uid": "AliasCode_37121", - "standard_code": "Code_44408" - }, - { - "id": 231369, - "soa_id": 3, - "alias_code_uid": "AliasCode_37122", - "standard_code": "Code_44409" - }, - { - "id": 231370, - "soa_id": 3, - "alias_code_uid": "AliasCode_37123", - "standard_code": "Code_44410" - }, - { - "id": 231371, - "soa_id": 3, - "alias_code_uid": "AliasCode_37124", - "standard_code": "Code_44411" - }, - { - "id": 231372, - "soa_id": 3, - "alias_code_uid": "AliasCode_37125", - "standard_code": "Code_44412" - }, - { - "id": 231373, - "soa_id": 3, - "alias_code_uid": "AliasCode_37126", - "standard_code": "Code_44413" - }, - { - "id": 231374, - "soa_id": 3, - "alias_code_uid": "AliasCode_37127", - "standard_code": "Code_44414" - }, - { - "id": 231375, - "soa_id": 3, - "alias_code_uid": "AliasCode_37128", - "standard_code": "Code_44415" - }, - { - "id": 231376, - "soa_id": 3, - "alias_code_uid": "AliasCode_37129", - "standard_code": "Code_44416" - }, - { - "id": 231377, - "soa_id": 3, - "alias_code_uid": "AliasCode_37130", - "standard_code": "Code_44417" - }, - { - "id": 231378, - "soa_id": 3, - "alias_code_uid": "AliasCode_37131", - "standard_code": "Code_44418" - }, - { - "id": 231379, - "soa_id": 3, - "alias_code_uid": "AliasCode_37132", - "standard_code": "Code_44419" - }, - { - "id": 231380, - "soa_id": 3, - "alias_code_uid": "AliasCode_37133", - "standard_code": "Code_44420" - }, - { - "id": 231381, - "soa_id": 3, - "alias_code_uid": "AliasCode_37134", - "standard_code": "Code_44421" - }, - { - "id": 231382, - "soa_id": 3, - "alias_code_uid": "AliasCode_37135", - "standard_code": "Code_44422" - }, - { - "id": 231383, - "soa_id": 3, - "alias_code_uid": "AliasCode_37136", - "standard_code": "Code_44423" - }, - { - "id": 231384, - "soa_id": 3, - "alias_code_uid": "AliasCode_37137", - "standard_code": "Code_44424" - }, - { - "id": 231385, - "soa_id": 3, - "alias_code_uid": "AliasCode_37138", - "standard_code": "Code_44425" - }, - { - "id": 231386, - "soa_id": 3, - "alias_code_uid": "AliasCode_37139", - "standard_code": "Code_44426" - }, - { - "id": 231387, - "soa_id": 3, - "alias_code_uid": "AliasCode_37140", - "standard_code": "Code_44427" - }, - { - "id": 231388, - "soa_id": 3, - "alias_code_uid": "AliasCode_37141", - "standard_code": "Code_44428" - }, - { - "id": 231389, - "soa_id": 3, - "alias_code_uid": "AliasCode_37142", - "standard_code": "Code_44429" - }, - { - "id": 231390, - "soa_id": 3, - "alias_code_uid": "AliasCode_37143", - "standard_code": "Code_44430" - }, - { - "id": 231391, - "soa_id": 3, - "alias_code_uid": "AliasCode_37144", - "standard_code": "Code_44431" - }, - { - "id": 231392, - "soa_id": 3, - "alias_code_uid": "AliasCode_37145", - "standard_code": "Code_44432" - }, - { - "id": 231393, - "soa_id": 3, - "alias_code_uid": "AliasCode_37146", - "standard_code": "Code_44433" - }, - { - "id": 231394, - "soa_id": 3, - "alias_code_uid": "AliasCode_37147", - "standard_code": "Code_44434" - }, - { - "id": 231395, - "soa_id": 3, - "alias_code_uid": "AliasCode_37148", - "standard_code": "Code_44435" - }, - { - "id": 231396, - "soa_id": 3, - "alias_code_uid": "AliasCode_37149", - "standard_code": "Code_44436" - }, - { - "id": 231397, - "soa_id": 3, - "alias_code_uid": "AliasCode_37150", - "standard_code": "Code_44437" - }, - { - "id": 231398, - "soa_id": 3, - "alias_code_uid": "AliasCode_37151", - "standard_code": "Code_44438" - }, - { - "id": 231399, - "soa_id": 3, - "alias_code_uid": "AliasCode_37152", - "standard_code": "Code_44439" - }, - { - "id": 231400, - "soa_id": 3, - "alias_code_uid": "AliasCode_37153", - "standard_code": "Code_44440" - }, - { - "id": 231401, - "soa_id": 3, - "alias_code_uid": "AliasCode_37154", - "standard_code": "Code_44441" - }, - { - "id": 231402, - "soa_id": 3, - "alias_code_uid": "AliasCode_37155", - "standard_code": "Code_44442" - }, - { - "id": 231403, - "soa_id": 3, - "alias_code_uid": "AliasCode_37156", - "standard_code": "Code_44443" - }, - { - "id": 231404, - "soa_id": 3, - "alias_code_uid": "AliasCode_37157", - "standard_code": "Code_44444" - }, - { - "id": 231405, - "soa_id": 3, - "alias_code_uid": "AliasCode_37158", - "standard_code": "Code_44445" - }, - { - "id": 231406, - "soa_id": 3, - "alias_code_uid": "AliasCode_37159", - "standard_code": "Code_44446" - }, - { - "id": 231407, - "soa_id": 3, - "alias_code_uid": "AliasCode_37160", - "standard_code": "Code_44447" - }, - { - "id": 231408, - "soa_id": 3, - "alias_code_uid": "AliasCode_37161", - "standard_code": "Code_44448" - }, - { - "id": 231409, - "soa_id": 3, - "alias_code_uid": "AliasCode_37162", - "standard_code": "Code_44449" - }, - { - "id": 231410, - "soa_id": 3, - "alias_code_uid": "AliasCode_37163", - "standard_code": "Code_44450" - }, - { - "id": 231411, - "soa_id": 3, - "alias_code_uid": "AliasCode_37164", - "standard_code": "Code_44451" - }, - { - "id": 231412, - "soa_id": 3, - "alias_code_uid": "AliasCode_37165", - "standard_code": "Code_44452" - }, - { - "id": 231413, - "soa_id": 3, - "alias_code_uid": "AliasCode_37166", - "standard_code": "Code_44453" - }, - { - "id": 231414, - "soa_id": 3, - "alias_code_uid": "AliasCode_37167", - "standard_code": "Code_44454" - }, - { - "id": 231415, - "soa_id": 3, - "alias_code_uid": "AliasCode_37168", - "standard_code": "Code_44455" - }, - { - "id": 231416, - "soa_id": 3, - "alias_code_uid": "AliasCode_37169", - "standard_code": "Code_44456" - }, - { - "id": 231417, - "soa_id": 3, - "alias_code_uid": "AliasCode_37170", - "standard_code": "Code_44457" - }, - { - "id": 231418, - "soa_id": 3, - "alias_code_uid": "AliasCode_37171", - "standard_code": "Code_44458" - }, - { - "id": 231419, - "soa_id": 3, - "alias_code_uid": "AliasCode_37172", - "standard_code": "Code_44459" - }, - { - "id": 231420, - "soa_id": 3, - "alias_code_uid": "AliasCode_37173", - "standard_code": "Code_44460" - }, - { - "id": 231421, - "soa_id": 3, - "alias_code_uid": "AliasCode_37174", - "standard_code": "Code_44461" - }, - { - "id": 231422, - "soa_id": 3, - "alias_code_uid": "AliasCode_37175", - "standard_code": "Code_44462" - }, - { - "id": 231423, - "soa_id": 3, - "alias_code_uid": "AliasCode_37176", - "standard_code": "Code_44463" - }, - { - "id": 231424, - "soa_id": 3, - "alias_code_uid": "AliasCode_37177", - "standard_code": "Code_44464" - }, - { - "id": 231425, - "soa_id": 3, - "alias_code_uid": "AliasCode_37178", - "standard_code": "Code_44465" - }, - { - "id": 231426, - "soa_id": 3, - "alias_code_uid": "AliasCode_37179", - "standard_code": "Code_44466" - }, - { - "id": 231427, - "soa_id": 3, - "alias_code_uid": "AliasCode_37180", - "standard_code": "Code_44467" - }, - { - "id": 231428, - "soa_id": 3, - "alias_code_uid": "AliasCode_37181", - "standard_code": "Code_44468" - }, - { - "id": 231429, - "soa_id": 3, - "alias_code_uid": "AliasCode_37182", - "standard_code": "Code_44469" - }, - { - "id": 231430, - "soa_id": 3, - "alias_code_uid": "AliasCode_37183", - "standard_code": "Code_44470" - }, - { - "id": 231431, - "soa_id": 3, - "alias_code_uid": "AliasCode_37184", - "standard_code": "Code_44471" - }, - { - "id": 231432, - "soa_id": 3, - "alias_code_uid": "AliasCode_37185", - "standard_code": "Code_44472" - }, - { - "id": 231433, - "soa_id": 3, - "alias_code_uid": "AliasCode_37186", - "standard_code": "Code_44473" - }, - { - "id": 231434, - "soa_id": 3, - "alias_code_uid": "AliasCode_37187", - "standard_code": "Code_44474" - }, - { - "id": 231435, - "soa_id": 3, - "alias_code_uid": "AliasCode_37188", - "standard_code": "Code_44475" - }, - { - "id": 231436, - "soa_id": 3, - "alias_code_uid": "AliasCode_37189", - "standard_code": "Code_44476" - }, - { - "id": 231437, - "soa_id": 3, - "alias_code_uid": "AliasCode_37190", - "standard_code": "Code_44477" - }, - { - "id": 231438, - "soa_id": 3, - "alias_code_uid": "AliasCode_37191", - "standard_code": "Code_44478" - }, - { - "id": 231439, - "soa_id": 3, - "alias_code_uid": "AliasCode_37192", - "standard_code": "Code_44479" - }, - { - "id": 231440, - "soa_id": 3, - "alias_code_uid": "AliasCode_37193", - "standard_code": "Code_44480" - }, - { - "id": 231441, - "soa_id": 3, - "alias_code_uid": "AliasCode_37194", - "standard_code": "Code_44481" - }, - { - "id": 231442, - "soa_id": 3, - "alias_code_uid": "AliasCode_37195", - "standard_code": "Code_44482" - }, - { - "id": 231443, - "soa_id": 3, - "alias_code_uid": "AliasCode_37196", - "standard_code": "Code_44483" - }, - { - "id": 231444, - "soa_id": 3, - "alias_code_uid": "AliasCode_37197", - "standard_code": "Code_44484" - }, - { - "id": 231445, - "soa_id": 3, - "alias_code_uid": "AliasCode_37198", - "standard_code": "Code_44485" - }, - { - "id": 231446, - "soa_id": 3, - "alias_code_uid": "AliasCode_37199", - "standard_code": "Code_44486" - }, - { - "id": 231447, - "soa_id": 3, - "alias_code_uid": "AliasCode_37200", - "standard_code": "Code_44487" - }, - { - "id": 231448, - "soa_id": 3, - "alias_code_uid": "AliasCode_37201", - "standard_code": "Code_44488" - }, - { - "id": 231449, - "soa_id": 3, - "alias_code_uid": "AliasCode_37202", - "standard_code": "Code_44489" - }, - { - "id": 231450, - "soa_id": 3, - "alias_code_uid": "AliasCode_37203", - "standard_code": "Code_44490" - }, - { - "id": 231451, - "soa_id": 3, - "alias_code_uid": "AliasCode_37204", - "standard_code": "Code_44491" - }, - { - "id": 231452, - "soa_id": 3, - "alias_code_uid": "AliasCode_37205", - "standard_code": "Code_44492" - }, - { - "id": 231453, - "soa_id": 3, - "alias_code_uid": "AliasCode_37206", - "standard_code": "Code_44493" - }, - { - "id": 231454, - "soa_id": 3, - "alias_code_uid": "AliasCode_37207", - "standard_code": "Code_44494" - }, - { - "id": 231455, - "soa_id": 3, - "alias_code_uid": "AliasCode_37208", - "standard_code": "Code_44495" - }, - { - "id": 231456, - "soa_id": 3, - "alias_code_uid": "AliasCode_37209", - "standard_code": "Code_44496" - }, - { - "id": 231457, - "soa_id": 3, - "alias_code_uid": "AliasCode_37210", - "standard_code": "Code_44497" - }, - { - "id": 231458, - "soa_id": 3, - "alias_code_uid": "AliasCode_37211", - "standard_code": "Code_44498" - }, - { - "id": 231459, - "soa_id": 3, - "alias_code_uid": "AliasCode_37212", - "standard_code": "Code_44499" - }, - { - "id": 231460, - "soa_id": 3, - "alias_code_uid": "AliasCode_37213", - "standard_code": "Code_44500" - }, - { - "id": 231461, - "soa_id": 3, - "alias_code_uid": "AliasCode_37214", - "standard_code": "Code_44501" - }, - { - "id": 231462, - "soa_id": 3, - "alias_code_uid": "AliasCode_37215", - "standard_code": "Code_44502" - }, - { - "id": 231463, - "soa_id": 3, - "alias_code_uid": "AliasCode_37216", - "standard_code": "Code_44503" - }, - { - "id": 231464, - "soa_id": 3, - "alias_code_uid": "AliasCode_37217", - "standard_code": "Code_44504" - }, - { - "id": 231465, - "soa_id": 3, - "alias_code_uid": "AliasCode_37218", - "standard_code": "Code_44505" - }, - { - "id": 231466, - "soa_id": 3, - "alias_code_uid": "AliasCode_37219", - "standard_code": "Code_44506" - }, - { - "id": 231467, - "soa_id": 3, - "alias_code_uid": "AliasCode_37220", - "standard_code": "Code_44507" - }, - { - "id": 231468, - "soa_id": 3, - "alias_code_uid": "AliasCode_37221", - "standard_code": "Code_44508" - }, - { - "id": 231469, - "soa_id": 3, - "alias_code_uid": "AliasCode_37222", - "standard_code": "Code_44509" - }, - { - "id": 231470, - "soa_id": 3, - "alias_code_uid": "AliasCode_37223", - "standard_code": "Code_44510" - }, - { - "id": 231471, - "soa_id": 3, - "alias_code_uid": "AliasCode_37224", - "standard_code": "Code_44511" - }, - { - "id": 231472, - "soa_id": 3, - "alias_code_uid": "AliasCode_37225", - "standard_code": "Code_44512" - }, - { - "id": 231473, - "soa_id": 3, - "alias_code_uid": "AliasCode_37226", - "standard_code": "Code_44513" - }, - { - "id": 231474, - "soa_id": 3, - "alias_code_uid": "AliasCode_37227", - "standard_code": "Code_44514" - }, - { - "id": 231475, - "soa_id": 3, - "alias_code_uid": "AliasCode_37228", - "standard_code": "Code_44515" - }, - { - "id": 231476, - "soa_id": 3, - "alias_code_uid": "AliasCode_37229", - "standard_code": "Code_44516" - }, - { - "id": 231477, - "soa_id": 3, - "alias_code_uid": "AliasCode_37230", - "standard_code": "Code_44517" - }, - { - "id": 231478, - "soa_id": 3, - "alias_code_uid": "AliasCode_37231", - "standard_code": "Code_44518" - }, - { - "id": 231479, - "soa_id": 3, - "alias_code_uid": "AliasCode_37232", - "standard_code": "Code_44519" - }, - { - "id": 231480, - "soa_id": 3, - "alias_code_uid": "AliasCode_37233", - "standard_code": "Code_44520" - }, - { - "id": 231481, - "soa_id": 3, - "alias_code_uid": "AliasCode_37234", - "standard_code": "Code_44521" - }, - { - "id": 231482, - "soa_id": 3, - "alias_code_uid": "AliasCode_37235", - "standard_code": "Code_44522" - }, - { - "id": 231483, - "soa_id": 3, - "alias_code_uid": "AliasCode_37236", - "standard_code": "Code_44523" - }, - { - "id": 231484, - "soa_id": 3, - "alias_code_uid": "AliasCode_37237", - "standard_code": "Code_44524" - }, - { - "id": 231485, - "soa_id": 3, - "alias_code_uid": "AliasCode_37238", - "standard_code": "Code_44525" - }, - { - "id": 231486, - "soa_id": 3, - "alias_code_uid": "AliasCode_37239", - "standard_code": "Code_44526" - }, - { - "id": 231487, - "soa_id": 3, - "alias_code_uid": "AliasCode_37240", - "standard_code": "Code_44527" - }, - { - "id": 231488, - "soa_id": 3, - "alias_code_uid": "AliasCode_37241", - "standard_code": "Code_44528" - }, - { - "id": 231489, - "soa_id": 3, - "alias_code_uid": "AliasCode_37242", - "standard_code": "Code_44529" - }, - { - "id": 231490, - "soa_id": 3, - "alias_code_uid": "AliasCode_37243", - "standard_code": "Code_44530" - }, - { - "id": 231491, - "soa_id": 3, - "alias_code_uid": "AliasCode_37244", - "standard_code": "Code_44531" - }, - { - "id": 231492, - "soa_id": 3, - "alias_code_uid": "AliasCode_37245", - "standard_code": "Code_44532" - }, - { - "id": 231493, - "soa_id": 3, - "alias_code_uid": "AliasCode_37246", - "standard_code": "Code_44533" - }, - { - "id": 231494, - "soa_id": 3, - "alias_code_uid": "AliasCode_37247", - "standard_code": "Code_44534" - }, - { - "id": 231495, - "soa_id": 3, - "alias_code_uid": "AliasCode_37248", - "standard_code": "Code_44535" - }, - { - "id": 231496, - "soa_id": 3, - "alias_code_uid": "AliasCode_37249", - "standard_code": "Code_44536" - }, - { - "id": 231497, - "soa_id": 3, - "alias_code_uid": "AliasCode_37250", - "standard_code": "Code_44537" - }, - { - "id": 231498, - "soa_id": 3, - "alias_code_uid": "AliasCode_37251", - "standard_code": "Code_44538" - }, - { - "id": 231499, - "soa_id": 3, - "alias_code_uid": "AliasCode_37252", - "standard_code": "Code_44539" - }, - { - "id": 231500, - "soa_id": 3, - "alias_code_uid": "AliasCode_37253", - "standard_code": "Code_44540" - }, - { - "id": 231501, - "soa_id": 3, - "alias_code_uid": "AliasCode_37254", - "standard_code": "Code_44541" - }, - { - "id": 231502, - "soa_id": 3, - "alias_code_uid": "AliasCode_37255", - "standard_code": "Code_44542" - }, - { - "id": 231503, - "soa_id": 3, - "alias_code_uid": "AliasCode_37256", - "standard_code": "Code_44543" - }, - { - "id": 231504, - "soa_id": 3, - "alias_code_uid": "AliasCode_37257", - "standard_code": "Code_44544" - }, - { - "id": 231505, - "soa_id": 3, - "alias_code_uid": "AliasCode_37258", - "standard_code": "Code_44545" - }, - { - "id": 231506, - "soa_id": 3, - "alias_code_uid": "AliasCode_37259", - "standard_code": "Code_44546" - }, - { - "id": 231507, - "soa_id": 3, - "alias_code_uid": "AliasCode_37260", - "standard_code": "Code_44547" - }, - { - "id": 231508, - "soa_id": 3, - "alias_code_uid": "AliasCode_37261", - "standard_code": "Code_44548" - }, - { - "id": 231509, - "soa_id": 3, - "alias_code_uid": "AliasCode_37262", - "standard_code": "Code_44549" - }, - { - "id": 231510, - "soa_id": 3, - "alias_code_uid": "AliasCode_37263", - "standard_code": "Code_44550" - }, - { - "id": 231511, - "soa_id": 3, - "alias_code_uid": "AliasCode_37264", - "standard_code": "Code_44551" - }, - { - "id": 231512, - "soa_id": 3, - "alias_code_uid": "AliasCode_37265", - "standard_code": "Code_44552" - }, - { - "id": 231513, - "soa_id": 3, - "alias_code_uid": "AliasCode_37266", - "standard_code": "Code_44553" - }, - { - "id": 231514, - "soa_id": 3, - "alias_code_uid": "AliasCode_37267", - "standard_code": "Code_44554" - }, - { - "id": 231515, - "soa_id": 3, - "alias_code_uid": "AliasCode_37268", - "standard_code": "Code_44555" - }, - { - "id": 231516, - "soa_id": 3, - "alias_code_uid": "AliasCode_37269", - "standard_code": "Code_44556" - }, - { - "id": 231517, - "soa_id": 3, - "alias_code_uid": "AliasCode_37270", - "standard_code": "Code_44557" - }, - { - "id": 231518, - "soa_id": 3, - "alias_code_uid": "AliasCode_37271", - "standard_code": "Code_44558" - }, - { - "id": 231519, - "soa_id": 3, - "alias_code_uid": "AliasCode_37272", - "standard_code": "Code_44559" - }, - { - "id": 231520, - "soa_id": 3, - "alias_code_uid": "AliasCode_37273", - "standard_code": "Code_44560" - }, - { - "id": 231521, - "soa_id": 3, - "alias_code_uid": "AliasCode_37274", - "standard_code": "Code_44561" - }, - { - "id": 231522, - "soa_id": 3, - "alias_code_uid": "AliasCode_37275", - "standard_code": "Code_44562" - }, - { - "id": 231523, - "soa_id": 3, - "alias_code_uid": "AliasCode_37276", - "standard_code": "Code_44563" - }, - { - "id": 231524, - "soa_id": 3, - "alias_code_uid": "AliasCode_37277", - "standard_code": "Code_44564" - }, - { - "id": 231525, - "soa_id": 3, - "alias_code_uid": "AliasCode_37278", - "standard_code": "Code_44565" - }, - { - "id": 231526, - "soa_id": 3, - "alias_code_uid": "AliasCode_37279", - "standard_code": "Code_44566" - }, - { - "id": 231527, - "soa_id": 3, - "alias_code_uid": "AliasCode_37280", - "standard_code": "Code_44567" - }, - { - "id": 231528, - "soa_id": 3, - "alias_code_uid": "AliasCode_37281", - "standard_code": "Code_44568" - }, - { - "id": 231529, - "soa_id": 3, - "alias_code_uid": "AliasCode_37282", - "standard_code": "Code_44569" - }, - { - "id": 231530, - "soa_id": 3, - "alias_code_uid": "AliasCode_37283", - "standard_code": "Code_44570" - }, - { - "id": 231531, - "soa_id": 3, - "alias_code_uid": "AliasCode_37284", - "standard_code": "Code_44571" - }, - { - "id": 231532, - "soa_id": 3, - "alias_code_uid": "AliasCode_37285", - "standard_code": "Code_44572" - }, - { - "id": 231533, - "soa_id": 3, - "alias_code_uid": "AliasCode_37286", - "standard_code": "Code_44573" - }, - { - "id": 231534, - "soa_id": 3, - "alias_code_uid": "AliasCode_37287", - "standard_code": "Code_44574" - }, - { - "id": 231535, - "soa_id": 3, - "alias_code_uid": "AliasCode_37288", - "standard_code": "Code_44575" - }, - { - "id": 231536, - "soa_id": 3, - "alias_code_uid": "AliasCode_37289", - "standard_code": "Code_44576" - }, - { - "id": 231537, - "soa_id": 3, - "alias_code_uid": "AliasCode_37290", - "standard_code": "Code_44577" - }, - { - "id": 231538, - "soa_id": 3, - "alias_code_uid": "AliasCode_37291", - "standard_code": "Code_44578" - }, - { - "id": 231539, - "soa_id": 3, - "alias_code_uid": "AliasCode_37292", - "standard_code": "Code_44579" - }, - { - "id": 231540, - "soa_id": 3, - "alias_code_uid": "AliasCode_37293", - "standard_code": "Code_44580" - }, - { - "id": 231541, - "soa_id": 3, - "alias_code_uid": "AliasCode_37294", - "standard_code": "Code_44581" - }, - { - "id": 231542, - "soa_id": 3, - "alias_code_uid": "AliasCode_37295", - "standard_code": "Code_44582" - }, - { - "id": 231543, - "soa_id": 3, - "alias_code_uid": "AliasCode_37296", - "standard_code": "Code_44583" - }, - { - "id": 231544, - "soa_id": 3, - "alias_code_uid": "AliasCode_37297", - "standard_code": "Code_44584" - }, - { - "id": 231545, - "soa_id": 3, - "alias_code_uid": "AliasCode_37298", - "standard_code": "Code_44585" - }, - { - "id": 231546, - "soa_id": 3, - "alias_code_uid": "AliasCode_37299", - "standard_code": "Code_44586" - }, - { - "id": 231547, - "soa_id": 3, - "alias_code_uid": "AliasCode_37300", - "standard_code": "Code_44587" - }, - { - "id": 231548, - "soa_id": 3, - "alias_code_uid": "AliasCode_37301", - "standard_code": "Code_44588" - }, - { - "id": 231549, - "soa_id": 3, - "alias_code_uid": "AliasCode_37302", - "standard_code": "Code_44589" - }, - { - "id": 231550, - "soa_id": 3, - "alias_code_uid": "AliasCode_37303", - "standard_code": "Code_44590" - }, - { - "id": 231551, - "soa_id": 3, - "alias_code_uid": "AliasCode_37304", - "standard_code": "Code_44591" - }, - { - "id": 231552, - "soa_id": 3, - "alias_code_uid": "AliasCode_37305", - "standard_code": "Code_44592" - }, - { - "id": 231553, - "soa_id": 3, - "alias_code_uid": "AliasCode_37306", - "standard_code": "Code_44593" - }, - { - "id": 231554, - "soa_id": 3, - "alias_code_uid": "AliasCode_37307", - "standard_code": "Code_44594" - }, - { - "id": 231555, - "soa_id": 3, - "alias_code_uid": "AliasCode_37308", - "standard_code": "Code_44595" - }, - { - "id": 231556, - "soa_id": 3, - "alias_code_uid": "AliasCode_37309", - "standard_code": "Code_44596" - }, - { - "id": 231557, - "soa_id": 3, - "alias_code_uid": "AliasCode_37310", - "standard_code": "Code_44597" - }, - { - "id": 231558, - "soa_id": 3, - "alias_code_uid": "AliasCode_37311", - "standard_code": "Code_44598" - }, - { - "id": 231559, - "soa_id": 3, - "alias_code_uid": "AliasCode_37312", - "standard_code": "Code_44599" - }, - { - "id": 231560, - "soa_id": 3, - "alias_code_uid": "AliasCode_37313", - "standard_code": "Code_44600" - }, - { - "id": 231561, - "soa_id": 3, - "alias_code_uid": "AliasCode_37314", - "standard_code": "Code_44601" - }, - { - "id": 231562, - "soa_id": 3, - "alias_code_uid": "AliasCode_37315", - "standard_code": "Code_44602" - }, - { - "id": 231563, - "soa_id": 3, - "alias_code_uid": "AliasCode_37316", - "standard_code": "Code_44603" - }, - { - "id": 231564, - "soa_id": 3, - "alias_code_uid": "AliasCode_37317", - "standard_code": "Code_44604" - }, - { - "id": 231565, - "soa_id": 3, - "alias_code_uid": "AliasCode_37318", - "standard_code": "Code_44605" - }, - { - "id": 231566, - "soa_id": 3, - "alias_code_uid": "AliasCode_37319", - "standard_code": "Code_44606" - }, - { - "id": 231567, - "soa_id": 3, - "alias_code_uid": "AliasCode_37320", - "standard_code": "Code_44607" - }, - { - "id": 231568, - "soa_id": 3, - "alias_code_uid": "AliasCode_37321", - "standard_code": "Code_44608" - }, - { - "id": 231569, - "soa_id": 3, - "alias_code_uid": "AliasCode_37322", - "standard_code": "Code_44609" - }, - { - "id": 231570, - "soa_id": 3, - "alias_code_uid": "AliasCode_37323", - "standard_code": "Code_44610" - }, - { - "id": 231571, - "soa_id": 3, - "alias_code_uid": "AliasCode_37324", - "standard_code": "Code_44611" - }, - { - "id": 231572, - "soa_id": 3, - "alias_code_uid": "AliasCode_37325", - "standard_code": "Code_44612" - }, - { - "id": 231573, - "soa_id": 3, - "alias_code_uid": "AliasCode_37326", - "standard_code": "Code_44613" - }, - { - "id": 231574, - "soa_id": 3, - "alias_code_uid": "AliasCode_37327", - "standard_code": "Code_44614" - }, - { - "id": 231575, - "soa_id": 3, - "alias_code_uid": "AliasCode_37328", - "standard_code": "Code_44615" - }, - { - "id": 231576, - "soa_id": 3, - "alias_code_uid": "AliasCode_37329", - "standard_code": "Code_44616" - }, - { - "id": 231577, - "soa_id": 3, - "alias_code_uid": "AliasCode_37330", - "standard_code": "Code_44617" - }, - { - "id": 231578, - "soa_id": 3, - "alias_code_uid": "AliasCode_37331", - "standard_code": "Code_44618" - }, - { - "id": 231579, - "soa_id": 3, - "alias_code_uid": "AliasCode_37332", - "standard_code": "Code_44619" - }, - { - "id": 231580, - "soa_id": 3, - "alias_code_uid": "AliasCode_37333", - "standard_code": "Code_44620" - }, - { - "id": 231581, - "soa_id": 3, - "alias_code_uid": "AliasCode_37334", - "standard_code": "Code_44621" - }, - { - "id": 231582, - "soa_id": 3, - "alias_code_uid": "AliasCode_37335", - "standard_code": "Code_44622" - }, - { - "id": 231583, - "soa_id": 3, - "alias_code_uid": "AliasCode_37336", - "standard_code": "Code_44623" - }, - { - "id": 231584, - "soa_id": 3, - "alias_code_uid": "AliasCode_37337", - "standard_code": "Code_44624" - }, - { - "id": 231585, - "soa_id": 3, - "alias_code_uid": "AliasCode_37338", - "standard_code": "Code_44625" - }, - { - "id": 231586, - "soa_id": 3, - "alias_code_uid": "AliasCode_37339", - "standard_code": "Code_44626" - }, - { - "id": 231587, - "soa_id": 3, - "alias_code_uid": "AliasCode_37340", - "standard_code": "Code_44627" - }, - { - "id": 231588, - "soa_id": 3, - "alias_code_uid": "AliasCode_37341", - "standard_code": "Code_44628" - }, - { - "id": 231589, - "soa_id": 3, - "alias_code_uid": "AliasCode_37342", - "standard_code": "Code_44629" - }, - { - "id": 231590, - "soa_id": 3, - "alias_code_uid": "AliasCode_37343", - "standard_code": "Code_44630" - }, - { - "id": 231591, - "soa_id": 3, - "alias_code_uid": "AliasCode_37344", - "standard_code": "Code_44631" - }, - { - "id": 231592, - "soa_id": 3, - "alias_code_uid": "AliasCode_37345", - "standard_code": "Code_44632" - }, - { - "id": 231593, - "soa_id": 3, - "alias_code_uid": "AliasCode_37346", - "standard_code": "Code_44633" - }, - { - "id": 231594, - "soa_id": 3, - "alias_code_uid": "AliasCode_37347", - "standard_code": "Code_44634" - }, - { - "id": 231595, - "soa_id": 3, - "alias_code_uid": "AliasCode_37348", - "standard_code": "Code_44635" - }, - { - "id": 231596, - "soa_id": 3, - "alias_code_uid": "AliasCode_37349", - "standard_code": "Code_44636" - }, - { - "id": 231597, - "soa_id": 3, - "alias_code_uid": "AliasCode_37350", - "standard_code": "Code_44637" - }, - { - "id": 231598, - "soa_id": 3, - "alias_code_uid": "AliasCode_37351", - "standard_code": "Code_44638" - }, - { - "id": 231599, - "soa_id": 3, - "alias_code_uid": "AliasCode_37352", - "standard_code": "Code_44639" - }, - { - "id": 231600, - "soa_id": 3, - "alias_code_uid": "AliasCode_37353", - "standard_code": "Code_44640" - }, - { - "id": 231601, - "soa_id": 3, - "alias_code_uid": "AliasCode_37354", - "standard_code": "Code_44641" - }, - { - "id": 231602, - "soa_id": 3, - "alias_code_uid": "AliasCode_37355", - "standard_code": "Code_44642" - }, - { - "id": 231603, - "soa_id": 3, - "alias_code_uid": "AliasCode_37356", - "standard_code": "Code_44643" - }, - { - "id": 231604, - "soa_id": 3, - "alias_code_uid": "AliasCode_37357", - "standard_code": "Code_44644" - }, - { - "id": 231605, - "soa_id": 3, - "alias_code_uid": "AliasCode_37358", - "standard_code": "Code_44645" - }, - { - "id": 231606, - "soa_id": 3, - "alias_code_uid": "AliasCode_37359", - "standard_code": "Code_44646" - }, - { - "id": 231607, - "soa_id": 3, - "alias_code_uid": "AliasCode_37360", - "standard_code": "Code_44647" - }, - { - "id": 231608, - "soa_id": 3, - "alias_code_uid": "AliasCode_37361", - "standard_code": "Code_44648" - }, - { - "id": 231609, - "soa_id": 3, - "alias_code_uid": "AliasCode_37362", - "standard_code": "Code_44649" - }, - { - "id": 231610, - "soa_id": 3, - "alias_code_uid": "AliasCode_37363", - "standard_code": "Code_44650" - }, - { - "id": 231611, - "soa_id": 3, - "alias_code_uid": "AliasCode_37364", - "standard_code": "Code_44651" - }, - { - "id": 231612, - "soa_id": 3, - "alias_code_uid": "AliasCode_37365", - "standard_code": "Code_44652" - }, - { - "id": 231613, - "soa_id": 3, - "alias_code_uid": "AliasCode_37366", - "standard_code": "Code_44653" - }, - { - "id": 231614, - "soa_id": 3, - "alias_code_uid": "AliasCode_37367", - "standard_code": "Code_44654" - }, - { - "id": 231615, - "soa_id": 3, - "alias_code_uid": "AliasCode_37368", - "standard_code": "Code_44655" - }, - { - "id": 231616, - "soa_id": 3, - "alias_code_uid": "AliasCode_37369", - "standard_code": "Code_44656" - }, - { - "id": 231617, - "soa_id": 3, - "alias_code_uid": "AliasCode_37370", - "standard_code": "Code_44657" - }, - { - "id": 231618, - "soa_id": 3, - "alias_code_uid": "AliasCode_37371", - "standard_code": "Code_44658" - }, - { - "id": 231619, - "soa_id": 3, - "alias_code_uid": "AliasCode_37372", - "standard_code": "Code_44659" - }, - { - "id": 231620, - "soa_id": 3, - "alias_code_uid": "AliasCode_37373", - "standard_code": "Code_44660" - }, - { - "id": 231621, - "soa_id": 3, - "alias_code_uid": "AliasCode_37374", - "standard_code": "Code_44661" - }, - { - "id": 231622, - "soa_id": 3, - "alias_code_uid": "AliasCode_37375", - "standard_code": "Code_44662" - }, - { - "id": 231623, - "soa_id": 3, - "alias_code_uid": "AliasCode_37376", - "standard_code": "Code_44663" - }, - { - "id": 231624, - "soa_id": 3, - "alias_code_uid": "AliasCode_37377", - "standard_code": "Code_44664" - }, - { - "id": 231625, - "soa_id": 3, - "alias_code_uid": "AliasCode_37378", - "standard_code": "Code_44665" - }, - { - "id": 231626, - "soa_id": 3, - "alias_code_uid": "AliasCode_37379", - "standard_code": "Code_44666" - }, - { - "id": 231627, - "soa_id": 3, - "alias_code_uid": "AliasCode_37380", - "standard_code": "Code_44667" - }, - { - "id": 231628, - "soa_id": 3, - "alias_code_uid": "AliasCode_37381", - "standard_code": "Code_44668" - }, - { - "id": 231629, - "soa_id": 3, - "alias_code_uid": "AliasCode_37382", - "standard_code": "Code_44669" - }, - { - "id": 231630, - "soa_id": 3, - "alias_code_uid": "AliasCode_37383", - "standard_code": "Code_44670" - }, - { - "id": 231631, - "soa_id": 3, - "alias_code_uid": "AliasCode_37384", - "standard_code": "Code_44671" - }, - { - "id": 231632, - "soa_id": 3, - "alias_code_uid": "AliasCode_37385", - "standard_code": "Code_44672" - }, - { - "id": 231633, - "soa_id": 3, - "alias_code_uid": "AliasCode_37386", - "standard_code": "Code_44673" - }, - { - "id": 231634, - "soa_id": 3, - "alias_code_uid": "AliasCode_37387", - "standard_code": "Code_44674" - }, - { - "id": 231635, - "soa_id": 3, - "alias_code_uid": "AliasCode_37388", - "standard_code": "Code_44675" - }, - { - "id": 231636, - "soa_id": 3, - "alias_code_uid": "AliasCode_37389", - "standard_code": "Code_44676" - }, - { - "id": 231637, - "soa_id": 3, - "alias_code_uid": "AliasCode_37390", - "standard_code": "Code_44677" - }, - { - "id": 231638, - "soa_id": 3, - "alias_code_uid": "AliasCode_37391", - "standard_code": "Code_44678" - }, - { - "id": 231639, - "soa_id": 3, - "alias_code_uid": "AliasCode_37392", - "standard_code": "Code_44679" - }, - { - "id": 231640, - "soa_id": 3, - "alias_code_uid": "AliasCode_37393", - "standard_code": "Code_44680" - }, - { - "id": 231641, - "soa_id": 3, - "alias_code_uid": "AliasCode_37394", - "standard_code": "Code_44681" - }, - { - "id": 231642, - "soa_id": 3, - "alias_code_uid": "AliasCode_37395", - "standard_code": "Code_44682" - }, - { - "id": 231643, - "soa_id": 3, - "alias_code_uid": "AliasCode_37396", - "standard_code": "Code_44683" - }, - { - "id": 231644, - "soa_id": 3, - "alias_code_uid": "AliasCode_37397", - "standard_code": "Code_44684" - }, - { - "id": 231645, - "soa_id": 3, - "alias_code_uid": "AliasCode_37398", - "standard_code": "Code_44685" - }, - { - "id": 231646, - "soa_id": 3, - "alias_code_uid": "AliasCode_37399", - "standard_code": "Code_44686" - }, - { - "id": 231647, - "soa_id": 3, - "alias_code_uid": "AliasCode_37400", - "standard_code": "Code_44687" - }, - { - "id": 231648, - "soa_id": 3, - "alias_code_uid": "AliasCode_37401", - "standard_code": "Code_44688" - }, - { - "id": 231649, - "soa_id": 3, - "alias_code_uid": "AliasCode_37402", - "standard_code": "Code_44689" - }, - { - "id": 231650, - "soa_id": 3, - "alias_code_uid": "AliasCode_37403", - "standard_code": "Code_44690" - }, - { - "id": 231651, - "soa_id": 3, - "alias_code_uid": "AliasCode_37404", - "standard_code": "Code_44691" - }, - { - "id": 231652, - "soa_id": 3, - "alias_code_uid": "AliasCode_37405", - "standard_code": "Code_44692" - }, - { - "id": 231653, - "soa_id": 3, - "alias_code_uid": "AliasCode_37406", - "standard_code": "Code_44693" - }, - { - "id": 231654, - "soa_id": 3, - "alias_code_uid": "AliasCode_37407", - "standard_code": "Code_44694" - }, - { - "id": 231655, - "soa_id": 3, - "alias_code_uid": "AliasCode_37408", - "standard_code": "Code_44695" - }, - { - "id": 231656, - "soa_id": 3, - "alias_code_uid": "AliasCode_37409", - "standard_code": "Code_44696" - }, - { - "id": 231657, - "soa_id": 3, - "alias_code_uid": "AliasCode_37410", - "standard_code": "Code_44697" - }, - { - "id": 231658, - "soa_id": 3, - "alias_code_uid": "AliasCode_37411", - "standard_code": "Code_44698" - }, - { - "id": 231659, - "soa_id": 3, - "alias_code_uid": "AliasCode_37412", - "standard_code": "Code_44699" - }, - { - "id": 231660, - "soa_id": 3, - "alias_code_uid": "AliasCode_37413", - "standard_code": "Code_44700" - }, - { - "id": 231661, - "soa_id": 3, - "alias_code_uid": "AliasCode_37414", - "standard_code": "Code_44701" - }, - { - "id": 231662, - "soa_id": 3, - "alias_code_uid": "AliasCode_37415", - "standard_code": "Code_44702" - }, - { - "id": 231663, - "soa_id": 3, - "alias_code_uid": "AliasCode_37416", - "standard_code": "Code_44703" - }, - { - "id": 231664, - "soa_id": 3, - "alias_code_uid": "AliasCode_37417", - "standard_code": "Code_44704" - }, - { - "id": 231665, - "soa_id": 3, - "alias_code_uid": "AliasCode_37418", - "standard_code": "Code_44705" - }, - { - "id": 231666, - "soa_id": 3, - "alias_code_uid": "AliasCode_37419", - "standard_code": "Code_44706" - }, - { - "id": 231667, - "soa_id": 3, - "alias_code_uid": "AliasCode_37420", - "standard_code": "Code_44707" - }, - { - "id": 231668, - "soa_id": 3, - "alias_code_uid": "AliasCode_37421", - "standard_code": "Code_44708" - }, - { - "id": 231669, - "soa_id": 3, - "alias_code_uid": "AliasCode_37422", - "standard_code": "Code_44709" - }, - { - "id": 231670, - "soa_id": 3, - "alias_code_uid": "AliasCode_37423", - "standard_code": "Code_44710" - }, - { - "id": 231671, - "soa_id": 3, - "alias_code_uid": "AliasCode_37424", - "standard_code": "Code_44711" - }, - { - "id": 231672, - "soa_id": 3, - "alias_code_uid": "AliasCode_37425", - "standard_code": "Code_44712" - }, - { - "id": 231673, - "soa_id": 3, - "alias_code_uid": "AliasCode_37426", - "standard_code": "Code_44713" - }, - { - "id": 231674, - "soa_id": 3, - "alias_code_uid": "AliasCode_37427", - "standard_code": "Code_44714" - }, - { - "id": 231675, - "soa_id": 3, - "alias_code_uid": "AliasCode_37428", - "standard_code": "Code_44715" - }, - { - "id": 231676, - "soa_id": 3, - "alias_code_uid": "AliasCode_37429", - "standard_code": "Code_44716" - }, - { - "id": 231677, - "soa_id": 3, - "alias_code_uid": "AliasCode_37430", - "standard_code": "Code_44717" - }, - { - "id": 231678, - "soa_id": 3, - "alias_code_uid": "AliasCode_37431", - "standard_code": "Code_44718" - }, - { - "id": 231679, - "soa_id": 3, - "alias_code_uid": "AliasCode_37432", - "standard_code": "Code_44719" - }, - { - "id": 231680, - "soa_id": 3, - "alias_code_uid": "AliasCode_37433", - "standard_code": "Code_44720" - }, - { - "id": 231681, - "soa_id": 3, - "alias_code_uid": "AliasCode_37434", - "standard_code": "Code_44721" - }, - { - "id": 231682, - "soa_id": 3, - "alias_code_uid": "AliasCode_37435", - "standard_code": "Code_44722" - }, - { - "id": 231683, - "soa_id": 3, - "alias_code_uid": "AliasCode_37436", - "standard_code": "Code_44723" - }, - { - "id": 231684, - "soa_id": 3, - "alias_code_uid": "AliasCode_37437", - "standard_code": "Code_44724" - }, - { - "id": 231685, - "soa_id": 3, - "alias_code_uid": "AliasCode_37438", - "standard_code": "Code_44725" - }, - { - "id": 231686, - "soa_id": 3, - "alias_code_uid": "AliasCode_37439", - "standard_code": "Code_44726" - }, - { - "id": 231687, - "soa_id": 3, - "alias_code_uid": "AliasCode_37440", - "standard_code": "Code_44727" - }, - { - "id": 231688, - "soa_id": 3, - "alias_code_uid": "AliasCode_37441", - "standard_code": "Code_44728" - }, - { - "id": 231689, - "soa_id": 3, - "alias_code_uid": "AliasCode_37442", - "standard_code": "Code_44729" - }, - { - "id": 231690, - "soa_id": 3, - "alias_code_uid": "AliasCode_37443", - "standard_code": "Code_44730" - }, - { - "id": 231691, - "soa_id": 3, - "alias_code_uid": "AliasCode_37444", - "standard_code": "Code_44731" - }, - { - "id": 231692, - "soa_id": 3, - "alias_code_uid": "AliasCode_37445", - "standard_code": "Code_44732" - }, - { - "id": 231693, - "soa_id": 3, - "alias_code_uid": "AliasCode_37446", - "standard_code": "Code_44733" - }, - { - "id": 231694, - "soa_id": 3, - "alias_code_uid": "AliasCode_37447", - "standard_code": "Code_44734" - }, - { - "id": 231695, - "soa_id": 3, - "alias_code_uid": "AliasCode_37448", - "standard_code": "Code_44735" - }, - { - "id": 231696, - "soa_id": 3, - "alias_code_uid": "AliasCode_37449", - "standard_code": "Code_44736" - }, - { - "id": 231697, - "soa_id": 3, - "alias_code_uid": "AliasCode_37450", - "standard_code": "Code_44737" - }, - { - "id": 231698, - "soa_id": 3, - "alias_code_uid": "AliasCode_37451", - "standard_code": "Code_44738" - }, - { - "id": 231699, - "soa_id": 3, - "alias_code_uid": "AliasCode_37452", - "standard_code": "Code_44739" - }, - { - "id": 231700, - "soa_id": 3, - "alias_code_uid": "AliasCode_37453", - "standard_code": "Code_44740" - }, - { - "id": 231701, - "soa_id": 3, - "alias_code_uid": "AliasCode_37454", - "standard_code": "Code_44741" - }, - { - "id": 231702, - "soa_id": 3, - "alias_code_uid": "AliasCode_37455", - "standard_code": "Code_44742" - }, - { - "id": 231703, - "soa_id": 3, - "alias_code_uid": "AliasCode_37456", - "standard_code": "Code_44743" - }, - { - "id": 231704, - "soa_id": 3, - "alias_code_uid": "AliasCode_37457", - "standard_code": "Code_44744" - }, - { - "id": 231705, - "soa_id": 3, - "alias_code_uid": "AliasCode_37458", - "standard_code": "Code_44745" - }, - { - "id": 231706, - "soa_id": 3, - "alias_code_uid": "AliasCode_37459", - "standard_code": "Code_44746" - }, - { - "id": 231707, - "soa_id": 3, - "alias_code_uid": "AliasCode_37460", - "standard_code": "Code_44747" - }, - { - "id": 231708, - "soa_id": 3, - "alias_code_uid": "AliasCode_37461", - "standard_code": "Code_44748" - }, - { - "id": 231709, - "soa_id": 3, - "alias_code_uid": "AliasCode_37462", - "standard_code": "Code_44749" - }, - { - "id": 231710, - "soa_id": 3, - "alias_code_uid": "AliasCode_37463", - "standard_code": "Code_44750" - }, - { - "id": 231711, - "soa_id": 3, - "alias_code_uid": "AliasCode_37464", - "standard_code": "Code_44751" - }, - { - "id": 231712, - "soa_id": 3, - "alias_code_uid": "AliasCode_37465", - "standard_code": "Code_44752" - }, - { - "id": 231713, - "soa_id": 3, - "alias_code_uid": "AliasCode_37466", - "standard_code": "Code_44753" - }, - { - "id": 231714, - "soa_id": 3, - "alias_code_uid": "AliasCode_37467", - "standard_code": "Code_44754" - }, - { - "id": 231715, - "soa_id": 3, - "alias_code_uid": "AliasCode_37468", - "standard_code": "Code_44755" - }, - { - "id": 231716, - "soa_id": 3, - "alias_code_uid": "AliasCode_37469", - "standard_code": "Code_44756" - }, - { - "id": 231717, - "soa_id": 3, - "alias_code_uid": "AliasCode_37470", - "standard_code": "Code_44757" - }, - { - "id": 231718, - "soa_id": 3, - "alias_code_uid": "AliasCode_37471", - "standard_code": "Code_44758" - }, - { - "id": 231719, - "soa_id": 3, - "alias_code_uid": "AliasCode_37472", - "standard_code": "Code_44759" - }, - { - "id": 231720, - "soa_id": 3, - "alias_code_uid": "AliasCode_37473", - "standard_code": "Code_44760" - }, - { - "id": 231721, - "soa_id": 3, - "alias_code_uid": "AliasCode_37474", - "standard_code": "Code_44761" - }, - { - "id": 231722, - "soa_id": 3, - "alias_code_uid": "AliasCode_37475", - "standard_code": "Code_44762" - }, - { - "id": 231723, - "soa_id": 3, - "alias_code_uid": "AliasCode_37476", - "standard_code": "Code_44763" - }, - { - "id": 231724, - "soa_id": 3, - "alias_code_uid": "AliasCode_37477", - "standard_code": "Code_44764" - }, - { - "id": 231725, - "soa_id": 3, - "alias_code_uid": "AliasCode_37478", - "standard_code": "Code_44765" - }, - { - "id": 231726, - "soa_id": 3, - "alias_code_uid": "AliasCode_37479", - "standard_code": "Code_44766" - }, - { - "id": 231727, - "soa_id": 3, - "alias_code_uid": "AliasCode_37480", - "standard_code": "Code_44767" - }, - { - "id": 231728, - "soa_id": 3, - "alias_code_uid": "AliasCode_37481", - "standard_code": "Code_44768" - }, - { - "id": 231729, - "soa_id": 3, - "alias_code_uid": "AliasCode_37482", - "standard_code": "Code_44769" - }, - { - "id": 231730, - "soa_id": 3, - "alias_code_uid": "AliasCode_37483", - "standard_code": "Code_44770" - }, - { - "id": 231731, - "soa_id": 3, - "alias_code_uid": "AliasCode_37484", - "standard_code": "Code_44771" - }, - { - "id": 231732, - "soa_id": 3, - "alias_code_uid": "AliasCode_37485", - "standard_code": "Code_44772" - }, - { - "id": 231733, - "soa_id": 3, - "alias_code_uid": "AliasCode_37486", - "standard_code": "Code_44773" - }, - { - "id": 231734, - "soa_id": 3, - "alias_code_uid": "AliasCode_37487", - "standard_code": "Code_44774" - }, - { - "id": 231735, - "soa_id": 3, - "alias_code_uid": "AliasCode_37488", - "standard_code": "Code_44775" - }, - { - "id": 231736, - "soa_id": 3, - "alias_code_uid": "AliasCode_37489", - "standard_code": "Code_44776" - }, - { - "id": 231737, - "soa_id": 3, - "alias_code_uid": "AliasCode_37490", - "standard_code": "Code_44777" - }, - { - "id": 231738, - "soa_id": 3, - "alias_code_uid": "AliasCode_37491", - "standard_code": "Code_44778" - }, - { - "id": 231739, - "soa_id": 3, - "alias_code_uid": "AliasCode_37492", - "standard_code": "Code_44779" - }, - { - "id": 231740, - "soa_id": 3, - "alias_code_uid": "AliasCode_37493", - "standard_code": "Code_44780" - }, - { - "id": 231741, - "soa_id": 3, - "alias_code_uid": "AliasCode_37494", - "standard_code": "Code_44781" - }, - { - "id": 231742, - "soa_id": 3, - "alias_code_uid": "AliasCode_37495", - "standard_code": "Code_44782" - }, - { - "id": 231743, - "soa_id": 3, - "alias_code_uid": "AliasCode_37496", - "standard_code": "Code_44783" - }, - { - "id": 231744, - "soa_id": 3, - "alias_code_uid": "AliasCode_37497", - "standard_code": "Code_44784" - }, - { - "id": 231745, - "soa_id": 3, - "alias_code_uid": "AliasCode_37498", - "standard_code": "Code_44785" - }, - { - "id": 231746, - "soa_id": 3, - "alias_code_uid": "AliasCode_37499", - "standard_code": "Code_44786" - }, - { - "id": 231747, - "soa_id": 3, - "alias_code_uid": "AliasCode_37500", - "standard_code": "Code_44787" - }, - { - "id": 231748, - "soa_id": 3, - "alias_code_uid": "AliasCode_37501", - "standard_code": "Code_44788" - }, - { - "id": 231749, - "soa_id": 3, - "alias_code_uid": "AliasCode_37502", - "standard_code": "Code_44789" - }, - { - "id": 231750, - "soa_id": 3, - "alias_code_uid": "AliasCode_37503", - "standard_code": "Code_44790" - }, - { - "id": 231751, - "soa_id": 3, - "alias_code_uid": "AliasCode_37504", - "standard_code": "Code_44791" - }, - { - "id": 231752, - "soa_id": 3, - "alias_code_uid": "AliasCode_37505", - "standard_code": "Code_44792" - }, - { - "id": 231753, - "soa_id": 3, - "alias_code_uid": "AliasCode_37506", - "standard_code": "Code_44793" - }, - { - "id": 231754, - "soa_id": 3, - "alias_code_uid": "AliasCode_37507", - "standard_code": "Code_44794" - }, - { - "id": 231755, - "soa_id": 3, - "alias_code_uid": "AliasCode_37508", - "standard_code": "Code_44795" - }, - { - "id": 231756, - "soa_id": 3, - "alias_code_uid": "AliasCode_37509", - "standard_code": "Code_44796" - }, - { - "id": 231757, - "soa_id": 3, - "alias_code_uid": "AliasCode_37510", - "standard_code": "Code_44797" - }, - { - "id": 231758, - "soa_id": 3, - "alias_code_uid": "AliasCode_37511", - "standard_code": "Code_44798" - }, - { - "id": 231759, - "soa_id": 3, - "alias_code_uid": "AliasCode_37512", - "standard_code": "Code_44799" - }, - { - "id": 231760, - "soa_id": 3, - "alias_code_uid": "AliasCode_37513", - "standard_code": "Code_44800" - }, - { - "id": 231761, - "soa_id": 3, - "alias_code_uid": "AliasCode_37514", - "standard_code": "Code_44801" - }, - { - "id": 231762, - "soa_id": 3, - "alias_code_uid": "AliasCode_37515", - "standard_code": "Code_44802" - }, - { - "id": 231763, - "soa_id": 3, - "alias_code_uid": "AliasCode_37516", - "standard_code": "Code_44803" - }, - { - "id": 231764, - "soa_id": 3, - "alias_code_uid": "AliasCode_37517", - "standard_code": "Code_44804" - }, - { - "id": 231765, - "soa_id": 3, - "alias_code_uid": "AliasCode_37518", - "standard_code": "Code_44805" - }, - { - "id": 231766, - "soa_id": 3, - "alias_code_uid": "AliasCode_37519", - "standard_code": "Code_44806" - }, - { - "id": 231767, - "soa_id": 3, - "alias_code_uid": "AliasCode_37520", - "standard_code": "Code_44807" - }, - { - "id": 231768, - "soa_id": 3, - "alias_code_uid": "AliasCode_37521", - "standard_code": "Code_44808" - }, - { - "id": 231769, - "soa_id": 3, - "alias_code_uid": "AliasCode_37522", - "standard_code": "Code_44809" - }, - { - "id": 231770, - "soa_id": 3, - "alias_code_uid": "AliasCode_37523", - "standard_code": "Code_44810" - }, - { - "id": 231771, - "soa_id": 3, - "alias_code_uid": "AliasCode_37524", - "standard_code": "Code_44811" - }, - { - "id": 231772, - "soa_id": 3, - "alias_code_uid": "AliasCode_37525", - "standard_code": "Code_44812" - }, - { - "id": 231773, - "soa_id": 3, - "alias_code_uid": "AliasCode_37526", - "standard_code": "Code_44813" - }, - { - "id": 231774, - "soa_id": 3, - "alias_code_uid": "AliasCode_37527", - "standard_code": "Code_44814" - }, - { - "id": 231775, - "soa_id": 3, - "alias_code_uid": "AliasCode_37528", - "standard_code": "Code_44815" - }, - { - "id": 231776, - "soa_id": 3, - "alias_code_uid": "AliasCode_37529", - "standard_code": "Code_44816" - }, - { - "id": 231777, - "soa_id": 3, - "alias_code_uid": "AliasCode_37530", - "standard_code": "Code_44817" - }, - { - "id": 231778, - "soa_id": 3, - "alias_code_uid": "AliasCode_37531", - "standard_code": "Code_44818" - }, - { - "id": 231779, - "soa_id": 3, - "alias_code_uid": "AliasCode_37532", - "standard_code": "Code_44819" - }, - { - "id": 231780, - "soa_id": 3, - "alias_code_uid": "AliasCode_37533", - "standard_code": "Code_44820" - }, - { - "id": 231781, - "soa_id": 3, - "alias_code_uid": "AliasCode_37534", - "standard_code": "Code_44821" - }, - { - "id": 231782, - "soa_id": 3, - "alias_code_uid": "AliasCode_37535", - "standard_code": "Code_44822" - }, - { - "id": 231783, - "soa_id": 3, - "alias_code_uid": "AliasCode_37536", - "standard_code": "Code_44823" - }, - { - "id": 231784, - "soa_id": 3, - "alias_code_uid": "AliasCode_37537", - "standard_code": "Code_44824" - }, - { - "id": 231785, - "soa_id": 3, - "alias_code_uid": "AliasCode_37538", - "standard_code": "Code_44825" - }, - { - "id": 231786, - "soa_id": 3, - "alias_code_uid": "AliasCode_37539", - "standard_code": "Code_44826" - }, - { - "id": 231787, - "soa_id": 3, - "alias_code_uid": "AliasCode_37540", - "standard_code": "Code_44827" - }, - { - "id": 231788, - "soa_id": 3, - "alias_code_uid": "AliasCode_37541", - "standard_code": "Code_44828" - }, - { - "id": 231789, - "soa_id": 3, - "alias_code_uid": "AliasCode_37542", - "standard_code": "Code_44829" - }, - { - "id": 231790, - "soa_id": 3, - "alias_code_uid": "AliasCode_37543", - "standard_code": "Code_44830" - }, - { - "id": 231791, - "soa_id": 3, - "alias_code_uid": "AliasCode_37544", - "standard_code": "Code_44831" - }, - { - "id": 231792, - "soa_id": 3, - "alias_code_uid": "AliasCode_37545", - "standard_code": "Code_44832" - }, - { - "id": 231793, - "soa_id": 3, - "alias_code_uid": "AliasCode_37546", - "standard_code": "Code_44833" - }, - { - "id": 231794, - "soa_id": 3, - "alias_code_uid": "AliasCode_37547", - "standard_code": "Code_44834" - }, - { - "id": 231795, - "soa_id": 3, - "alias_code_uid": "AliasCode_37548", - "standard_code": "Code_44835" - }, - { - "id": 231796, - "soa_id": 3, - "alias_code_uid": "AliasCode_37549", - "standard_code": "Code_44836" - }, - { - "id": 231797, - "soa_id": 3, - "alias_code_uid": "AliasCode_37550", - "standard_code": "Code_44837" - }, - { - "id": 231798, - "soa_id": 3, - "alias_code_uid": "AliasCode_37551", - "standard_code": "Code_44838" - }, - { - "id": 231799, - "soa_id": 3, - "alias_code_uid": "AliasCode_37552", - "standard_code": "Code_44839" - }, - { - "id": 231800, - "soa_id": 3, - "alias_code_uid": "AliasCode_37553", - "standard_code": "Code_44840" - }, - { - "id": 231801, - "soa_id": 3, - "alias_code_uid": "AliasCode_37554", - "standard_code": "Code_44841" - }, - { - "id": 231802, - "soa_id": 3, - "alias_code_uid": "AliasCode_37555", - "standard_code": "Code_44842" - }, - { - "id": 231803, - "soa_id": 3, - "alias_code_uid": "AliasCode_37556", - "standard_code": "Code_44843" - }, - { - "id": 231804, - "soa_id": 3, - "alias_code_uid": "AliasCode_37557", - "standard_code": "Code_44844" - }, - { - "id": 231805, - "soa_id": 3, - "alias_code_uid": "AliasCode_37558", - "standard_code": "Code_44845" - }, - { - "id": 231806, - "soa_id": 3, - "alias_code_uid": "AliasCode_37559", - "standard_code": "Code_44846" - }, - { - "id": 231807, - "soa_id": 3, - "alias_code_uid": "AliasCode_37560", - "standard_code": "Code_44847" - }, - { - "id": 231808, - "soa_id": 3, - "alias_code_uid": "AliasCode_37561", - "standard_code": "Code_44848" - }, - { - "id": 231809, - "soa_id": 3, - "alias_code_uid": "AliasCode_37562", - "standard_code": "Code_44849" - }, - { - "id": 231810, - "soa_id": 3, - "alias_code_uid": "AliasCode_37563", - "standard_code": "Code_44850" - }, - { - "id": 231811, - "soa_id": 3, - "alias_code_uid": "AliasCode_37564", - "standard_code": "Code_44851" - }, - { - "id": 231812, - "soa_id": 3, - "alias_code_uid": "AliasCode_37565", - "standard_code": "Code_44852" - }, - { - "id": 231813, - "soa_id": 3, - "alias_code_uid": "AliasCode_37566", - "standard_code": "Code_44853" - }, - { - "id": 231814, - "soa_id": 3, - "alias_code_uid": "AliasCode_37567", - "standard_code": "Code_44854" - }, - { - "id": 231815, - "soa_id": 3, - "alias_code_uid": "AliasCode_37568", - "standard_code": "Code_44855" - }, - { - "id": 231816, - "soa_id": 3, - "alias_code_uid": "AliasCode_37569", - "standard_code": "Code_44856" - }, - { - "id": 231817, - "soa_id": 3, - "alias_code_uid": "AliasCode_37570", - "standard_code": "Code_44857" - }, - { - "id": 231818, - "soa_id": 3, - "alias_code_uid": "AliasCode_37571", - "standard_code": "Code_44858" - }, - { - "id": 231819, - "soa_id": 3, - "alias_code_uid": "AliasCode_37572", - "standard_code": "Code_44859" - }, - { - "id": 231820, - "soa_id": 3, - "alias_code_uid": "AliasCode_37573", - "standard_code": "Code_44860" - }, - { - "id": 231821, - "soa_id": 3, - "alias_code_uid": "AliasCode_37574", - "standard_code": "Code_44861" - }, - { - "id": 231822, - "soa_id": 3, - "alias_code_uid": "AliasCode_37575", - "standard_code": "Code_44862" - }, - { - "id": 231823, - "soa_id": 3, - "alias_code_uid": "AliasCode_37576", - "standard_code": "Code_44863" - }, - { - "id": 231824, - "soa_id": 3, - "alias_code_uid": "AliasCode_37577", - "standard_code": "Code_44864" - }, - { - "id": 231825, - "soa_id": 3, - "alias_code_uid": "AliasCode_37578", - "standard_code": "Code_44865" - }, - { - "id": 231826, - "soa_id": 3, - "alias_code_uid": "AliasCode_37579", - "standard_code": "Code_44866" - }, - { - "id": 231827, - "soa_id": 3, - "alias_code_uid": "AliasCode_37580", - "standard_code": "Code_44867" - }, - { - "id": 231828, - "soa_id": 3, - "alias_code_uid": "AliasCode_37581", - "standard_code": "Code_44868" - }, - { - "id": 231829, - "soa_id": 3, - "alias_code_uid": "AliasCode_37582", - "standard_code": "Code_44869" - }, - { - "id": 231830, - "soa_id": 3, - "alias_code_uid": "AliasCode_37583", - "standard_code": "Code_44870" - }, - { - "id": 231831, - "soa_id": 3, - "alias_code_uid": "AliasCode_37584", - "standard_code": "Code_44871" - }, - { - "id": 231832, - "soa_id": 3, - "alias_code_uid": "AliasCode_37585", - "standard_code": "Code_44872" - }, - { - "id": 231833, - "soa_id": 3, - "alias_code_uid": "AliasCode_37586", - "standard_code": "Code_44873" - }, - { - "id": 231834, - "soa_id": 3, - "alias_code_uid": "AliasCode_37587", - "standard_code": "Code_44874" - }, - { - "id": 231835, - "soa_id": 3, - "alias_code_uid": "AliasCode_37588", - "standard_code": "Code_44875" - }, - { - "id": 231836, - "soa_id": 3, - "alias_code_uid": "AliasCode_37589", - "standard_code": "Code_44876" - }, - { - "id": 231837, - "soa_id": 3, - "alias_code_uid": "AliasCode_37590", - "standard_code": "Code_44877" - }, - { - "id": 231838, - "soa_id": 3, - "alias_code_uid": "AliasCode_37591", - "standard_code": "Code_44878" - }, - { - "id": 231839, - "soa_id": 3, - "alias_code_uid": "AliasCode_37592", - "standard_code": "Code_44879" - }, - { - "id": 231840, - "soa_id": 3, - "alias_code_uid": "AliasCode_37593", - "standard_code": "Code_44880" - }, - { - "id": 231841, - "soa_id": 3, - "alias_code_uid": "AliasCode_37594", - "standard_code": "Code_44881" - }, - { - "id": 231842, - "soa_id": 3, - "alias_code_uid": "AliasCode_37595", - "standard_code": "Code_44882" - }, - { - "id": 231843, - "soa_id": 3, - "alias_code_uid": "AliasCode_37596", - "standard_code": "Code_44883" - }, - { - "id": 231844, - "soa_id": 3, - "alias_code_uid": "AliasCode_37597", - "standard_code": "Code_44884" - }, - { - "id": 231845, - "soa_id": 3, - "alias_code_uid": "AliasCode_37598", - "standard_code": "Code_44885" - }, - { - "id": 231846, - "soa_id": 3, - "alias_code_uid": "AliasCode_37599", - "standard_code": "Code_44886" - }, - { - "id": 231847, - "soa_id": 3, - "alias_code_uid": "AliasCode_37600", - "standard_code": "Code_44887" - }, - { - "id": 231848, - "soa_id": 3, - "alias_code_uid": "AliasCode_37601", - "standard_code": "Code_44888" - }, - { - "id": 231849, - "soa_id": 3, - "alias_code_uid": "AliasCode_37602", - "standard_code": "Code_44889" - }, - { - "id": 231850, - "soa_id": 3, - "alias_code_uid": "AliasCode_37603", - "standard_code": "Code_44890" - }, - { - "id": 231851, - "soa_id": 3, - "alias_code_uid": "AliasCode_37604", - "standard_code": "Code_44891" - }, - { - "id": 231852, - "soa_id": 3, - "alias_code_uid": "AliasCode_37605", - "standard_code": "Code_44892" - }, - { - "id": 231853, - "soa_id": 3, - "alias_code_uid": "AliasCode_37606", - "standard_code": "Code_44893" - }, - { - "id": 231854, - "soa_id": 3, - "alias_code_uid": "AliasCode_37607", - "standard_code": "Code_44894" - }, - { - "id": 231855, - "soa_id": 3, - "alias_code_uid": "AliasCode_37608", - "standard_code": "Code_44895" - }, - { - "id": 231856, - "soa_id": 3, - "alias_code_uid": "AliasCode_37609", - "standard_code": "Code_44896" - }, - { - "id": 231857, - "soa_id": 3, - "alias_code_uid": "AliasCode_37610", - "standard_code": "Code_44897" - }, - { - "id": 231858, - "soa_id": 3, - "alias_code_uid": "AliasCode_37611", - "standard_code": "Code_44898" - }, - { - "id": 231859, - "soa_id": 3, - "alias_code_uid": "AliasCode_37612", - "standard_code": "Code_44899" - }, - { - "id": 231860, - "soa_id": 3, - "alias_code_uid": "AliasCode_37613", - "standard_code": "Code_44900" - }, - { - "id": 231861, - "soa_id": 3, - "alias_code_uid": "AliasCode_37614", - "standard_code": "Code_44901" - }, - { - "id": 231862, - "soa_id": 3, - "alias_code_uid": "AliasCode_37615", - "standard_code": "Code_44902" - }, - { - "id": 231863, - "soa_id": 3, - "alias_code_uid": "AliasCode_37616", - "standard_code": "Code_44903" - }, - { - "id": 231864, - "soa_id": 3, - "alias_code_uid": "AliasCode_37617", - "standard_code": "Code_44904" - }, - { - "id": 231865, - "soa_id": 3, - "alias_code_uid": "AliasCode_37618", - "standard_code": "Code_44905" - }, - { - "id": 231866, - "soa_id": 3, - "alias_code_uid": "AliasCode_37619", - "standard_code": "Code_44906" - }, - { - "id": 231867, - "soa_id": 3, - "alias_code_uid": "AliasCode_37620", - "standard_code": "Code_44907" - }, - { - "id": 231868, - "soa_id": 3, - "alias_code_uid": "AliasCode_37621", - "standard_code": "Code_44908" - }, - { - "id": 231869, - "soa_id": 3, - "alias_code_uid": "AliasCode_37622", - "standard_code": "Code_44909" - }, - { - "id": 231870, - "soa_id": 3, - "alias_code_uid": "AliasCode_37623", - "standard_code": "Code_44910" - }, - { - "id": 231871, - "soa_id": 3, - "alias_code_uid": "AliasCode_37624", - "standard_code": "Code_44911" - }, - { - "id": 231872, - "soa_id": 3, - "alias_code_uid": "AliasCode_37625", - "standard_code": "Code_44912" - }, - { - "id": 231873, - "soa_id": 3, - "alias_code_uid": "AliasCode_37626", - "standard_code": "Code_44913" - }, - { - "id": 231874, - "soa_id": 3, - "alias_code_uid": "AliasCode_37627", - "standard_code": "Code_44914" - }, - { - "id": 231875, - "soa_id": 3, - "alias_code_uid": "AliasCode_37628", - "standard_code": "Code_44915" - }, - { - "id": 231876, - "soa_id": 3, - "alias_code_uid": "AliasCode_37629", - "standard_code": "Code_44916" - }, - { - "id": 231877, - "soa_id": 3, - "alias_code_uid": "AliasCode_37630", - "standard_code": "Code_44917" - }, - { - "id": 231878, - "soa_id": 3, - "alias_code_uid": "AliasCode_37631", - "standard_code": "Code_44918" - }, - { - "id": 231879, - "soa_id": 3, - "alias_code_uid": "AliasCode_37632", - "standard_code": "Code_44919" - }, - { - "id": 231880, - "soa_id": 3, - "alias_code_uid": "AliasCode_37633", - "standard_code": "Code_44920" - }, - { - "id": 231881, - "soa_id": 3, - "alias_code_uid": "AliasCode_37634", - "standard_code": "Code_44921" - }, - { - "id": 231882, - "soa_id": 3, - "alias_code_uid": "AliasCode_37635", - "standard_code": "Code_44922" - }, - { - "id": 231883, - "soa_id": 3, - "alias_code_uid": "AliasCode_37636", - "standard_code": "Code_44923" - }, - { - "id": 231884, - "soa_id": 3, - "alias_code_uid": "AliasCode_37637", - "standard_code": "Code_44924" - }, - { - "id": 231885, - "soa_id": 3, - "alias_code_uid": "AliasCode_37638", - "standard_code": "Code_44925" - }, - { - "id": 231886, - "soa_id": 3, - "alias_code_uid": "AliasCode_37639", - "standard_code": "Code_44926" - }, - { - "id": 231887, - "soa_id": 3, - "alias_code_uid": "AliasCode_37640", - "standard_code": "Code_44927" - }, - { - "id": 231888, - "soa_id": 3, - "alias_code_uid": "AliasCode_37641", - "standard_code": "Code_44928" - }, - { - "id": 231889, - "soa_id": 3, - "alias_code_uid": "AliasCode_37642", - "standard_code": "Code_44929" - }, - { - "id": 231890, - "soa_id": 3, - "alias_code_uid": "AliasCode_37643", - "standard_code": "Code_44930" - }, - { - "id": 231891, - "soa_id": 3, - "alias_code_uid": "AliasCode_37644", - "standard_code": "Code_44931" - }, - { - "id": 231892, - "soa_id": 3, - "alias_code_uid": "AliasCode_37645", - "standard_code": "Code_44932" - }, - { - "id": 231893, - "soa_id": 3, - "alias_code_uid": "AliasCode_37646", - "standard_code": "Code_44933" - }, - { - "id": 231894, - "soa_id": 3, - "alias_code_uid": "AliasCode_37647", - "standard_code": "Code_44934" - }, - { - "id": 231895, - "soa_id": 3, - "alias_code_uid": "AliasCode_37648", - "standard_code": "Code_44935" - }, - { - "id": 231896, - "soa_id": 3, - "alias_code_uid": "AliasCode_37649", - "standard_code": "Code_44936" - }, - { - "id": 231897, - "soa_id": 3, - "alias_code_uid": "AliasCode_37650", - "standard_code": "Code_44937" - }, - { - "id": 231898, - "soa_id": 3, - "alias_code_uid": "AliasCode_37651", - "standard_code": "Code_44938" - }, - { - "id": 231899, - "soa_id": 3, - "alias_code_uid": "AliasCode_37652", - "standard_code": "Code_44939" - }, - { - "id": 231900, - "soa_id": 3, - "alias_code_uid": "AliasCode_37653", - "standard_code": "Code_44940" - }, - { - "id": 231901, - "soa_id": 3, - "alias_code_uid": "AliasCode_37654", - "standard_code": "Code_44941" - }, - { - "id": 231902, - "soa_id": 3, - "alias_code_uid": "AliasCode_37655", - "standard_code": "Code_44942" - }, - { - "id": 231903, - "soa_id": 3, - "alias_code_uid": "AliasCode_37656", - "standard_code": "Code_44943" - }, - { - "id": 231904, - "soa_id": 3, - "alias_code_uid": "AliasCode_37657", - "standard_code": "Code_44944" - }, - { - "id": 231905, - "soa_id": 3, - "alias_code_uid": "AliasCode_37658", - "standard_code": "Code_44945" - }, - { - "id": 231906, - "soa_id": 3, - "alias_code_uid": "AliasCode_37659", - "standard_code": "Code_44946" - }, - { - "id": 231907, - "soa_id": 3, - "alias_code_uid": "AliasCode_37660", - "standard_code": "Code_44947" - }, - { - "id": 231908, - "soa_id": 3, - "alias_code_uid": "AliasCode_37661", - "standard_code": "Code_44948" - }, - { - "id": 231909, - "soa_id": 3, - "alias_code_uid": "AliasCode_37662", - "standard_code": "Code_44949" - }, - { - "id": 231910, - "soa_id": 3, - "alias_code_uid": "AliasCode_37663", - "standard_code": "Code_44950" - }, - { - "id": 231911, - "soa_id": 3, - "alias_code_uid": "AliasCode_37664", - "standard_code": "Code_44951" - }, - { - "id": 231912, - "soa_id": 3, - "alias_code_uid": "AliasCode_37665", - "standard_code": "Code_44952" - }, - { - "id": 231913, - "soa_id": 3, - "alias_code_uid": "AliasCode_37666", - "standard_code": "Code_44953" - }, - { - "id": 231914, - "soa_id": 3, - "alias_code_uid": "AliasCode_37667", - "standard_code": "Code_44954" - }, - { - "id": 231915, - "soa_id": 3, - "alias_code_uid": "AliasCode_37668", - "standard_code": "Code_44955" - }, - { - "id": 231916, - "soa_id": 3, - "alias_code_uid": "AliasCode_37669", - "standard_code": "Code_44956" - }, - { - "id": 231917, - "soa_id": 3, - "alias_code_uid": "AliasCode_37670", - "standard_code": "Code_44957" - }, - { - "id": 231918, - "soa_id": 3, - "alias_code_uid": "AliasCode_37671", - "standard_code": "Code_44958" - }, - { - "id": 231919, - "soa_id": 3, - "alias_code_uid": "AliasCode_37672", - "standard_code": "Code_44959" - }, - { - "id": 231920, - "soa_id": 3, - "alias_code_uid": "AliasCode_37673", - "standard_code": "Code_44960" - }, - { - "id": 231921, - "soa_id": 3, - "alias_code_uid": "AliasCode_37674", - "standard_code": "Code_44961" - }, - { - "id": 231922, - "soa_id": 3, - "alias_code_uid": "AliasCode_37675", - "standard_code": "Code_44962" - }, - { - "id": 231923, - "soa_id": 3, - "alias_code_uid": "AliasCode_37676", - "standard_code": "Code_44963" - }, - { - "id": 231924, - "soa_id": 3, - "alias_code_uid": "AliasCode_37677", - "standard_code": "Code_44964" - }, - { - "id": 231925, - "soa_id": 3, - "alias_code_uid": "AliasCode_37678", - "standard_code": "Code_44965" - }, - { - "id": 231926, - "soa_id": 3, - "alias_code_uid": "AliasCode_37679", - "standard_code": "Code_44966" - }, - { - "id": 231927, - "soa_id": 3, - "alias_code_uid": "AliasCode_37680", - "standard_code": "Code_44967" - }, - { - "id": 231928, - "soa_id": 3, - "alias_code_uid": "AliasCode_37681", - "standard_code": "Code_44968" - }, - { - "id": 231929, - "soa_id": 3, - "alias_code_uid": "AliasCode_37682", - "standard_code": "Code_44969" - }, - { - "id": 231930, - "soa_id": 3, - "alias_code_uid": "AliasCode_37683", - "standard_code": "Code_44970" - }, - { - "id": 231931, - "soa_id": 3, - "alias_code_uid": "AliasCode_37684", - "standard_code": "Code_44971" - }, - { - "id": 231932, - "soa_id": 3, - "alias_code_uid": "AliasCode_37685", - "standard_code": "Code_44972" - }, - { - "id": 231933, - "soa_id": 3, - "alias_code_uid": "AliasCode_37686", - "standard_code": "Code_44973" - }, - { - "id": 231934, - "soa_id": 3, - "alias_code_uid": "AliasCode_37687", - "standard_code": "Code_44974" - }, - { - "id": 231935, - "soa_id": 3, - "alias_code_uid": "AliasCode_37688", - "standard_code": "Code_44975" - }, - { - "id": 231936, - "soa_id": 3, - "alias_code_uid": "AliasCode_37689", - "standard_code": "Code_44976" - }, - { - "id": 231937, - "soa_id": 3, - "alias_code_uid": "AliasCode_37690", - "standard_code": "Code_44977" - }, - { - "id": 231938, - "soa_id": 3, - "alias_code_uid": "AliasCode_37691", - "standard_code": "Code_44978" - }, - { - "id": 231939, - "soa_id": 3, - "alias_code_uid": "AliasCode_37692", - "standard_code": "Code_44979" - }, - { - "id": 231940, - "soa_id": 3, - "alias_code_uid": "AliasCode_37693", - "standard_code": "Code_44980" - }, - { - "id": 231941, - "soa_id": 3, - "alias_code_uid": "AliasCode_37694", - "standard_code": "Code_44981" - }, - { - "id": 231942, - "soa_id": 3, - "alias_code_uid": "AliasCode_37695", - "standard_code": "Code_44982" - }, - { - "id": 231943, - "soa_id": 3, - "alias_code_uid": "AliasCode_37696", - "standard_code": "Code_44983" - }, - { - "id": 231944, - "soa_id": 3, - "alias_code_uid": "AliasCode_37697", - "standard_code": "Code_44984" - }, - { - "id": 231945, - "soa_id": 3, - "alias_code_uid": "AliasCode_37698", - "standard_code": "Code_44985" - }, - { - "id": 231946, - "soa_id": 3, - "alias_code_uid": "AliasCode_37699", - "standard_code": "Code_44986" - }, - { - "id": 231947, - "soa_id": 3, - "alias_code_uid": "AliasCode_37700", - "standard_code": "Code_44987" - }, - { - "id": 231948, - "soa_id": 3, - "alias_code_uid": "AliasCode_37701", - "standard_code": "Code_44988" - }, - { - "id": 231949, - "soa_id": 3, - "alias_code_uid": "AliasCode_37702", - "standard_code": "Code_44989" - }, - { - "id": 231950, - "soa_id": 3, - "alias_code_uid": "AliasCode_37703", - "standard_code": "Code_44990" - }, - { - "id": 231951, - "soa_id": 3, - "alias_code_uid": "AliasCode_37704", - "standard_code": "Code_44991" - }, - { - "id": 231952, - "soa_id": 3, - "alias_code_uid": "AliasCode_37705", - "standard_code": "Code_44992" - }, - { - "id": 231953, - "soa_id": 3, - "alias_code_uid": "AliasCode_37706", - "standard_code": "Code_44993" - }, - { - "id": 231954, - "soa_id": 3, - "alias_code_uid": "AliasCode_37707", - "standard_code": "Code_44994" - }, - { - "id": 231955, - "soa_id": 3, - "alias_code_uid": "AliasCode_37708", - "standard_code": "Code_44995" - }, - { - "id": 231956, - "soa_id": 3, - "alias_code_uid": "AliasCode_37709", - "standard_code": "Code_44996" - }, - { - "id": 231957, - "soa_id": 3, - "alias_code_uid": "AliasCode_37710", - "standard_code": "Code_44997" - }, - { - "id": 231958, - "soa_id": 3, - "alias_code_uid": "AliasCode_37711", - "standard_code": "Code_44998" - }, - { - "id": 231959, - "soa_id": 3, - "alias_code_uid": "AliasCode_37712", - "standard_code": "Code_44999" - }, - { - "id": 231960, - "soa_id": 3, - "alias_code_uid": "AliasCode_37713", - "standard_code": "Code_45000" - }, - { - "id": 231961, - "soa_id": 3, - "alias_code_uid": "AliasCode_37714", - "standard_code": "Code_45001" - }, - { - "id": 231962, - "soa_id": 3, - "alias_code_uid": "AliasCode_37715", - "standard_code": "Code_45002" - }, - { - "id": 231963, - "soa_id": 3, - "alias_code_uid": "AliasCode_37716", - "standard_code": "Code_45003" - }, - { - "id": 231964, - "soa_id": 3, - "alias_code_uid": "AliasCode_37717", - "standard_code": "Code_45004" - }, - { - "id": 231965, - "soa_id": 3, - "alias_code_uid": "AliasCode_37718", - "standard_code": "Code_45005" - }, - { - "id": 231966, - "soa_id": 3, - "alias_code_uid": "AliasCode_37719", - "standard_code": "Code_45006" - }, - { - "id": 231967, - "soa_id": 3, - "alias_code_uid": "AliasCode_37720", - "standard_code": "Code_45007" - }, - { - "id": 231968, - "soa_id": 3, - "alias_code_uid": "AliasCode_37721", - "standard_code": "Code_45008" - }, - { - "id": 231969, - "soa_id": 3, - "alias_code_uid": "AliasCode_37722", - "standard_code": "Code_45009" - }, - { - "id": 231970, - "soa_id": 3, - "alias_code_uid": "AliasCode_37723", - "standard_code": "Code_45010" - }, - { - "id": 231971, - "soa_id": 3, - "alias_code_uid": "AliasCode_37724", - "standard_code": "Code_45011" - }, - { - "id": 231972, - "soa_id": 3, - "alias_code_uid": "AliasCode_37725", - "standard_code": "Code_45012" - }, - { - "id": 231973, - "soa_id": 3, - "alias_code_uid": "AliasCode_37726", - "standard_code": "Code_45013" - }, - { - "id": 231974, - "soa_id": 3, - "alias_code_uid": "AliasCode_37727", - "standard_code": "Code_45014" - }, - { - "id": 231975, - "soa_id": 3, - "alias_code_uid": "AliasCode_37728", - "standard_code": "Code_45015" - }, - { - "id": 231976, - "soa_id": 3, - "alias_code_uid": "AliasCode_37729", - "standard_code": "Code_45016" - }, - { - "id": 231977, - "soa_id": 3, - "alias_code_uid": "AliasCode_37730", - "standard_code": "Code_45017" - }, - { - "id": 231978, - "soa_id": 3, - "alias_code_uid": "AliasCode_37731", - "standard_code": "Code_45018" - }, - { - "id": 231979, - "soa_id": 3, - "alias_code_uid": "AliasCode_37732", - "standard_code": "Code_45019" - }, - { - "id": 231980, - "soa_id": 3, - "alias_code_uid": "AliasCode_37733", - "standard_code": "Code_45020" - }, - { - "id": 231981, - "soa_id": 3, - "alias_code_uid": "AliasCode_37734", - "standard_code": "Code_45021" - }, - { - "id": 231982, - "soa_id": 3, - "alias_code_uid": "AliasCode_37735", - "standard_code": "Code_45022" - }, - { - "id": 231983, - "soa_id": 3, - "alias_code_uid": "AliasCode_37736", - "standard_code": "Code_45023" - }, - { - "id": 231984, - "soa_id": 3, - "alias_code_uid": "AliasCode_37737", - "standard_code": "Code_45024" - }, - { - "id": 231985, - "soa_id": 3, - "alias_code_uid": "AliasCode_37738", - "standard_code": "Code_45025" - }, - { - "id": 231986, - "soa_id": 3, - "alias_code_uid": "AliasCode_37739", - "standard_code": "Code_45026" - }, - { - "id": 231987, - "soa_id": 3, - "alias_code_uid": "AliasCode_37740", - "standard_code": "Code_45027" - }, - { - "id": 231988, - "soa_id": 3, - "alias_code_uid": "AliasCode_37741", - "standard_code": "Code_45028" - }, - { - "id": 231989, - "soa_id": 3, - "alias_code_uid": "AliasCode_37742", - "standard_code": "Code_45029" - }, - { - "id": 231990, - "soa_id": 3, - "alias_code_uid": "AliasCode_37743", - "standard_code": "Code_45030" - }, - { - "id": 231991, - "soa_id": 3, - "alias_code_uid": "AliasCode_37744", - "standard_code": "Code_45031" - }, - { - "id": 231992, - "soa_id": 3, - "alias_code_uid": "AliasCode_37745", - "standard_code": "Code_45032" - }, - { - "id": 231993, - "soa_id": 3, - "alias_code_uid": "AliasCode_37746", - "standard_code": "Code_45033" - }, - { - "id": 231994, - "soa_id": 3, - "alias_code_uid": "AliasCode_37747", - "standard_code": "Code_45034" - }, - { - "id": 231995, - "soa_id": 3, - "alias_code_uid": "AliasCode_37748", - "standard_code": "Code_45035" - }, - { - "id": 231996, - "soa_id": 3, - "alias_code_uid": "AliasCode_37749", - "standard_code": "Code_45036" - }, - { - "id": 231997, - "soa_id": 3, - "alias_code_uid": "AliasCode_37750", - "standard_code": "Code_45037" - }, - { - "id": 231998, - "soa_id": 3, - "alias_code_uid": "AliasCode_37751", - "standard_code": "Code_45038" - }, - { - "id": 231999, - "soa_id": 3, - "alias_code_uid": "AliasCode_37752", - "standard_code": "Code_45039" - }, - { - "id": 232000, - "soa_id": 3, - "alias_code_uid": "AliasCode_37753", - "standard_code": "Code_45040" - }, - { - "id": 232001, - "soa_id": 3, - "alias_code_uid": "AliasCode_37754", - "standard_code": "Code_45041" - }, - { - "id": 232002, - "soa_id": 3, - "alias_code_uid": "AliasCode_37755", - "standard_code": "Code_45042" - }, - { - "id": 232003, - "soa_id": 3, - "alias_code_uid": "AliasCode_37756", - "standard_code": "Code_45043" - }, - { - "id": 232004, - "soa_id": 3, - "alias_code_uid": "AliasCode_37757", - "standard_code": "Code_45044" - }, - { - "id": 232005, - "soa_id": 3, - "alias_code_uid": "AliasCode_37758", - "standard_code": "Code_45045" - }, - { - "id": 232006, - "soa_id": 3, - "alias_code_uid": "AliasCode_37759", - "standard_code": "Code_45046" - }, - { - "id": 232007, - "soa_id": 3, - "alias_code_uid": "AliasCode_37760", - "standard_code": "Code_45047" - }, - { - "id": 232008, - "soa_id": 3, - "alias_code_uid": "AliasCode_37761", - "standard_code": "Code_45048" - }, - { - "id": 232009, - "soa_id": 3, - "alias_code_uid": "AliasCode_37762", - "standard_code": "Code_45049" - }, - { - "id": 232010, - "soa_id": 3, - "alias_code_uid": "AliasCode_37763", - "standard_code": "Code_45050" - }, - { - "id": 232011, - "soa_id": 3, - "alias_code_uid": "AliasCode_37764", - "standard_code": "Code_45051" - }, - { - "id": 232012, - "soa_id": 3, - "alias_code_uid": "AliasCode_37765", - "standard_code": "Code_45052" - }, - { - "id": 232013, - "soa_id": 3, - "alias_code_uid": "AliasCode_37766", - "standard_code": "Code_45053" - }, - { - "id": 232014, - "soa_id": 3, - "alias_code_uid": "AliasCode_37767", - "standard_code": "Code_45054" - }, - { - "id": 232015, - "soa_id": 3, - "alias_code_uid": "AliasCode_37768", - "standard_code": "Code_45055" - }, - { - "id": 232016, - "soa_id": 3, - "alias_code_uid": "AliasCode_37769", - "standard_code": "Code_45056" - }, - { - "id": 232017, - "soa_id": 3, - "alias_code_uid": "AliasCode_37770", - "standard_code": "Code_45057" - }, - { - "id": 232018, - "soa_id": 3, - "alias_code_uid": "AliasCode_37771", - "standard_code": "Code_45058" - }, - { - "id": 232019, - "soa_id": 3, - "alias_code_uid": "AliasCode_37772", - "standard_code": "Code_45059" - }, - { - "id": 232020, - "soa_id": 3, - "alias_code_uid": "AliasCode_37773", - "standard_code": "Code_45060" - }, - { - "id": 232021, - "soa_id": 3, - "alias_code_uid": "AliasCode_37774", - "standard_code": "Code_45061" - }, - { - "id": 232022, - "soa_id": 3, - "alias_code_uid": "AliasCode_37775", - "standard_code": "Code_45062" - }, - { - "id": 232023, - "soa_id": 3, - "alias_code_uid": "AliasCode_37776", - "standard_code": "Code_45063" - }, - { - "id": 232024, - "soa_id": 3, - "alias_code_uid": "AliasCode_37777", - "standard_code": "Code_45064" - }, - { - "id": 232025, - "soa_id": 3, - "alias_code_uid": "AliasCode_37778", - "standard_code": "Code_45065" - }, - { - "id": 232026, - "soa_id": 3, - "alias_code_uid": "AliasCode_37779", - "standard_code": "Code_45066" - }, - { - "id": 232027, - "soa_id": 3, - "alias_code_uid": "AliasCode_37780", - "standard_code": "Code_45067" - }, - { - "id": 232028, - "soa_id": 3, - "alias_code_uid": "AliasCode_37781", - "standard_code": "Code_45068" - }, - { - "id": 232029, - "soa_id": 3, - "alias_code_uid": "AliasCode_37782", - "standard_code": "Code_45069" - }, - { - "id": 232030, - "soa_id": 3, - "alias_code_uid": "AliasCode_37783", - "standard_code": "Code_45070" - }, - { - "id": 232031, - "soa_id": 3, - "alias_code_uid": "AliasCode_37784", - "standard_code": "Code_45071" - }, - { - "id": 232032, - "soa_id": 3, - "alias_code_uid": "AliasCode_37785", - "standard_code": "Code_45072" - }, - { - "id": 232033, - "soa_id": 3, - "alias_code_uid": "AliasCode_37786", - "standard_code": "Code_45073" - }, - { - "id": 232034, - "soa_id": 3, - "alias_code_uid": "AliasCode_37787", - "standard_code": "Code_45074" - }, - { - "id": 232035, - "soa_id": 3, - "alias_code_uid": "AliasCode_37788", - "standard_code": "Code_45075" - }, - { - "id": 232036, - "soa_id": 3, - "alias_code_uid": "AliasCode_37789", - "standard_code": "Code_45076" - }, - { - "id": 232037, - "soa_id": 3, - "alias_code_uid": "AliasCode_37790", - "standard_code": "Code_45077" - }, - { - "id": 232038, - "soa_id": 3, - "alias_code_uid": "AliasCode_37791", - "standard_code": "Code_45078" - }, - { - "id": 232039, - "soa_id": 3, - "alias_code_uid": "AliasCode_37792", - "standard_code": "Code_45079" - }, - { - "id": 232040, - "soa_id": 3, - "alias_code_uid": "AliasCode_37793", - "standard_code": "Code_45080" - }, - { - "id": 232041, - "soa_id": 3, - "alias_code_uid": "AliasCode_37794", - "standard_code": "Code_45081" - }, - { - "id": 232042, - "soa_id": 3, - "alias_code_uid": "AliasCode_37795", - "standard_code": "Code_45082" - }, - { - "id": 232043, - "soa_id": 3, - "alias_code_uid": "AliasCode_37796", - "standard_code": "Code_45083" - }, - { - "id": 232044, - "soa_id": 3, - "alias_code_uid": "AliasCode_37797", - "standard_code": "Code_45084" - }, - { - "id": 232045, - "soa_id": 3, - "alias_code_uid": "AliasCode_37798", - "standard_code": "Code_45085" - }, - { - "id": 232046, - "soa_id": 3, - "alias_code_uid": "AliasCode_37799", - "standard_code": "Code_45086" - }, - { - "id": 232047, - "soa_id": 3, - "alias_code_uid": "AliasCode_37800", - "standard_code": "Code_45087" - }, - { - "id": 232048, - "soa_id": 3, - "alias_code_uid": "AliasCode_37801", - "standard_code": "Code_45088" - }, - { - "id": 232049, - "soa_id": 3, - "alias_code_uid": "AliasCode_37802", - "standard_code": "Code_45089" - }, - { - "id": 232050, - "soa_id": 3, - "alias_code_uid": "AliasCode_37803", - "standard_code": "Code_45090" - }, - { - "id": 232051, - "soa_id": 3, - "alias_code_uid": "AliasCode_37804", - "standard_code": "Code_45091" - }, - { - "id": 232052, - "soa_id": 3, - "alias_code_uid": "AliasCode_37805", - "standard_code": "Code_45092" - }, - { - "id": 232053, - "soa_id": 3, - "alias_code_uid": "AliasCode_37806", - "standard_code": "Code_45093" - }, - { - "id": 232054, - "soa_id": 3, - "alias_code_uid": "AliasCode_37807", - "standard_code": "Code_45094" - }, - { - "id": 232055, - "soa_id": 3, - "alias_code_uid": "AliasCode_37808", - "standard_code": "Code_45095" - }, - { - "id": 232056, - "soa_id": 3, - "alias_code_uid": "AliasCode_37809", - "standard_code": "Code_45096" - }, - { - "id": 232057, - "soa_id": 3, - "alias_code_uid": "AliasCode_37810", - "standard_code": "Code_45097" - }, - { - "id": 232058, - "soa_id": 3, - "alias_code_uid": "AliasCode_37811", - "standard_code": "Code_45098" - }, - { - "id": 232059, - "soa_id": 3, - "alias_code_uid": "AliasCode_37812", - "standard_code": "Code_45099" - }, - { - "id": 232060, - "soa_id": 3, - "alias_code_uid": "AliasCode_37813", - "standard_code": "Code_45100" - }, - { - "id": 232061, - "soa_id": 3, - "alias_code_uid": "AliasCode_37814", - "standard_code": "Code_45101" - }, - { - "id": 232062, - "soa_id": 3, - "alias_code_uid": "AliasCode_37815", - "standard_code": "Code_45102" - }, - { - "id": 232063, - "soa_id": 3, - "alias_code_uid": "AliasCode_37816", - "standard_code": "Code_45103" - }, - { - "id": 232064, - "soa_id": 3, - "alias_code_uid": "AliasCode_37817", - "standard_code": "Code_45104" - }, - { - "id": 232065, - "soa_id": 3, - "alias_code_uid": "AliasCode_37818", - "standard_code": "Code_45105" - }, - { - "id": 232066, - "soa_id": 3, - "alias_code_uid": "AliasCode_37819", - "standard_code": "Code_45106" - }, - { - "id": 232067, - "soa_id": 3, - "alias_code_uid": "AliasCode_37820", - "standard_code": "Code_45107" - }, - { - "id": 232068, - "soa_id": 3, - "alias_code_uid": "AliasCode_37821", - "standard_code": "Code_45108" - }, - { - "id": 232069, - "soa_id": 3, - "alias_code_uid": "AliasCode_37822", - "standard_code": "Code_45109" - }, - { - "id": 232070, - "soa_id": 3, - "alias_code_uid": "AliasCode_37823", - "standard_code": "Code_45110" - }, - { - "id": 232071, - "soa_id": 3, - "alias_code_uid": "AliasCode_37824", - "standard_code": "Code_45111" - }, - { - "id": 232072, - "soa_id": 3, - "alias_code_uid": "AliasCode_37825", - "standard_code": "Code_45112" - }, - { - "id": 232073, - "soa_id": 3, - "alias_code_uid": "AliasCode_37826", - "standard_code": "Code_45113" - }, - { - "id": 232074, - "soa_id": 3, - "alias_code_uid": "AliasCode_37827", - "standard_code": "Code_45114" - }, - { - "id": 232075, - "soa_id": 3, - "alias_code_uid": "AliasCode_37828", - "standard_code": "Code_45115" - }, - { - "id": 232076, - "soa_id": 3, - "alias_code_uid": "AliasCode_37829", - "standard_code": "Code_45116" - }, - { - "id": 232077, - "soa_id": 3, - "alias_code_uid": "AliasCode_37830", - "standard_code": "Code_45117" - }, - { - "id": 232078, - "soa_id": 3, - "alias_code_uid": "AliasCode_37831", - "standard_code": "Code_45118" - }, - { - "id": 232079, - "soa_id": 3, - "alias_code_uid": "AliasCode_37832", - "standard_code": "Code_45119" - }, - { - "id": 232080, - "soa_id": 3, - "alias_code_uid": "AliasCode_37833", - "standard_code": "Code_45120" - }, - { - "id": 232081, - "soa_id": 3, - "alias_code_uid": "AliasCode_37834", - "standard_code": "Code_45121" - }, - { - "id": 232082, - "soa_id": 3, - "alias_code_uid": "AliasCode_37835", - "standard_code": "Code_45122" - }, - { - "id": 232083, - "soa_id": 3, - "alias_code_uid": "AliasCode_37836", - "standard_code": "Code_45123" - }, - { - "id": 232084, - "soa_id": 3, - "alias_code_uid": "AliasCode_37837", - "standard_code": "Code_45124" - }, - { - "id": 232085, - "soa_id": 3, - "alias_code_uid": "AliasCode_37838", - "standard_code": "Code_45125" - }, - { - "id": 232086, - "soa_id": 3, - "alias_code_uid": "AliasCode_37839", - "standard_code": "Code_45126" - }, - { - "id": 232087, - "soa_id": 3, - "alias_code_uid": "AliasCode_37840", - "standard_code": "Code_45127" - }, - { - "id": 232088, - "soa_id": 3, - "alias_code_uid": "AliasCode_37841", - "standard_code": "Code_45128" - }, - { - "id": 232089, - "soa_id": 3, - "alias_code_uid": "AliasCode_37842", - "standard_code": "Code_45129" - }, - { - "id": 232090, - "soa_id": 3, - "alias_code_uid": "AliasCode_37843", - "standard_code": "Code_45130" - }, - { - "id": 232091, - "soa_id": 3, - "alias_code_uid": "AliasCode_37844", - "standard_code": "Code_45131" - }, - { - "id": 232092, - "soa_id": 3, - "alias_code_uid": "AliasCode_37845", - "standard_code": "Code_45132" - }, - { - "id": 232093, - "soa_id": 3, - "alias_code_uid": "AliasCode_37846", - "standard_code": "Code_45133" - }, - { - "id": 232094, - "soa_id": 3, - "alias_code_uid": "AliasCode_37847", - "standard_code": "Code_45134" - }, - { - "id": 232095, - "soa_id": 3, - "alias_code_uid": "AliasCode_37848", - "standard_code": "Code_45135" - }, - { - "id": 232096, - "soa_id": 3, - "alias_code_uid": "AliasCode_37849", - "standard_code": "Code_45136" - }, - { - "id": 232097, - "soa_id": 3, - "alias_code_uid": "AliasCode_37850", - "standard_code": "Code_45137" - }, - { - "id": 232098, - "soa_id": 3, - "alias_code_uid": "AliasCode_37851", - "standard_code": "Code_45138" - }, - { - "id": 232099, - "soa_id": 3, - "alias_code_uid": "AliasCode_37852", - "standard_code": "Code_45139" - }, - { - "id": 232100, - "soa_id": 3, - "alias_code_uid": "AliasCode_37853", - "standard_code": "Code_45140" - }, - { - "id": 232101, - "soa_id": 3, - "alias_code_uid": "AliasCode_37854", - "standard_code": "Code_45141" - }, - { - "id": 232102, - "soa_id": 3, - "alias_code_uid": "AliasCode_37855", - "standard_code": "Code_45142" - }, - { - "id": 232103, - "soa_id": 3, - "alias_code_uid": "AliasCode_37856", - "standard_code": "Code_45143" - }, - { - "id": 232104, - "soa_id": 3, - "alias_code_uid": "AliasCode_37857", - "standard_code": "Code_45144" - }, - { - "id": 232105, - "soa_id": 3, - "alias_code_uid": "AliasCode_37858", - "standard_code": "Code_45145" - }, - { - "id": 232106, - "soa_id": 3, - "alias_code_uid": "AliasCode_37859", - "standard_code": "Code_45146" - }, - { - "id": 232107, - "soa_id": 3, - "alias_code_uid": "AliasCode_37860", - "standard_code": "Code_45147" - }, - { - "id": 232108, - "soa_id": 3, - "alias_code_uid": "AliasCode_37861", - "standard_code": "Code_45148" - }, - { - "id": 232109, - "soa_id": 3, - "alias_code_uid": "AliasCode_37862", - "standard_code": "Code_45149" - }, - { - "id": 232110, - "soa_id": 3, - "alias_code_uid": "AliasCode_37863", - "standard_code": "Code_45150" - }, - { - "id": 232111, - "soa_id": 3, - "alias_code_uid": "AliasCode_37864", - "standard_code": "Code_45151" - }, - { - "id": 232112, - "soa_id": 3, - "alias_code_uid": "AliasCode_37865", - "standard_code": "Code_45152" - }, - { - "id": 232113, - "soa_id": 3, - "alias_code_uid": "AliasCode_37866", - "standard_code": "Code_45153" - }, - { - "id": 232114, - "soa_id": 3, - "alias_code_uid": "AliasCode_37867", - "standard_code": "Code_45154" - }, - { - "id": 232115, - "soa_id": 3, - "alias_code_uid": "AliasCode_37868", - "standard_code": "Code_45155" - }, - { - "id": 232116, - "soa_id": 3, - "alias_code_uid": "AliasCode_37869", - "standard_code": "Code_45156" - }, - { - "id": 232117, - "soa_id": 3, - "alias_code_uid": "AliasCode_37870", - "standard_code": "Code_45157" - } - ], - "code_association": [ - { - "id": 52, - "soa_id": 3, - "code_uid": "Code_1", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "C174268", - "decode": "Placebo Comparator Arm" - }, - { - "id": 53, - "soa_id": 3, - "code_uid": "Code_2", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188727", - "code": "C188866", - "decode": "Data Generated Within Study" - }, - { - "id": 54, - "soa_id": 3, - "code_uid": "Code_3", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "C174267", - "decode": "Active Comparator Arm" - }, - { - "id": 55, - "soa_id": 3, - "code_uid": "Code_4", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188727", - "code": "C188866", - "decode": "Data Generated Within Study" - }, - { - "id": 56, - "soa_id": 3, - "code_uid": "Code_5", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "C174267", - "decode": "Active Comparator Arm" - }, - { - "id": 57, - "soa_id": 3, - "code_uid": "Code_6", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188727", - "code": "C188866", - "decode": "Data Generated Within Study" - }, - { - "id": 58, - "soa_id": 3, - "code_uid": "Code_7", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C42872", - "decode": "C42872" - }, - { - "id": 59, - "soa_id": 3, - "code_uid": "Code_8", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C42872", - "decode": "C42872" - }, - { - "id": 60, - "soa_id": 3, - "code_uid": "Code_9", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C125938", - "decode": "C125938" - }, - { - "id": 61, - "soa_id": 3, - "code_uid": "Code_10", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C202487", - "decode": "C202487" - }, - { - "id": 62, - "soa_id": 3, - "code_uid": "Code_11", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C101526", - "decode": "C101526" - }, - { - "id": 63, - "soa_id": 3, - "code_uid": "Code_12", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C202578", - "decode": "C202578" - }, - { - "id": 64, - "soa_id": 3, - "code_uid": "Code_13", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C101526", - "decode": "C101526" - }, - { - "id": 65, - "soa_id": 3, - "code_uid": "Code_14", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C101526", - "decode": "C101526" - }, - { - "id": 66, - "soa_id": 3, - "code_uid": "Code_15", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201357", - "decode": "Before" - }, - { - "id": 67, - "soa_id": 3, - "code_uid": "Code_16", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201357", - "decode": "Before" - }, - { - "id": 68, - "soa_id": 3, - "code_uid": "Code_17", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201358", - "decode": "Fixed Reference" - }, - { - "id": 69, - "soa_id": 3, - "code_uid": "Code_18", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201358", - "decode": "Fixed Reference" - }, - { - "id": 70, - "soa_id": 3, - "code_uid": "Code_19", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 71, - "soa_id": 3, - "code_uid": "Code_20", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201357", - "decode": "Before" - }, - { - "id": 72, - "soa_id": 3, - "code_uid": "Code_21", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 73, - "soa_id": 3, - "code_uid": "Code_22", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201357", - "decode": "Before" - }, - { - "id": 74, - "soa_id": 3, - "code_uid": "Code_23", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201354", - "decode": "Start to End" - }, - { - "id": 75, - "soa_id": 3, - "code_uid": "Code_24", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201352", - "decode": "End to End" - }, - { - "id": 76, - "soa_id": 3, - "code_uid": "Code_25", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 77, - "soa_id": 3, - "code_uid": "Code_26", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201357", - "decode": "Before" - }, - { - "id": 78, - "soa_id": 3, - "code_uid": "Code_27", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 79, - "soa_id": 3, - "code_uid": "Code_28", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 80, - "soa_id": 3, - "code_uid": "Code_29", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 81, - "soa_id": 3, - "code_uid": "Code_30", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 82, - "soa_id": 3, - "code_uid": "Code_31", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 83, - "soa_id": 3, - "code_uid": "Code_32", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 84, - "soa_id": 3, - "code_uid": "Code_33", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 85, - "soa_id": 3, - "code_uid": "Code_34", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 86, - "soa_id": 3, - "code_uid": "Code_35", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 87, - "soa_id": 3, - "code_uid": "Code_36", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 88, - "soa_id": 3, - "code_uid": "Code_37", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 89, - "soa_id": 3, - "code_uid": "Code_38", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 90, - "soa_id": 3, - "code_uid": "Code_39", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 91, - "soa_id": 3, - "code_uid": "Code_40", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 92, - "soa_id": 3, - "code_uid": "Code_41", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 93, - "soa_id": 3, - "code_uid": "Code_42", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 94, - "soa_id": 3, - "code_uid": "Code_43", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 95, - "soa_id": 3, - "code_uid": "Code_44", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 96, - "soa_id": 3, - "code_uid": "Code_45", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 97, - "soa_id": 3, - "code_uid": "Code_46", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 98, - "soa_id": 3, - "code_uid": "Code_47", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 99, - "soa_id": 3, - "code_uid": "Code_48", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 100, - "soa_id": 3, - "code_uid": "Code_49", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 101, - "soa_id": 3, - "code_uid": "Code_50", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 102, - "soa_id": 3, - "code_uid": "Code_51", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 103, - "soa_id": 3, - "code_uid": "Code_52", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 104, - "soa_id": 3, - "code_uid": "Code_53", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 115, - "soa_id": 3, - "code_uid": "Code_54", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 116, - "soa_id": 3, - "code_uid": "Code_55", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 117, - "soa_id": 3, - "code_uid": "Code_56", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 118, - "soa_id": 3, - "code_uid": "Code_57", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 119, - "soa_id": 3, - "code_uid": "Code_58", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 120, - "soa_id": 3, - "code_uid": "Code_59", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 121, - "soa_id": 3, - "code_uid": "Code_60", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 122, - "soa_id": 3, - "code_uid": "Code_61", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 123, - "soa_id": 3, - "code_uid": "Code_62", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 124, - "soa_id": 3, - "code_uid": "Code_63", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 125, - "soa_id": 3, - "code_uid": "Code_64", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 126, - "soa_id": 3, - "code_uid": "Code_65", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 127, - "soa_id": 3, - "code_uid": "Code_66", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 128, - "soa_id": 3, - "code_uid": "Code_67", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 129, - "soa_id": 3, - "code_uid": "Code_68", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 130, - "soa_id": 3, - "code_uid": "Code_69", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 131, - "soa_id": 3, - "code_uid": "Code_70", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 132, - "soa_id": 3, - "code_uid": "Code_71", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 133, - "soa_id": 3, - "code_uid": "Code_72", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 134, - "soa_id": 3, - "code_uid": "Code_73", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C125938", - "decode": "C125938" - }, - { - "id": 135, - "soa_id": 3, - "code_uid": "Code_74", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C102256", - "decode": "C102256" - }, - { - "id": 136, - "soa_id": 3, - "code_uid": "Code_75", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C202578", - "decode": "C202578" - }, - { - "id": 137, - "soa_id": 3, - "code_uid": "Code_76", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 138, - "soa_id": 3, - "code_uid": "Code_77", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 139, - "soa_id": 3, - "code_uid": "Code_78", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 140, - "soa_id": 3, - "code_uid": "Code_79", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 141, - "soa_id": 3, - "code_uid": "Code_80", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 142, - "soa_id": 3, - "code_uid": "Code_81", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 143, - "soa_id": 3, - "code_uid": "Code_82", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 144, - "soa_id": 3, - "code_uid": "Code_83", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 145, - "soa_id": 3, - "code_uid": "Code_84", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 146, - "soa_id": 3, - "code_uid": "Code_85", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 147, - "soa_id": 3, - "code_uid": "Code_86", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 148, - "soa_id": 3, - "code_uid": "Code_87", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 149, - "soa_id": 3, - "code_uid": "Code_88", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 150, - "soa_id": 3, - "code_uid": "Code_89", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 151, - "soa_id": 3, - "code_uid": "Code_90", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 152, - "soa_id": 3, - "code_uid": "Code_91", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 153, - "soa_id": 3, - "code_uid": "Code_92", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 154, - "soa_id": 3, - "code_uid": "Code_93", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 155, - "soa_id": 3, - "code_uid": "Code_94", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 156, - "soa_id": 3, - "code_uid": "Code_95", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 157, - "soa_id": 3, - "code_uid": "Code_96", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 158, - "soa_id": 3, - "code_uid": "Code_97", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 159, - "soa_id": 3, - "code_uid": "Code_98", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 160, - "soa_id": 3, - "code_uid": "Code_99", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 161, - "soa_id": 3, - "code_uid": "Code_100", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 162, - "soa_id": 3, - "code_uid": "Code_101", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201358", - "decode": "Fixed Reference" - }, - { - "id": 163, - "soa_id": 3, - "code_uid": "Code_102", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201354", - "decode": "Start to End" - }, - { - "id": 164, - "soa_id": 3, - "code_uid": "Code_103", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 165, - "soa_id": 3, - "code_uid": "Code_104", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201353", - "decode": "End to Start" - }, - { - "id": 166, - "soa_id": 3, - "code_uid": "Code_105", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201358", - "decode": "Fixed Reference" - }, - { - "id": 167, - "soa_id": 3, - "code_uid": "Code_106", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 168, - "soa_id": 3, - "code_uid": "Code_107", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201358", - "decode": "Fixed Reference" - }, - { - "id": 169, - "soa_id": 3, - "code_uid": "Code_108", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 170, - "soa_id": 3, - "code_uid": "Code_109", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201358", - "decode": "Fixed Reference" - }, - { - "id": 171, - "soa_id": 3, - "code_uid": "Code_110", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 172, - "soa_id": 3, - "code_uid": "Code_111", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 173, - "soa_id": 3, - "code_uid": "Code_112", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 174, - "soa_id": 3, - "code_uid": "Code_113", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 175, - "soa_id": 3, - "code_uid": "Code_114", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201353", - "decode": "End to Start" - }, - { - "id": 176, - "soa_id": 3, - "code_uid": "Code_115", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 177, - "soa_id": 3, - "code_uid": "Code_116", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 178, - "soa_id": 3, - "code_uid": "Code_117", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 179, - "soa_id": 3, - "code_uid": "Code_118", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201353", - "decode": "End to Start" - }, - { - "id": 180, - "soa_id": 3, - "code_uid": "Code_119", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201264", - "code": "C201356", - "decode": "After" - }, - { - "id": 181, - "soa_id": 3, - "code_uid": "Code_120", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C201265", - "code": "C201355", - "decode": "Start to Start" - }, - { - "id": 182, - "soa_id": 3, - "code_uid": "Code_121", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 183, - "soa_id": 3, - "code_uid": "Code_122", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 184, - "soa_id": 3, - "code_uid": "Code_123", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 185, - "soa_id": 3, - "code_uid": "Code_124", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 186, - "soa_id": 3, - "code_uid": "Code_125", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 187, - "soa_id": 3, - "code_uid": "Code_126", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 188, - "soa_id": 3, - "code_uid": "Code_127", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 189, - "soa_id": 3, - "code_uid": "Code_128", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 190, - "soa_id": 3, - "code_uid": "Code_129", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 191, - "soa_id": 3, - "code_uid": "Code_130", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 192, - "soa_id": 3, - "code_uid": "Code_131", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 193, - "soa_id": 3, - "code_uid": "Code_132", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 194, - "soa_id": 3, - "code_uid": "Code_133", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 195, - "soa_id": 3, - "code_uid": "Code_134", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 196, - "soa_id": 3, - "code_uid": "Code_135", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 197, - "soa_id": 3, - "code_uid": "Code_136", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C51282", - "decode": "C51282" - }, - { - "id": 198, - "soa_id": 3, - "code_uid": "Code_137", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 199, - "soa_id": 3, - "code_uid": "Code_138", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C48953", - "decode": "C48953" - }, - { - "id": 200, - "soa_id": 3, - "code_uid": "Code_139", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C211570", - "decode": "C211570" - }, - { - "id": 201, - "soa_id": 3, - "code_uid": "Code_140", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 202, - "soa_id": 3, - "code_uid": "Code_141", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C127785", - "decode": "C127785" - }, - { - "id": 203, - "soa_id": 3, - "code_uid": "Code_142", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 204, - "soa_id": 3, - "code_uid": "Code_143", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C181530", - "decode": "C181530" - }, - { - "id": 205, - "soa_id": 3, - "code_uid": "Code_144", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 206, - "soa_id": 3, - "code_uid": "Code_145", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C181529", - "decode": "C181529" - }, - { - "id": 207, - "soa_id": 3, - "code_uid": "Code_146", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 208, - "soa_id": 3, - "code_uid": "Code_147", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C41206", - "decode": "C41206" - }, - { - "id": 209, - "soa_id": 3, - "code_uid": "Code_148", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 210, - "soa_id": 3, - "code_uid": "Code_149", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C17118", - "decode": "C17118" - }, - { - "id": 211, - "soa_id": 3, - "code_uid": "Code_150", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 212, - "soa_id": 3, - "code_uid": "Code_151", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "C102650", - "decode": "C102650" - }, - { - "id": 213, - "soa_id": 3, - "code_uid": "Code_152", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C25170", - "decode": "C25170" - }, - { - "id": 214, - "soa_id": 3, - "code_uid": "Code_153", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C177933", - "decode": "C177933" - }, - { - "id": 215, - "soa_id": 3, - "code_uid": "Code_154", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C70805", - "decode": "C70805" - }, - { - "id": 216, - "soa_id": 3, - "code_uid": "Code_155", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C171533", - "decode": "C171533" - }, - { - "id": 217, - "soa_id": 3, - "code_uid": "Code_156", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 218, - "soa_id": 3, - "code_uid": "Code_157", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C127262", - "code": "", - "decode": null - }, - { - "id": 219, - "soa_id": 3, - "code_uid": "Code_158", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C25170", - "decode": "C25170" - }, - { - "id": 220, - "soa_id": 3, - "code_uid": "Code_159", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188728", - "code": "C25716", - "decode": "Visit" - }, - { - "id": 221, - "soa_id": 3, - "code_uid": "Code_160", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C177933", - "decode": "C177933" - }, - { - "id": 222, - "soa_id": 3, - "code_uid": "Code_161", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C102255", - "decode": "C102255" - }, - { - "id": 223, - "soa_id": 3, - "code_uid": "Code_162", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C125938", - "decode": "C125938" - }, - { - "id": 224, - "soa_id": 3, - "code_uid": "Code_163", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C99079", - "code": "C202578", - "decode": "C202578" - }, - { - "id": 225, - "soa_id": 3, - "code_uid": "Code_164", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 226, - "soa_id": 3, - "code_uid": "Code_165", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 227, - "soa_id": 3, - "code_uid": "Code_166", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 228, - "soa_id": 3, - "code_uid": "Code_167", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 229, - "soa_id": 3, - "code_uid": "Code_168", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 230, - "soa_id": 3, - "code_uid": "Code_169", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 231, - "soa_id": 3, - "code_uid": "Code_170", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 232, - "soa_id": 3, - "code_uid": "Code_171", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 233, - "soa_id": 3, - "code_uid": "Code_172", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 234, - "soa_id": 3, - "code_uid": "Code_173", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 235, - "soa_id": 3, - "code_uid": "Code_174", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 236, - "soa_id": 3, - "code_uid": "Code_175", - "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", - "codelist_code": "C171445", - "code": "C175574", - "decode": "C175574" - }, - { - "id": 237, - "soa_id": 3, - "code_uid": "Code_176", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "C174267", - "decode": "Active Comparator Arm" - }, - { - "id": 238, - "soa_id": 3, - "code_uid": "Code_177", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "C174267", - "decode": "Active Comparator Arm" - }, - { - "id": 239, - "soa_id": 3, - "code_uid": "Code_178", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "C174267", - "decode": "Active Comparator Arm" - }, - { - "id": 240, - "soa_id": 3, - "code_uid": "Code_179", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188727", - "code": "C165830", - "decode": "Real World Data" - }, - { - "id": 241, - "soa_id": 3, - "code_uid": "Code_180", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "C174266", - "decode": "Experimental Arm" - }, - { - "id": 242, - "soa_id": 3, - "code_uid": "Code_181", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "C174266", - "decode": "Experimental Arm" - }, - { - "id": 243, - "soa_id": 3, - "code_uid": "Code_182", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "C174226", - "decode": "Control Arm" - }, - { - "id": 244, - "soa_id": 3, - "code_uid": "Code_183", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188727", - "code": "C188866", - "decode": "Data Generated Within Study" - }, - { - "id": 245, - "soa_id": 3, - "code_uid": "Code_184", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "", - "decode": null - }, - { - "id": 246, - "soa_id": 3, - "code_uid": "Code_185", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188727", - "code": "C188866", - "decode": "Data Generated Within Study" - }, - { - "id": 247, - "soa_id": 3, - "code_uid": "Code_186", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188727", - "code": "C188866", - "decode": "Data Generated Within Study" - }, - { - "id": 248, - "soa_id": 3, - "code_uid": "Code_187", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "C174226", - "decode": "Control Arm" - }, - { - "id": 249, - "soa_id": 3, - "code_uid": "Code_188", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188727", - "code": "C188864", - "decode": "Historical Data" - }, - { - "id": 250, - "soa_id": 3, - "code_uid": "Code_189", - "codelist_table": "db://protocol_terminology", - "codelist_code": "C174222", - "code": "C174267", - "decode": "Active Comparator Arm" - }, - { - "id": 251, - "soa_id": 3, - "code_uid": "Code_190", - "codelist_table": "http://www.cdisc.org", - "codelist_code": "C188727", - "code": "C165830", - "decode": "Real World Data" - }, - { - "id": 535, - "soa_id": 3, - "code_uid": "Code_2508", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188725", - "code": "C85826", - "decode": "Study Primary Objective" - }, - { - "id": 536, - "soa_id": 3, - "code_uid": "Code_2509", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188725", - "code": "C85826", - "decode": "Study Primary Objective" - }, - { - "id": 537, - "soa_id": 3, - "code_uid": "Code_2510", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188725", - "code": "C85827", - "decode": "Study Secondary Objective" - }, - { - "id": 538, - "soa_id": 3, - "code_uid": "Code_2511", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188725", - "code": "C85827", - "decode": "Study Secondary Objective" - }, - { - "id": 539, - "soa_id": 3, - "code_uid": "Code_2512", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188725", - "code": "C85827", - "decode": "Study Secondary Objective" - }, - { - "id": 540, - "soa_id": 3, - "code_uid": "Code_2513", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188725", - "code": "C85827", - "decode": "Study Secondary Objective" - }, - { - "id": 541, - "soa_id": 3, - "code_uid": "Code_2514", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188726", - "code": "C94496", - "decode": "Primary Endpoint" - }, - { - "id": 542, - "soa_id": 3, - "code_uid": "Code_2515", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188726", - "code": "C94496", - "decode": "Primary Endpoint" - }, - { - "id": 543, - "soa_id": 3, - "code_uid": "Code_2516", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188726", - "code": "C94496", - "decode": "Primary Endpoint" - }, - { - "id": 544, - "soa_id": 3, - "code_uid": "Code_2517", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188726", - "code": "C94496", - "decode": "Primary Endpoint" - }, - { - "id": 545, - "soa_id": 3, - "code_uid": "Code_2518", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188726", - "code": "C94496", - "decode": "Primary Endpoint" - }, - { - "id": 546, - "soa_id": 3, - "code_uid": "Code_2519", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188726", - "code": "C139173", - "decode": "Secondary Endpoint" - }, - { - "id": 547, - "soa_id": 3, - "code_uid": "Code_2520", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188726", - "code": "C139173", - "decode": "Secondary Endpoint" - }, - { - "id": 548, - "soa_id": 3, - "code_uid": "Code_2521", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188726", - "code": "C139173", - "decode": "Secondary Endpoint" - }, - { - "id": 549, - "soa_id": 3, - "code_uid": "Code_2522", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188726", - "code": "C139173", - "decode": "Secondary Endpoint" - }, - { - "id": 550, - "soa_id": 3, - "code_uid": "Code_2523", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188726", - "code": "C139173", - "decode": "Secondary Endpoint" - }, - { - "id": 551, - "soa_id": 3, - "code_uid": "Code_2524", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C188726", - "code": "C139173", - "decode": "Secondary Endpoint" - }, - { - "id": 559, - "soa_id": 3, - "code_uid": "Code_2525", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C207415", - "code": "C207605", - "decode": "IRB/IEC Feedback" - }, - { - "id": 560, - "soa_id": 3, - "code_uid": "Code_2526", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C207415", - "code": "C17649", - "decode": "OTHER" - }, - { - "id": 561, - "soa_id": 3, - "code_uid": "Code_2527", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C215481", - "code": "C215665", - "decode": "Study Subject Safety" - }, - { - "id": 570, - "soa_id": 3, - "code_uid": "Code_12462", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C207412", - "code": "C68846", - "decode": "Global" - }, - { - "id": 571, - "soa_id": 3, - "code_uid": "Code_13051", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C207413", - "code": "C215663", - "decode": "Effective Date" - }, - { - "id": 575, - "soa_id": 3, - "code_uid": "Code_20010", - "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", - "codelist_code": "C207412", - "code": "C41129", - "decode": "Region" - } - ], - "epoch": [ - { - "id": 1, - "soa_id": 3, - "name": "Screening", - "order_index": 1, - "epoch_seq": 1, - "epoch_label": "Screening", - "epoch_description": "Screening Epoch", - "type": "Code_10", - "epoch_uid": "StudyEpoch_1" - }, - { - "id": 2, - "soa_id": 3, - "name": "Follow-up", - "order_index": 5, - "epoch_seq": 2, - "epoch_label": "Follow-up", - "epoch_description": "Follow-up Epoch", - "type": "Code_12", - "epoch_uid": "StudyEpoch_2" - }, - { - "id": 3, - "soa_id": 3, - "name": "Treatment 1", - "order_index": 2, - "epoch_seq": 3, - "epoch_label": "Treatment 1", - "epoch_description": "Treatment 1 Epoch", - "type": "Code_11", - "epoch_uid": "StudyEpoch_3" - }, - { - "id": 4, - "soa_id": 3, - "name": "Treatment 2", - "order_index": 3, - "epoch_seq": 4, - "epoch_label": "Treatment 2", - "epoch_description": "Treatment 2 Epoch", - "type": "Code_13", - "epoch_uid": "StudyEpoch_4" - }, - { - "id": 5, - "soa_id": 3, - "name": "Treatment 3", - "order_index": 4, - "epoch_seq": 5, - "epoch_label": "Treatment 3", - "epoch_description": "Treatment 3 Epoch", - "type": "Code_14", - "epoch_uid": "StudyEpoch_5" - } - ], - "arm": [ - { - "id": 1, - "soa_id": 3, - "name": "Placebo", - "label": "Placebo", - "description": "Placebo ARM", - "order_index": 1, - "arm_uid": "StudyArm_1", - "type": "Code_1", - "data_origin_type": "Code_2" - }, - { - "id": 2, - "soa_id": 3, - "name": "Xanomeline Low Dose", - "label": "Xanomeline Low Dose", - "description": "Active substance low dose", - "order_index": 2, - "arm_uid": "StudyArm_2", - "type": "Code_3", - "data_origin_type": "Code_4" - }, - { - "id": 3, - "soa_id": 3, - "name": "Xanomeline High Dose", - "label": "Xanomeline High Dose", - "description": "Active Substance high dose", - "order_index": 3, - "arm_uid": "StudyArm_3", - "type": "Code_5", - "data_origin_type": "Code_6" - } - ], - "visit": [ - { - "id": 4, - "soa_id": 3, - "name": "SCREEN1", - "label": "Screening 1", - "order_index": 1, - "epoch_id": 1, - "encounter_uid": "Encounter_1", - "description": "Screening encounter", - "type": "Code_55", - "environmentalSettings": "Code_84", - "contactModes": "Code_164", - "transitionStartRule": "TransitionRule_17", - "transitionEndRule": "TransitionRule_18", - "scheduledAtId": "3" - }, - { - "id": 5, - "soa_id": 3, - "name": "SCREEN2", - "label": "Screening 2", - "order_index": 2, - "epoch_id": 1, - "encounter_uid": "Encounter_2", - "description": "Screening encounter - Ambulatory ECG Placement", - "type": "Code_56", - "environmentalSettings": "Code_85", - "contactModes": "Code_165", - "transitionStartRule": null, - "transitionEndRule": "TransitionRule_19", - "scheduledAtId": "4" - }, - { - "id": 6, - "soa_id": 3, - "name": "DOSE", - "label": "Baseline", - "order_index": 3, - "epoch_id": 3, - "encounter_uid": "Encounter_3", - "description": "Baseline encounter - Ambulatory ECG Removal", - "type": "Code_57", - "environmentalSettings": "Code_86", - "contactModes": "Code_166", - "transitionStartRule": "TransitionRule_20", - "transitionEndRule": "TransitionRule_21", - "scheduledAtId": "5" - }, - { - "id": 7, - "soa_id": 3, - "name": "WEEK2", - "label": "Week 2", - "order_index": 4, - "epoch_id": 3, - "encounter_uid": "Encounter_4", - "description": "Day 14", - "type": "Code_58", - "environmentalSettings": "Code_87", - "contactModes": "Code_167", - "transitionStartRule": null, - "transitionEndRule": null, - "scheduledAtId": "6" - }, - { - "id": 8, - "soa_id": 3, - "name": "WEEK4", - "label": "Week 4", - "order_index": 5, - "epoch_id": 4, - "encounter_uid": "Encounter_5", - "description": "Day 28", - "type": "Code_59", - "environmentalSettings": "Code_88", - "contactModes": "Code_168", - "transitionStartRule": null, - "transitionEndRule": null, - "scheduledAtId": "7" - }, - { - "id": 9, - "soa_id": 3, - "name": "WEEK6", - "label": "Week 6", - "order_index": 6, - "epoch_id": 4, - "encounter_uid": "Encounter_6", - "description": "Day 42", - "type": "Code_60", - "environmentalSettings": "Code_89", - "contactModes": "Code_169", - "transitionStartRule": null, - "transitionEndRule": null, - "scheduledAtId": "8" - }, - { - "id": 10, - "soa_id": 3, - "name": "WEEK8", - "label": "Week 8", - "order_index": 7, - "epoch_id": 4, - "encounter_uid": "Encounter_7", - "description": "Day 56", - "type": "Code_61", - "environmentalSettings": "Code_90", - "contactModes": "Code_170", - "transitionStartRule": null, - "transitionEndRule": null, - "scheduledAtId": "9" - }, - { - "id": 12, - "soa_id": 3, - "name": "WEEK12", - "label": "Week 12", - "order_index": 8, - "epoch_id": 4, - "encounter_uid": "Encounter_9", - "description": "Day 84", - "type": "Code_63", - "environmentalSettings": "Code_92", - "contactModes": "Code_171", - "transitionStartRule": null, - "transitionEndRule": null, - "scheduledAtId": "10" - }, - { - "id": 14, - "soa_id": 3, - "name": "WEEK16", - "label": "Week 16", - "order_index": 9, - "epoch_id": 4, - "encounter_uid": "Encounter_11", - "description": "Day 112", - "type": "Code_65", - "environmentalSettings": "Code_94", - "contactModes": "Code_172", - "transitionStartRule": null, - "transitionEndRule": null, - "scheduledAtId": "11" - }, - { - "id": 16, - "soa_id": 3, - "name": "WEEK20", - "label": "Week 20", - "order_index": 10, - "epoch_id": 4, - "encounter_uid": "Encounter_13", - "description": "Day 140", - "type": "Code_67", - "environmentalSettings": "Code_96", - "contactModes": "Code_173", - "transitionStartRule": null, - "transitionEndRule": null, - "scheduledAtId": "12" - }, - { - "id": 18, - "soa_id": 3, - "name": "WEEK24", - "label": "Week 24", - "order_index": 11, - "epoch_id": 5, - "encounter_uid": "Encounter_15", - "description": "Day 168", - "type": "Code_69", - "environmentalSettings": "Code_98", - "contactModes": "Code_174", - "transitionStartRule": null, - "transitionEndRule": null, - "scheduledAtId": "13" - }, - { - "id": 19, - "soa_id": 3, - "name": "WEEK26", - "label": "Week 26", - "order_index": 12, - "epoch_id": 2, - "encounter_uid": "Encounter_16", - "description": "Day 182", - "type": "Code_70", - "environmentalSettings": "Code_99", - "contactModes": "Code_175", - "transitionStartRule": null, - "transitionEndRule": "TransitionRule_22", - "scheduledAtId": "14" - } - ], - "activity": [ - { - "id": 3, - "soa_id": 3, - "name": "Informed Consent", - "order_index": 1, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_1", - "label": "Informed Consent", - "description": "Informed consent activity" - }, - { - "id": 4, - "soa_id": 3, - "name": "Inclusion/Exclusion Criteria", - "order_index": 2, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_2", - "label": "Inclusion/Exclusion Criteria", - "description": "Inclusion/Exclusion Criteria activity" - }, - { - "id": 5, - "soa_id": 3, - "name": "Patient number assigned", - "order_index": 3, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_3", - "label": "Patient Number assigned", - "description": "Patient Number assigned activity" - }, - { - "id": 6, - "soa_id": 3, - "name": "Demographics", - "order_index": 4, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_4", - "label": "Demographics", - "description": "Demographics activity" - }, - { - "id": 7, - "soa_id": 3, - "name": "Education", - "order_index": 5, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_5", - "label": "Education", - "description": "Education activity" - }, - { - "id": 8, - "soa_id": 3, - "name": "Hachinski", - "order_index": 6, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_6", - "label": "Hachinski", - "description": "Hachinski test" - }, - { - "id": 9, - "soa_id": 3, - "name": "MMSE", - "order_index": 7, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_7", - "label": "MMSE", - "description": "MMSE test" - }, - { - "id": 10, - "soa_id": 3, - "name": "Physical examination", - "order_index": 8, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_8", - "label": "Physical examination", - "description": "Physical examination results" - }, - { - "id": 12, - "soa_id": 3, - "name": "Medical History", - "order_index": 9, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_9", - "label": "Medical History", - "description": "Medical History response" - }, - { - "id": 13, - "soa_id": 3, - "name": "Habits", - "order_index": 10, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_10", - "label": "Habits", - "description": "List of habits" - }, - { - "id": 17, - "soa_id": 3, - "name": "Chest X-ray", - "order_index": 11, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_11", - "label": "Chest X-ray", - "description": "Chest X-ray result" - }, - { - "id": 18, - "soa_id": 3, - "name": "Apo E genotyping", - "order_index": 12, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_12", - "label": "Apo E genotyping", - "description": "Apo E genotyping test" - }, - { - "id": 19, - "soa_id": 3, - "name": "Patient randomised", - "order_index": 13, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_13", - "label": "Patient randomized", - "description": "Patient randomized activity" - }, - { - "id": 20, - "soa_id": 3, - "name": "Vital Signs", - "order_index": 14, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_14", - "label": "Vital Signs", - "description": "Vital Signs result" - }, - { - "id": 21, - "soa_id": 3, - "name": "Ambulatory ECG placed", - "order_index": 15, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_15", - "label": "Ambulatory ECG placed", - "description": "Ambulatory ECG placed activity" - }, - { - "id": 22, - "soa_id": 3, - "name": "Ambulatory ECG removed", - "order_index": 16, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_16", - "label": "Ambulatory ECG removed", - "description": "Ambulatory ECG removed activity" - }, - { - "id": 23, - "soa_id": 3, - "name": "ECG", - "order_index": 17, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_17", - "label": "ECG", - "description": "ECG results" - }, - { - "id": 24, - "soa_id": 3, - "name": "Placebo TTS Test", - "order_index": 18, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_18", - "label": "Placebo TTS Test", - "description": "Placebo TTS Test results" - }, - { - "id": 25, - "soa_id": 3, - "name": "CT Scan", - "order_index": 19, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_19", - "label": "CT Scan", - "description": "CT Scan results" - }, - { - "id": 26, - "soa_id": 3, - "name": "MRI", - "order_index": 20, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_20", - "label": "MRI", - "description": "MRI results" - }, - { - "id": 27, - "soa_id": 3, - "name": "MRI, CT Scan", - "order_index": 21, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_21", - "label": "MRI, CT Scan", - "description": "MRI, CT Scan results" - }, - { - "id": 28, - "soa_id": 3, - "name": "Concomitant medications", - "order_index": 22, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_22", - "label": "Concomitant medications", - "description": "Concomitant medications information" - }, - { - "id": 29, - "soa_id": 3, - "name": "Hematology", - "order_index": 23, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_23", - "label": "Hematology", - "description": "Hematology results" - }, - { - "id": 30, - "soa_id": 3, - "name": "Chemistry", - "order_index": 24, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_24", - "label": "Chemistry", - "description": "Chemistry test results" - }, - { - "id": 31, - "soa_id": 3, - "name": "Urinalysis", - "order_index": 25, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_25", - "label": "Urinalysis", - "description": "Urinalysis results" - }, - { - "id": 32, - "soa_id": 3, - "name": "Plasma Specimen (Xanomeline)", - "order_index": 26, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_26", - "label": "Plasma Specimen (Xanomeline)", - "description": "Plasma Specimen (Xanomeline) results" - }, - { - "id": 33, - "soa_id": 3, - "name": "Hemoglobin A1C", - "order_index": 27, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_27", - "label": "Hemoglobin A1C", - "description": "Hemoglobin A1C results" - }, - { - "id": 34, - "soa_id": 3, - "name": "Study Drug", - "order_index": 28, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_28", - "label": "Study Drug", - "description": "Study Drug activity" - }, - { - "id": 35, - "soa_id": 3, - "name": "TTS Acceptability Survey", - "order_index": 29, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_29", - "label": "TTS Acceptability Survey", - "description": "TTS Acceptability Survey results" - }, - { - "id": 36, - "soa_id": 3, - "name": "ADAS-Cog", - "order_index": 30, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_30", - "label": "ADAS-Cog", - "description": "ADAS-Cog results" - }, - { - "id": 37, - "soa_id": 3, - "name": "CIBIC+", - "order_index": 31, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_31", - "label": "CIBIC+", - "description": "CIBIC+ results" - }, - { - "id": 38, - "soa_id": 3, - "name": "DAD", - "order_index": 32, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_32", - "label": "DAD", - "description": "DAD results" - }, - { - "id": 39, - "soa_id": 3, - "name": "NPI-X", - "order_index": 33, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_33", - "label": "NPI-X", - "description": "NPI-X results" - }, - { - "id": 92, - "soa_id": 3, - "name": "Adverse Events", - "order_index": 34, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_34", - "label": "Adverse Events", - "description": "Activities to conduct if occurence of Adverse Event" - }, - { - "id": 93, - "soa_id": 3, - "name": "Check Adverse Events", - "order_index": 35, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_35", - "label": "Check Adverse Events", - "description": "TL: Adverse Event Timeline" - }, - { - "id": 94, - "soa_id": 3, - "name": "Patient Summary", - "order_index": 36, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_36", - "label": "Patient Summary", - "description": "Patient Summary (Study Conclusion)" - }, - { - "id": 95, - "soa_id": 3, - "name": "Supine", - "order_index": 37, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_37", - "label": "Supine", - "description": "Supine" - }, - { - "id": 96, - "soa_id": 3, - "name": "Vital Signs Supine", - "order_index": 38, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_38", - "label": "Vital Signs Supine", - "description": "Vital Signs Supine" - }, - { - "id": 97, - "soa_id": 3, - "name": "Stand", - "order_index": 39, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_39", - "label": "Stand", - "description": "Stand" - }, - { - "id": 98, - "soa_id": 3, - "name": "Vital Signs Standing", - "order_index": 40, - "primary_concept_code": null, - "primary_concept_title": null, - "activity_uid": "Activity_40", - "label": "Vital Signs Standing", - "description": "Vital Signs Standing" - } - ], - "element": [ - { - "id": 48, - "soa_id": 3, - "element_id": "StudyElement_1", - "name": "EL1", - "label": "Screening", - "description": "Screening Element", - "testrl": "TransitionRule_23", - "teenrl": "TransitionRule_24", - "order_index": 1, - "created_at": "2026-01-16T13:36:07.339001+00:00" - }, - { - "id": 56, - "soa_id": 3, - "element_id": "StudyElement_2", - "name": "EL2", - "label": "Placebo", - "description": "Placebo TTS (adhesive patches)", - "testrl": "TransitionRule_27", - "teenrl": null, - "order_index": 2, - "created_at": "2026-01-16T13:36:07.339001+00:00" - }, - { - "id": 57, - "soa_id": 3, - "element_id": "StudyElement_3", - "name": "EL3", - "label": "Low", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "testrl": "TransitionRule_28", - "teenrl": null, - "order_index": 3, - "created_at": "2026-01-16T13:36:07.339001+00:00" - }, - { - "id": 58, - "soa_id": 3, - "element_id": "StudyElement_4", - "name": "EL4", - "label": "High - Start", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "testrl": "TransitionRule_29", - "teenrl": null, - "order_index": 4, - "created_at": "2026-01-16T13:36:07.339001+00:00" - }, - { - "id": 59, - "soa_id": 3, - "element_id": "StudyElement_5", - "name": "EL5", - "label": "High - Middle", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg + 25 cm2, 27 mg", - "testrl": "TransitionRule_30", - "teenrl": null, - "order_index": 5, - "created_at": "2026-01-16T13:36:07.339001+00:00" - }, - { - "id": 60, - "soa_id": 3, - "element_id": "StudyElement_6", - "name": "EL6", - "label": "High - End", - "description": "Xanomeline TTS (adhesive patches) 50 cm2, 54 mg", - "testrl": "TransitionRule_31", - "teenrl": null, - "order_index": 6, - "created_at": "2026-01-16T13:36:07.339001+00:00" - }, - { - "id": 61, - "soa_id": 3, - "element_id": "StudyElement_7", - "name": "EL7", - "label": "Follow up", - "description": "Follow up Element", - "testrl": "TransitionRule_25", - "teenrl": "TransitionRule_26", - "order_index": 7, - "created_at": "2026-01-16T13:36:07.339001+00:00" - } - ], - "study_cell": [ - { - "id": 21, - "soa_id": 3, - "study_cell_uid": "StudyCell_1", - "arm_uid": "StudyArm_1", - "epoch_uid": "StudyEpoch_1", - "element_uid": "StudyElement_1", - "order_index": null - }, - { - "id": 31, - "soa_id": 3, - "study_cell_uid": "StudyCell_11", - "arm_uid": "StudyArm_3", - "epoch_uid": "StudyEpoch_1", - "element_uid": "StudyElement_1", - "order_index": null - }, - { - "id": 32, - "soa_id": 3, - "study_cell_uid": "StudyCell_12", - "arm_uid": "StudyArm_3", - "epoch_uid": "StudyEpoch_3", - "element_uid": "StudyElement_4", - "order_index": null - }, - { - "id": 33, - "soa_id": 3, - "study_cell_uid": "StudyCell_13", - "arm_uid": "StudyArm_3", - "epoch_uid": "StudyEpoch_4", - "element_uid": "StudyElement_5", - "order_index": null - }, - { - "id": 34, - "soa_id": 3, - "study_cell_uid": "StudyCell_14", - "arm_uid": "StudyArm_3", - "epoch_uid": "StudyEpoch_5", - "element_uid": "StudyElement_6", - "order_index": null - }, - { - "id": 35, - "soa_id": 3, - "study_cell_uid": "StudyCell_15", - "arm_uid": "StudyArm_3", - "epoch_uid": "StudyEpoch_2", - "element_uid": "StudyElement_7", - "order_index": null - }, - { - "id": 37, - "soa_id": 3, - "study_cell_uid": "StudyCell_16", - "arm_uid": "StudyArm_2", - "epoch_uid": "StudyEpoch_1", - "element_uid": "StudyElement_1", - "order_index": null - }, - { - "id": 38, - "soa_id": 3, - "study_cell_uid": "StudyCell_17", - "arm_uid": "StudyArm_2", - "epoch_uid": "StudyEpoch_3", - "element_uid": "StudyElement_3", - "order_index": null - }, - { - "id": 39, - "soa_id": 3, - "study_cell_uid": "StudyCell_18", - "arm_uid": "StudyArm_2", - "epoch_uid": "StudyEpoch_4", - "element_uid": "StudyElement_3", - "order_index": null - }, - { - "id": 40, - "soa_id": 3, - "study_cell_uid": "StudyCell_19", - "arm_uid": "StudyArm_2", - "epoch_uid": "StudyEpoch_5", - "element_uid": "StudyElement_3", - "order_index": null - }, - { - "id": 22, - "soa_id": 3, - "study_cell_uid": "StudyCell_2", - "arm_uid": "StudyArm_1", - "epoch_uid": "StudyEpoch_3", - "element_uid": "StudyElement_2", - "order_index": null - }, - { - "id": 41, - "soa_id": 3, - "study_cell_uid": "StudyCell_20", - "arm_uid": "StudyArm_2", - "epoch_uid": "StudyEpoch_2", - "element_uid": "StudyElement_7", - "order_index": null - }, - { - "id": 23, - "soa_id": 3, - "study_cell_uid": "StudyCell_3", - "arm_uid": "StudyArm_1", - "epoch_uid": "StudyEpoch_4", - "element_uid": "StudyElement_2", - "order_index": null - }, - { - "id": 24, - "soa_id": 3, - "study_cell_uid": "StudyCell_4", - "arm_uid": "StudyArm_1", - "epoch_uid": "StudyEpoch_5", - "element_uid": "StudyElement_2", - "order_index": null - }, - { - "id": 25, - "soa_id": 3, - "study_cell_uid": "StudyCell_5", - "arm_uid": "StudyArm_1", - "epoch_uid": "StudyEpoch_2", - "element_uid": "StudyElement_7", - "order_index": null - } - ], - "schedule_timelines": [ - { - "id": 2, - "soa_id": 3, - "schedule_timeline_uid": "ScheduleTimeline_1", - "name": "Main Timeline", - "label": "Main Timeline", - "description": "This is the main timeline for the study design", - "main_timeline": 1, - "entry_condition": "Potential subject identified", - "entry_id": "ScheduledActivityInstance_1", - "exit_id": null, - "order_index": 1 - }, - { - "id": 7, - "soa_id": 3, - "schedule_timeline_uid": "ScheduleTimeline_6", - "name": "Adverse Event Timeline", - "label": "Adverse Event Timeline", - "description": "This is the adverse event timeline", - "main_timeline": 0, - "entry_condition": "Subject suffers an adverse event", - "entry_id": "ScheduledActivityInstance_11", - "exit_id": null, - "order_index": 6 - }, - { - "id": 8, - "soa_id": 3, - "schedule_timeline_uid": "ScheduleTimeline_7", - "name": "Early Termination Timeline", - "label": "Early Termination Timeline", - "description": "This is the early termination processing", - "main_timeline": 0, - "entry_condition": "Subject terminates the study early", - "entry_id": "ScheduledActivityInstance_12", - "exit_id": null, - "order_index": 7 - }, - { - "id": 9, - "soa_id": 3, - "schedule_timeline_uid": "ScheduleTimeline_8", - "name": "Vital Sign Blood Pressure Timeline", - "label": "Vital Sign Blood Pressure Timeline", - "description": "BP Profile", - "main_timeline": 0, - "entry_condition": "Automatic execution", - "entry_id": "ScheduledActivityInstance_13", - "exit_id": null, - "order_index": 8 - } - ], - "instances": [ - { - "id": 2, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_1", - "name": "SCREEN1", - "label": "Screen 1", - "description": "Screen 1 Activity Instance", - "default_condition_uid": "ScheduledActivityInstance_2", - "epoch_uid": "StudyEpoch_1", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 1, - "encounter_uid": "Encounter_1", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 4, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_2", - "name": "SCREEN2", - "label": "Screen 2", - "description": "Screen 2 Activity Instance", - "default_condition_uid": "ScheduledActivityInstance_3", - "epoch_uid": "StudyEpoch_1", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 2, - "encounter_uid": "Encounter_2", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 5, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_3", - "name": "DOSE", - "label": "Dose", - "description": "Dose Activity Instance", - "default_condition_uid": "ScheduledActivityInstance_4", - "epoch_uid": "StudyEpoch_3", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 3, - "encounter_uid": "Encounter_3", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 6, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_4", - "name": "WEEK2", - "label": "Week 2", - "description": "Week 2 Activity Instance", - "default_condition_uid": "ScheduledActivityInstance_5", - "epoch_uid": "StudyEpoch_3", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 4, - "encounter_uid": "Encounter_4", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 7, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_5", - "name": "WEEK4", - "label": "Week 4", - "description": "Week 4 Activity Instance", - "default_condition_uid": "ScheduledActivityInstance_6", - "epoch_uid": "StudyEpoch_4", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 5, - "encounter_uid": "Encounter_5", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 8, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_6", - "name": "WEEK6", - "label": "Week 6", - "description": "Week 6 Activity Instance", - "default_condition_uid": "ScheduledActivityInstance_7", - "epoch_uid": "StudyEpoch_4", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 6, - "encounter_uid": "Encounter_6", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 9, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_7", - "name": "WEEK8", - "label": "Week 8", - "description": "Week 8 Activity Instance", - "default_condition_uid": "ScheduledActivityInstance_8", - "epoch_uid": "StudyEpoch_4", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 7, - "encounter_uid": "Encounter_7", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 10, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_8", - "name": "WEEK8N", - "label": "Week 8 NPI", - "description": "Week 8 NPI Activity Instance", - "default_condition_uid": "ScheduledActivityInstance_19", - "epoch_uid": "StudyEpoch_4", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 8, - "encounter_uid": "Encounter_7", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 13, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_11", - "name": "AE", - "label": "Adverse Event", - "description": "Occurrence of Adverse Event", - "default_condition_uid": null, - "epoch_uid": null, - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 11, - "encounter_uid": null, - "member_of_timeline": "ScheduleTimeline_6" - }, - { - "id": 14, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_12", - "name": "ET", - "label": "Early Termination", - "description": "Early Termination", - "default_condition_uid": null, - "epoch_uid": null, - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 12, - "encounter_uid": null, - "member_of_timeline": "ScheduleTimeline_7" - }, - { - "id": 15, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_13", - "name": "VS_5MIN", - "label": "5 minute supine", - "description": "VS 5 minute supine", - "default_condition_uid": "ScheduledActivityInstance_14", - "epoch_uid": null, - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 13, - "encounter_uid": null, - "member_of_timeline": "ScheduleTimeline_8" - }, - { - "id": 16, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_14", - "name": "VS_SUPINE", - "label": "Vital signs supine", - "description": "VS Vital signs supine", - "default_condition_uid": "ScheduledActivityInstance_15", - "epoch_uid": null, - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 14, - "encounter_uid": null, - "member_of_timeline": "ScheduleTimeline_8" - }, - { - "id": 17, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_15", - "name": "VS_1MIN", - "label": "1 minute standing", - "description": "VS 1 minute standing", - "default_condition_uid": "ScheduledActivityInstance_16", - "epoch_uid": null, - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 15, - "encounter_uid": null, - "member_of_timeline": "ScheduleTimeline_8" - }, - { - "id": 18, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_16", - "name": "VS_STAND1", - "label": "Vital signs after 1 min standing", - "description": "VS Vital signs after 1 min standing", - "default_condition_uid": "ScheduledActivityInstance_17", - "epoch_uid": null, - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 16, - "encounter_uid": null, - "member_of_timeline": "ScheduleTimeline_8" - }, - { - "id": 19, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_17", - "name": "VS_2MIN", - "label": "2 minute standing", - "description": "VS 2 minute standing", - "default_condition_uid": "ScheduledActivityInstance_18", - "epoch_uid": null, - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 17, - "encounter_uid": null, - "member_of_timeline": "ScheduleTimeline_8" - }, - { - "id": 20, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_18", - "name": "VS_STAND3", - "label": "Vital signs after 3 min standing", - "description": "VS Vital signs after 3 min standing", - "default_condition_uid": null, - "epoch_uid": null, - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 18, - "encounter_uid": null, - "member_of_timeline": "ScheduleTimeline_8" - }, - { - "id": 21, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_19", - "name": "WEEK12", - "label": "Week 12", - "description": "Week 12", - "default_condition_uid": "ScheduledActivityInstance_20", - "epoch_uid": "StudyEpoch_4", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 19, - "encounter_uid": "Encounter_9", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 22, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_20", - "name": "WEEK12N", - "label": "Week 12 NPI", - "description": "Week 12 NPI", - "default_condition_uid": "ScheduledActivityInstance_21", - "epoch_uid": "StudyEpoch_4", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 20, - "encounter_uid": "Encounter_9", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 23, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_21", - "name": "WEEK16", - "label": "Week 16", - "description": "Week 16", - "default_condition_uid": "ScheduledActivityInstance_22", - "epoch_uid": "StudyEpoch_4", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 21, - "encounter_uid": "Encounter_11", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 24, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_22", - "name": "WEEK16N", - "label": "Week 16 NPI", - "description": "Week 16 NPI", - "default_condition_uid": "ScheduledActivityInstance_23", - "epoch_uid": "StudyEpoch_4", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 22, - "encounter_uid": "Encounter_11", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 25, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_23", - "name": "WEEK20", - "label": "Week 20", - "description": "Week 20", - "default_condition_uid": "ScheduledActivityInstance_24", - "epoch_uid": "StudyEpoch_4", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 23, - "encounter_uid": "Encounter_13", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 26, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_24", - "name": "WEEK20N", - "label": "Week 20 NPI", - "description": "Week 20 NPI", - "default_condition_uid": "ScheduledActivityInstance_25", - "epoch_uid": "StudyEpoch_4", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 24, - "encounter_uid": "Encounter_13", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 27, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_25", - "name": "WEEK24", - "label": "Week 24", - "description": "Week 24", - "default_condition_uid": "ScheduledActivityInstance_26", - "epoch_uid": "StudyEpoch_5", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 25, - "encounter_uid": "Encounter_15", - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 28, - "soa_id": 3, - "instance_uid": "ScheduledActivityInstance_26", - "name": "WEEK26", - "label": "Week 26", - "description": "Week 26", - "default_condition_uid": null, - "epoch_uid": "StudyEpoch_2", - "timeline_id": null, - "timeline_exit_id": null, - "order_index": 26, - "encounter_uid": "Encounter_16", - "member_of_timeline": "ScheduleTimeline_1" - } - ], - "decision_instances": [ - { - "id": 1, - "soa_id": 3, - "instance_uid": "ScheduledDecisionInstance_1", - "name": "testDecisionInstance", - "label": "testDecisionInstance", - "description": "testDecisionInstance", - "default_condition_uid": null, - "epoch_uid": "StudyEpoch_3", - "member_of_timeline": "ScheduleTimeline_1", - "order_index": 1 - }, - { - "id": 2, - "soa_id": 3, - "instance_uid": "ScheduledDecisionInstance_2", - "name": "test_2", - "label": "test_2", - "description": "test_2", - "default_condition_uid": "blahblahblah", - "epoch_uid": "StudyEpoch_4", - "member_of_timeline": "ScheduleTimeline_1", - "order_index": 2 - }, - { - "id": 3, - "soa_id": 3, - "instance_uid": "ScheduledDecisionInstance_3", - "name": "test3", - "label": "test3", - "description": "test3", - "default_condition_uid": "ScheduledActivityInstance_11", - "epoch_uid": "StudyEpoch_3", - "member_of_timeline": "ScheduleTimeline_1", - "order_index": 3 - } - ], - "condition_assignment": [ - { - "id": 1, - "soa_id": 3, - "condition_assignment_uid": "Condition_1", - "name": "test_condition_1", - "label": "test_condition_1", - "description": "test_condition_1", - "condition": "is not null", - "decision_instance_uid": "ScheduledDecisionInstance_1", - "condition_target_uid": "ScheduledActivityInstance_3", - "order_index": 1 - }, - { - "id": 2, - "soa_id": 3, - "condition_assignment_uid": "Condition_2", - "name": "SCREEN_FAIL", - "label": "SCREEN_FAIL", - "description": "Failure at SCREEN 2", - "condition": "IF SCREEN FAIL", - "decision_instance_uid": "ScheduledActivityInstance_2", - "condition_target_uid": "ScheduledActivityInstance_12", - "order_index": 2 - } - ], - "timing": [ - { - "id": 3, - "soa_id": 3, - "timing_uid": "Timing_1", - "name": "TIM1", - "label": "Screening", - "description": "Screening Timing", - "type": "Code_20", - "value": "-P2W", - "value_label": "2 Weeks Before Dose", - "relative_to_from": "Code_27", - "relative_from_schedule_instance": "ScheduledActivityInstance_1", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 1, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 4, - "soa_id": 3, - "timing_uid": "Timing_2", - "name": "TIM2", - "label": "Pre-dose", - "description": "Pre-dose Timing", - "type": "Code_22", - "value": "-P2D", - "value_label": "2 Days Before Dose", - "relative_to_from": "Code_28", - "relative_from_schedule_instance": "ScheduledActivityInstance_2", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": "-4..0 hours", - "window_upper": "PT0H", - "window_lower": "PT4H", - "order_index": 2, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 5, - "soa_id": 3, - "timing_uid": "Timing_3", - "name": "TIM3", - "label": "Dosing", - "description": "Dosing Anchor", - "type": "Code_18", - "value": "P1D", - "value_label": "1 Day", - "relative_to_from": "Code_19", - "relative_from_schedule_instance": "ScheduledActivityInstance_3", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 3, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 6, - "soa_id": 3, - "timing_uid": "Timing_4", - "name": "TIM4", - "label": "Week 2", - "description": "Week 2 timing", - "type": "Code_29", - "value": "P2W", - "value_label": "2 Weeks", - "relative_to_from": "Code_25", - "relative_from_schedule_instance": "ScheduledActivityInstance_4", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": "-3..3 days", - "window_upper": "P3D", - "window_lower": "P3D", - "order_index": 4, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 7, - "soa_id": 3, - "timing_uid": "Timing_5", - "name": "TIM5", - "label": "Week 4", - "description": "Week 4 Timing", - "type": "Code_30", - "value": "P4W", - "value_label": "4 Weeks", - "relative_to_from": "Code_31", - "relative_from_schedule_instance": "ScheduledActivityInstance_5", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": "-3..3 days", - "window_upper": "P3D", - "window_lower": "P3D", - "order_index": 5, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 8, - "soa_id": 3, - "timing_uid": "Timing_6", - "name": "TIM6", - "label": "Week 6", - "description": "Week 6 Timing", - "type": "Code_32", - "value": "P6W", - "value_label": "6 Weeks", - "relative_to_from": "Code_33", - "relative_from_schedule_instance": "ScheduledActivityInstance_6", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": "-3..3 days", - "window_upper": "P3D", - "window_lower": "P3D", - "order_index": 6, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 9, - "soa_id": 3, - "timing_uid": "Timing_7", - "name": "TIM7", - "label": "Week 8", - "description": "Week 8 Timing", - "type": "Code_34", - "value": "P8W", - "value_label": "8 Weeks", - "relative_to_from": "Code_35", - "relative_from_schedule_instance": "ScheduledActivityInstance_7", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": "-3..3 days", - "window_upper": "P3D", - "window_lower": "P3D", - "order_index": 7, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 10, - "soa_id": 3, - "timing_uid": "Timing_8", - "name": "TIM9", - "label": "Week 12", - "description": "Week 12 Timing", - "type": "Code_36", - "value": "P12W", - "value_label": "12 Weeks", - "relative_to_from": "Code_37", - "relative_from_schedule_instance": "ScheduledActivityInstance_19", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": "-4..4 days", - "window_upper": "P4D", - "window_lower": "P4D", - "order_index": 8, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 11, - "soa_id": 3, - "timing_uid": "Timing_9", - "name": "TIM11", - "label": "Week 16", - "description": "Week 16 Timing", - "type": "Code_38", - "value": "P16W", - "value_label": "16 Weeks", - "relative_to_from": "Code_39", - "relative_from_schedule_instance": "ScheduledActivityInstance_21", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": "-4..4 days", - "window_upper": "P4D", - "window_lower": "P4D", - "order_index": 9, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 12, - "soa_id": 3, - "timing_uid": "Timing_10", - "name": "TIM13", - "label": "Week 20", - "description": "Week 20 Timing", - "type": "Code_40", - "value": "P20W", - "value_label": "20 Weeks", - "relative_to_from": "Code_41", - "relative_from_schedule_instance": "ScheduledActivityInstance_23", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": "-4..4 days", - "window_upper": "P4D", - "window_lower": "P4D", - "order_index": 10, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 13, - "soa_id": 3, - "timing_uid": "Timing_11", - "name": "TIM15", - "label": "Week 24", - "description": "Week 24 Timing", - "type": "Code_42", - "value": "P24W", - "value_label": "24 Weeks", - "relative_to_from": "Code_43", - "relative_from_schedule_instance": "ScheduledActivityInstance_25", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": "-4..4 days", - "window_upper": "P4D", - "window_lower": "P4D", - "order_index": 11, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 14, - "soa_id": 3, - "timing_uid": "Timing_12", - "name": "TIM16", - "label": "Week 26", - "description": "Week 26 Timing", - "type": "Code_44", - "value": "P26W", - "value_label": "26 Weeks", - "relative_to_from": "Code_45", - "relative_from_schedule_instance": "ScheduledActivityInstance_26", - "relative_to_schedule_instance": "ScheduledActivityInstance_3", - "window_label": "-3..3 days", - "window_upper": "P3D", - "window_lower": "P3D", - "order_index": 12, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 15, - "soa_id": 3, - "timing_uid": "Timing_13", - "name": "TIM8", - "label": "Week 8 Home", - "description": "Week 8 Home Timing", - "type": "Code_46", - "value": "P2W", - "value_label": "2 Weeks", - "relative_to_from": "Code_47", - "relative_from_schedule_instance": "ScheduledActivityInstance_8", - "relative_to_schedule_instance": "ScheduledActivityInstance_7", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 13, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 16, - "soa_id": 3, - "timing_uid": "Timing_14", - "name": "TIM10", - "label": "Week 12 Home", - "description": "Week 12 Home Timing", - "type": "Code_48", - "value": "P2W", - "value_label": "2 Weeks", - "relative_to_from": "Code_49", - "relative_from_schedule_instance": "ScheduledActivityInstance_20", - "relative_to_schedule_instance": "ScheduledActivityInstance_19", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 14, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 17, - "soa_id": 3, - "timing_uid": "Timing_15", - "name": "TIM12", - "label": "Week 16 Home", - "description": "Week 16 Home Timing", - "type": "Code_50", - "value": "P2W", - "value_label": "2 Weeks", - "relative_to_from": "Code_51", - "relative_from_schedule_instance": "ScheduledActivityInstance_22", - "relative_to_schedule_instance": "ScheduledActivityInstance_21", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 15, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 18, - "soa_id": 3, - "timing_uid": "Timing_16", - "name": "TIM14", - "label": "Week 20 Home", - "description": "Week 20 Home Timing", - "type": "Code_52", - "value": "P2W", - "value_label": "2 Weeks", - "relative_to_from": "Code_53", - "relative_from_schedule_instance": "ScheduledActivityInstance_24", - "relative_to_schedule_instance": "ScheduledActivityInstance_23", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 16, - "member_of_timeline": "ScheduleTimeline_1" - }, - { - "id": 22, - "soa_id": 3, - "timing_uid": "Timing_17", - "name": "TIM17", - "label": "Adverse Event", - "description": "Adverse Event Timing", - "type": "Code_105", - "value": "P1D", - "value_label": "1 Day", - "relative_to_from": "Code_106", - "relative_from_schedule_instance": "ScheduledActivityInstance_11", - "relative_to_schedule_instance": "ScheduledActivityInstance_11", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 17, - "member_of_timeline": "ScheduleTimeline_6" - }, - { - "id": 23, - "soa_id": 3, - "timing_uid": "Timing_18", - "name": "TIM18", - "label": "Early Termination", - "description": "Early Termination Timing", - "type": "Code_107", - "value": "P1D", - "value_label": "1 Day", - "relative_to_from": "Code_108", - "relative_from_schedule_instance": "ScheduledActivityInstance_12", - "relative_to_schedule_instance": "ScheduledActivityInstance_12", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 18, - "member_of_timeline": "ScheduleTimeline_7" - }, - { - "id": 24, - "soa_id": 3, - "timing_uid": "Timing_19", - "name": "TIM19", - "label": "Supine", - "description": "VS Supine", - "type": "Code_109", - "value": "PT0M", - "value_label": "0 mins", - "relative_to_from": "Code_110", - "relative_from_schedule_instance": "ScheduledActivityInstance_13", - "relative_to_schedule_instance": "ScheduledActivityInstance_13", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 19, - "member_of_timeline": "ScheduleTimeline_8" - }, - { - "id": 25, - "soa_id": 3, - "timing_uid": "Timing_20", - "name": "TIM20", - "label": "VS while supine", - "description": "VS while supine", - "type": "Code_111", - "value": "PT5M", - "value_label": "5 mins", - "relative_to_from": "Code_112", - "relative_from_schedule_instance": "ScheduledActivityInstance_14", - "relative_to_schedule_instance": "ScheduledActivityInstance_13", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 20, - "member_of_timeline": "ScheduleTimeline_8" - }, - { - "id": 26, - "soa_id": 3, - "timing_uid": "Timing_21", - "name": "TIM21", - "label": "Standing", - "description": "VS Standing", - "type": "Code_113", - "value": "PT0M", - "value_label": "0 mins", - "relative_to_from": "Code_114", - "relative_from_schedule_instance": "ScheduledActivityInstance_15", - "relative_to_schedule_instance": "ScheduledActivityInstance_14", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 21, - "member_of_timeline": "ScheduleTimeline_8" - }, - { - "id": 27, - "soa_id": 3, - "timing_uid": "Timing_22", - "name": "TIM22", - "label": "VS while standing", - "description": "VS while standing", - "type": "Code_115", - "value": "PT1M", - "value_label": "1 min", - "relative_to_from": "Code_116", - "relative_from_schedule_instance": "ScheduledActivityInstance_16", - "relative_to_schedule_instance": "ScheduledActivityInstance_15", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 22, - "member_of_timeline": "ScheduleTimeline_8" - }, - { - "id": 28, - "soa_id": 3, - "timing_uid": "Timing_23", - "name": "TIM23", - "label": "Standing", - "description": "VS Standing", - "type": "Code_117", - "value": "PT0M", - "value_label": "0 min", - "relative_to_from": "Code_118", - "relative_from_schedule_instance": "ScheduledActivityInstance_17", - "relative_to_schedule_instance": "ScheduledActivityInstance_16", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 23, - "member_of_timeline": "ScheduleTimeline_8" - }, - { - "id": 29, - "soa_id": 3, - "timing_uid": "Timing_24", - "name": "TIM24", - "label": "VS while standing", - "description": "VS while standing", - "type": "Code_119", - "value": "PT2M", - "value_label": "2 min", - "relative_to_from": "Code_120", - "relative_from_schedule_instance": "ScheduledActivityInstance_18", - "relative_to_schedule_instance": "ScheduledActivityInstance_17", - "window_label": null, - "window_upper": null, - "window_lower": null, - "order_index": 24, - "member_of_timeline": "ScheduleTimeline_8" - } - ], - "transition_rule": [ - { - "id": 28, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_17", - "name": "ENCOUNTER_START_RULE_1", - "label": null, - "description": null, - "text": "Subject identifier", - "order_index": 1, - "created_at": "2026-01-08T16:29:11.773003+00:00" - }, - { - "id": 29, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_18", - "name": "ENCOUNTER_END_RULE_2", - "label": null, - "description": null, - "text": "completion of screening activities", - "order_index": 2, - "created_at": "2026-01-08T16:30:02.928851+00:00" - }, - { - "id": 30, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_19", - "name": "ENCOUNTER_START_RULE_2", - "label": null, - "description": null, - "text": "subject leaves clinic after connection of ambulatory ECG machine", - "order_index": 3, - "created_at": "2026-01-08T16:30:39.115975+00:00" - }, - { - "id": 31, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_20", - "name": "ENCOUNTER_START_RULE_3", - "label": null, - "description": null, - "text": "subject has connection of ambulatory ECG machine removed", - "order_index": 4, - "created_at": "2026-01-08T16:31:17.923131+00:00" - }, - { - "id": 32, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_21", - "name": "ENCOUNTER_END_RULE_5", - "label": null, - "description": null, - "text": "Radomized", - "order_index": 5, - "created_at": "2026-01-08T16:31:46.231865+00:00" - }, - { - "id": 33, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_22", - "name": "ENCOUNTER_START_RULE_12", - "label": null, - "description": null, - "text": "End of treatment", - "order_index": 6, - "created_at": "2026-01-08T16:33:15.366865+00:00" - }, - { - "id": 34, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_23", - "name": "ELEMENT_START_RULE_1", - "label": null, - "description": null, - "text": "Informed consent", - "order_index": 7, - "created_at": "2026-01-08T16:35:20.925452+00:00" - }, - { - "id": 35, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_24", - "name": "ELEMENT_END_RULE_1", - "label": null, - "description": null, - "text": "Completion of all screening activities and no more than 2 weeks from informed consent", - "order_index": 8, - "created_at": "2026-01-08T16:35:41.133896+00:00" - }, - { - "id": 36, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_25", - "name": "ELEMENT_START_RULE_7", - "label": null, - "description": null, - "text": "End\\u00a0of\\u00a0last\\u00a0scheduled\\u00a0visit\\u00a0on\\u00a0study\\u00a0(including\\u00a0early\\u00a0termination)", - "order_index": 9, - "created_at": "2026-01-08T16:37:17.766554+00:00" - }, - { - "id": 37, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_26", - "name": "ELEMENT_END_RULE_7", - "label": null, - "description": null, - "text": "Completion\\u00a0of\\u00a0all\\u00a0specified\\u00a0followup\\u00a0activities\\u00a0(which\\u00a0vary\\u00a0on\\u00a0a\\u00a0patient-by-patient\\u00a0basis)", - "order_index": 10, - "created_at": "2026-01-08T16:37:51.275490+00:00" - }, - { - "id": 38, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_27", - "name": "ELEMENT_START_RULE_2", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose", - "order_index": 11, - "created_at": "2026-01-08T16:39:13.813740+00:00" - }, - { - "id": 39, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_28", - "name": "ELEMENT_START_RULE_3", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose", - "order_index": 12, - "created_at": "2026-01-08T16:39:54.079954+00:00" - }, - { - "id": 40, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_29", - "name": "ELEMENT_START_RULE_4", - "label": null, - "description": null, - "text": "Randomized", - "order_index": 13, - "created_at": "2026-01-08T16:40:26.713806+00:00" - }, - { - "id": 41, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_30", - "name": "ELEMENT_START_RULE_5", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose\\u00a0(from\\u00a0patches\\u00a0supplied\\u00a0at\\u00a0Visit\\u00a04)", - "order_index": 14, - "created_at": "2026-01-08T16:41:05.574473+00:00" - }, - { - "id": 42, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_31", - "name": "ELEMENT_START_RULE_6", - "label": null, - "description": null, - "text": "Administration\\u00a0of\\u00a0first\\u00a0dose\\u00a0(from\\u00a0patches\\u00a0supplied\\u00a0at\\u00a0Visit\\u00a012)", - "order_index": 15, - "created_at": "2026-01-08T16:41:39.782132+00:00" - }, - { - "id": 45, - "soa_id": 3, - "transition_rule_uid": "TransitionRule_34", - "name": "test", - "label": "test", - "description": "test", - "text": "test", - "order_index": 16, - "created_at": null - } - ], - "matrix_cells": [ - { - "id": 7, - "soa_id": 3, - "visit_id": 4, - "activity_id": 3, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 8, - "soa_id": 3, - "visit_id": 4, - "activity_id": 4, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 9, - "soa_id": 3, - "visit_id": 4, - "activity_id": 5, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 10, - "soa_id": 3, - "visit_id": 4, - "activity_id": 6, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 11, - "soa_id": 3, - "visit_id": 4, - "activity_id": 7, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 12, - "soa_id": 3, - "visit_id": 4, - "activity_id": 8, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 13, - "soa_id": 3, - "visit_id": 4, - "activity_id": 9, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 14, - "soa_id": 3, - "visit_id": 4, - "activity_id": 10, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 15, - "soa_id": 3, - "visit_id": 4, - "activity_id": 12, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 16, - "soa_id": 3, - "visit_id": 4, - "activity_id": 13, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 17, - "soa_id": 3, - "visit_id": 4, - "activity_id": 17, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 18, - "soa_id": 3, - "visit_id": 4, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 19, - "soa_id": 3, - "visit_id": 4, - "activity_id": 23, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 20, - "soa_id": 3, - "visit_id": 4, - "activity_id": 24, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 21, - "soa_id": 3, - "visit_id": 4, - "activity_id": 25, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 22, - "soa_id": 3, - "visit_id": 4, - "activity_id": 26, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 23, - "soa_id": 3, - "visit_id": 4, - "activity_id": 27, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 24, - "soa_id": 3, - "visit_id": 4, - "activity_id": 28, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 25, - "soa_id": 3, - "visit_id": 4, - "activity_id": 29, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 26, - "soa_id": 3, - "visit_id": 4, - "activity_id": 30, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 27, - "soa_id": 3, - "visit_id": 4, - "activity_id": 31, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 28, - "soa_id": 3, - "visit_id": 4, - "activity_id": 33, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 29, - "soa_id": 3, - "visit_id": 4, - "activity_id": 37, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 30, - "soa_id": 3, - "visit_id": 4, - "activity_id": 38, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 32, - "soa_id": 3, - "visit_id": 5, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 33, - "soa_id": 3, - "visit_id": 5, - "activity_id": 21, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 34, - "soa_id": 3, - "visit_id": 6, - "activity_id": 19, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 35, - "soa_id": 3, - "visit_id": 6, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 36, - "soa_id": 3, - "visit_id": 6, - "activity_id": 22, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 37, - "soa_id": 3, - "visit_id": 6, - "activity_id": 28, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 38, - "soa_id": 3, - "visit_id": 6, - "activity_id": 34, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 39, - "soa_id": 3, - "visit_id": 6, - "activity_id": 32, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 40, - "soa_id": 3, - "visit_id": 6, - "activity_id": 36, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 41, - "soa_id": 3, - "visit_id": 6, - "activity_id": 37, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 42, - "soa_id": 3, - "visit_id": 6, - "activity_id": 38, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 44, - "soa_id": 3, - "visit_id": 7, - "activity_id": 18, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 45, - "soa_id": 3, - "visit_id": 7, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 46, - "soa_id": 3, - "visit_id": 7, - "activity_id": 28, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 47, - "soa_id": 3, - "visit_id": 7, - "activity_id": 29, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 48, - "soa_id": 3, - "visit_id": 7, - "activity_id": 31, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 49, - "soa_id": 3, - "visit_id": 7, - "activity_id": 32, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 50, - "soa_id": 3, - "visit_id": 7, - "activity_id": 34, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 56, - "soa_id": 3, - "visit_id": 12, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 60, - "soa_id": 3, - "visit_id": 16, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 62, - "soa_id": 3, - "visit_id": 18, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 63, - "soa_id": 3, - "visit_id": 19, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 64, - "soa_id": 3, - "visit_id": 8, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 65, - "soa_id": 3, - "visit_id": 9, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 66, - "soa_id": 3, - "visit_id": 10, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 67, - "soa_id": 3, - "visit_id": 12, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 68, - "soa_id": 3, - "visit_id": 14, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 69, - "soa_id": 3, - "visit_id": 16, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 70, - "soa_id": 3, - "visit_id": 18, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 71, - "soa_id": 3, - "visit_id": 19, - "activity_id": 20, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 72, - "soa_id": 3, - "visit_id": 7, - "activity_id": 23, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 73, - "soa_id": 3, - "visit_id": 8, - "activity_id": 23, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 74, - "soa_id": 3, - "visit_id": 9, - "activity_id": 23, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 75, - "soa_id": 3, - "visit_id": 10, - "activity_id": 23, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 76, - "soa_id": 3, - "visit_id": 12, - "activity_id": 23, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 77, - "soa_id": 3, - "visit_id": 14, - "activity_id": 23, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 78, - "soa_id": 3, - "visit_id": 16, - "activity_id": 23, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 79, - "soa_id": 3, - "visit_id": 18, - "activity_id": 23, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 80, - "soa_id": 3, - "visit_id": 19, - "activity_id": 23, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 81, - "soa_id": 3, - "visit_id": 8, - "activity_id": 28, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 82, - "soa_id": 3, - "visit_id": 9, - "activity_id": 28, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 83, - "soa_id": 3, - "visit_id": 10, - "activity_id": 28, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 84, - "soa_id": 3, - "visit_id": 12, - "activity_id": 28, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 85, - "soa_id": 3, - "visit_id": 14, - "activity_id": 28, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 86, - "soa_id": 3, - "visit_id": 16, - "activity_id": 28, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 87, - "soa_id": 3, - "visit_id": 18, - "activity_id": 28, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 88, - "soa_id": 3, - "visit_id": 19, - "activity_id": 28, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 89, - "soa_id": 3, - "visit_id": 8, - "activity_id": 29, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 90, - "soa_id": 3, - "visit_id": 9, - "activity_id": 29, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 91, - "soa_id": 3, - "visit_id": 10, - "activity_id": 29, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 92, - "soa_id": 3, - "visit_id": 12, - "activity_id": 29, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 93, - "soa_id": 3, - "visit_id": 14, - "activity_id": 29, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 94, - "soa_id": 3, - "visit_id": 16, - "activity_id": 29, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 95, - "soa_id": 3, - "visit_id": 18, - "activity_id": 29, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 96, - "soa_id": 3, - "visit_id": 19, - "activity_id": 29, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 97, - "soa_id": 3, - "visit_id": 7, - "activity_id": 30, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 98, - "soa_id": 3, - "visit_id": 8, - "activity_id": 30, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 99, - "soa_id": 3, - "visit_id": 9, - "activity_id": 30, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 100, - "soa_id": 3, - "visit_id": 10, - "activity_id": 30, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 101, - "soa_id": 3, - "visit_id": 12, - "activity_id": 30, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 102, - "soa_id": 3, - "visit_id": 14, - "activity_id": 30, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 103, - "soa_id": 3, - "visit_id": 16, - "activity_id": 30, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 104, - "soa_id": 3, - "visit_id": 18, - "activity_id": 30, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 105, - "soa_id": 3, - "visit_id": 19, - "activity_id": 30, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 106, - "soa_id": 3, - "visit_id": 12, - "activity_id": 31, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 107, - "soa_id": 3, - "visit_id": 18, - "activity_id": 31, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 108, - "soa_id": 3, - "visit_id": 8, - "activity_id": 32, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 109, - "soa_id": 3, - "visit_id": 9, - "activity_id": 32, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 110, - "soa_id": 3, - "visit_id": 12, - "activity_id": 32, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 111, - "soa_id": 3, - "visit_id": 16, - "activity_id": 32, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 112, - "soa_id": 3, - "visit_id": 8, - "activity_id": 34, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 113, - "soa_id": 3, - "visit_id": 9, - "activity_id": 34, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 114, - "soa_id": 3, - "visit_id": 10, - "activity_id": 34, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 115, - "soa_id": 3, - "visit_id": 12, - "activity_id": 34, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 116, - "soa_id": 3, - "visit_id": 14, - "activity_id": 34, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 117, - "soa_id": 3, - "visit_id": 16, - "activity_id": 34, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 118, - "soa_id": 3, - "visit_id": 18, - "activity_id": 34, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 119, - "soa_id": 3, - "visit_id": 19, - "activity_id": 34, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 120, - "soa_id": 3, - "visit_id": 19, - "activity_id": 35, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 121, - "soa_id": 3, - "visit_id": 18, - "activity_id": 36, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 122, - "soa_id": 3, - "visit_id": 10, - "activity_id": 36, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 123, - "soa_id": 3, - "visit_id": 10, - "activity_id": 37, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 124, - "soa_id": 3, - "visit_id": 10, - "activity_id": 38, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 125, - "soa_id": 3, - "visit_id": 14, - "activity_id": 36, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 126, - "soa_id": 3, - "visit_id": 18, - "activity_id": 38, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 127, - "soa_id": 3, - "visit_id": 18, - "activity_id": 37, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 128, - "soa_id": 3, - "visit_id": 14, - "activity_id": 38, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 129, - "soa_id": 3, - "visit_id": 14, - "activity_id": 37, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 132, - "soa_id": 3, - "visit_id": 4, - "activity_id": 36, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 143, - "soa_id": 3, - "visit_id": 2, - "activity_id": 3, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 149, - "soa_id": 3, - "visit_id": 9, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 150, - "soa_id": 3, - "visit_id": 10, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 152, - "soa_id": 3, - "visit_id": 22, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 153, - "soa_id": 3, - "visit_id": 21, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 154, - "soa_id": 3, - "visit_id": 23, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 155, - "soa_id": 3, - "visit_id": 24, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 156, - "soa_id": 3, - "visit_id": 25, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 157, - "soa_id": 3, - "visit_id": 26, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 158, - "soa_id": 3, - "visit_id": 27, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 159, - "soa_id": 3, - "visit_id": 28, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 160, - "soa_id": 3, - "visit_id": 14, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 162, - "soa_id": 3, - "visit_id": 2, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 163, - "soa_id": 3, - "visit_id": 4, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 164, - "soa_id": 3, - "visit_id": 5, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 165, - "soa_id": 3, - "visit_id": 6, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 166, - "soa_id": 3, - "visit_id": 7, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 167, - "soa_id": 3, - "visit_id": 8, - "activity_id": 39, - "status": "X", - "instance_id": null, - "superscript": null - }, - { - "id": 168, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 2, - "superscript": "5" - }, - { - "id": 170, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 5, - "superscript": null - }, - { - "id": 171, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 6, - "superscript": null - }, - { - "id": 172, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 7, - "superscript": null - }, - { - "id": 173, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 8, - "superscript": null - }, - { - "id": 174, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 9, - "superscript": null - }, - { - "id": 175, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 10, - "superscript": null - }, - { - "id": 176, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 21, - "superscript": null - }, - { - "id": 177, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 178, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 22, - "superscript": null - }, - { - "id": 179, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 23, - "superscript": null - }, - { - "id": 180, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 24, - "superscript": null - }, - { - "id": 181, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 25, - "superscript": null - }, - { - "id": 182, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 26, - "superscript": null - }, - { - "id": 183, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 27, - "superscript": null - }, - { - "id": 184, - "soa_id": 3, - "visit_id": null, - "activity_id": 39, - "status": "X", - "instance_id": 28, - "superscript": null - }, - { - "id": 197, - "soa_id": 3, - "visit_id": null, - "activity_id": 3, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 198, - "soa_id": 3, - "visit_id": null, - "activity_id": 4, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 199, - "soa_id": 3, - "visit_id": null, - "activity_id": 5, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 200, - "soa_id": 3, - "visit_id": null, - "activity_id": 6, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 201, - "soa_id": 3, - "visit_id": null, - "activity_id": 7, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 202, - "soa_id": 3, - "visit_id": null, - "activity_id": 8, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 203, - "soa_id": 3, - "visit_id": null, - "activity_id": 9, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 204, - "soa_id": 3, - "visit_id": null, - "activity_id": 12, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 205, - "soa_id": 3, - "visit_id": null, - "activity_id": 10, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 206, - "soa_id": 3, - "visit_id": null, - "activity_id": 13, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 207, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 208, - "soa_id": 3, - "visit_id": null, - "activity_id": 17, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 209, - "soa_id": 3, - "visit_id": null, - "activity_id": 23, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 210, - "soa_id": 3, - "visit_id": null, - "activity_id": 24, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 211, - "soa_id": 3, - "visit_id": null, - "activity_id": 25, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 212, - "soa_id": 3, - "visit_id": null, - "activity_id": 26, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 213, - "soa_id": 3, - "visit_id": null, - "activity_id": 27, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 214, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 215, - "soa_id": 3, - "visit_id": null, - "activity_id": 29, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 216, - "soa_id": 3, - "visit_id": null, - "activity_id": 30, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 217, - "soa_id": 3, - "visit_id": null, - "activity_id": 31, - "status": "X", - "instance_id": 2, - "superscript": null - }, - { - "id": 218, - "soa_id": 3, - "visit_id": null, - "activity_id": 33, - "status": "X", - "instance_id": 2, - "superscript": "1" - }, - { - "id": 220, - "soa_id": 3, - "visit_id": null, - "activity_id": 37, - "status": "X", - "instance_id": 2, - "superscript": "3" - }, - { - "id": 221, - "soa_id": 3, - "visit_id": null, - "activity_id": 38, - "status": "X", - "instance_id": 2, - "superscript": "4" - }, - { - "id": 222, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 4, - "superscript": null - }, - { - "id": 223, - "soa_id": 3, - "visit_id": null, - "activity_id": 21, - "status": "X", - "instance_id": 4, - "superscript": null - }, - { - "id": 224, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 5, - "superscript": null - }, - { - "id": 225, - "soa_id": 3, - "visit_id": null, - "activity_id": 19, - "status": "X", - "instance_id": 5, - "superscript": null - }, - { - "id": 226, - "soa_id": 3, - "visit_id": null, - "activity_id": 22, - "status": "X", - "instance_id": 5, - "superscript": null - }, - { - "id": 227, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 5, - "superscript": null - }, - { - "id": 228, - "soa_id": 3, - "visit_id": null, - "activity_id": 32, - "status": "X", - "instance_id": 5, - "superscript": null - }, - { - "id": 229, - "soa_id": 3, - "visit_id": null, - "activity_id": 34, - "status": "X", - "instance_id": 5, - "superscript": null - }, - { - "id": 230, - "soa_id": 3, - "visit_id": null, - "activity_id": 36, - "status": "X", - "instance_id": 5, - "superscript": null - }, - { - "id": 231, - "soa_id": 3, - "visit_id": null, - "activity_id": 37, - "status": "X", - "instance_id": 5, - "superscript": null - }, - { - "id": 232, - "soa_id": 3, - "visit_id": null, - "activity_id": 38, - "status": "X", - "instance_id": 5, - "superscript": null - }, - { - "id": 233, - "soa_id": 3, - "visit_id": null, - "activity_id": 18, - "status": "X", - "instance_id": 6, - "superscript": null - }, - { - "id": 234, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 6, - "superscript": null - }, - { - "id": 235, - "soa_id": 3, - "visit_id": null, - "activity_id": 23, - "status": "X", - "instance_id": 6, - "superscript": null - }, - { - "id": 236, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 6, - "superscript": null - }, - { - "id": 237, - "soa_id": 3, - "visit_id": null, - "activity_id": 29, - "status": "X", - "instance_id": 6, - "superscript": null - }, - { - "id": 238, - "soa_id": 3, - "visit_id": null, - "activity_id": 30, - "status": "X", - "instance_id": 6, - "superscript": null - }, - { - "id": 239, - "soa_id": 3, - "visit_id": null, - "activity_id": 31, - "status": "X", - "instance_id": 6, - "superscript": null - }, - { - "id": 240, - "soa_id": 3, - "visit_id": null, - "activity_id": 32, - "status": "X", - "instance_id": 6, - "superscript": null - }, - { - "id": 241, - "soa_id": 3, - "visit_id": null, - "activity_id": 34, - "status": "X", - "instance_id": 6, - "superscript": null - }, - { - "id": 242, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 7, - "superscript": null - }, - { - "id": 243, - "soa_id": 3, - "visit_id": null, - "activity_id": 23, - "status": "X", - "instance_id": 7, - "superscript": null - }, - { - "id": 244, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 7, - "superscript": null - }, - { - "id": 245, - "soa_id": 3, - "visit_id": null, - "activity_id": 29, - "status": "X", - "instance_id": 7, - "superscript": null - }, - { - "id": 246, - "soa_id": 3, - "visit_id": null, - "activity_id": 30, - "status": "X", - "instance_id": 7, - "superscript": null - }, - { - "id": 247, - "soa_id": 3, - "visit_id": null, - "activity_id": 32, - "status": "X", - "instance_id": 7, - "superscript": null - }, - { - "id": 248, - "soa_id": 3, - "visit_id": null, - "activity_id": 34, - "status": "X", - "instance_id": 7, - "superscript": null - }, - { - "id": 249, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 8, - "superscript": null - }, - { - "id": 250, - "soa_id": 3, - "visit_id": null, - "activity_id": 23, - "status": "X", - "instance_id": 8, - "superscript": null - }, - { - "id": 251, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 8, - "superscript": null - }, - { - "id": 252, - "soa_id": 3, - "visit_id": null, - "activity_id": 29, - "status": "X", - "instance_id": 8, - "superscript": null - }, - { - "id": 253, - "soa_id": 3, - "visit_id": null, - "activity_id": 30, - "status": "X", - "instance_id": 8, - "superscript": null - }, - { - "id": 254, - "soa_id": 3, - "visit_id": null, - "activity_id": 32, - "status": "X", - "instance_id": 8, - "superscript": null - }, - { - "id": 255, - "soa_id": 3, - "visit_id": null, - "activity_id": 34, - "status": "X", - "instance_id": 8, - "superscript": null - }, - { - "id": 256, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 9, - "superscript": null - }, - { - "id": 257, - "soa_id": 3, - "visit_id": null, - "activity_id": 23, - "status": "X", - "instance_id": 9, - "superscript": null - }, - { - "id": 258, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 9, - "superscript": null - }, - { - "id": 259, - "soa_id": 3, - "visit_id": null, - "activity_id": 29, - "status": "X", - "instance_id": 9, - "superscript": null - }, - { - "id": 260, - "soa_id": 3, - "visit_id": null, - "activity_id": 30, - "status": "X", - "instance_id": 9, - "superscript": null - }, - { - "id": 261, - "soa_id": 3, - "visit_id": null, - "activity_id": 34, - "status": "X", - "instance_id": 9, - "superscript": null - }, - { - "id": 262, - "soa_id": 3, - "visit_id": null, - "activity_id": 36, - "status": "X", - "instance_id": 9, - "superscript": null - }, - { - "id": 263, - "soa_id": 3, - "visit_id": null, - "activity_id": 37, - "status": "X", - "instance_id": 9, - "superscript": null - }, - { - "id": 264, - "soa_id": 3, - "visit_id": null, - "activity_id": 38, - "status": "X", - "instance_id": 9, - "superscript": null - }, - { - "id": 265, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 21, - "superscript": null - }, - { - "id": 266, - "soa_id": 3, - "visit_id": null, - "activity_id": 23, - "status": "X", - "instance_id": 21, - "superscript": null - }, - { - "id": 267, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 21, - "superscript": null - }, - { - "id": 268, - "soa_id": 3, - "visit_id": null, - "activity_id": 29, - "status": "X", - "instance_id": 21, - "superscript": null - }, - { - "id": 269, - "soa_id": 3, - "visit_id": null, - "activity_id": 30, - "status": "X", - "instance_id": 21, - "superscript": null - }, - { - "id": 270, - "soa_id": 3, - "visit_id": null, - "activity_id": 31, - "status": "X", - "instance_id": 21, - "superscript": null - }, - { - "id": 271, - "soa_id": 3, - "visit_id": null, - "activity_id": 32, - "status": "X", - "instance_id": 21, - "superscript": null - }, - { - "id": 272, - "soa_id": 3, - "visit_id": null, - "activity_id": 34, - "status": "X", - "instance_id": 21, - "superscript": null - }, - { - "id": 273, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 23, - "superscript": null - }, - { - "id": 274, - "soa_id": 3, - "visit_id": null, - "activity_id": 23, - "status": "X", - "instance_id": 23, - "superscript": null - }, - { - "id": 275, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 23, - "superscript": null - }, - { - "id": 276, - "soa_id": 3, - "visit_id": null, - "activity_id": 29, - "status": "X", - "instance_id": 23, - "superscript": null - }, - { - "id": 277, - "soa_id": 3, - "visit_id": null, - "activity_id": 30, - "status": "X", - "instance_id": 23, - "superscript": null - }, - { - "id": 278, - "soa_id": 3, - "visit_id": null, - "activity_id": 34, - "status": "X", - "instance_id": 23, - "superscript": null - }, - { - "id": 279, - "soa_id": 3, - "visit_id": null, - "activity_id": 36, - "status": "X", - "instance_id": 23, - "superscript": null - }, - { - "id": 280, - "soa_id": 3, - "visit_id": null, - "activity_id": 37, - "status": "X", - "instance_id": 23, - "superscript": null - }, - { - "id": 281, - "soa_id": 3, - "visit_id": null, - "activity_id": 38, - "status": "X", - "instance_id": 23, - "superscript": null - }, - { - "id": 282, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 25, - "superscript": null - }, - { - "id": 283, - "soa_id": 3, - "visit_id": null, - "activity_id": 23, - "status": "X", - "instance_id": 25, - "superscript": null - }, - { - "id": 284, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 25, - "superscript": null - }, - { - "id": 285, - "soa_id": 3, - "visit_id": null, - "activity_id": 29, - "status": "X", - "instance_id": 25, - "superscript": null - }, - { - "id": 286, - "soa_id": 3, - "visit_id": null, - "activity_id": 30, - "status": "X", - "instance_id": 25, - "superscript": null - }, - { - "id": 287, - "soa_id": 3, - "visit_id": null, - "activity_id": 32, - "status": "X", - "instance_id": 25, - "superscript": null - }, - { - "id": 288, - "soa_id": 3, - "visit_id": null, - "activity_id": 34, - "status": "X", - "instance_id": 25, - "superscript": null - }, - { - "id": 289, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 27, - "superscript": null - }, - { - "id": 290, - "soa_id": 3, - "visit_id": null, - "activity_id": 23, - "status": "X", - "instance_id": 27, - "superscript": null - }, - { - "id": 291, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 27, - "superscript": null - }, - { - "id": 292, - "soa_id": 3, - "visit_id": null, - "activity_id": 29, - "status": "X", - "instance_id": 27, - "superscript": null - }, - { - "id": 293, - "soa_id": 3, - "visit_id": null, - "activity_id": 30, - "status": "X", - "instance_id": 27, - "superscript": null - }, - { - "id": 294, - "soa_id": 3, - "visit_id": null, - "activity_id": 31, - "status": "X", - "instance_id": 27, - "superscript": null - }, - { - "id": 295, - "soa_id": 3, - "visit_id": null, - "activity_id": 34, - "status": "X", - "instance_id": 27, - "superscript": null - }, - { - "id": 296, - "soa_id": 3, - "visit_id": null, - "activity_id": 36, - "status": "X", - "instance_id": 27, - "superscript": null - }, - { - "id": 297, - "soa_id": 3, - "visit_id": null, - "activity_id": 37, - "status": "X", - "instance_id": 27, - "superscript": null - }, - { - "id": 298, - "soa_id": 3, - "visit_id": null, - "activity_id": 38, - "status": "X", - "instance_id": 27, - "superscript": null - }, - { - "id": 299, - "soa_id": 3, - "visit_id": null, - "activity_id": 10, - "status": "X", - "instance_id": 28, - "superscript": null - }, - { - "id": 300, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 28, - "superscript": null - }, - { - "id": 301, - "soa_id": 3, - "visit_id": null, - "activity_id": 23, - "status": "X", - "instance_id": 28, - "superscript": null - }, - { - "id": 302, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 28, - "superscript": null - }, - { - "id": 303, - "soa_id": 3, - "visit_id": null, - "activity_id": 29, - "status": "X", - "instance_id": 28, - "superscript": null - }, - { - "id": 304, - "soa_id": 3, - "visit_id": null, - "activity_id": 30, - "status": "X", - "instance_id": 28, - "superscript": null - }, - { - "id": 305, - "soa_id": 3, - "visit_id": null, - "activity_id": 34, - "status": "X", - "instance_id": 28, - "superscript": null - }, - { - "id": 306, - "soa_id": 3, - "visit_id": null, - "activity_id": 35, - "status": "X", - "instance_id": 28, - "superscript": null - }, - { - "id": 307, - "soa_id": 3, - "visit_id": null, - "activity_id": 92, - "status": "X", - "instance_id": 13, - "superscript": null - }, - { - "id": 308, - "soa_id": 3, - "visit_id": null, - "activity_id": 10, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 309, - "soa_id": 3, - "visit_id": null, - "activity_id": 20, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 310, - "soa_id": 3, - "visit_id": null, - "activity_id": 23, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 311, - "soa_id": 3, - "visit_id": null, - "activity_id": 28, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 312, - "soa_id": 3, - "visit_id": null, - "activity_id": 29, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 313, - "soa_id": 3, - "visit_id": null, - "activity_id": 30, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 314, - "soa_id": 3, - "visit_id": null, - "activity_id": 31, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 315, - "soa_id": 3, - "visit_id": null, - "activity_id": 32, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 316, - "soa_id": 3, - "visit_id": null, - "activity_id": 34, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 317, - "soa_id": 3, - "visit_id": null, - "activity_id": 35, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 318, - "soa_id": 3, - "visit_id": null, - "activity_id": 36, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 319, - "soa_id": 3, - "visit_id": null, - "activity_id": 37, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 320, - "soa_id": 3, - "visit_id": null, - "activity_id": 38, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 321, - "soa_id": 3, - "visit_id": null, - "activity_id": 93, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 322, - "soa_id": 3, - "visit_id": null, - "activity_id": 94, - "status": "X", - "instance_id": 14, - "superscript": null - }, - { - "id": 324, - "soa_id": 3, - "visit_id": null, - "activity_id": 95, - "status": "X", - "instance_id": 15, - "superscript": null - }, - { - "id": 325, - "soa_id": 3, - "visit_id": null, - "activity_id": 96, - "status": "X", - "instance_id": 16, - "superscript": null - }, - { - "id": 326, - "soa_id": 3, - "visit_id": null, - "activity_id": 97, - "status": "X", - "instance_id": 17, - "superscript": null - }, - { - "id": 327, - "soa_id": 3, - "visit_id": null, - "activity_id": 98, - "status": "X", - "instance_id": 18, - "superscript": null - }, - { - "id": 328, - "soa_id": 3, - "visit_id": null, - "activity_id": 97, - "status": "X", - "instance_id": 19, - "superscript": null - }, - { - "id": 329, - "soa_id": 3, - "visit_id": null, - "activity_id": 98, - "status": "X", - "instance_id": 20, - "superscript": null - }, - { - "id": 629, - "soa_id": 3, - "visit_id": null, - "activity_id": 36, - "status": "X", - "instance_id": 2, - "superscript": "2" - } - ], - "biomedical_concept": [ - { - "id": 261, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_1", - "name": "Informed Consent", - "label": null, - "description": null, - "code": "AliasCode_3151" - }, - { - "id": 262, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_2", - "name": "Inclusion Criteria", - "label": "Inclusion Criteria", - "description": "Medical and/or social characteristics which are necessary for a subject to be allowed to participate in a clinical study, as outlined in the study protocol. Meeting inclusion criteria is not a sufficient condition for entry or recruitment of a subject into the study. Characteristics limiting the eligibility of a subject for the clinical study must be considered.", - "code": "AliasCode_24523" - }, - { - "id": 263, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_3", - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "description": "An indication of whether inclusion or exclusion criteria has been met.", - "code": "AliasCode_31819" - }, - { - "id": 264, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_4", - "name": "Exclusion Criteria", - "label": "Exclusion Criteria", - "description": "Medical and/or social characteristics that prevent a subject from being allowed to participate in a clinical study, as outlined in the study protocol.", - "code": "AliasCode_3153" - }, - { - "id": 265, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_5", - "name": "Subject is Randomized", - "label": "Subject is Randomized", - "description": "A status indication that a subject is already assigned to an arm of a clinical trial by chance.", - "code": "AliasCode_3160" - }, - { - "id": 266, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_6", - "name": "Race", - "label": "Race", - "description": "A geographic ancestral origin category that is assigned to a population group based mainly on physical characteristics that are thought to be distinct and inherent.", - "code": "AliasCode_31820" - }, - { - "id": 267, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_7", - "name": "Ethnic Group", - "label": "Ethnic Group", - "description": "A social group characterized by a distinctive social and cultural tradition that is maintained from generation to generation. Members share a common history and origin and a sense of identification with the group. They have similar and distinctive features in their lifestyle habits and shared experiences. They often have a common genetic heritage which may be reflected in their experience of health and disease.", - "code": "AliasCode_31821" - }, - { - "id": 268, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_8", - "name": "Subject Age", - "label": "Subject Age", - "description": "The age of a person who is the subject in a study.", - "code": "AliasCode_24524" - }, - { - "id": 269, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_9", - "name": "Birth Date and Time", - "label": "Birth Date and Time", - "description": "The date and time of a birth event.", - "code": "AliasCode_3155" - }, - { - "id": 270, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_10", - "name": "Sex", - "label": null, - "description": null, - "code": "AliasCode_24525" - }, - { - "id": 271, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_11", - "name": "Education Level", - "label": "Education Level", - "description": "An indication of the years of schooling completed in graded public, private, or parochial schools, and in colleges, universities, or professional schools.", - "code": "AliasCode_24526" - }, - { - "id": 272, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_12", - "name": "Number of Years of Education", - "label": "Number of Years of Education", - "description": "The number of education years that a subject has competed.", - "code": "AliasCode_24527" - }, - { - "id": 274, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_14", - "name": "Solicited Medical History", - "label": "Solicited Medical History", - "description": "Information about an individual's personal medical history that is reported by a healthcare professional, consumer, or patient through an organized data collection system.", - "code": "AliasCode_3156" - }, - { - "id": 275, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_15", - "name": "Alcohol Use History", - "label": "Alcohol Use History", - "description": "A description of an individual's current and past experience with alcoholic beverage consumption.", - "code": "AliasCode_24528" - }, - { - "id": 276, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_16", - "name": "Caffeine Use History", - "label": "Caffeine Use History", - "description": "A description of an individual's current or previous caffeine consumption.", - "code": "AliasCode_3157" - }, - { - "id": 277, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_17", - "name": "History of Tobacco Use", - "label": "History of Tobacco Use", - "description": "A description of an individual's current or previous use of tobacco.", - "code": "AliasCode_3158" - }, - { - "id": 278, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_18", - "name": "X-Ray Imaging", - "label": "X-Ray Imaging", - "description": "A radiographic procedure using the emission of x-rays to form an image of the structure penetrated by the radiation.", - "code": "AliasCode_33681" - }, - { - "id": 279, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_19", - "name": "Subject is Randomized", - "label": null, - "description": null, - "code": "AliasCode_3160" - }, - { - "id": 280, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_20", - "name": "Body Temperature", - "label": "Body Temperature", - "description": "A measurement of the temperature of the body.", - "code": "AliasCode_2640" - }, - { - "id": 281, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_21", - "name": "Body Weight", - "label": "Body Weight", - "description": "The weight of a subject.", - "code": "AliasCode_3161" - }, - { - "id": 282, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_22", - "name": "Body Height", - "label": "Body Height", - "description": "The vertical measurement or distance from the base to the top of a subject or participant.", - "code": "AliasCode_24529" - }, - { - "id": 283, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_23", - "name": "Pulse Rate", - "label": "Pulse Rate", - "description": "The rate of the pulse as observed in an artery, expressed as beats per minute. It can be measured at several anatomic sites, including the wrist, neck, temple, groin, behind the knees, or on top of the foot.", - "code": "AliasCode_2664" - }, - { - "id": 284, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_24", - "name": "Respiratory Rate", - "label": "Respiratory Rate", - "description": "The rate of breathing (inhalation and exhalation) measured within in a unit time, usually expressed as breaths per minute.", - "code": "AliasCode_2680" - }, - { - "id": 285, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_25", - "name": "Body Mass Index", - "label": "Body Mass Index", - "description": "An individual's weight in kilograms divided by the square of the height in meters.", - "code": "AliasCode_24530" - }, - { - "id": 286, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_26", - "name": "Blood Pressure", - "label": "Blood Pressure", - "description": "The pressure of the circulating blood against the walls of the blood vessels.", - "code": "AliasCode_3162" - }, - { - "id": 287, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_27", - "name": "Electrocardiogram Analysis", - "label": "Electrocardiogram Analysis", - "description": "The examination and interpretation of electrocardiogram data.", - "code": "AliasCode_24531" - }, - { - "id": 288, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_28", - "name": "Atrioventricular Conduction ECG Assessment", - "label": "Atrioventricular Conduction ECG Assessment", - "description": "An electrocardiographic assessment of the transmission of electrical impulses between the atria and ventricles.", - "code": "AliasCode_24532" - }, - { - "id": 289, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_29", - "name": "Axis and Voltage ECG Assessment", - "label": "Axis and Voltage ECG Assessment", - "description": "An electrocardiographic assessment of the mean cardiac electrical vector and ECG voltage.", - "code": "AliasCode_24533" - }, - { - "id": 290, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_30", - "name": "Chamber Hypertrophy or Enlargement ECG Assessment", - "label": "Chamber Hypertrophy or Enlargement ECG Assessment", - "description": "An electrocardiographic assessment of chamber hypertrophy or enlargement.", - "code": "AliasCode_24534" - }, - { - "id": 291, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_31", - "name": "ECG Technical Quality", - "label": "ECG Technical Quality", - "description": "A statement about an electrocardiographic recording describing technical issues or interference during the recording, processing, or transmission of the data. This does not represent an electrocardiographic diagnosis. (CDISC)", - "code": "AliasCode_24535" - }, - { - "id": 292, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_32", - "name": "Intraventricular and Intraatrial Conduction ECG Assessment", - "label": "Intraventricular and Intraatrial Conduction ECG Assessment", - "description": "An electrocardiographic assessment of the transmission of electrical impulses through the cardiac atria and ventricles.", - "code": "AliasCode_24536" - }, - { - "id": 293, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_33", - "name": "Myocardial Infarction ECG Assessment", - "label": "Myocardial Infarction ECG Assessment", - "description": "An electrocardiographic assessment of findings that suggest the occurrence of a myocardial infarction.", - "code": "AliasCode_24537" - }, - { - "id": 294, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_34", - "name": "Pacemaker ECG Assessment", - "label": "Pacemaker ECG Assessment", - "description": "An electrocardiographic assessment of the rate of firing of a an artificial, mechanical pacemaker.", - "code": "AliasCode_24538" - }, - { - "id": 295, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_35", - "name": "Rhythm Not Otherwise Specified ECG Assessment", - "label": "Rhythm Not Otherwise Specified ECG Assessment", - "description": "An electrocardiographic assessment of a cardiac rhythm that is not specified in a particular list.", - "code": "AliasCode_24539" - }, - { - "id": 296, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_36", - "name": "ST Segment, T wave, and U wave ECG Assessment", - "label": "ST Segment, T wave, and U wave ECG Assessment", - "description": "An electrocardiographic assessment of the characteristics of the ST segment, T wave, and U wave.", - "code": "AliasCode_24540" - }, - { - "id": 297, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_37", - "name": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "label": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "description": "An electrocardiographic assessment of the typical and atypical cardiac rhythms originating from the sinoatrial node.", - "code": "AliasCode_24541" - }, - { - "id": 298, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_38", - "name": "Supraventricular Arrhythmia ECG Assessment", - "label": "Supraventricular Arrhythmia ECG Assessment", - "description": "An electrocardiographic assessment of the atypical cardiac rhythms originating in the atrium, AV node or AV junction.", - "code": "AliasCode_24542" - }, - { - "id": 299, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_39", - "name": "Supraventricular Tachyarrhythmia ECG Assessment", - "label": "Supraventricular Tachyarrhythmia ECG Assessment", - "description": "An electrocardiographic assessment of the abnormally fast cardiac rhythms originating above the ventricles.", - "code": "AliasCode_24543" - }, - { - "id": 300, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_40", - "name": "Aggregate PR Interval", - "label": "Aggregate PR Interval", - "description": "An aggregate PR value based on the measurement of PR intervals from multiple beats within a single ECG. The method of aggregation, which can vary, is typically a measure of central tendency such as the mean. (CDISC)", - "code": "AliasCode_24544" - }, - { - "id": 301, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_41", - "name": "Aggregate QRS Duration", - "label": "Aggregate QRS Duration", - "description": "An aggregate QRS value based on the measurement of QRS intervals from multiple beats within a single ECG. The method of aggregation, which can vary, is typically a measure of central tendency such as the mean. (CDISC)", - "code": "AliasCode_24545" - }, - { - "id": 302, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_42", - "name": "Aggregate QT Interval", - "label": "Aggregate QT Interval", - "description": "An aggregate QT value based on the measurement of QT intervals from multiple beats within a single ECG. The method of aggregation, which can vary, is typically a measure of central tendency such as the mean. (CDISC)", - "code": "AliasCode_24546" - }, - { - "id": 303, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_43", - "name": "Aggregate QTCB Interval", - "label": "Aggregate QTCB Interval", - "description": "A QT aggregate interval corrected for heart rate using Bazett's formula.", - "code": "AliasCode_24547" - }, - { - "id": 304, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_44", - "name": "Aggregate QTCF Interval", - "label": "Aggregate QTCF Interval", - "description": "A QT aggregate interval corrected for heart rate using Fridericia's formula.", - "code": "AliasCode_24548" - }, - { - "id": 305, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_45", - "name": "Aggregate RR Interval", - "label": "Aggregate RR Interval", - "description": "An aggregate RR value based on the measurement of RR intervals from multiple beats within a single ECG. The method of aggregation, which can vary, is typically a measure of central tendency such as the mean. (CDISC)", - "code": "AliasCode_24549" - }, - { - "id": 306, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_46", - "name": "Mean Heart Rate by Electrocardiogram", - "label": "Mean Heart Rate by Electrocardiogram", - "description": "The calculated average rate of depolarisation of a specific region of the heart, most often the ventricles, as measured and recorded by an electrocardiograph during a specified, extended period of time, and which is usually expressed in beats per minute.", - "code": "AliasCode_24550" - }, - { - "id": 307, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_47", - "name": "QRS Axis", - "label": "QRS Axis", - "description": "A numerical representation of the electrocardiographic vector assessed at maximum deviation of the QRS complex from the isoelectric baseline, usually reported for the frontal plane. (CDISC)", - "code": "AliasCode_24551" - }, - { - "id": 308, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_48", - "name": "QTc Correction Method Unspecified, Aggregate", - "label": "QTc Correction Method Unspecified, Aggregate", - "description": "A QT aggregate interval that is corrected for heart rate by unspecified correction method, or by non-standard correction methods.", - "code": "AliasCode_24552" - }, - { - "id": 309, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_49", - "name": "Ventricular Arrhythmia ECG Assessment", - "label": "Ventricular Arrhythmia ECG Assessment", - "description": "An electrocardiographic assessment of the atypical cardiac rhythms originating in the ventricle.", - "code": "AliasCode_24553" - }, - { - "id": 310, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_50", - "name": "Ventricular Tachyarrhythmia ECG Assessment", - "label": "Ventricular Tachyarrhythmia ECG Assessment", - "description": "An electrocardiographic assessment of the abnormally fast cardiac rhythms originating within the ventricles.", - "code": "AliasCode_24554" - }, - { - "id": 311, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_51", - "name": "Computed Tomography", - "label": "Computed Tomography", - "description": "A method of examining structures within the body by scanning them with X rays and using a computer to construct a series of cross-sectional scans along a single axis.", - "code": "AliasCode_26218" - }, - { - "id": 312, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_52", - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "description": "Imaging that uses radiofrequency waves and a strong magnetic field rather than x-rays to provide detailed pictures of internal organs and tissues. The technique is valuable for the diagnosis of many pathologic conditions, including cancer, heart and vascular disease, stroke, and joint and musculoskeletal disorders.", - "code": "AliasCode_10845" - }, - { - "id": 314, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_54", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "description": "An indication of whether concomitant medication usage has occurred.", - "code": "AliasCode_24555" - }, - { - "id": 315, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_55", - "name": "Concomitant Therapy", - "label": "Concomitant Therapy", - "description": "Any pharmaceutical agent, other than the primary therapy, that is administered to or used by the subject prior to or during a specified time period.", - "code": "AliasCode_24556" - }, - { - "id": 316, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_56", - "name": "Hemoglobin Measurement", - "label": "Hemoglobin Measurement", - "description": "A quantitative measurement of the amount of hemoglobin present in a biospecimen.", - "code": "AliasCode_24557" - }, - { - "id": 317, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_57", - "name": "Hematocrit Measurement", - "label": "Hematocrit Measurement", - "description": "A measure of the volume of red blood cells expressed as a percentage of the total blood volume. Normal in males is 43-49%, in females 37-43%.", - "code": "AliasCode_24558" - }, - { - "id": 318, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_58", - "name": "Erythrocyte Count", - "label": "Erythrocyte Count", - "description": "The determination of the number of erythrocytes in a biospecimen.", - "code": "AliasCode_24559" - }, - { - "id": 319, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_59", - "name": "Erythrocyte Mean Corpuscular Hemoglobin", - "label": "Erythrocyte Mean Corpuscular Hemoglobin", - "description": "The mean cell hemoglobin (MCH), which is the average amount of hemoglobin in the average red cell. The MCH is a calculated value derived from the measurement of hemoglobin and the red cell count.", - "code": "AliasCode_24560" - }, - { - "id": 320, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_60", - "name": "Erythrocyte Mean Corpuscular Volume", - "label": "Erythrocyte Mean Corpuscular Volume", - "description": "The mean cell volume is the average volume of a red blood cell. This is a calculated value derived from the hematocrit and the red cell count.", - "code": "AliasCode_24561" - }, - { - "id": 321, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_61", - "name": "Leukocyte Count", - "label": "Leukocyte Count", - "description": "A test to determine the number of leukocytes in a biospecimen.", - "code": "AliasCode_24562" - }, - { - "id": 322, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_62", - "name": "Segmented Neutrophil Count", - "label": "Segmented Neutrophil Count", - "description": "The determination of the amount of segmented neutrophils present in a sample.", - "code": "AliasCode_24563" - }, - { - "id": 323, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_63", - "name": "Neutrophil Band Form Count", - "label": "Neutrophil Band Form Count", - "description": "The determination of the number of band neutrophils in a blood sample.", - "code": "AliasCode_24564" - }, - { - "id": 324, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_64", - "name": "Absolute Neutrophil Count", - "label": "Absolute Neutrophil Count", - "description": "The real number of white blood cells (WBC) that are neutrophils. It is derived by multiplying the WBC count by the percent of neutrophils in the differential WBC count. The normal range for ANC is 1.5 to 8.0 (1,500 to 8,000/mm3).", - "code": "AliasCode_24565" - }, - { - "id": 325, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_65", - "name": "Monocyte Count", - "label": "Monocyte Count", - "description": "The determination of the number of monocytes in a blood sample.", - "code": "AliasCode_24566" - }, - { - "id": 326, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_66", - "name": "Eosinophil Count", - "label": "Eosinophil Count", - "description": "The determination of the number of eosinophils in a blood sample.", - "code": "AliasCode_24567" - }, - { - "id": 327, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_67", - "name": "Absolute Basophil Count", - "label": "Absolute Basophil Count", - "description": "The total number of white blood cells that are basophils. It is calculated by multiplying the white blood cell count by the percent of basophils in the differential white blood cell count.", - "code": "AliasCode_3354" - }, - { - "id": 328, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_68", - "name": "Platelet Count", - "label": "Platelet Count", - "description": "The determination of the number of platelets in a biospecimen.", - "code": "AliasCode_24568" - }, - { - "id": 329, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_69", - "name": "Microcyte Count", - "label": "Microcyte Count", - "description": "The determination of the number of microcytes in a blood sample.", - "code": "AliasCode_24569" - }, - { - "id": 330, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_70", - "name": "Macrocyte Count", - "label": "Macrocyte Count", - "description": "The determination of the number of macrocytes in a blood sample.", - "code": "AliasCode_24570" - }, - { - "id": 331, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_71", - "name": "Anisocyte Measurement", - "label": "Anisocyte Measurement", - "description": "The determination of the number of anisocytes present in a sample.", - "code": "AliasCode_24571" - }, - { - "id": 332, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_72", - "name": "Poikilocyte Measurement", - "label": "Poikilocyte Measurement", - "description": "The determination of the number of poikilocytes present in a sample.", - "code": "AliasCode_24572" - }, - { - "id": 333, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_73", - "name": "Polychromasia", - "label": "Polychromasia", - "description": "The reaction of red cells to stain as indicated by the appearance of bluish or grayish colored erythrocytes.", - "code": "AliasCode_24573" - }, - { - "id": 334, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_74", - "name": "Alanine Aminotransferase Measurement", - "label": "Alanine Aminotransferase Measurement", - "description": "A quantitative measurement of alanine aminotransferase present in a sample.", - "code": "AliasCode_24574" - }, - { - "id": 335, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_75", - "name": "Albumin Measurement", - "label": "Albumin Measurement", - "description": "A quantitative measurement of albumin present in a sample.", - "code": "AliasCode_24575" - }, - { - "id": 336, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_76", - "name": "Alkaline Phosphatase Measurement", - "label": "Alkaline Phosphatase Measurement", - "description": "A quantitative measurement of alkaline phosphatase present in a sample.", - "code": "AliasCode_24576" - }, - { - "id": 337, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_77", - "name": "Aspartate Aminotransferase Measurement", - "label": "Aspartate Aminotransferase Measurement", - "description": "A quantitative measurement of aspartate aminotransferase present in a sample.", - "code": "AliasCode_24577" - }, - { - "id": 338, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_78", - "name": "Creatinine Measurement", - "label": "Creatinine Measurement", - "description": "A quantitative measurement of the amount of creatinine present in a sample.", - "code": "AliasCode_3355" - }, - { - "id": 339, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_79", - "name": "Potassium Measurement", - "label": "Potassium Measurement", - "description": "A quantitative measurement of the amount of potassium present in a sample.", - "code": "AliasCode_24578" - }, - { - "id": 340, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_80", - "name": "Sodium Measurement", - "label": "Sodium Measurement", - "description": "A quantitative measurement of the amount of sodium present in a sample.", - "code": "AliasCode_24579" - }, - { - "id": 341, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_81", - "name": "Urea Nitrogen Measurement", - "label": "Urea Nitrogen Measurement", - "description": "The determination of the amount of urea nitrogen present in a sample.", - "code": "AliasCode_24580" - }, - { - "id": 342, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_82", - "name": "Bicarbonate Measurement", - "label": "Bicarbonate Measurement", - "description": "The determination of the amount of bicarbonate present in a sample.", - "code": "AliasCode_24581" - }, - { - "id": 343, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_83", - "name": "Chloride Measurement", - "label": "Chloride Measurement", - "description": "A quantitative measurement of the amount of chloride present in a sample.", - "code": "AliasCode_24582" - }, - { - "id": 344, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_84", - "name": "Total Bilirubin Measurement", - "label": "Total Bilirubin Measurement", - "description": "The measurement of the total amount of bilirubin present in a particular substrate. The substrate most often tested is blood, but other fluids extracted from the body may be used periodically depending on the purpose of the test.", - "code": "AliasCode_24583" - }, - { - "id": 345, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_85", - "name": "Gamma Glutamyl Transpeptidase Measurement", - "label": "Gamma Glutamyl Transpeptidase Measurement", - "description": "A quantitative measurement of the amount of gamma glutamyl transpeptidase present in a sample.", - "code": "AliasCode_5782" - }, - { - "id": 346, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_86", - "name": "Urate Measurement", - "label": "Urate Measurement", - "description": "A quantitative measurement of the amount of urate present in a sample.", - "code": "AliasCode_24584" - }, - { - "id": 347, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_87", - "name": "Phosphate Measurement", - "label": "Phosphate Measurement", - "description": "A quantitative measurement of the amount of phosphate present in a sample.", - "code": "AliasCode_24585" - }, - { - "id": 348, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_88", - "name": "Calcium Measurement", - "label": "Calcium Measurement", - "description": "A quantitative measurement of the amount of calcium present in a sample.", - "code": "AliasCode_24586" - }, - { - "id": 349, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_89", - "name": "Glucose Measurement", - "label": "Glucose Measurement", - "description": "The determination of the amount of glucose present in a sample.", - "code": "AliasCode_24587" - }, - { - "id": 350, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_90", - "name": "Total Protein Measurement", - "label": "Total Protein Measurement", - "description": "A quantitative measurement of the amount of total protein present in a sample.", - "code": "AliasCode_24588" - }, - { - "id": 351, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_91", - "name": "Cholesterol Measurement", - "label": "Cholesterol Measurement", - "description": "The determination of the amount of total cholesterol present in a sample.", - "code": "AliasCode_24589" - }, - { - "id": 352, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_92", - "name": "Triiodothyronine Uptake Measurement", - "label": "Triiodothyronine Uptake Measurement", - "description": "The determination of the binding of triiodothyonine to thyroxine binding globulin protein in a sample.", - "code": "AliasCode_24590" - }, - { - "id": 353, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_93", - "name": "Triiodothyronine Measurement", - "label": "Triiodothyronine Measurement", - "description": "The determination of the amount of free and bound triiodothyronine present in a sample.", - "code": "AliasCode_24591" - }, - { - "id": 354, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_94", - "name": "Free Thyroxine Measurement", - "label": "Free Thyroxine Measurement", - "description": "The determination of the amount of free thyroxine present in a sample.", - "code": "AliasCode_24592" - }, - { - "id": 355, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_95", - "name": "Free Thyroxine Index", - "label": "Free Thyroxine Index", - "description": "A measurement of the thyroid status (function, disease diagnosis, or therapy effectiveness) in a biological specimen. This is calculated by a mathematical formula that takes into account the total thyroxine and unbound thyroxine binding globulins.", - "code": "AliasCode_24593" - }, - { - "id": 356, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_96", - "name": "Thyrotropin Measurement", - "label": "Thyrotropin Measurement", - "description": "A quantitative measurement of the amount of thyrotropin present in a sample.", - "code": "AliasCode_24594" - }, - { - "id": 357, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_97", - "name": "Folic Acid Measurement", - "label": "Folic Acid Measurement", - "description": "The determination of the amount of folic acid present in a sample.", - "code": "AliasCode_3218" - }, - { - "id": 358, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_98", - "name": "Vitamin B12 Measurement", - "label": "Vitamin B12 Measurement", - "description": "A quantitative measurement of the amount of vitamin B12 present in a sample.", - "code": "AliasCode_24595" - }, - { - "id": 359, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_99", - "name": "Treponema pallidum Antibody Measurement", - "label": "Treponema pallidum Antibody Measurement", - "description": "The determination of the amount of Treponema pallidum antibody in a biological sample.", - "code": "AliasCode_24596" - }, - { - "id": 360, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_100", - "name": "Treponema pallidum DNA Measurement", - "label": "Treponema pallidum DNA Measurement", - "description": "The determination of the amount of Treponema pallidum DNA present in a sample.", - "code": "AliasCode_24597" - }, - { - "id": 361, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_101", - "name": "Color Assessment", - "label": "Color Assessment", - "description": "A qualitative assessment of the color of a biological specimen.", - "code": "AliasCode_24598" - }, - { - "id": 362, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_102", - "name": "Specific Gravity", - "label": "Specific Gravity", - "description": "The density (mass per unit volume) of any material divided by that of water at a standard temperature.", - "code": "AliasCode_3219" - }, - { - "id": 363, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_103", - "name": "Total Protein Measurement", - "label": null, - "description": null, - "code": "AliasCode_24588" - }, - { - "id": 364, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_104", - "name": "Glucose Measurement", - "label": null, - "description": null, - "code": "AliasCode_24587" - }, - { - "id": 365, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_105", - "name": "Ketone Measurement", - "label": "Ketone Measurement", - "description": "A quantitative measurement of the amount of ketones present in a sample.", - "code": "AliasCode_24599" - }, - { - "id": 366, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_106", - "name": "Total Bilirubin Measurement", - "label": null, - "description": null, - "code": "AliasCode_24583" - }, - { - "id": 367, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_107", - "name": "Urobilinogen Measurement", - "label": "Urobilinogen Measurement", - "description": "A quantitative measurement of the amount of urobilinogen present in a sample.", - "code": "AliasCode_24600" - }, - { - "id": 368, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_108", - "name": "Occult Blood Measurement", - "label": "Occult Blood Measurement", - "description": "A measurement of the blood in body products such as a urine or stool sample, not detectable on gross examination.", - "code": "AliasCode_3356" - }, - { - "id": 369, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_109", - "name": "Nitrite Measurement", - "label": "Nitrite Measurement", - "description": "A quantitative measurement of the amount of nitrite present in a sample.", - "code": "AliasCode_3357" - }, - { - "id": 370, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_110", - "name": "Hemoglobin A1C Measurement", - "label": "Hemoglobin A1C Measurement", - "description": "The determination of the amount of hemoglobin A1C present in a sample.", - "code": "AliasCode_24601" - }, - { - "id": 371, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_111", - "name": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "label": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "description": "The determination of the ratio of the glycosylated hemoglobin compared to total hemoglobin present in a sample. The measurement may be expressed as a ratio or percentage.", - "code": "AliasCode_24602" - }, - { - "id": 372, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_112", - "name": "Exposure as Collected Domain", - "label": "Exposure as Collected Domain", - "description": "This interventions domain model reflects protocol-specified study treatment administrations, as collected.", - "code": "AliasCode_24603" - }, - { - "id": 373, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_113", - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "description": "A survey question to assess acceptability of the transdermal patch", - "code": "AliasCode_24604" - }, - { - "id": 374, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_114", - "name": "TTS Acceptability Survey - Patch Acceptability", - "label": "TTS Acceptability Survey - Patch Acceptability", - "description": "A survey question to assess acceptability of using a transdermal patch compared to oral medication", - "code": "AliasCode_24605" - }, - { - "id": 375, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_115", - "name": "TTS Acceptability Survey - Patch Appearance", - "label": "TTS Acceptability Survey - Patch Appearance", - "description": "A survey question to assess acceptability of the appearance of a transdermal patch", - "code": "AliasCode_24606" - }, - { - "id": 376, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_116", - "name": "TTS Acceptability Survey - Patch Durability", - "label": "TTS Acceptability Survey - Patch Durability", - "description": "A survey question to assess acceptability of the durability of a transdermal patch", - "code": "AliasCode_24607" - }, - { - "id": 377, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_117", - "name": "TTS Acceptability Survey - Patch Size", - "label": "TTS Acceptability Survey - Patch Size", - "description": "A survey question to assess acceptability of the size of a transdermal patch", - "code": "AliasCode_24608" - }, - { - "id": 394, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_134", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "description": "An indication of whether an adverse event has occurred.", - "code": "AliasCode_24609" - }, - { - "id": 395, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_135", - "name": "Solicited Adverse Event", - "label": "Solicited Adverse Event", - "description": "An adverse event that is reported by a healthcare professional, consumer, or patient through an organized data collection system.", - "code": "AliasCode_24610" - }, - { - "id": 396, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_136", - "name": "Complete", - "label": "Complete", - "description": "To possess every necessary or normal part or component or step; having come or been brought to a conclusion.", - "code": "AliasCode_24611" - }, - { - "id": 397, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_137", - "name": "Failure To Meet Continuation Criteria", - "label": "Failure To Meet Continuation Criteria", - "description": "An indication that the subject has not been able to meet protocol-defined continuation criteria and will not continue to participate in the clinical trial.", - "code": "AliasCode_24612" - }, - { - "id": 398, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_138", - "name": "Dead", - "label": "Dead", - "description": "The cessation of life.", - "code": "AliasCode_24613" - }, - { - "id": 399, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_139", - "name": "Lack of Efficacy", - "label": "Lack of Efficacy", - "description": "The lack of expected or desired effect related to a therapy.", - "code": "AliasCode_24614" - }, - { - "id": 400, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_140", - "name": "Lost To Follow-Up", - "label": "Lost To Follow-Up", - "description": "The loss or lack of continuation of subject participation after a study has officially closed.", - "code": "AliasCode_24615" - }, - { - "id": 401, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_141", - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "description": "Any unfavorable or unintended disease, sign, or symptom (including an abnormal laboratory finding) that is temporally associated with the use of a medical treatment or procedure, and that may or may not be considered related to the medical treatment or procedure. Such events can be related to the intervention, dose, route of administration, patient, or caused by an interaction with another drug(s) or procedure(s). [RETIRED]", - "code": "AliasCode_24616" - }, - { - "id": 402, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_142", - "name": "Physician Decision", - "label": "Physician Decision", - "description": "A position, opinion or judgment reached after consideration by a physician with reference to subject.", - "code": "AliasCode_24617" - }, - { - "id": 403, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_143", - "name": "Pregnant Subject", - "label": "Pregnant Subject", - "description": "An indication that the study subject is pregnant.", - "code": "AliasCode_24618" - }, - { - "id": 404, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_144", - "name": "Progressive Disease", - "label": "Progressive Disease", - "description": "A clinical, pathologic, and/or molecular finding indicating that the course of a disease is worsening in terms of extent or severity.", - "code": "AliasCode_24619" - }, - { - "id": 405, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_145", - "name": "Protocol Deviation", - "label": "Protocol Deviation", - "description": "A variation from processes or procedures defined in a protocol. Deviations usually do not preclude the overall evaluability of subject data for either efficacy or safety, and are often acknowledged and accepted in advance by the sponsor. (CDISC Glossary)", - "code": "AliasCode_1747" - }, - { - "id": 406, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_146", - "name": "Study Site Transfer", - "label": "Study Site Transfer", - "description": "The study subject has been assigned to a different study site.", - "code": "AliasCode_1753" - }, - { - "id": 407, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_147", - "name": "Study Terminated By Sponsor", - "label": "Study Terminated By Sponsor", - "description": "An indication that a clinical study was stopped by its sponsor.", - "code": "AliasCode_1758" - }, - { - "id": 408, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_148", - "name": "Subject Removed at Sponsor Request", - "label": "Subject Removed at Sponsor Request", - "description": "An indication that the study subject was removed from the study at the sponsor's request.", - "code": "AliasCode_29205" - }, - { - "id": 409, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_149", - "name": "Trial Screen Failure", - "label": "Trial Screen Failure", - "description": "The failure of a potential subject of meeting one or more criteria required for participation in a trial.", - "code": "AliasCode_1760" - }, - { - "id": 410, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_150", - "name": "Trial Site Terminated by Sponsor", - "label": "Trial Site Terminated by Sponsor", - "description": "An indication that a clinical study was stopped at a particular site by its sponsor.", - "code": "AliasCode_1761" - }, - { - "id": 411, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_151", - "name": "Withdrawal by Subject", - "label": "Withdrawal by Subject", - "description": "An indication that a study participant has removed themself from the study or from one or more segments of the study.", - "code": "AliasCode_1762" - }, - { - "id": 412, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_152", - "name": "Withdrawal of Consent From Protocol-Specified Activity", - "label": "Withdrawal of Consent From Protocol-Specified Activity", - "description": "The subject or parent/guardian withdraws their consent for the subject to participate in certain protocol-specified study activities, but does not withdraw consent from participation in the study as a whole.", - "code": "AliasCode_31663" - }, - { - "id": 413, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_153", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "description": "The maximum pressure exerted into the systemic arterial circulation during the contraction of the left ventricle of the heart.", - "code": "AliasCode_1834" - }, - { - "id": 414, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_154", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "description": "The minimum pressure exerted into the systemic arterial circulation during cardiac ventricular relaxation and filling.", - "code": "AliasCode_26219" - }, - { - "id": 415, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_155", - "name": "Heart Rate", - "label": "Heart Rate", - "description": "The number of heartbeats per unit of time, usually expressed as beats per minute.", - "code": "AliasCode_1833" - }, - { - "id": 419, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_156", - "name": "Systolic Blood Pressure", - "label": "Systolic Blood Pressure", - "description": "The maximum pressure exerted into the systemic arterial circulation during the contraction of the left ventricle of the heart.", - "code": "AliasCode_1834" - }, - { - "id": 420, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_157", - "name": "Diastolic Blood Pressure", - "label": "Diastolic Blood Pressure", - "description": "The minimum pressure exerted into the systemic arterial circulation during cardiac ventricular relaxation and filling.", - "code": "AliasCode_26219" - }, - { - "id": 421, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_158", - "name": "Heart Rate", - "label": "Heart Rate", - "description": "The number of heartbeats per unit of time, usually expressed as beats per minute.", - "code": "AliasCode_1833" - }, - { - "id": 508, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_159", - "name": "Isometric Muscle Strength", - "label": "Isometric Muscle Strength", - "description": "Isometric Muscle Strength.", - "code": "AliasCode_2312" - }, - { - "id": 509, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_160", - "name": "Skeletal Muscle Mass Measurement", - "label": "Skeletal Muscle Mass Measurement", - "description": "A measurement of the mass of all skeletal muscle in the body.", - "code": "AliasCode_2313" - }, - { - "id": 510, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_161", - "name": "Muscle Endurance Measurement", - "label": "Muscle Endurance Measurement", - "description": "A measurement of a muscle's ability to perform repetitive contractions against a force.", - "code": "AliasCode_24620" - }, - { - "id": 511, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_162", - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "description": "An indication as to whether the 10-second ECGs for this study were extracted from a continuous recording.", - "code": "AliasCode_2311" - }, - { - "id": 513, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_164", - "name": "TTS Acceptability Survey", - "label": "TTS Acceptability Survey", - "description": "A survey question to assess acceptability of the transdermal patch", - "code": "AliasCode_24604" - }, - { - "id": 514, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_165", - "name": "Magnetic Resonance Imaging", - "label": "Magnetic Resonance Imaging", - "description": "Imaging that uses radiofrequency waves and a strong magnetic field rather than x-rays to provide detailed pictures of internal organs and tissues. The technique is valuable for the diagnosis of many pathologic conditions, including cancer, heart and vascular disease, stroke, and joint and musculoskeletal disorders.", - "code": "AliasCode_10845" - }, - { - "id": 515, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_166", - "name": "Computed Tomography", - "label": "Computed Tomography", - "description": "A method of examining structures within the body by scanning them with X rays and using a computer to construct a series of cross-sectional scans along a single axis.", - "code": "AliasCode_26218" - }, - { - "id": 517, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_168", - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "description": "The act of assessing an individual's current temperature, heart rate, respiratory rate, pulse oxygenation, and blood pressure.", - "code": "AliasCode_24621" - }, - { - "id": 518, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_169", - "name": "Vital Signs Measurement", - "label": "Vital Signs Measurement", - "description": "The act of assessing an individual's current temperature, heart rate, respiratory rate, pulse oxygenation, and blood pressure.", - "code": "AliasCode_24621" - }, - { - "id": 519, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_170", - "name": "Adverse Event [RETIRED]", - "label": "Adverse Event [RETIRED]", - "description": "Any unfavorable or unintended disease, sign, or symptom (including an abnormal laboratory finding) that is temporally associated with the use of a medical treatment or procedure, and that may or may not be considered related to the medical treatment or procedure. Such events can be related to the intervention, dose, route of administration, patient, or caused by an interaction with another drug(s) or procedure(s). [RETIRED]", - "code": "AliasCode_24616" - }, - { - "id": 520, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_171", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "description": "An indication of whether an adverse event has occurred.", - "code": "AliasCode_24609" - }, - { - "id": 521, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_172", - "name": "CDISC ADAS-Cog - Word Recall Average Score", - "label": "CDISC ADAS-Cog - Word Recall Average Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recall task word average score of trials 1, 2, 3.", - "code": "AliasCode_24622" - }, - { - "id": 522, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_173", - "name": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "label": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Naming task summary score for object and fingers.", - "code": "AliasCode_27242" - }, - { - "id": 523, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_174", - "name": "CDISC ADAS-Cog - Commands Summary Score", - "label": "CDISC ADAS-Cog - Commands Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for commands.", - "code": "AliasCode_24623" - }, - { - "id": 524, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_175", - "name": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "label": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for delayed word recall.", - "code": "AliasCode_27243" - }, - { - "id": 525, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_176", - "name": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "label": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for constructional praxis.", - "code": "AliasCode_27244" - }, - { - "id": 526, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_177", - "name": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "label": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for ideational praxis.", - "code": "AliasCode_24624" - }, - { - "id": 527, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_178", - "name": "CDISC ADAS-Cog - Orientation Summary Score", - "label": "CDISC ADAS-Cog - Orientation Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for orientation.", - "code": "AliasCode_27245" - }, - { - "id": 528, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_179", - "name": "CDISC ADAS-Cog - Word Recognition Summary Score", - "label": "CDISC ADAS-Cog - Word Recognition Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for word recognition across trials 1-3.", - "code": "AliasCode_24625" - }, - { - "id": 529, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_180", - "name": "CDISC ADAS-Cog - Remembering Test Instructions", - "label": "CDISC ADAS-Cog - Remembering Test Instructions", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Remembering test instructions.", - "code": "AliasCode_24626" - }, - { - "id": 530, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_181", - "name": "CDISC ADAS-Cog - Spoken Language Ability", - "label": "CDISC ADAS-Cog - Spoken Language Ability", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Global rating of the quality of speech, or difficulty in making oneself understood.", - "code": "AliasCode_24627" - }, - { - "id": 531, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_182", - "name": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "label": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Difficulty finding the desired word in spontaneous speech.", - "code": "AliasCode_24628" - }, - { - "id": 532, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_183", - "name": "CDISC ADAS-Cog - Comprehension", - "label": "CDISC ADAS-Cog - Comprehension", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Ability to comprehend speech.", - "code": "AliasCode_24629" - }, - { - "id": 533, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_184", - "name": "CDISC ADAS-Cog - Concentration/Distractibility", - "label": "CDISC ADAS-Cog - Concentration/Distractibility", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Ability to concentrate or easily be distracted.", - "code": "AliasCode_24630" - }, - { - "id": 534, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_185", - "name": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "label": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for the number cancellation tasks.", - "code": "AliasCode_24631" - }, - { - "id": 535, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_186", - "name": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "label": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Number of errors during the executive function maze task.", - "code": "AliasCode_24632" - }, - { - "id": 536, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_187", - "name": "CDISC ADAS-Cog - Executive Function Maze: Time", - "label": "CDISC ADAS-Cog - Executive Function Maze: Time", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) The time taken to complete the executive function maze task.", - "code": "AliasCode_24633" - }, - { - "id": 538, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_189", - "name": "CDISC ADAS-Cog - Naming Objects and Fingers: Ring", - "label": "CDISC ADAS-Cog - Naming Objects and Fingers: Ring", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Naming task for fingers of the dominant hand, ring finger.", - "code": "AliasCode_1900" - }, - { - "id": 539, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_190", - "name": "CDISC ADAS-Cog - Naming Objects and Fingers: Pinky", - "label": "CDISC ADAS-Cog - Naming Objects and Fingers: Pinky", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Naming task for fingers of the dominant hand, little finger or pinky.", - "code": "AliasCode_1901" - }, - { - "id": 540, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_191", - "name": "CDISC ADAS-Cog - Commands Summary Score", - "label": "CDISC ADAS-Cog - Commands Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for commands.", - "code": "AliasCode_1902" - }, - { - "id": 541, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_192", - "name": "CDISC ADAS-Cog - Commands: Fist", - "label": "CDISC ADAS-Cog - Commands: Fist", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Commands task for making a fist.", - "code": "AliasCode_1903" - }, - { - "id": 542, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_193", - "name": "CDISC ADAS-Cog - Commands: Ceiling", - "label": "CDISC ADAS-Cog - Commands: Ceiling", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Commands task for pointing to the ceiling then to the floor.", - "code": "AliasCode_1904" - }, - { - "id": 543, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_194", - "name": "CDISC ADAS-Cog - Commands: Pencil", - "label": "CDISC ADAS-Cog - Commands: Pencil", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Commands task for put the pencil on top of the card and then put it back.", - "code": "AliasCode_1905" - }, - { - "id": 544, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_195", - "name": "CDISC ADAS-Cog - Commands: Watch", - "label": "CDISC ADAS-Cog - Commands: Watch", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Commands task for put the watch on the other side of the pencil and then turn over the card.", - "code": "AliasCode_1906" - }, - { - "id": 545, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_196", - "name": "CDISC ADAS-Cog - Commands: Shoulder", - "label": "CDISC ADAS-Cog - Commands: Shoulder", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Commands task for tap each shoulder twice with two fingers keeping your eyes shut.", - "code": "AliasCode_1907" - }, - { - "id": 546, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_197", - "name": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "label": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for delayed word recall.", - "code": "AliasCode_1908" - }, - { - "id": 547, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_198", - "name": "CDISC ADAS-Cog - Delayed Word Recall: Word 1", - "label": "CDISC ADAS-Cog - Delayed Word Recall: Word 1", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Delayed word recall task for word 1.", - "code": "AliasCode_1909" - }, - { - "id": 548, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_199", - "name": "CDISC ADAS-Cog - Delayed Word Recall: Word 2", - "label": "CDISC ADAS-Cog - Delayed Word Recall: Word 2", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Delayed word recall task for word 2.", - "code": "AliasCode_1910" - }, - { - "id": 549, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_200", - "name": "CDISC ADAS-Cog - Delayed Word Recall: Word 3", - "label": "CDISC ADAS-Cog - Delayed Word Recall: Word 3", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Delayed word recall task for word 3.", - "code": "AliasCode_1911" - }, - { - "id": 550, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_201", - "name": "CDISC ADAS-Cog - Delayed Word Recall: Word 4", - "label": "CDISC ADAS-Cog - Delayed Word Recall: Word 4", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Delayed word recall task for word 4.", - "code": "AliasCode_1912" - }, - { - "id": 551, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_202", - "name": "CDISC ADAS-Cog - Delayed Word Recall: Word 5", - "label": "CDISC ADAS-Cog - Delayed Word Recall: Word 5", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Delayed word recall task for word 5.", - "code": "AliasCode_1913" - }, - { - "id": 552, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_203", - "name": "CDISC ADAS-Cog - Delayed Word Recall: Word 6", - "label": "CDISC ADAS-Cog - Delayed Word Recall: Word 6", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Delayed word recall task for word 6.", - "code": "AliasCode_1914" - }, - { - "id": 553, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_204", - "name": "CDISC ADAS-Cog - Delayed Word Recall: Word 7", - "label": "CDISC ADAS-Cog - Delayed Word Recall: Word 7", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Delayed word recall task for word 7.", - "code": "AliasCode_1915" - }, - { - "id": 554, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_205", - "name": "CDISC ADAS-Cog - Delayed Word Recall: Word 8", - "label": "CDISC ADAS-Cog - Delayed Word Recall: Word 8", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Delayed word recall task for word 8.", - "code": "AliasCode_1916" - }, - { - "id": 555, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_206", - "name": "CDISC ADAS-Cog - Delayed Word Recall: Word 9", - "label": "CDISC ADAS-Cog - Delayed Word Recall: Word 9", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Delayed word recall task for word 9.", - "code": "AliasCode_1917" - }, - { - "id": 556, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_207", - "name": "CDISC ADAS-Cog - Delayed Word Recall: Word 10", - "label": "CDISC ADAS-Cog - Delayed Word Recall: Word 10", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Delayed word recall task for word 10.", - "code": "AliasCode_1918" - }, - { - "id": 557, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_208", - "name": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "label": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for constructional praxis.", - "code": "AliasCode_1919" - }, - { - "id": 558, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_209", - "name": "CDISC ADAS-Cog - Constructional Praxis: Circle", - "label": "CDISC ADAS-Cog - Constructional Praxis: Circle", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Constructional praxis task for copying a circle.", - "code": "AliasCode_1920" - }, - { - "id": 559, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_210", - "name": "CDISC ADAS-Cog - Constructional Praxis: 2 Rectangles", - "label": "CDISC ADAS-Cog - Constructional Praxis: 2 Rectangles", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Constructional praxis task for copying two overlapping rectangles.", - "code": "AliasCode_1921" - }, - { - "id": 560, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_211", - "name": "CDISC ADAS-Cog - Constructional Praxis: Diamond", - "label": "CDISC ADAS-Cog - Constructional Praxis: Diamond", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Constructional praxis task for copying a diamond.", - "code": "AliasCode_1922" - }, - { - "id": 561, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_212", - "name": "CDISC ADAS-Cog - Constructional Praxis: Cube", - "label": "CDISC ADAS-Cog - Constructional Praxis: Cube", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Constructional praxis task for copying a cube.", - "code": "AliasCode_1923" - }, - { - "id": 562, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_213", - "name": "CDISC ADAS-Cog - Attempt to Draw", - "label": "CDISC ADAS-Cog - Attempt to Draw", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Constructional praxis attempted to draw, but drew no forms correctly.", - "code": "AliasCode_1924" - }, - { - "id": 563, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_214", - "name": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "label": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for ideational praxis.", - "code": "AliasCode_1925" - }, - { - "id": 564, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_215", - "name": "CDISC ADAS-Cog - Ideational Praxis: Fold", - "label": "CDISC ADAS-Cog - Ideational Praxis: Fold", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Ideational praxis task for folding the paper.", - "code": "AliasCode_1926" - }, - { - "id": 565, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_216", - "name": "CDISC ADAS-Cog - Ideational Praxis: Insert", - "label": "CDISC ADAS-Cog - Ideational Praxis: Insert", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Ideational praxis task for put the paper in the envelop.", - "code": "AliasCode_1927" - }, - { - "id": 566, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_217", - "name": "CDISC ADAS-Cog - Ideational Praxis: Seal", - "label": "CDISC ADAS-Cog - Ideational Praxis: Seal", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Ideational praxis task for seal the envelop.", - "code": "AliasCode_1928" - }, - { - "id": 567, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_218", - "name": "CDISC ADAS-Cog - Ideational Praxis: Address", - "label": "CDISC ADAS-Cog - Ideational Praxis: Address", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Ideational praxis task for address the envelop to yourself.", - "code": "AliasCode_1929" - }, - { - "id": 568, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_219", - "name": "CDISC ADAS-Cog - Ideational Praxis: Stamp", - "label": "CDISC ADAS-Cog - Ideational Praxis: Stamp", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Ideational praxis task for showing where the stamp goes.", - "code": "AliasCode_1930" - }, - { - "id": 569, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_220", - "name": "CDISC ADAS-Cog - Orientation Summary Score", - "label": "CDISC ADAS-Cog - Orientation Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for orientation.", - "code": "AliasCode_1931" - }, - { - "id": 570, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_221", - "name": "CDISC ADAS-Cog - Orientation: Full Name", - "label": "CDISC ADAS-Cog - Orientation: Full Name", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Orientation task for knowing one's own full name.", - "code": "AliasCode_1932" - }, - { - "id": 571, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_222", - "name": "CDISC ADAS-Cog - Orientation: Month", - "label": "CDISC ADAS-Cog - Orientation: Month", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Orientation task for knowing the current month.", - "code": "AliasCode_1933" - }, - { - "id": 572, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_223", - "name": "CDISC ADAS-Cog - Orientation: Date", - "label": "CDISC ADAS-Cog - Orientation: Date", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Orientation task for knowing the current day.", - "code": "AliasCode_1934" - }, - { - "id": 573, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_224", - "name": "CDISC ADAS-Cog - Orientation: Year", - "label": "CDISC ADAS-Cog - Orientation: Year", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Orientation task for knowing the current year.", - "code": "AliasCode_1935" - }, - { - "id": 574, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_225", - "name": "CDISC ADAS-Cog - Orientation: Day of Week", - "label": "CDISC ADAS-Cog - Orientation: Day of Week", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Orientation task for knowing the current day of the week.", - "code": "AliasCode_1936" - }, - { - "id": 575, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_226", - "name": "CDISC ADAS-Cog - Orientation: Season", - "label": "CDISC ADAS-Cog - Orientation: Season", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Orientation task for knowing the current season.", - "code": "AliasCode_1937" - }, - { - "id": 576, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_227", - "name": "CDISC ADAS-Cog - Orientation: Place", - "label": "CDISC ADAS-Cog - Orientation: Place", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Orientation task for knowing the current place.", - "code": "AliasCode_1938" - }, - { - "id": 577, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_228", - "name": "CDISC ADAS-Cog - Orientation: Time", - "label": "CDISC ADAS-Cog - Orientation: Time", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Orientation task for knowing the approximate current clock time.", - "code": "AliasCode_1939" - }, - { - "id": 578, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_229", - "name": "CDISC ADAS-Cog - Word Recognition Summary Score", - "label": "CDISC ADAS-Cog - Word Recognition Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for word recognition across trials 1-3.", - "code": "AliasCode_1940" - }, - { - "id": 579, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_230", - "name": "CDISC ADAS-Cog - Word Recognition Trial 1 Summary Score", - "label": "CDISC ADAS-Cog - Word Recognition Trial 1 Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Sub-score for word recognition trial 1.", - "code": "AliasCode_1941" - }, - { - "id": 580, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_231", - "name": "CDISC ADAS-Cog - Word Recognition Trial 2 Summary Score", - "label": "CDISC ADAS-Cog - Word Recognition Trial 2 Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Sub-score for word recognition trial 2.", - "code": "AliasCode_1942" - }, - { - "id": 581, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_232", - "name": "CDISC ADAS-Cog - Word Recognition Trial 3 Summary Score", - "label": "CDISC ADAS-Cog - Word Recognition Trial 3 Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Sub-score for word recognition trial 3.", - "code": "AliasCode_1943" - }, - { - "id": 582, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_233", - "name": "CDISC ADAS-Cog - Word Recognition: Word 1", - "label": "CDISC ADAS-Cog - Word Recognition: Word 1", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 1 Trials 1, 2, 3.", - "code": "AliasCode_1944" - }, - { - "id": 583, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_234", - "name": "CDISC ADAS-Cog - Word Recognition: Word 2", - "label": "CDISC ADAS-Cog - Word Recognition: Word 2", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 2 Trials 1, 2, 3.", - "code": "AliasCode_1945" - }, - { - "id": 584, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_235", - "name": "CDISC ADAS-Cog - Word Recognition: Word 3", - "label": "CDISC ADAS-Cog - Word Recognition: Word 3", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 3 Trials 1, 2, 3.", - "code": "AliasCode_1946" - }, - { - "id": 585, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_236", - "name": "CDISC ADAS-Cog - Word Recognition: Word 4", - "label": "CDISC ADAS-Cog - Word Recognition: Word 4", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 4 Trials 1, 2, 3.", - "code": "AliasCode_1947" - }, - { - "id": 586, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_237", - "name": "CDISC ADAS-Cog - Word Recognition: Word 5", - "label": "CDISC ADAS-Cog - Word Recognition: Word 5", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 5 Trials 1, 2, 3.", - "code": "AliasCode_1948" - }, - { - "id": 587, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_238", - "name": "CDISC ADAS-Cog - Word Recognition: Word 6", - "label": "CDISC ADAS-Cog - Word Recognition: Word 6", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 6 Trials 1, 2, 3.", - "code": "AliasCode_1949" - }, - { - "id": 588, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_239", - "name": "CDISC ADAS-Cog - Word Recognition: Word 7", - "label": "CDISC ADAS-Cog - Word Recognition: Word 7", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 7 Trials 1, 2, 3.", - "code": "AliasCode_1950" - }, - { - "id": 589, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_240", - "name": "CDISC ADAS-Cog - Word Recognition: Word 8", - "label": "CDISC ADAS-Cog - Word Recognition: Word 8", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 8 Trials 1, 2, 3.", - "code": "AliasCode_1951" - }, - { - "id": 590, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_241", - "name": "CDISC ADAS-Cog - Word Recognition: Word 9", - "label": "CDISC ADAS-Cog - Word Recognition: Word 9", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 9 Trials 1, 2, 3.", - "code": "AliasCode_1952" - }, - { - "id": 591, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_242", - "name": "CDISC ADAS-Cog - Word Recognition: Word 10", - "label": "CDISC ADAS-Cog - Word Recognition: Word 10", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 10 Trials 1, 2, 3.", - "code": "AliasCode_1953" - }, - { - "id": 592, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_243", - "name": "CDISC ADAS-Cog - Word Recognition: Word 11", - "label": "CDISC ADAS-Cog - Word Recognition: Word 11", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 11 Trials 1, 2, 3.", - "code": "AliasCode_1954" - }, - { - "id": 593, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_244", - "name": "CDISC ADAS-Cog - Word Recognition: Word 12", - "label": "CDISC ADAS-Cog - Word Recognition: Word 12", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 12 Trials 1, 2, 3.", - "code": "AliasCode_1955" - }, - { - "id": 594, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_245", - "name": "CDISC ADAS-Cog - Word Recognition: Word 13", - "label": "CDISC ADAS-Cog - Word Recognition: Word 13", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 13 Trials 1, 2, 3.", - "code": "AliasCode_1956" - }, - { - "id": 595, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_246", - "name": "CDISC ADAS-Cog - Word Recognition: Word 14", - "label": "CDISC ADAS-Cog - Word Recognition: Word 14", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 14 Trials 1, 2, 3.", - "code": "AliasCode_1957" - }, - { - "id": 596, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_247", - "name": "CDISC ADAS-Cog - Word Recognition: Word 15", - "label": "CDISC ADAS-Cog - Word Recognition: Word 15", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 15 Trials 1, 2, 3.", - "code": "AliasCode_1958" - }, - { - "id": 597, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_248", - "name": "CDISC ADAS-Cog - Word Recognition: Word 16", - "label": "CDISC ADAS-Cog - Word Recognition: Word 16", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 16 Trials 1, 2, 3.", - "code": "AliasCode_1959" - }, - { - "id": 598, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_249", - "name": "CDISC ADAS-Cog - Word Recognition: Word 17", - "label": "CDISC ADAS-Cog - Word Recognition: Word 17", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 17 Trials 1, 2, 3.", - "code": "AliasCode_1960" - }, - { - "id": 599, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_250", - "name": "CDISC ADAS-Cog - Word Recognition: Word 18", - "label": "CDISC ADAS-Cog - Word Recognition: Word 18", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 18 Trials 1, 2, 3.", - "code": "AliasCode_1961" - }, - { - "id": 600, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_251", - "name": "CDISC ADAS-Cog - Word Recognition: Word 19", - "label": "CDISC ADAS-Cog - Word Recognition: Word 19", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 19 Trials 1, 2, 3.", - "code": "AliasCode_1962" - }, - { - "id": 601, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_252", - "name": "CDISC ADAS-Cog - Word Recognition: Word 20", - "label": "CDISC ADAS-Cog - Word Recognition: Word 20", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 20 Trials 1, 2, 3.", - "code": "AliasCode_1963" - }, - { - "id": 602, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_253", - "name": "CDISC ADAS-Cog - Word Recognition: Word 21", - "label": "CDISC ADAS-Cog - Word Recognition: Word 21", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 21 Trials 1, 2, 3.", - "code": "AliasCode_1964" - }, - { - "id": 603, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_254", - "name": "CDISC ADAS-Cog - Word Recognition: Word 22", - "label": "CDISC ADAS-Cog - Word Recognition: Word 22", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 22 Trials 1, 2, 3.", - "code": "AliasCode_1965" - }, - { - "id": 604, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_255", - "name": "CDISC ADAS-Cog - Word Recognition: Word 23", - "label": "CDISC ADAS-Cog - Word Recognition: Word 23", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 23 Trials 1, 2, 3.", - "code": "AliasCode_1966" - }, - { - "id": 605, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_256", - "name": "CDISC ADAS-Cog - Word Recognition: Word 24", - "label": "CDISC ADAS-Cog - Word Recognition: Word 24", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Word recognition task for word 24 Trials 1, 2, 3.", - "code": "AliasCode_1967" - }, - { - "id": 606, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_257", - "name": "CDISC ADAS-Cog - Remembering Test Instructions", - "label": "CDISC ADAS-Cog - Remembering Test Instructions", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Remembering test instructions.", - "code": "AliasCode_1968" - }, - { - "id": 607, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_258", - "name": "CDISC ADAS-Cog - Spoken Language Ability", - "label": "CDISC ADAS-Cog - Spoken Language Ability", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Global rating of the quality of speech, or difficulty in making oneself understood.", - "code": "AliasCode_1969" - }, - { - "id": 608, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_259", - "name": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "label": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Difficulty finding the desired word in spontaneous speech.", - "code": "AliasCode_1970" - }, - { - "id": 609, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_260", - "name": "CDISC ADAS-Cog - Comprehension", - "label": "CDISC ADAS-Cog - Comprehension", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Ability to comprehend speech.", - "code": "AliasCode_1971" - }, - { - "id": 610, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_261", - "name": "CDISC ADAS-Cog - Concentration/Distractibility", - "label": "CDISC ADAS-Cog - Concentration/Distractibility", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Ability to concentrate or easily be distracted.", - "code": "AliasCode_1972" - }, - { - "id": 611, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_262", - "name": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "label": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for the number cancellation tasks.", - "code": "AliasCode_1973" - }, - { - "id": 612, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_263", - "name": "CDISC ADAS-Cog - Number Cancellation: Correct", - "label": "CDISC ADAS-Cog - Number Cancellation: Correct", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Number of targets hit during the number cancellation task.", - "code": "AliasCode_1974" - }, - { - "id": 613, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_264", - "name": "CDISC ADAS-Cog - Number Cancellation: Errors", - "label": "CDISC ADAS-Cog - Number Cancellation: Errors", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Number of errors during the number cancellation task.", - "code": "AliasCode_1975" - }, - { - "id": 614, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_265", - "name": "CDISC ADAS-Cog - Number Cancellation: Remind", - "label": "CDISC ADAS-Cog - Number Cancellation: Remind", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Number of times reminded for the number cancellation task.", - "code": "AliasCode_1976" - }, - { - "id": 615, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_266", - "name": "CDISC ADAS-Cog - Executive Function Maze Summary Score", - "label": "CDISC ADAS-Cog - Executive Function Maze Summary Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Summary score for the executive function maze tasks.", - "code": "AliasCode_1977" - }, - { - "id": 616, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_267", - "name": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "label": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Number of errors during the executive function maze task.", - "code": "AliasCode_1978" - }, - { - "id": 617, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_268", - "name": "CDISC ADAS-Cog - Executive Function Maze: Time", - "label": "CDISC ADAS-Cog - Executive Function Maze: Time", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) The time taken to complete the executive function maze task.", - "code": "AliasCode_1979" - }, - { - "id": 618, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_269", - "name": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version Functional Test", - "label": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version Functional Test", - "description": "The CDISC version of the Alzheimer's Disease Assessment Scale-Cognitive (CDISC ADAS-Cog) containing 15 summary-level tests. This version is based on combining the total pool of ADAS-Cog tests that were observed during a review of multiple case report forms administered in clinical trials of Alzheimer's disease, as well as the CRF administered in the Alzheimer's Disease Neuroimaging Initiative (ADNI) observational study. (Modified from Mohs RC, Rosen WG, Davis KL. The Alzheimer's disease assessment scale: an instrument for assessing treatment efficacy. Psychopharmacol Bull 1983;19(3):448-450. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry 1984;141(11):1356-1364. Mohs RC, Knopman D, Petersen RC et al. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broaden its scope. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord 1997;11 Suppl 2:S13-S21. Wouters H, van Gool WA, Schmand B, Lindeboom R. Revising the ADAS-cog for a more accurate assessment of cognitive impairment. Alzheimer Dis Assoc Disord 2008;22(3):236-244.).", - "code": "AliasCode_1980" - }, - { - "id": 619, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_270", - "name": "CDISC ADAS-Cog - Total Score", - "label": "CDISC ADAS-Cog - Total Score", - "description": "Alzheimer's Disease Assessment Scale-Cognitive CDISC Version (ADAS-Cog CDISC Version) Total score.", - "code": "AliasCode_1981" - }, - { - "id": 620, - "soa_id": 3, - "biomedical_concept_uid": "BiomedicalConcept_163", - "name": "ECG Continuous Monitoring Indicator", - "label": "ECG Continuous Monitoring Indicator", - "description": "An indication as to whether the 10-second ECGs for this study were extracted from a continuous recording.", - "code": "AliasCode_2311" - } - ], - "biomedical_concept_property": [ - { - "id": 215688, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1", - "name": "DSDECOD", - "label": "DSDECOD", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37048", - "biomedical_concept_uid": "BiomedicalConcept_1" - }, - { - "id": 215689, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_2", - "name": "DSTERM", - "label": "DSTERM", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37049", - "biomedical_concept_uid": "BiomedicalConcept_1" - }, - { - "id": 215690, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_3", - "name": "DSSTDTC", - "label": "DSSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37050", - "biomedical_concept_uid": "BiomedicalConcept_1" - }, - { - "id": 215691, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_4", - "name": "TIVERS", - "label": "TIVERS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37051", - "biomedical_concept_uid": "BiomedicalConcept_2" - }, - { - "id": 215692, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_5", - "name": "IEORRES", - "label": "IEORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37052", - "biomedical_concept_uid": "BiomedicalConcept_2" - }, - { - "id": 215693, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_6", - "name": "IEDTC", - "label": "IEDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37053", - "biomedical_concept_uid": "BiomedicalConcept_2" - }, - { - "id": 215694, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_7", - "name": "Inclusion Exclusion Criteria Yes No Indicator", - "label": "Inclusion Exclusion Criteria Yes No Indicator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37054", - "biomedical_concept_uid": "BiomedicalConcept_3" - }, - { - "id": 215695, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_8", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37055", - "biomedical_concept_uid": "BiomedicalConcept_3" - }, - { - "id": 215696, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_9", - "name": "TIVERS", - "label": "TIVERS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37056", - "biomedical_concept_uid": "BiomedicalConcept_4" - }, - { - "id": 215697, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_10", - "name": "IEORRES", - "label": "IEORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37057", - "biomedical_concept_uid": "BiomedicalConcept_4" - }, - { - "id": 215698, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_11", - "name": "IEDTC", - "label": "IEDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37058", - "biomedical_concept_uid": "BiomedicalConcept_4" - }, - { - "id": 215699, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_12", - "name": "DSDECOD", - "label": "DSDECOD", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37059", - "biomedical_concept_uid": "BiomedicalConcept_5" - }, - { - "id": 215700, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_13", - "name": "DSTERM", - "label": "DSTERM", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37060", - "biomedical_concept_uid": "BiomedicalConcept_5" - }, - { - "id": 215701, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_14", - "name": "DSSTDTC", - "label": "DSSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37061", - "biomedical_concept_uid": "BiomedicalConcept_5" - }, - { - "id": 215702, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_15", - "name": "RACE", - "label": "RACE", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37062", - "biomedical_concept_uid": "BiomedicalConcept_6" - }, - { - "id": 215703, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_16", - "name": "DMDTC", - "label": "DMDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37063", - "biomedical_concept_uid": "BiomedicalConcept_6" - }, - { - "id": 215704, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_17", - "name": "ETHNIC", - "label": "ETHNIC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37064", - "biomedical_concept_uid": "BiomedicalConcept_7" - }, - { - "id": 215705, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_18", - "name": "DMDTC", - "label": "DMDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37065", - "biomedical_concept_uid": "BiomedicalConcept_7" - }, - { - "id": 215706, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_19", - "name": "AGE", - "label": "AGE", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37066", - "biomedical_concept_uid": "BiomedicalConcept_8" - }, - { - "id": 215707, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_20", - "name": "AGEU", - "label": "AGEU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37067", - "biomedical_concept_uid": "BiomedicalConcept_8" - }, - { - "id": 215708, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_21", - "name": "DMDTC", - "label": "DMDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37068", - "biomedical_concept_uid": "BiomedicalConcept_8" - }, - { - "id": 215709, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_22", - "name": "BRTHDTC", - "label": "BRTHDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37069", - "biomedical_concept_uid": "BiomedicalConcept_9" - }, - { - "id": 215710, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_23", - "name": "DMDTC", - "label": "DMDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37070", - "biomedical_concept_uid": "BiomedicalConcept_9" - }, - { - "id": 215711, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_24", - "name": "SEX", - "label": "SEX", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37071", - "biomedical_concept_uid": "BiomedicalConcept_10" - }, - { - "id": 215712, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_25", - "name": "DMDTC", - "label": "DMDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37072", - "biomedical_concept_uid": "BiomedicalConcept_10" - }, - { - "id": 215713, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_26", - "name": "SCORRES", - "label": "SCORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37073", - "biomedical_concept_uid": "BiomedicalConcept_11" - }, - { - "id": 215714, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_27", - "name": "SCDTC", - "label": "SCDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37074", - "biomedical_concept_uid": "BiomedicalConcept_11" - }, - { - "id": 215715, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_28", - "name": "SCORRES", - "label": "SCORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37075", - "biomedical_concept_uid": "BiomedicalConcept_12" - }, - { - "id": 215716, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_29", - "name": "SCORRESU", - "label": "SCORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37076", - "biomedical_concept_uid": "BiomedicalConcept_12" - }, - { - "id": 215717, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_30", - "name": "SCDTC", - "label": "SCDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37077", - "biomedical_concept_uid": "BiomedicalConcept_12" - }, - { - "id": 215718, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_31", - "name": "MHTERM", - "label": "MHTERM", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37078", - "biomedical_concept_uid": "BiomedicalConcept_14" - }, - { - "id": 215719, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_32", - "name": "MHDECOD", - "label": "MHDECOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37079", - "biomedical_concept_uid": "BiomedicalConcept_14" - }, - { - "id": 215720, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_33", - "name": "MHSTDTC", - "label": "MHSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37080", - "biomedical_concept_uid": "BiomedicalConcept_14" - }, - { - "id": 215721, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_34", - "name": "MHENDTC", - "label": "MHENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37081", - "biomedical_concept_uid": "BiomedicalConcept_14" - }, - { - "id": 215722, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_35", - "name": "MHENRF", - "label": "MHENRF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37082", - "biomedical_concept_uid": "BiomedicalConcept_14" - }, - { - "id": 215723, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_36", - "name": "MHENRTPT", - "label": "MHENRTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37083", - "biomedical_concept_uid": "BiomedicalConcept_14" - }, - { - "id": 215724, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_37", - "name": "MHENTPT", - "label": "MHENTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37084", - "biomedical_concept_uid": "BiomedicalConcept_14" - }, - { - "id": 215725, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_38", - "name": "SUTRT", - "label": "SUTRT", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37085", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215726, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_39", - "name": "SUPRESP", - "label": "SUPRESP", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37086", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215727, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_40", - "name": "SUOCCUR", - "label": "SUOCCUR", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37087", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215728, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_41", - "name": "SUDOSE", - "label": "SUDOSE", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37088", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215729, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_42", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37089", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215730, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_43", - "name": "SUDOSU", - "label": "SUDOSU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37090", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215731, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_44", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37091", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215732, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_45", - "name": "SUSTDTC", - "label": "SUSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37092", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215733, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_46", - "name": "SUENDTC", - "label": "SUENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37093", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215734, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_47", - "name": "SUSTRF", - "label": "SUSTRF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37094", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215735, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_48", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37095", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215736, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_49", - "name": "SUSTTPT", - "label": "SUSTTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37096", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215737, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_50", - "name": "SUENRF", - "label": "SUENRF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37097", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215738, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_51", - "name": "SUENRTPT", - "label": "SUENRTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37098", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215739, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_52", - "name": "SUENTPT", - "label": "SUENTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37099", - "biomedical_concept_uid": "BiomedicalConcept_15" - }, - { - "id": 215740, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_53", - "name": "SUTRT", - "label": "SUTRT", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37100", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215741, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_54", - "name": "SUPRESP", - "label": "SUPRESP", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37101", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215742, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_55", - "name": "SUOCCUR", - "label": "SUOCCUR", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37102", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215743, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_56", - "name": "SUDOSE", - "label": "SUDOSE", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37103", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215744, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_57", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37104", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215745, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_58", - "name": "SUDOSU", - "label": "SUDOSU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37105", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215746, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_59", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37106", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215747, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_60", - "name": "SUSTDTC", - "label": "SUSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37107", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215748, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_61", - "name": "SUENDTC", - "label": "SUENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37108", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215749, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_62", - "name": "SUSTRF", - "label": "SUSTRF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37109", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215750, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_63", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37110", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215751, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_64", - "name": "SUSTTPT", - "label": "SUSTTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37111", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215752, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_65", - "name": "SUENRF", - "label": "SUENRF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37112", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215753, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_66", - "name": "SUENRTPT", - "label": "SUENRTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37113", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215754, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_67", - "name": "SUENTPT", - "label": "SUENTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37114", - "biomedical_concept_uid": "BiomedicalConcept_16" - }, - { - "id": 215755, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_68", - "name": "SUTRT", - "label": "SUTRT", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37115", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215756, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_69", - "name": "SUPRESP", - "label": "SUPRESP", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37116", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215757, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_70", - "name": "SUOCCUR", - "label": "SUOCCUR", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37117", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215758, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_71", - "name": "SUDOSE", - "label": "SUDOSE", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37118", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215759, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_72", - "name": "SUDOSTXT", - "label": "SUDOSTXT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37119", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215760, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_73", - "name": "SUDOSU", - "label": "SUDOSU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37120", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215761, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_74", - "name": "SUDOSFRQ", - "label": "SUDOSFRQ", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37121", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215762, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_75", - "name": "SUSTDTC", - "label": "SUSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37122", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215763, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_76", - "name": "SUENDTC", - "label": "SUENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37123", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215764, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_77", - "name": "SUDUR", - "label": "SUDUR", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37124", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215765, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_78", - "name": "SUSTRF", - "label": "SUSTRF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37125", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215766, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_79", - "name": "SUSTRTPT", - "label": "SUSTRTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37126", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215767, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_80", - "name": "SUSTTPT", - "label": "SUSTTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37127", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215768, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_81", - "name": "SUENRF", - "label": "SUENRF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37128", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215769, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_82", - "name": "SUENRTPT", - "label": "SUENRTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37129", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215770, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_83", - "name": "SUENTPT", - "label": "SUENTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37130", - "biomedical_concept_uid": "BiomedicalConcept_17" - }, - { - "id": 215771, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_84", - "name": "PRTRT", - "label": "PRTRT", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37131", - "biomedical_concept_uid": "BiomedicalConcept_18" - }, - { - "id": 215772, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_85", - "name": "PRDECOD", - "label": "PRDECOD", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37132", - "biomedical_concept_uid": "BiomedicalConcept_18" - }, - { - "id": 215773, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_86", - "name": "PRPRESP", - "label": "PRPRESP", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37133", - "biomedical_concept_uid": "BiomedicalConcept_18" - }, - { - "id": 215774, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_87", - "name": "PROCCUR", - "label": "PROCCUR", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37134", - "biomedical_concept_uid": "BiomedicalConcept_18" - }, - { - "id": 215775, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_88", - "name": "PRLOC", - "label": "PRLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37135", - "biomedical_concept_uid": "BiomedicalConcept_18" - }, - { - "id": 215776, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_89", - "name": "PRSTDTC", - "label": "PRSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37136", - "biomedical_concept_uid": "BiomedicalConcept_18" - }, - { - "id": 215777, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_90", - "name": "PRENDTC", - "label": "PRENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37137", - "biomedical_concept_uid": "BiomedicalConcept_18" - }, - { - "id": 215778, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_91", - "name": "DSDECOD", - "label": "DSDECOD", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37138", - "biomedical_concept_uid": "BiomedicalConcept_19" - }, - { - "id": 215779, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_92", - "name": "DSTERM", - "label": "DSTERM", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37139", - "biomedical_concept_uid": "BiomedicalConcept_19" - }, - { - "id": 215780, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_93", - "name": "DSSTDTC", - "label": "DSSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37140", - "biomedical_concept_uid": "BiomedicalConcept_19" - }, - { - "id": 215781, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_94", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37141", - "biomedical_concept_uid": "BiomedicalConcept_20" - }, - { - "id": 215782, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_95", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37142", - "biomedical_concept_uid": "BiomedicalConcept_20" - }, - { - "id": 215783, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_96", - "name": "VSLOC", - "label": "VSLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37143", - "biomedical_concept_uid": "BiomedicalConcept_20" - }, - { - "id": 215784, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_97", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37144", - "biomedical_concept_uid": "BiomedicalConcept_20" - }, - { - "id": 215785, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_98", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37145", - "biomedical_concept_uid": "BiomedicalConcept_21" - }, - { - "id": 215786, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_99", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37146", - "biomedical_concept_uid": "BiomedicalConcept_21" - }, - { - "id": 215787, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_100", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37147", - "biomedical_concept_uid": "BiomedicalConcept_21" - }, - { - "id": 215788, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_101", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37148", - "biomedical_concept_uid": "BiomedicalConcept_22" - }, - { - "id": 215789, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_102", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37149", - "biomedical_concept_uid": "BiomedicalConcept_22" - }, - { - "id": 215790, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_103", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37150", - "biomedical_concept_uid": "BiomedicalConcept_22" - }, - { - "id": 215791, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_104", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37151", - "biomedical_concept_uid": "BiomedicalConcept_23" - }, - { - "id": 215792, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_105", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37152", - "biomedical_concept_uid": "BiomedicalConcept_23" - }, - { - "id": 215793, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_106", - "name": "VSPOS", - "label": "VSPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37153", - "biomedical_concept_uid": "BiomedicalConcept_23" - }, - { - "id": 215794, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_107", - "name": "VSLOC", - "label": "VSLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37154", - "biomedical_concept_uid": "BiomedicalConcept_23" - }, - { - "id": 215795, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_108", - "name": "VSLAT", - "label": "VSLAT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37155", - "biomedical_concept_uid": "BiomedicalConcept_23" - }, - { - "id": 215796, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_109", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37156", - "biomedical_concept_uid": "BiomedicalConcept_23" - }, - { - "id": 215797, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_110", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37157", - "biomedical_concept_uid": "BiomedicalConcept_24" - }, - { - "id": 215798, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_111", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37158", - "biomedical_concept_uid": "BiomedicalConcept_24" - }, - { - "id": 215799, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_112", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37159", - "biomedical_concept_uid": "BiomedicalConcept_24" - }, - { - "id": 215800, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_113", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37160", - "biomedical_concept_uid": "BiomedicalConcept_25" - }, - { - "id": 215801, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_114", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37161", - "biomedical_concept_uid": "BiomedicalConcept_25" - }, - { - "id": 215802, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_115", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37162", - "biomedical_concept_uid": "BiomedicalConcept_25" - }, - { - "id": 215803, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_116", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37163", - "biomedical_concept_uid": "BiomedicalConcept_27" - }, - { - "id": 215804, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_117", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37164", - "biomedical_concept_uid": "BiomedicalConcept_27" - }, - { - "id": 215805, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_118", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37165", - "biomedical_concept_uid": "BiomedicalConcept_27" - }, - { - "id": 215806, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_119", - "name": "EGCLSIG", - "label": "EGCLSIG", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37166", - "biomedical_concept_uid": "BiomedicalConcept_27" - }, - { - "id": 215807, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_120", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37167", - "biomedical_concept_uid": "BiomedicalConcept_27" - }, - { - "id": 215808, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_121", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37168", - "biomedical_concept_uid": "BiomedicalConcept_28" - }, - { - "id": 215809, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_122", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37169", - "biomedical_concept_uid": "BiomedicalConcept_28" - }, - { - "id": 215810, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_123", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37170", - "biomedical_concept_uid": "BiomedicalConcept_28" - }, - { - "id": 215811, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_124", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37171", - "biomedical_concept_uid": "BiomedicalConcept_28" - }, - { - "id": 215812, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_125", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37172", - "biomedical_concept_uid": "BiomedicalConcept_28" - }, - { - "id": 215813, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_126", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37173", - "biomedical_concept_uid": "BiomedicalConcept_29" - }, - { - "id": 215814, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_127", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37174", - "biomedical_concept_uid": "BiomedicalConcept_29" - }, - { - "id": 215815, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_128", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37175", - "biomedical_concept_uid": "BiomedicalConcept_29" - }, - { - "id": 215816, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_129", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37176", - "biomedical_concept_uid": "BiomedicalConcept_29" - }, - { - "id": 215817, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_130", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37177", - "biomedical_concept_uid": "BiomedicalConcept_29" - }, - { - "id": 215818, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_131", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37178", - "biomedical_concept_uid": "BiomedicalConcept_30" - }, - { - "id": 215819, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_132", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37179", - "biomedical_concept_uid": "BiomedicalConcept_30" - }, - { - "id": 215820, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_133", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37180", - "biomedical_concept_uid": "BiomedicalConcept_30" - }, - { - "id": 215821, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_134", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37181", - "biomedical_concept_uid": "BiomedicalConcept_30" - }, - { - "id": 215822, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_135", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37182", - "biomedical_concept_uid": "BiomedicalConcept_30" - }, - { - "id": 215823, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_136", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37183", - "biomedical_concept_uid": "BiomedicalConcept_31" - }, - { - "id": 215824, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_137", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37184", - "biomedical_concept_uid": "BiomedicalConcept_31" - }, - { - "id": 215825, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_138", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37185", - "biomedical_concept_uid": "BiomedicalConcept_31" - }, - { - "id": 215826, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_139", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37186", - "biomedical_concept_uid": "BiomedicalConcept_31" - }, - { - "id": 215827, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_140", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37187", - "biomedical_concept_uid": "BiomedicalConcept_32" - }, - { - "id": 215828, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_141", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37188", - "biomedical_concept_uid": "BiomedicalConcept_32" - }, - { - "id": 215829, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_142", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37189", - "biomedical_concept_uid": "BiomedicalConcept_32" - }, - { - "id": 215830, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_143", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37190", - "biomedical_concept_uid": "BiomedicalConcept_32" - }, - { - "id": 215831, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_144", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37191", - "biomedical_concept_uid": "BiomedicalConcept_32" - }, - { - "id": 215832, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_145", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37192", - "biomedical_concept_uid": "BiomedicalConcept_33" - }, - { - "id": 215833, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_146", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37193", - "biomedical_concept_uid": "BiomedicalConcept_33" - }, - { - "id": 215834, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_147", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37194", - "biomedical_concept_uid": "BiomedicalConcept_33" - }, - { - "id": 215835, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_148", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37195", - "biomedical_concept_uid": "BiomedicalConcept_33" - }, - { - "id": 215836, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_149", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37196", - "biomedical_concept_uid": "BiomedicalConcept_34" - }, - { - "id": 215837, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_150", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37197", - "biomedical_concept_uid": "BiomedicalConcept_34" - }, - { - "id": 215838, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_151", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37198", - "biomedical_concept_uid": "BiomedicalConcept_34" - }, - { - "id": 215839, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_152", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37199", - "biomedical_concept_uid": "BiomedicalConcept_34" - }, - { - "id": 215840, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_153", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37200", - "biomedical_concept_uid": "BiomedicalConcept_34" - }, - { - "id": 215841, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_154", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37201", - "biomedical_concept_uid": "BiomedicalConcept_35" - }, - { - "id": 215842, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_155", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37202", - "biomedical_concept_uid": "BiomedicalConcept_35" - }, - { - "id": 215843, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_156", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37203", - "biomedical_concept_uid": "BiomedicalConcept_35" - }, - { - "id": 215844, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_157", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37204", - "biomedical_concept_uid": "BiomedicalConcept_35" - }, - { - "id": 215845, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_158", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37205", - "biomedical_concept_uid": "BiomedicalConcept_35" - }, - { - "id": 215846, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_159", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37206", - "biomedical_concept_uid": "BiomedicalConcept_36" - }, - { - "id": 215847, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_160", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37207", - "biomedical_concept_uid": "BiomedicalConcept_36" - }, - { - "id": 215848, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_161", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37208", - "biomedical_concept_uid": "BiomedicalConcept_36" - }, - { - "id": 215849, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_162", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37209", - "biomedical_concept_uid": "BiomedicalConcept_36" - }, - { - "id": 215850, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_163", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37210", - "biomedical_concept_uid": "BiomedicalConcept_36" - }, - { - "id": 215851, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_164", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37211", - "biomedical_concept_uid": "BiomedicalConcept_37" - }, - { - "id": 215852, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_165", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37212", - "biomedical_concept_uid": "BiomedicalConcept_37" - }, - { - "id": 215853, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_166", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37213", - "biomedical_concept_uid": "BiomedicalConcept_37" - }, - { - "id": 215854, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_167", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37214", - "biomedical_concept_uid": "BiomedicalConcept_37" - }, - { - "id": 215855, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_168", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37215", - "biomedical_concept_uid": "BiomedicalConcept_37" - }, - { - "id": 215856, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_169", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37216", - "biomedical_concept_uid": "BiomedicalConcept_38" - }, - { - "id": 215857, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_170", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37217", - "biomedical_concept_uid": "BiomedicalConcept_38" - }, - { - "id": 215858, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_171", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37218", - "biomedical_concept_uid": "BiomedicalConcept_38" - }, - { - "id": 215859, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_172", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37219", - "biomedical_concept_uid": "BiomedicalConcept_38" - }, - { - "id": 215860, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_173", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37220", - "biomedical_concept_uid": "BiomedicalConcept_38" - }, - { - "id": 215861, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_174", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37221", - "biomedical_concept_uid": "BiomedicalConcept_39" - }, - { - "id": 215862, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_175", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37222", - "biomedical_concept_uid": "BiomedicalConcept_39" - }, - { - "id": 215863, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_176", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37223", - "biomedical_concept_uid": "BiomedicalConcept_39" - }, - { - "id": 215864, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_177", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37224", - "biomedical_concept_uid": "BiomedicalConcept_39" - }, - { - "id": 215865, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_178", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37225", - "biomedical_concept_uid": "BiomedicalConcept_39" - }, - { - "id": 215866, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_179", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37226", - "biomedical_concept_uid": "BiomedicalConcept_40" - }, - { - "id": 215867, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_180", - "name": "EGORRESU", - "label": "EGORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37227", - "biomedical_concept_uid": "BiomedicalConcept_40" - }, - { - "id": 215868, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_181", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37228", - "biomedical_concept_uid": "BiomedicalConcept_40" - }, - { - "id": 215869, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_182", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37229", - "biomedical_concept_uid": "BiomedicalConcept_40" - }, - { - "id": 215870, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_183", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37230", - "biomedical_concept_uid": "BiomedicalConcept_40" - }, - { - "id": 215871, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_184", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37231", - "biomedical_concept_uid": "BiomedicalConcept_40" - }, - { - "id": 215872, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_185", - "name": "EGENDTC", - "label": "EGENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37232", - "biomedical_concept_uid": "BiomedicalConcept_40" - }, - { - "id": 215873, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_186", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37233", - "biomedical_concept_uid": "BiomedicalConcept_41" - }, - { - "id": 215874, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_187", - "name": "EGORRESU", - "label": "EGORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37234", - "biomedical_concept_uid": "BiomedicalConcept_41" - }, - { - "id": 215875, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_188", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37235", - "biomedical_concept_uid": "BiomedicalConcept_41" - }, - { - "id": 215876, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_189", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37236", - "biomedical_concept_uid": "BiomedicalConcept_41" - }, - { - "id": 215877, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_190", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37237", - "biomedical_concept_uid": "BiomedicalConcept_41" - }, - { - "id": 215878, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_191", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37238", - "biomedical_concept_uid": "BiomedicalConcept_41" - }, - { - "id": 215879, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_192", - "name": "EGENDTC", - "label": "EGENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37239", - "biomedical_concept_uid": "BiomedicalConcept_41" - }, - { - "id": 215880, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_193", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37240", - "biomedical_concept_uid": "BiomedicalConcept_42" - }, - { - "id": 215881, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_194", - "name": "EGORRESU", - "label": "EGORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37241", - "biomedical_concept_uid": "BiomedicalConcept_42" - }, - { - "id": 215882, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_195", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37242", - "biomedical_concept_uid": "BiomedicalConcept_42" - }, - { - "id": 215883, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_196", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37243", - "biomedical_concept_uid": "BiomedicalConcept_42" - }, - { - "id": 215884, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_197", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37244", - "biomedical_concept_uid": "BiomedicalConcept_42" - }, - { - "id": 215885, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_198", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37245", - "biomedical_concept_uid": "BiomedicalConcept_42" - }, - { - "id": 215886, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_199", - "name": "EGENDTC", - "label": "EGENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37246", - "biomedical_concept_uid": "BiomedicalConcept_42" - }, - { - "id": 215887, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_200", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37247", - "biomedical_concept_uid": "BiomedicalConcept_43" - }, - { - "id": 215888, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_201", - "name": "EGORRESU", - "label": "EGORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37248", - "biomedical_concept_uid": "BiomedicalConcept_43" - }, - { - "id": 215889, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_202", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37249", - "biomedical_concept_uid": "BiomedicalConcept_43" - }, - { - "id": 215890, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_203", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37250", - "biomedical_concept_uid": "BiomedicalConcept_43" - }, - { - "id": 215891, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_204", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37251", - "biomedical_concept_uid": "BiomedicalConcept_43" - }, - { - "id": 215892, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_205", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37252", - "biomedical_concept_uid": "BiomedicalConcept_43" - }, - { - "id": 215893, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_206", - "name": "EGENDTC", - "label": "EGENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37253", - "biomedical_concept_uid": "BiomedicalConcept_43" - }, - { - "id": 215894, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_207", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37254", - "biomedical_concept_uid": "BiomedicalConcept_44" - }, - { - "id": 215895, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_208", - "name": "EGORRESU", - "label": "EGORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37255", - "biomedical_concept_uid": "BiomedicalConcept_44" - }, - { - "id": 215896, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_209", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37256", - "biomedical_concept_uid": "BiomedicalConcept_44" - }, - { - "id": 215897, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_210", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37257", - "biomedical_concept_uid": "BiomedicalConcept_44" - }, - { - "id": 215898, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_211", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37258", - "biomedical_concept_uid": "BiomedicalConcept_44" - }, - { - "id": 215899, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_212", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37259", - "biomedical_concept_uid": "BiomedicalConcept_44" - }, - { - "id": 215900, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_213", - "name": "EGENDTC", - "label": "EGENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37260", - "biomedical_concept_uid": "BiomedicalConcept_44" - }, - { - "id": 215901, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_214", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37261", - "biomedical_concept_uid": "BiomedicalConcept_45" - }, - { - "id": 215902, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_215", - "name": "EGORRESU", - "label": "EGORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37262", - "biomedical_concept_uid": "BiomedicalConcept_45" - }, - { - "id": 215903, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_216", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37263", - "biomedical_concept_uid": "BiomedicalConcept_45" - }, - { - "id": 215904, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_217", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37264", - "biomedical_concept_uid": "BiomedicalConcept_45" - }, - { - "id": 215905, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_218", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37265", - "biomedical_concept_uid": "BiomedicalConcept_45" - }, - { - "id": 215906, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_219", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37266", - "biomedical_concept_uid": "BiomedicalConcept_45" - }, - { - "id": 215907, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_220", - "name": "EGENDTC", - "label": "EGENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37267", - "biomedical_concept_uid": "BiomedicalConcept_45" - }, - { - "id": 215908, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_221", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37268", - "biomedical_concept_uid": "BiomedicalConcept_46" - }, - { - "id": 215909, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_222", - "name": "EGORRESU", - "label": "EGORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37269", - "biomedical_concept_uid": "BiomedicalConcept_46" - }, - { - "id": 215910, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_223", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37270", - "biomedical_concept_uid": "BiomedicalConcept_46" - }, - { - "id": 215911, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_224", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37271", - "biomedical_concept_uid": "BiomedicalConcept_46" - }, - { - "id": 215912, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_225", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37272", - "biomedical_concept_uid": "BiomedicalConcept_46" - }, - { - "id": 215913, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_226", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37273", - "biomedical_concept_uid": "BiomedicalConcept_46" - }, - { - "id": 215914, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_227", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37274", - "biomedical_concept_uid": "BiomedicalConcept_47" - }, - { - "id": 215915, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_228", - "name": "EGORRESU", - "label": "EGORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37275", - "biomedical_concept_uid": "BiomedicalConcept_47" - }, - { - "id": 215916, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_229", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37276", - "biomedical_concept_uid": "BiomedicalConcept_47" - }, - { - "id": 215917, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_230", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37277", - "biomedical_concept_uid": "BiomedicalConcept_47" - }, - { - "id": 215918, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_231", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37278", - "biomedical_concept_uid": "BiomedicalConcept_47" - }, - { - "id": 215919, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_232", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37279", - "biomedical_concept_uid": "BiomedicalConcept_47" - }, - { - "id": 215920, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_233", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37280", - "biomedical_concept_uid": "BiomedicalConcept_48" - }, - { - "id": 215921, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_234", - "name": "EGORRESU", - "label": "EGORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37281", - "biomedical_concept_uid": "BiomedicalConcept_48" - }, - { - "id": 215922, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_235", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37282", - "biomedical_concept_uid": "BiomedicalConcept_48" - }, - { - "id": 215923, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_236", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37283", - "biomedical_concept_uid": "BiomedicalConcept_48" - }, - { - "id": 215924, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_237", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37284", - "biomedical_concept_uid": "BiomedicalConcept_48" - }, - { - "id": 215925, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_238", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37285", - "biomedical_concept_uid": "BiomedicalConcept_48" - }, - { - "id": 215926, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_239", - "name": "EGENDTC", - "label": "EGENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37286", - "biomedical_concept_uid": "BiomedicalConcept_48" - }, - { - "id": 215927, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_240", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37287", - "biomedical_concept_uid": "BiomedicalConcept_49" - }, - { - "id": 215928, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_241", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37288", - "biomedical_concept_uid": "BiomedicalConcept_49" - }, - { - "id": 215929, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_242", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37289", - "biomedical_concept_uid": "BiomedicalConcept_49" - }, - { - "id": 215930, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_243", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37290", - "biomedical_concept_uid": "BiomedicalConcept_49" - }, - { - "id": 215931, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_244", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37291", - "biomedical_concept_uid": "BiomedicalConcept_49" - }, - { - "id": 215932, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_245", - "name": "EGORRES", - "label": "EGORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37292", - "biomedical_concept_uid": "BiomedicalConcept_50" - }, - { - "id": 215933, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_246", - "name": "EGPOS", - "label": "EGPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37293", - "biomedical_concept_uid": "BiomedicalConcept_50" - }, - { - "id": 215934, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_247", - "name": "EGMETHOD", - "label": "EGMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37294", - "biomedical_concept_uid": "BiomedicalConcept_50" - }, - { - "id": 215935, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_248", - "name": "EGEVAL", - "label": "EGEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37295", - "biomedical_concept_uid": "BiomedicalConcept_50" - }, - { - "id": 215936, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_249", - "name": "EGDTC", - "label": "EGDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37296", - "biomedical_concept_uid": "BiomedicalConcept_50" - }, - { - "id": 215937, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_250", - "name": "PRTRT", - "label": "PRTRT", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37297", - "biomedical_concept_uid": "BiomedicalConcept_51" - }, - { - "id": 215938, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_251", - "name": "PRDECOD", - "label": "PRDECOD", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37298", - "biomedical_concept_uid": "BiomedicalConcept_51" - }, - { - "id": 215939, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_252", - "name": "PRPRESP", - "label": "PRPRESP", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37299", - "biomedical_concept_uid": "BiomedicalConcept_51" - }, - { - "id": 215940, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_253", - "name": "PROCCUR", - "label": "PROCCUR", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37300", - "biomedical_concept_uid": "BiomedicalConcept_51" - }, - { - "id": 215941, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_254", - "name": "PRLOC", - "label": "PRLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37301", - "biomedical_concept_uid": "BiomedicalConcept_51" - }, - { - "id": 215942, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_255", - "name": "PRSTDTC", - "label": "PRSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37302", - "biomedical_concept_uid": "BiomedicalConcept_51" - }, - { - "id": 215943, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_256", - "name": "PRENDTC", - "label": "PRENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37303", - "biomedical_concept_uid": "BiomedicalConcept_51" - }, - { - "id": 215944, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_257", - "name": "PRTRT", - "label": "PRTRT", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37304", - "biomedical_concept_uid": "BiomedicalConcept_52" - }, - { - "id": 215945, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_258", - "name": "PRDECOD", - "label": "PRDECOD", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37305", - "biomedical_concept_uid": "BiomedicalConcept_52" - }, - { - "id": 215946, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_259", - "name": "PRPRESP", - "label": "PRPRESP", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37306", - "biomedical_concept_uid": "BiomedicalConcept_52" - }, - { - "id": 215947, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_260", - "name": "PROCCUR", - "label": "PROCCUR", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37307", - "biomedical_concept_uid": "BiomedicalConcept_52" - }, - { - "id": 215948, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_261", - "name": "PRLOC", - "label": "PRLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37308", - "biomedical_concept_uid": "BiomedicalConcept_52" - }, - { - "id": 215949, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_262", - "name": "PRSTDTC", - "label": "PRSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37309", - "biomedical_concept_uid": "BiomedicalConcept_52" - }, - { - "id": 215950, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_263", - "name": "PRENDTC", - "label": "PRENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37310", - "biomedical_concept_uid": "BiomedicalConcept_52" - }, - { - "id": 215951, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_264", - "name": "Concomitant Medication Yes No Indicator", - "label": "Concomitant Medication Yes No Indicator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37311", - "biomedical_concept_uid": "BiomedicalConcept_54" - }, - { - "id": 215952, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_265", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37312", - "biomedical_concept_uid": "BiomedicalConcept_54" - }, - { - "id": 215953, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_266", - "name": "CMTRT", - "label": "CMTRT", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37313", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215954, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_267", - "name": "CMDECOD", - "label": "CMDECOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37314", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215955, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_268", - "name": "CMCLAS", - "label": "CMCLAS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37315", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215956, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_269", - "name": "CMINDC", - "label": "CMINDC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37316", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215957, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_270", - "name": "CMDOSE", - "label": "CMDOSE", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37317", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215958, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_271", - "name": "CMDOSTXT", - "label": "CMDOSTXT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37318", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215959, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_272", - "name": "CMDOSU", - "label": "CMDOSU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37319", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215960, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_273", - "name": "CMDOSFRM", - "label": "CMDOSFRM", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37320", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215961, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_274", - "name": "CMDOSFRQ", - "label": "CMDOSFRQ", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37321", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215962, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_275", - "name": "CMROUTE", - "label": "CMROUTE", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37322", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215963, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_276", - "name": "CMSTDTC", - "label": "CMSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37323", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215964, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_277", - "name": "CMENDTC", - "label": "CMENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37324", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215965, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_278", - "name": "CMSTRF", - "label": "CMSTRF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37325", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215966, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_279", - "name": "CMSTRTPT", - "label": "CMSTRTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37326", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215967, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_280", - "name": "CMSTTPT", - "label": "CMSTTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37327", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215968, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_281", - "name": "CMENRF", - "label": "CMENRF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37328", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215969, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_282", - "name": "CMENRTPT", - "label": "CMENRTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37329", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215970, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_283", - "name": "CMENTPT", - "label": "CMENTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37330", - "biomedical_concept_uid": "BiomedicalConcept_55" - }, - { - "id": 215971, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_284", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37331", - "biomedical_concept_uid": "BiomedicalConcept_56" - }, - { - "id": 215972, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_285", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37332", - "biomedical_concept_uid": "BiomedicalConcept_56" - }, - { - "id": 215973, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_286", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37333", - "biomedical_concept_uid": "BiomedicalConcept_56" - }, - { - "id": 215974, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_287", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37334", - "biomedical_concept_uid": "BiomedicalConcept_56" - }, - { - "id": 215975, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_288", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37335", - "biomedical_concept_uid": "BiomedicalConcept_56" - }, - { - "id": 215976, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_289", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37336", - "biomedical_concept_uid": "BiomedicalConcept_57" - }, - { - "id": 215977, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_290", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37337", - "biomedical_concept_uid": "BiomedicalConcept_57" - }, - { - "id": 215978, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_291", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37338", - "biomedical_concept_uid": "BiomedicalConcept_57" - }, - { - "id": 215979, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_292", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37339", - "biomedical_concept_uid": "BiomedicalConcept_57" - }, - { - "id": 215980, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_293", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37340", - "biomedical_concept_uid": "BiomedicalConcept_57" - }, - { - "id": 215981, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_294", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37341", - "biomedical_concept_uid": "BiomedicalConcept_58" - }, - { - "id": 215982, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_295", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37342", - "biomedical_concept_uid": "BiomedicalConcept_58" - }, - { - "id": 215983, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_296", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37343", - "biomedical_concept_uid": "BiomedicalConcept_58" - }, - { - "id": 215984, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_297", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37344", - "biomedical_concept_uid": "BiomedicalConcept_58" - }, - { - "id": 215985, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_298", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37345", - "biomedical_concept_uid": "BiomedicalConcept_58" - }, - { - "id": 215986, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_299", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37346", - "biomedical_concept_uid": "BiomedicalConcept_59" - }, - { - "id": 215987, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_300", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37347", - "biomedical_concept_uid": "BiomedicalConcept_59" - }, - { - "id": 215988, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_301", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37348", - "biomedical_concept_uid": "BiomedicalConcept_59" - }, - { - "id": 215989, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_302", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37349", - "biomedical_concept_uid": "BiomedicalConcept_59" - }, - { - "id": 215990, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_303", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37350", - "biomedical_concept_uid": "BiomedicalConcept_59" - }, - { - "id": 215991, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_304", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37351", - "biomedical_concept_uid": "BiomedicalConcept_60" - }, - { - "id": 215992, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_305", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37352", - "biomedical_concept_uid": "BiomedicalConcept_60" - }, - { - "id": 215993, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_306", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37353", - "biomedical_concept_uid": "BiomedicalConcept_60" - }, - { - "id": 215994, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_307", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37354", - "biomedical_concept_uid": "BiomedicalConcept_60" - }, - { - "id": 215995, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_308", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37355", - "biomedical_concept_uid": "BiomedicalConcept_60" - }, - { - "id": 215996, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_309", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37356", - "biomedical_concept_uid": "BiomedicalConcept_61" - }, - { - "id": 215997, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_310", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37357", - "biomedical_concept_uid": "BiomedicalConcept_61" - }, - { - "id": 215998, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_311", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37358", - "biomedical_concept_uid": "BiomedicalConcept_61" - }, - { - "id": 215999, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_312", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37359", - "biomedical_concept_uid": "BiomedicalConcept_61" - }, - { - "id": 216000, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_313", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37360", - "biomedical_concept_uid": "BiomedicalConcept_61" - }, - { - "id": 216001, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_314", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37361", - "biomedical_concept_uid": "BiomedicalConcept_62" - }, - { - "id": 216002, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_315", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37362", - "biomedical_concept_uid": "BiomedicalConcept_62" - }, - { - "id": 216003, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_316", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37363", - "biomedical_concept_uid": "BiomedicalConcept_62" - }, - { - "id": 216004, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_317", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37364", - "biomedical_concept_uid": "BiomedicalConcept_62" - }, - { - "id": 216005, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_318", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37365", - "biomedical_concept_uid": "BiomedicalConcept_62" - }, - { - "id": 216006, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_319", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37366", - "biomedical_concept_uid": "BiomedicalConcept_63" - }, - { - "id": 216007, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_320", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37367", - "biomedical_concept_uid": "BiomedicalConcept_63" - }, - { - "id": 216008, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_321", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37368", - "biomedical_concept_uid": "BiomedicalConcept_63" - }, - { - "id": 216009, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_322", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37369", - "biomedical_concept_uid": "BiomedicalConcept_63" - }, - { - "id": 216010, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_323", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37370", - "biomedical_concept_uid": "BiomedicalConcept_63" - }, - { - "id": 216011, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_324", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37371", - "biomedical_concept_uid": "BiomedicalConcept_64" - }, - { - "id": 216012, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_325", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37372", - "biomedical_concept_uid": "BiomedicalConcept_64" - }, - { - "id": 216013, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_326", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37373", - "biomedical_concept_uid": "BiomedicalConcept_64" - }, - { - "id": 216014, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_327", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37374", - "biomedical_concept_uid": "BiomedicalConcept_64" - }, - { - "id": 216015, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_328", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37375", - "biomedical_concept_uid": "BiomedicalConcept_64" - }, - { - "id": 216016, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_329", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37376", - "biomedical_concept_uid": "BiomedicalConcept_65" - }, - { - "id": 216017, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_330", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37377", - "biomedical_concept_uid": "BiomedicalConcept_65" - }, - { - "id": 216018, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_331", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37378", - "biomedical_concept_uid": "BiomedicalConcept_65" - }, - { - "id": 216019, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_332", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37379", - "biomedical_concept_uid": "BiomedicalConcept_65" - }, - { - "id": 216020, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_333", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37380", - "biomedical_concept_uid": "BiomedicalConcept_65" - }, - { - "id": 216021, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_334", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37381", - "biomedical_concept_uid": "BiomedicalConcept_66" - }, - { - "id": 216022, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_335", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37382", - "biomedical_concept_uid": "BiomedicalConcept_66" - }, - { - "id": 216023, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_336", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37383", - "biomedical_concept_uid": "BiomedicalConcept_66" - }, - { - "id": 216024, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_337", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37384", - "biomedical_concept_uid": "BiomedicalConcept_66" - }, - { - "id": 216025, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_338", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37385", - "biomedical_concept_uid": "BiomedicalConcept_66" - }, - { - "id": 216026, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_339", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37386", - "biomedical_concept_uid": "BiomedicalConcept_67" - }, - { - "id": 216027, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_340", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37387", - "biomedical_concept_uid": "BiomedicalConcept_67" - }, - { - "id": 216028, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_341", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37388", - "biomedical_concept_uid": "BiomedicalConcept_67" - }, - { - "id": 216029, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_342", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37389", - "biomedical_concept_uid": "BiomedicalConcept_67" - }, - { - "id": 216030, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_343", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37390", - "biomedical_concept_uid": "BiomedicalConcept_67" - }, - { - "id": 216031, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_344", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37391", - "biomedical_concept_uid": "BiomedicalConcept_68" - }, - { - "id": 216032, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_345", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37392", - "biomedical_concept_uid": "BiomedicalConcept_68" - }, - { - "id": 216033, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_346", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37393", - "biomedical_concept_uid": "BiomedicalConcept_68" - }, - { - "id": 216034, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_347", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37394", - "biomedical_concept_uid": "BiomedicalConcept_68" - }, - { - "id": 216035, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_348", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37395", - "biomedical_concept_uid": "BiomedicalConcept_68" - }, - { - "id": 216036, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_349", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37396", - "biomedical_concept_uid": "BiomedicalConcept_69" - }, - { - "id": 216037, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_350", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37397", - "biomedical_concept_uid": "BiomedicalConcept_69" - }, - { - "id": 216038, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_351", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37398", - "biomedical_concept_uid": "BiomedicalConcept_69" - }, - { - "id": 216039, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_352", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37399", - "biomedical_concept_uid": "BiomedicalConcept_69" - }, - { - "id": 216040, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_353", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37400", - "biomedical_concept_uid": "BiomedicalConcept_70" - }, - { - "id": 216041, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_354", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37401", - "biomedical_concept_uid": "BiomedicalConcept_70" - }, - { - "id": 216042, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_355", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37402", - "biomedical_concept_uid": "BiomedicalConcept_70" - }, - { - "id": 216043, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_356", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37403", - "biomedical_concept_uid": "BiomedicalConcept_70" - }, - { - "id": 216044, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_357", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37404", - "biomedical_concept_uid": "BiomedicalConcept_71" - }, - { - "id": 216045, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_358", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37405", - "biomedical_concept_uid": "BiomedicalConcept_71" - }, - { - "id": 216046, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_359", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37406", - "biomedical_concept_uid": "BiomedicalConcept_71" - }, - { - "id": 216047, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_360", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37407", - "biomedical_concept_uid": "BiomedicalConcept_71" - }, - { - "id": 216048, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_361", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37408", - "biomedical_concept_uid": "BiomedicalConcept_72" - }, - { - "id": 216049, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_362", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37409", - "biomedical_concept_uid": "BiomedicalConcept_72" - }, - { - "id": 216050, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_363", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37410", - "biomedical_concept_uid": "BiomedicalConcept_72" - }, - { - "id": 216051, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_364", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37411", - "biomedical_concept_uid": "BiomedicalConcept_72" - }, - { - "id": 216052, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_365", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37412", - "biomedical_concept_uid": "BiomedicalConcept_73" - }, - { - "id": 216053, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_366", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37413", - "biomedical_concept_uid": "BiomedicalConcept_73" - }, - { - "id": 216054, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_367", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37414", - "biomedical_concept_uid": "BiomedicalConcept_73" - }, - { - "id": 216055, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_368", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37415", - "biomedical_concept_uid": "BiomedicalConcept_73" - }, - { - "id": 216056, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_369", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37416", - "biomedical_concept_uid": "BiomedicalConcept_74" - }, - { - "id": 216057, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_370", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37417", - "biomedical_concept_uid": "BiomedicalConcept_74" - }, - { - "id": 216058, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_371", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37418", - "biomedical_concept_uid": "BiomedicalConcept_74" - }, - { - "id": 216059, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_372", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37419", - "biomedical_concept_uid": "BiomedicalConcept_74" - }, - { - "id": 216060, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_373", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37420", - "biomedical_concept_uid": "BiomedicalConcept_74" - }, - { - "id": 216061, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_374", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37421", - "biomedical_concept_uid": "BiomedicalConcept_75" - }, - { - "id": 216062, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_375", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37422", - "biomedical_concept_uid": "BiomedicalConcept_75" - }, - { - "id": 216063, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_376", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37423", - "biomedical_concept_uid": "BiomedicalConcept_75" - }, - { - "id": 216064, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_377", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37424", - "biomedical_concept_uid": "BiomedicalConcept_75" - }, - { - "id": 216065, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_378", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37425", - "biomedical_concept_uid": "BiomedicalConcept_75" - }, - { - "id": 216066, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_379", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37426", - "biomedical_concept_uid": "BiomedicalConcept_76" - }, - { - "id": 216067, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_380", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37427", - "biomedical_concept_uid": "BiomedicalConcept_76" - }, - { - "id": 216068, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_381", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37428", - "biomedical_concept_uid": "BiomedicalConcept_76" - }, - { - "id": 216069, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_382", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37429", - "biomedical_concept_uid": "BiomedicalConcept_76" - }, - { - "id": 216070, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_383", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37430", - "biomedical_concept_uid": "BiomedicalConcept_76" - }, - { - "id": 216071, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_384", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37431", - "biomedical_concept_uid": "BiomedicalConcept_77" - }, - { - "id": 216072, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_385", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37432", - "biomedical_concept_uid": "BiomedicalConcept_77" - }, - { - "id": 216073, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_386", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37433", - "biomedical_concept_uid": "BiomedicalConcept_77" - }, - { - "id": 216074, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_387", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37434", - "biomedical_concept_uid": "BiomedicalConcept_77" - }, - { - "id": 216075, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_388", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37435", - "biomedical_concept_uid": "BiomedicalConcept_77" - }, - { - "id": 216076, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_389", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37436", - "biomedical_concept_uid": "BiomedicalConcept_78" - }, - { - "id": 216077, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_390", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37437", - "biomedical_concept_uid": "BiomedicalConcept_78" - }, - { - "id": 216078, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_391", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37438", - "biomedical_concept_uid": "BiomedicalConcept_78" - }, - { - "id": 216079, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_392", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37439", - "biomedical_concept_uid": "BiomedicalConcept_78" - }, - { - "id": 216080, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_393", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37440", - "biomedical_concept_uid": "BiomedicalConcept_78" - }, - { - "id": 216081, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_394", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37441", - "biomedical_concept_uid": "BiomedicalConcept_79" - }, - { - "id": 216082, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_395", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37442", - "biomedical_concept_uid": "BiomedicalConcept_79" - }, - { - "id": 216083, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_396", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37443", - "biomedical_concept_uid": "BiomedicalConcept_79" - }, - { - "id": 216084, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_397", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37444", - "biomedical_concept_uid": "BiomedicalConcept_79" - }, - { - "id": 216085, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_398", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37445", - "biomedical_concept_uid": "BiomedicalConcept_79" - }, - { - "id": 216086, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_399", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37446", - "biomedical_concept_uid": "BiomedicalConcept_80" - }, - { - "id": 216087, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_400", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37447", - "biomedical_concept_uid": "BiomedicalConcept_80" - }, - { - "id": 216088, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_401", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37448", - "biomedical_concept_uid": "BiomedicalConcept_80" - }, - { - "id": 216089, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_402", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37449", - "biomedical_concept_uid": "BiomedicalConcept_80" - }, - { - "id": 216090, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_403", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37450", - "biomedical_concept_uid": "BiomedicalConcept_80" - }, - { - "id": 216091, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_404", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37451", - "biomedical_concept_uid": "BiomedicalConcept_81" - }, - { - "id": 216092, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_405", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37452", - "biomedical_concept_uid": "BiomedicalConcept_81" - }, - { - "id": 216093, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_406", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37453", - "biomedical_concept_uid": "BiomedicalConcept_81" - }, - { - "id": 216094, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_407", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37454", - "biomedical_concept_uid": "BiomedicalConcept_81" - }, - { - "id": 216095, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_408", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37455", - "biomedical_concept_uid": "BiomedicalConcept_81" - }, - { - "id": 216096, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_409", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37456", - "biomedical_concept_uid": "BiomedicalConcept_82" - }, - { - "id": 216097, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_410", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37457", - "biomedical_concept_uid": "BiomedicalConcept_82" - }, - { - "id": 216098, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_411", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37458", - "biomedical_concept_uid": "BiomedicalConcept_82" - }, - { - "id": 216099, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_412", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37459", - "biomedical_concept_uid": "BiomedicalConcept_82" - }, - { - "id": 216100, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_413", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37460", - "biomedical_concept_uid": "BiomedicalConcept_82" - }, - { - "id": 216101, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_414", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37461", - "biomedical_concept_uid": "BiomedicalConcept_83" - }, - { - "id": 216102, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_415", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37462", - "biomedical_concept_uid": "BiomedicalConcept_83" - }, - { - "id": 216103, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_416", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37463", - "biomedical_concept_uid": "BiomedicalConcept_83" - }, - { - "id": 216104, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_417", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37464", - "biomedical_concept_uid": "BiomedicalConcept_83" - }, - { - "id": 216105, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_418", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37465", - "biomedical_concept_uid": "BiomedicalConcept_83" - }, - { - "id": 216106, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_419", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37466", - "biomedical_concept_uid": "BiomedicalConcept_84" - }, - { - "id": 216107, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_420", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37467", - "biomedical_concept_uid": "BiomedicalConcept_84" - }, - { - "id": 216108, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_421", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37468", - "biomedical_concept_uid": "BiomedicalConcept_84" - }, - { - "id": 216109, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_422", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37469", - "biomedical_concept_uid": "BiomedicalConcept_84" - }, - { - "id": 216110, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_423", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37470", - "biomedical_concept_uid": "BiomedicalConcept_84" - }, - { - "id": 216111, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_424", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37471", - "biomedical_concept_uid": "BiomedicalConcept_85" - }, - { - "id": 216112, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_425", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37472", - "biomedical_concept_uid": "BiomedicalConcept_85" - }, - { - "id": 216113, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_426", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37473", - "biomedical_concept_uid": "BiomedicalConcept_85" - }, - { - "id": 216114, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_427", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37474", - "biomedical_concept_uid": "BiomedicalConcept_85" - }, - { - "id": 216115, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_428", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37475", - "biomedical_concept_uid": "BiomedicalConcept_85" - }, - { - "id": 216116, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_429", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37476", - "biomedical_concept_uid": "BiomedicalConcept_86" - }, - { - "id": 216117, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_430", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37477", - "biomedical_concept_uid": "BiomedicalConcept_86" - }, - { - "id": 216118, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_431", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37478", - "biomedical_concept_uid": "BiomedicalConcept_86" - }, - { - "id": 216119, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_432", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37479", - "biomedical_concept_uid": "BiomedicalConcept_86" - }, - { - "id": 216120, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_433", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37480", - "biomedical_concept_uid": "BiomedicalConcept_86" - }, - { - "id": 216121, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_434", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37481", - "biomedical_concept_uid": "BiomedicalConcept_87" - }, - { - "id": 216122, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_435", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37482", - "biomedical_concept_uid": "BiomedicalConcept_87" - }, - { - "id": 216123, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_436", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37483", - "biomedical_concept_uid": "BiomedicalConcept_87" - }, - { - "id": 216124, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_437", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37484", - "biomedical_concept_uid": "BiomedicalConcept_87" - }, - { - "id": 216125, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_438", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37485", - "biomedical_concept_uid": "BiomedicalConcept_87" - }, - { - "id": 216126, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_439", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37486", - "biomedical_concept_uid": "BiomedicalConcept_88" - }, - { - "id": 216127, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_440", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37487", - "biomedical_concept_uid": "BiomedicalConcept_88" - }, - { - "id": 216128, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_441", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37488", - "biomedical_concept_uid": "BiomedicalConcept_88" - }, - { - "id": 216129, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_442", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37489", - "biomedical_concept_uid": "BiomedicalConcept_88" - }, - { - "id": 216130, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_443", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37490", - "biomedical_concept_uid": "BiomedicalConcept_88" - }, - { - "id": 216131, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_444", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37491", - "biomedical_concept_uid": "BiomedicalConcept_89" - }, - { - "id": 216132, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_445", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37492", - "biomedical_concept_uid": "BiomedicalConcept_89" - }, - { - "id": 216133, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_446", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37493", - "biomedical_concept_uid": "BiomedicalConcept_89" - }, - { - "id": 216134, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_447", - "name": "LBMETHOD", - "label": "LBMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37494", - "biomedical_concept_uid": "BiomedicalConcept_89" - }, - { - "id": 216135, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_448", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37495", - "biomedical_concept_uid": "BiomedicalConcept_89" - }, - { - "id": 216136, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_449", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37496", - "biomedical_concept_uid": "BiomedicalConcept_89" - }, - { - "id": 216137, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_450", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37497", - "biomedical_concept_uid": "BiomedicalConcept_90" - }, - { - "id": 216138, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_451", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37498", - "biomedical_concept_uid": "BiomedicalConcept_90" - }, - { - "id": 216139, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_452", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37499", - "biomedical_concept_uid": "BiomedicalConcept_90" - }, - { - "id": 216140, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_453", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37500", - "biomedical_concept_uid": "BiomedicalConcept_90" - }, - { - "id": 216141, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_454", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37501", - "biomedical_concept_uid": "BiomedicalConcept_90" - }, - { - "id": 216142, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_455", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37502", - "biomedical_concept_uid": "BiomedicalConcept_91" - }, - { - "id": 216143, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_456", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37503", - "biomedical_concept_uid": "BiomedicalConcept_91" - }, - { - "id": 216144, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_457", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37504", - "biomedical_concept_uid": "BiomedicalConcept_91" - }, - { - "id": 216145, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_458", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37505", - "biomedical_concept_uid": "BiomedicalConcept_91" - }, - { - "id": 216146, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_459", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37506", - "biomedical_concept_uid": "BiomedicalConcept_91" - }, - { - "id": 216147, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_460", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37507", - "biomedical_concept_uid": "BiomedicalConcept_92" - }, - { - "id": 216148, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_461", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37508", - "biomedical_concept_uid": "BiomedicalConcept_92" - }, - { - "id": 216149, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_462", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37509", - "biomedical_concept_uid": "BiomedicalConcept_92" - }, - { - "id": 216150, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_463", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37510", - "biomedical_concept_uid": "BiomedicalConcept_92" - }, - { - "id": 216151, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_464", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37511", - "biomedical_concept_uid": "BiomedicalConcept_92" - }, - { - "id": 216152, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_465", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37512", - "biomedical_concept_uid": "BiomedicalConcept_93" - }, - { - "id": 216153, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_466", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37513", - "biomedical_concept_uid": "BiomedicalConcept_93" - }, - { - "id": 216154, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_467", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37514", - "biomedical_concept_uid": "BiomedicalConcept_93" - }, - { - "id": 216155, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_468", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37515", - "biomedical_concept_uid": "BiomedicalConcept_93" - }, - { - "id": 216156, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_469", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37516", - "biomedical_concept_uid": "BiomedicalConcept_93" - }, - { - "id": 216157, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_470", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37517", - "biomedical_concept_uid": "BiomedicalConcept_94" - }, - { - "id": 216158, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_471", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37518", - "biomedical_concept_uid": "BiomedicalConcept_94" - }, - { - "id": 216159, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_472", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37519", - "biomedical_concept_uid": "BiomedicalConcept_94" - }, - { - "id": 216160, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_473", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37520", - "biomedical_concept_uid": "BiomedicalConcept_94" - }, - { - "id": 216161, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_474", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37521", - "biomedical_concept_uid": "BiomedicalConcept_94" - }, - { - "id": 216162, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_475", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37522", - "biomedical_concept_uid": "BiomedicalConcept_95" - }, - { - "id": 216163, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_476", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37523", - "biomedical_concept_uid": "BiomedicalConcept_95" - }, - { - "id": 216164, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_477", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37524", - "biomedical_concept_uid": "BiomedicalConcept_95" - }, - { - "id": 216165, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_478", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37525", - "biomedical_concept_uid": "BiomedicalConcept_95" - }, - { - "id": 216166, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_479", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37526", - "biomedical_concept_uid": "BiomedicalConcept_96" - }, - { - "id": 216167, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_480", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37527", - "biomedical_concept_uid": "BiomedicalConcept_96" - }, - { - "id": 216168, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_481", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37528", - "biomedical_concept_uid": "BiomedicalConcept_96" - }, - { - "id": 216169, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_482", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37529", - "biomedical_concept_uid": "BiomedicalConcept_96" - }, - { - "id": 216170, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_483", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37530", - "biomedical_concept_uid": "BiomedicalConcept_96" - }, - { - "id": 216171, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_484", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37531", - "biomedical_concept_uid": "BiomedicalConcept_97" - }, - { - "id": 216172, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_485", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37532", - "biomedical_concept_uid": "BiomedicalConcept_97" - }, - { - "id": 216173, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_486", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37533", - "biomedical_concept_uid": "BiomedicalConcept_97" - }, - { - "id": 216174, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_487", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37534", - "biomedical_concept_uid": "BiomedicalConcept_97" - }, - { - "id": 216175, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_488", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37535", - "biomedical_concept_uid": "BiomedicalConcept_97" - }, - { - "id": 216176, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_489", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37536", - "biomedical_concept_uid": "BiomedicalConcept_98" - }, - { - "id": 216177, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_490", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37537", - "biomedical_concept_uid": "BiomedicalConcept_98" - }, - { - "id": 216178, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_491", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37538", - "biomedical_concept_uid": "BiomedicalConcept_98" - }, - { - "id": 216179, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_492", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37539", - "biomedical_concept_uid": "BiomedicalConcept_98" - }, - { - "id": 216180, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_493", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37540", - "biomedical_concept_uid": "BiomedicalConcept_98" - }, - { - "id": 216181, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_494", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37541", - "biomedical_concept_uid": "BiomedicalConcept_99" - }, - { - "id": 216182, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_495", - "name": "MBORRES", - "label": "MBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37542", - "biomedical_concept_uid": "BiomedicalConcept_99" - }, - { - "id": 216183, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_496", - "name": "MBSPEC", - "label": "MBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37543", - "biomedical_concept_uid": "BiomedicalConcept_99" - }, - { - "id": 216184, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_497", - "name": "MBMETHOD", - "label": "MBMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37544", - "biomedical_concept_uid": "BiomedicalConcept_99" - }, - { - "id": 216185, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_498", - "name": "MBDTC", - "label": "MBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37545", - "biomedical_concept_uid": "BiomedicalConcept_99" - }, - { - "id": 216186, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_499", - "name": "MBTSTDTL", - "label": "MBTSTDTL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37546", - "biomedical_concept_uid": "BiomedicalConcept_100" - }, - { - "id": 216187, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_500", - "name": "MBORRES", - "label": "MBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37547", - "biomedical_concept_uid": "BiomedicalConcept_100" - }, - { - "id": 216188, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_501", - "name": "MBSPEC", - "label": "MBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37548", - "biomedical_concept_uid": "BiomedicalConcept_100" - }, - { - "id": 216189, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_502", - "name": "MBMETHOD", - "label": "MBMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37549", - "biomedical_concept_uid": "BiomedicalConcept_100" - }, - { - "id": 216190, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_503", - "name": "MBDTC", - "label": "MBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37550", - "biomedical_concept_uid": "BiomedicalConcept_100" - }, - { - "id": 216191, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_504", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37551", - "biomedical_concept_uid": "BiomedicalConcept_101" - }, - { - "id": 216192, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_505", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37552", - "biomedical_concept_uid": "BiomedicalConcept_101" - }, - { - "id": 216193, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_506", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37553", - "biomedical_concept_uid": "BiomedicalConcept_101" - }, - { - "id": 216194, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_507", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37554", - "biomedical_concept_uid": "BiomedicalConcept_102" - }, - { - "id": 216195, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_508", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37555", - "biomedical_concept_uid": "BiomedicalConcept_102" - }, - { - "id": 216196, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_509", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37556", - "biomedical_concept_uid": "BiomedicalConcept_102" - }, - { - "id": 216197, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_510", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37557", - "biomedical_concept_uid": "BiomedicalConcept_102" - }, - { - "id": 216198, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_511", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37558", - "biomedical_concept_uid": "BiomedicalConcept_103" - }, - { - "id": 216199, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_512", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37559", - "biomedical_concept_uid": "BiomedicalConcept_103" - }, - { - "id": 216200, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_513", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37560", - "biomedical_concept_uid": "BiomedicalConcept_103" - }, - { - "id": 216201, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_514", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37561", - "biomedical_concept_uid": "BiomedicalConcept_103" - }, - { - "id": 216202, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_515", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37562", - "biomedical_concept_uid": "BiomedicalConcept_103" - }, - { - "id": 216203, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_516", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37563", - "biomedical_concept_uid": "BiomedicalConcept_104" - }, - { - "id": 216204, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_517", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37564", - "biomedical_concept_uid": "BiomedicalConcept_104" - }, - { - "id": 216205, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_518", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37565", - "biomedical_concept_uid": "BiomedicalConcept_104" - }, - { - "id": 216206, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_519", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37566", - "biomedical_concept_uid": "BiomedicalConcept_104" - }, - { - "id": 216207, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_520", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37567", - "biomedical_concept_uid": "BiomedicalConcept_104" - }, - { - "id": 216208, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_521", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37568", - "biomedical_concept_uid": "BiomedicalConcept_105" - }, - { - "id": 216209, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_522", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37569", - "biomedical_concept_uid": "BiomedicalConcept_105" - }, - { - "id": 216210, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_523", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37570", - "biomedical_concept_uid": "BiomedicalConcept_105" - }, - { - "id": 216211, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_524", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37571", - "biomedical_concept_uid": "BiomedicalConcept_105" - }, - { - "id": 216212, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_525", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37572", - "biomedical_concept_uid": "BiomedicalConcept_105" - }, - { - "id": 216213, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_526", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37573", - "biomedical_concept_uid": "BiomedicalConcept_106" - }, - { - "id": 216214, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_527", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37574", - "biomedical_concept_uid": "BiomedicalConcept_106" - }, - { - "id": 216215, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_528", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37575", - "biomedical_concept_uid": "BiomedicalConcept_106" - }, - { - "id": 216216, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_529", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37576", - "biomedical_concept_uid": "BiomedicalConcept_106" - }, - { - "id": 216217, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_530", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37577", - "biomedical_concept_uid": "BiomedicalConcept_106" - }, - { - "id": 216218, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_531", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37578", - "biomedical_concept_uid": "BiomedicalConcept_107" - }, - { - "id": 216219, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_532", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37579", - "biomedical_concept_uid": "BiomedicalConcept_107" - }, - { - "id": 216220, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_533", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37580", - "biomedical_concept_uid": "BiomedicalConcept_107" - }, - { - "id": 216221, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_534", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37581", - "biomedical_concept_uid": "BiomedicalConcept_107" - }, - { - "id": 216222, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_535", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37582", - "biomedical_concept_uid": "BiomedicalConcept_107" - }, - { - "id": 216223, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_536", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37583", - "biomedical_concept_uid": "BiomedicalConcept_108" - }, - { - "id": 216224, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_537", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37584", - "biomedical_concept_uid": "BiomedicalConcept_108" - }, - { - "id": 216225, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_538", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37585", - "biomedical_concept_uid": "BiomedicalConcept_108" - }, - { - "id": 216226, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_539", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37586", - "biomedical_concept_uid": "BiomedicalConcept_108" - }, - { - "id": 216227, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_540", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37587", - "biomedical_concept_uid": "BiomedicalConcept_109" - }, - { - "id": 216228, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_541", - "name": "LBORRESU", - "label": "LBORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37588", - "biomedical_concept_uid": "BiomedicalConcept_109" - }, - { - "id": 216229, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_542", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37589", - "biomedical_concept_uid": "BiomedicalConcept_109" - }, - { - "id": 216230, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_543", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37590", - "biomedical_concept_uid": "BiomedicalConcept_109" - }, - { - "id": 216231, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_544", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37591", - "biomedical_concept_uid": "BiomedicalConcept_109" - }, - { - "id": 216232, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_545", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37592", - "biomedical_concept_uid": "BiomedicalConcept_110" - }, - { - "id": 216233, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_546", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37593", - "biomedical_concept_uid": "BiomedicalConcept_110" - }, - { - "id": 216234, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_547", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37594", - "biomedical_concept_uid": "BiomedicalConcept_110" - }, - { - "id": 216235, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_548", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37595", - "biomedical_concept_uid": "BiomedicalConcept_110" - }, - { - "id": 216236, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_549", - "name": "LBORRES", - "label": "LBORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37596", - "biomedical_concept_uid": "BiomedicalConcept_111" - }, - { - "id": 216237, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_550", - "name": "LBSPEC", - "label": "LBSPEC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37597", - "biomedical_concept_uid": "BiomedicalConcept_111" - }, - { - "id": 216238, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_551", - "name": "LBFAST", - "label": "LBFAST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37598", - "biomedical_concept_uid": "BiomedicalConcept_111" - }, - { - "id": 216239, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_552", - "name": "LBDTC", - "label": "LBDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37599", - "biomedical_concept_uid": "BiomedicalConcept_111" - }, - { - "id": 216240, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_553", - "name": "ECTRT", - "label": "ECTRT", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37600", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216241, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_554", - "name": "ECREFID", - "label": "ECREFID", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37601", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216242, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_555", - "name": "ECDOSE", - "label": "ECDOSE", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37602", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216243, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_556", - "name": "ECDOSTXT", - "label": "ECDOSTXT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37603", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216244, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_557", - "name": "ECDOSU", - "label": "ECDOSU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37604", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216245, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_558", - "name": "ECDOSFRM", - "label": "ECDOSFRM", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37605", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216246, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_559", - "name": "ECDOSFRQ", - "label": "ECDOSFRQ", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37606", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216247, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_560", - "name": "ECDOSRGM", - "label": "ECDOSRGM", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37607", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216248, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_561", - "name": "ECROUTE", - "label": "ECROUTE", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37608", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216249, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_562", - "name": "ECLOC", - "label": "ECLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37609", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216250, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_563", - "name": "ECLAT", - "label": "ECLAT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37610", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216251, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_564", - "name": "ECDIR", - "label": "ECDIR", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37611", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216252, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_565", - "name": "ECSTDTC", - "label": "ECSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37612", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216253, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_566", - "name": "ECENDTC", - "label": "ECENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37613", - "biomedical_concept_uid": "BiomedicalConcept_112" - }, - { - "id": 216254, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_567", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37614", - "biomedical_concept_uid": "BiomedicalConcept_113" - }, - { - "id": 216255, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_568", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37615", - "biomedical_concept_uid": "BiomedicalConcept_113" - }, - { - "id": 216256, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_569", - "name": "Test Occurrence", - "label": "Test Occurrence", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37616", - "biomedical_concept_uid": "BiomedicalConcept_113" - }, - { - "id": 216257, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_570", - "name": "QSORRES", - "label": "QSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37617", - "biomedical_concept_uid": "BiomedicalConcept_114" - }, - { - "id": 216258, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_571", - "name": "QSDTC", - "label": "QSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37618", - "biomedical_concept_uid": "BiomedicalConcept_114" - }, - { - "id": 216259, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_572", - "name": "QSEVAL", - "label": "QSEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37619", - "biomedical_concept_uid": "BiomedicalConcept_114" - }, - { - "id": 216260, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_573", - "name": "QSORRES", - "label": "QSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37620", - "biomedical_concept_uid": "BiomedicalConcept_115" - }, - { - "id": 216261, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_574", - "name": "QSDTC", - "label": "QSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37621", - "biomedical_concept_uid": "BiomedicalConcept_115" - }, - { - "id": 216262, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_575", - "name": "QSEVAL", - "label": "QSEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37622", - "biomedical_concept_uid": "BiomedicalConcept_115" - }, - { - "id": 216263, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_576", - "name": "QSORRES", - "label": "QSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37623", - "biomedical_concept_uid": "BiomedicalConcept_116" - }, - { - "id": 216264, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_577", - "name": "QSDTC", - "label": "QSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37624", - "biomedical_concept_uid": "BiomedicalConcept_116" - }, - { - "id": 216265, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_578", - "name": "QSEVAL", - "label": "QSEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37625", - "biomedical_concept_uid": "BiomedicalConcept_116" - }, - { - "id": 216266, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_579", - "name": "QSORRES", - "label": "QSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37626", - "biomedical_concept_uid": "BiomedicalConcept_117" - }, - { - "id": 216267, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_580", - "name": "QSDTC", - "label": "QSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37627", - "biomedical_concept_uid": "BiomedicalConcept_117" - }, - { - "id": 216268, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_581", - "name": "QSEVAL", - "label": "QSEVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37628", - "biomedical_concept_uid": "BiomedicalConcept_117" - }, - { - "id": 216269, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_582", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37629", - "biomedical_concept_uid": "BiomedicalConcept_134" - }, - { - "id": 216270, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_583", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37630", - "biomedical_concept_uid": "BiomedicalConcept_134" - }, - { - "id": 216271, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_584", - "name": "AETERM", - "label": "AETERM", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37631", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216272, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_585", - "name": "AEDECOD", - "label": "AEDECOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37632", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216273, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_586", - "name": "AELOC", - "label": "AELOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37633", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216274, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_587", - "name": "AESEV", - "label": "AESEV", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37634", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216275, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_588", - "name": "AESER", - "label": "AESER", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37635", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216276, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_589", - "name": "AEACN", - "label": "AEACN", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37636", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216277, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_590", - "name": "AEACNOTH", - "label": "AEACNOTH", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37637", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216278, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_591", - "name": "AEREL", - "label": "AEREL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37638", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216279, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_592", - "name": "AERELNST", - "label": "AERELNST", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37639", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216280, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_593", - "name": "AEPATT", - "label": "AEPATT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37640", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216281, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_594", - "name": "AEOUT", - "label": "AEOUT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37641", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216282, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_595", - "name": "AESCAN", - "label": "AESCAN", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37642", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216283, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_596", - "name": "AESCONG", - "label": "AESCONG", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37643", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216284, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_597", - "name": "AESDISAB", - "label": "AESDISAB", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37644", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216285, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_598", - "name": "AESDTH", - "label": "AESDTH", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37645", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216286, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_599", - "name": "AESHOSP", - "label": "AESHOSP", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37646", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216287, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_600", - "name": "AESLIFE", - "label": "AESLIFE", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37647", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216288, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_601", - "name": "AESOD", - "label": "AESOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37648", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216289, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_602", - "name": "AESMIE", - "label": "AESMIE", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37649", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216290, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_603", - "name": "AECONTRT", - "label": "AECONTRT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37650", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216291, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_604", - "name": "AETOXGR", - "label": "AETOXGR", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37651", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216292, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_605", - "name": "AESTDTC", - "label": "AESTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37652", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216293, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_606", - "name": "AEENDTC", - "label": "AEENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37653", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216294, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_607", - "name": "AEENRF", - "label": "AEENRF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37654", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216295, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_608", - "name": "AEENRTPT", - "label": "AEENRTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37655", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216296, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_609", - "name": "AEENTPT", - "label": "AEENTPT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37656", - "biomedical_concept_uid": "BiomedicalConcept_135" - }, - { - "id": 216297, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_610", - "name": "DSDECOD", - "label": "DSDECOD", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37657", - "biomedical_concept_uid": "BiomedicalConcept_146" - }, - { - "id": 216298, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_611", - "name": "DSTERM", - "label": "DSTERM", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37658", - "biomedical_concept_uid": "BiomedicalConcept_146" - }, - { - "id": 216299, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_612", - "name": "DSSTDTC", - "label": "DSSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37659", - "biomedical_concept_uid": "BiomedicalConcept_146" - }, - { - "id": 216300, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_613", - "name": "DSDECOD", - "label": "DSDECOD", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37660", - "biomedical_concept_uid": "BiomedicalConcept_152" - }, - { - "id": 216301, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_614", - "name": "DSTERM", - "label": "DSTERM", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37661", - "biomedical_concept_uid": "BiomedicalConcept_152" - }, - { - "id": 216302, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_615", - "name": "DSSTDTC", - "label": "DSSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37662", - "biomedical_concept_uid": "BiomedicalConcept_152" - }, - { - "id": 216303, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_616", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37663", - "biomedical_concept_uid": "BiomedicalConcept_153" - }, - { - "id": 216304, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_617", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37664", - "biomedical_concept_uid": "BiomedicalConcept_153" - }, - { - "id": 216305, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_618", - "name": "VSPOS", - "label": "VSPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37665", - "biomedical_concept_uid": "BiomedicalConcept_153" - }, - { - "id": 216306, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_619", - "name": "VSLOC", - "label": "VSLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37666", - "biomedical_concept_uid": "BiomedicalConcept_153" - }, - { - "id": 216307, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_620", - "name": "VSLAT", - "label": "VSLAT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37667", - "biomedical_concept_uid": "BiomedicalConcept_153" - }, - { - "id": 216308, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_621", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37668", - "biomedical_concept_uid": "BiomedicalConcept_153" - }, - { - "id": 216309, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_622", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37669", - "biomedical_concept_uid": "BiomedicalConcept_154" - }, - { - "id": 216310, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_623", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37670", - "biomedical_concept_uid": "BiomedicalConcept_154" - }, - { - "id": 216311, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_624", - "name": "VSPOS", - "label": "VSPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37671", - "biomedical_concept_uid": "BiomedicalConcept_154" - }, - { - "id": 216312, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_625", - "name": "VSLOC", - "label": "VSLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37672", - "biomedical_concept_uid": "BiomedicalConcept_154" - }, - { - "id": 216313, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_626", - "name": "VSLAT", - "label": "VSLAT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37673", - "biomedical_concept_uid": "BiomedicalConcept_154" - }, - { - "id": 216314, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_627", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37674", - "biomedical_concept_uid": "BiomedicalConcept_154" - }, - { - "id": 216315, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_628", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37675", - "biomedical_concept_uid": "BiomedicalConcept_155" - }, - { - "id": 216316, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_629", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37676", - "biomedical_concept_uid": "BiomedicalConcept_155" - }, - { - "id": 216317, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_630", - "name": "VSPOS", - "label": "VSPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37677", - "biomedical_concept_uid": "BiomedicalConcept_155" - }, - { - "id": 216318, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_631", - "name": "VSLOC", - "label": "VSLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37678", - "biomedical_concept_uid": "BiomedicalConcept_155" - }, - { - "id": 216319, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_632", - "name": "VSLAT", - "label": "VSLAT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37679", - "biomedical_concept_uid": "BiomedicalConcept_155" - }, - { - "id": 216320, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_633", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37680", - "biomedical_concept_uid": "BiomedicalConcept_155" - }, - { - "id": 216321, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_634", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37681", - "biomedical_concept_uid": "BiomedicalConcept_156" - }, - { - "id": 216322, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_635", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37682", - "biomedical_concept_uid": "BiomedicalConcept_156" - }, - { - "id": 216323, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_636", - "name": "VSPOS", - "label": "VSPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37683", - "biomedical_concept_uid": "BiomedicalConcept_156" - }, - { - "id": 216324, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_637", - "name": "VSLOC", - "label": "VSLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37684", - "biomedical_concept_uid": "BiomedicalConcept_156" - }, - { - "id": 216325, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_638", - "name": "VSLAT", - "label": "VSLAT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37685", - "biomedical_concept_uid": "BiomedicalConcept_156" - }, - { - "id": 216326, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_639", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37686", - "biomedical_concept_uid": "BiomedicalConcept_156" - }, - { - "id": 216327, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_640", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37687", - "biomedical_concept_uid": "BiomedicalConcept_157" - }, - { - "id": 216328, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_641", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37688", - "biomedical_concept_uid": "BiomedicalConcept_157" - }, - { - "id": 216329, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_642", - "name": "VSPOS", - "label": "VSPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37689", - "biomedical_concept_uid": "BiomedicalConcept_157" - }, - { - "id": 216330, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_643", - "name": "VSLOC", - "label": "VSLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37690", - "biomedical_concept_uid": "BiomedicalConcept_157" - }, - { - "id": 216331, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_644", - "name": "VSLAT", - "label": "VSLAT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37691", - "biomedical_concept_uid": "BiomedicalConcept_157" - }, - { - "id": 216332, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_645", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37692", - "biomedical_concept_uid": "BiomedicalConcept_157" - }, - { - "id": 216333, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_646", - "name": "VSORRES", - "label": "VSORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37693", - "biomedical_concept_uid": "BiomedicalConcept_158" - }, - { - "id": 216334, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_647", - "name": "VSORRESU", - "label": "VSORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37694", - "biomedical_concept_uid": "BiomedicalConcept_158" - }, - { - "id": 216335, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_648", - "name": "VSPOS", - "label": "VSPOS", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37695", - "biomedical_concept_uid": "BiomedicalConcept_158" - }, - { - "id": 216336, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_649", - "name": "VSLOC", - "label": "VSLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37696", - "biomedical_concept_uid": "BiomedicalConcept_158" - }, - { - "id": 216337, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_650", - "name": "VSLAT", - "label": "VSLAT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37697", - "biomedical_concept_uid": "BiomedicalConcept_158" - }, - { - "id": 216338, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_651", - "name": "VSDTC", - "label": "VSDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37698", - "biomedical_concept_uid": "BiomedicalConcept_158" - }, - { - "id": 216339, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_652", - "name": "MKORRES", - "label": "MKORRES", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37699", - "biomedical_concept_uid": "BiomedicalConcept_160" - }, - { - "id": 216340, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_653", - "name": "MKORRESU", - "label": "MKORRESU", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37700", - "biomedical_concept_uid": "BiomedicalConcept_160" - }, - { - "id": 216341, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_654", - "name": "MKLOC", - "label": "MKLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37701", - "biomedical_concept_uid": "BiomedicalConcept_160" - }, - { - "id": 216342, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_655", - "name": "MKLAT", - "label": "MKLAT", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37702", - "biomedical_concept_uid": "BiomedicalConcept_160" - }, - { - "id": 216343, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_656", - "name": "MKMETHOD", - "label": "MKMETHOD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37703", - "biomedical_concept_uid": "BiomedicalConcept_160" - }, - { - "id": 216344, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_657", - "name": "MKDTC", - "label": "MKDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37704", - "biomedical_concept_uid": "BiomedicalConcept_160" - }, - { - "id": 216345, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_658", - "name": "Observation Result", - "label": "Observation Result", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37705", - "biomedical_concept_uid": "BiomedicalConcept_161" - }, - { - "id": 216346, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_659", - "name": "Unit of Time", - "label": "Unit of Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37706", - "biomedical_concept_uid": "BiomedicalConcept_161" - }, - { - "id": 216347, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_660", - "name": "Anatomic Site", - "label": "Anatomic Site", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37707", - "biomedical_concept_uid": "BiomedicalConcept_161" - }, - { - "id": 216348, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_661", - "name": "Laterality", - "label": "Laterality", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37708", - "biomedical_concept_uid": "BiomedicalConcept_161" - }, - { - "id": 216349, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_662", - "name": "Test Method", - "label": "Test Method", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37709", - "biomedical_concept_uid": "BiomedicalConcept_161" - }, - { - "id": 216350, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_663", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37710", - "biomedical_concept_uid": "BiomedicalConcept_161" - }, - { - "id": 216351, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_664", - "name": "TSPARMCD", - "label": "TSPARMCD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37711", - "biomedical_concept_uid": "BiomedicalConcept_162" - }, - { - "id": 216352, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_665", - "name": "TSPARM", - "label": "TSPARM", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37712", - "biomedical_concept_uid": "BiomedicalConcept_162" - }, - { - "id": 216353, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_666", - "name": "TSVAL", - "label": "TSVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37713", - "biomedical_concept_uid": "BiomedicalConcept_162" - }, - { - "id": 216354, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_667", - "name": "TSVALCD", - "label": "TSVALCD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37714", - "biomedical_concept_uid": "BiomedicalConcept_162" - }, - { - "id": 216355, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_668", - "name": "TSVCDREF", - "label": "TSVCDREF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37715", - "biomedical_concept_uid": "BiomedicalConcept_162" - }, - { - "id": 216356, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_669", - "name": "TSVCDVER", - "label": "TSVCDVER", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37716", - "biomedical_concept_uid": "BiomedicalConcept_162" - }, - { - "id": 216357, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_670", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37717", - "biomedical_concept_uid": "BiomedicalConcept_164" - }, - { - "id": 216358, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_671", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37718", - "biomedical_concept_uid": "BiomedicalConcept_164" - }, - { - "id": 216359, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_672", - "name": "Test Occurrence", - "label": "Test Occurrence", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37719", - "biomedical_concept_uid": "BiomedicalConcept_164" - }, - { - "id": 216360, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_673", - "name": "PRTRT", - "label": "PRTRT", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37720", - "biomedical_concept_uid": "BiomedicalConcept_165" - }, - { - "id": 216361, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_674", - "name": "PRDECOD", - "label": "PRDECOD", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37721", - "biomedical_concept_uid": "BiomedicalConcept_165" - }, - { - "id": 216362, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_675", - "name": "PRPRESP", - "label": "PRPRESP", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37722", - "biomedical_concept_uid": "BiomedicalConcept_165" - }, - { - "id": 216363, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_676", - "name": "PROCCUR", - "label": "PROCCUR", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37723", - "biomedical_concept_uid": "BiomedicalConcept_165" - }, - { - "id": 216364, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_677", - "name": "PRLOC", - "label": "PRLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37724", - "biomedical_concept_uid": "BiomedicalConcept_165" - }, - { - "id": 216365, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_678", - "name": "PRSTDTC", - "label": "PRSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37725", - "biomedical_concept_uid": "BiomedicalConcept_165" - }, - { - "id": 216366, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_679", - "name": "PRENDTC", - "label": "PRENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37726", - "biomedical_concept_uid": "BiomedicalConcept_165" - }, - { - "id": 216367, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_680", - "name": "PRTRT", - "label": "PRTRT", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37727", - "biomedical_concept_uid": "BiomedicalConcept_166" - }, - { - "id": 216368, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_681", - "name": "PRDECOD", - "label": "PRDECOD", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37728", - "biomedical_concept_uid": "BiomedicalConcept_166" - }, - { - "id": 216369, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_682", - "name": "PRPRESP", - "label": "PRPRESP", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37729", - "biomedical_concept_uid": "BiomedicalConcept_166" - }, - { - "id": 216370, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_683", - "name": "PROCCUR", - "label": "PROCCUR", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37730", - "biomedical_concept_uid": "BiomedicalConcept_166" - }, - { - "id": 216371, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_684", - "name": "PRLOC", - "label": "PRLOC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37731", - "biomedical_concept_uid": "BiomedicalConcept_166" - }, - { - "id": 216372, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_685", - "name": "PRSTDTC", - "label": "PRSTDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37732", - "biomedical_concept_uid": "BiomedicalConcept_166" - }, - { - "id": 216373, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_686", - "name": "PRENDTC", - "label": "PRENDTC", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37733", - "biomedical_concept_uid": "BiomedicalConcept_166" - }, - { - "id": 216374, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_687", - "name": "Adverse Event Yes No Indicator", - "label": "Adverse Event Yes No Indicator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37734", - "biomedical_concept_uid": "BiomedicalConcept_171" - }, - { - "id": 216375, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_688", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37735", - "biomedical_concept_uid": "BiomedicalConcept_171" - }, - { - "id": 216376, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_689", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37736", - "biomedical_concept_uid": "BiomedicalConcept_172" - }, - { - "id": 216377, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_690", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37737", - "biomedical_concept_uid": "BiomedicalConcept_172" - }, - { - "id": 216378, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_691", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37738", - "biomedical_concept_uid": "BiomedicalConcept_172" - }, - { - "id": 216379, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_692", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37739", - "biomedical_concept_uid": "BiomedicalConcept_172" - }, - { - "id": 216380, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_693", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37740", - "biomedical_concept_uid": "BiomedicalConcept_172" - }, - { - "id": 216381, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_694", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37741", - "biomedical_concept_uid": "BiomedicalConcept_172" - }, - { - "id": 216382, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_695", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37742", - "biomedical_concept_uid": "BiomedicalConcept_172" - }, - { - "id": 216383, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_696", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37743", - "biomedical_concept_uid": "BiomedicalConcept_172" - }, - { - "id": 216384, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_697", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37744", - "biomedical_concept_uid": "BiomedicalConcept_173" - }, - { - "id": 216385, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_698", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37745", - "biomedical_concept_uid": "BiomedicalConcept_173" - }, - { - "id": 216386, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_699", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37746", - "biomedical_concept_uid": "BiomedicalConcept_173" - }, - { - "id": 216387, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_700", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37747", - "biomedical_concept_uid": "BiomedicalConcept_173" - }, - { - "id": 216388, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_701", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37748", - "biomedical_concept_uid": "BiomedicalConcept_173" - }, - { - "id": 216389, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_702", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37749", - "biomedical_concept_uid": "BiomedicalConcept_173" - }, - { - "id": 216390, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_703", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37750", - "biomedical_concept_uid": "BiomedicalConcept_173" - }, - { - "id": 216391, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_704", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37751", - "biomedical_concept_uid": "BiomedicalConcept_173" - }, - { - "id": 216392, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_705", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37752", - "biomedical_concept_uid": "BiomedicalConcept_174" - }, - { - "id": 216393, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_706", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37753", - "biomedical_concept_uid": "BiomedicalConcept_174" - }, - { - "id": 216394, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_707", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37754", - "biomedical_concept_uid": "BiomedicalConcept_174" - }, - { - "id": 216395, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_708", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37755", - "biomedical_concept_uid": "BiomedicalConcept_174" - }, - { - "id": 216396, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_709", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37756", - "biomedical_concept_uid": "BiomedicalConcept_174" - }, - { - "id": 216397, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_710", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37757", - "biomedical_concept_uid": "BiomedicalConcept_174" - }, - { - "id": 216398, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_711", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37758", - "biomedical_concept_uid": "BiomedicalConcept_174" - }, - { - "id": 216399, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_712", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37759", - "biomedical_concept_uid": "BiomedicalConcept_174" - }, - { - "id": 216400, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_713", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37760", - "biomedical_concept_uid": "BiomedicalConcept_175" - }, - { - "id": 216401, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_714", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37761", - "biomedical_concept_uid": "BiomedicalConcept_175" - }, - { - "id": 216402, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_715", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37762", - "biomedical_concept_uid": "BiomedicalConcept_175" - }, - { - "id": 216403, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_716", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37763", - "biomedical_concept_uid": "BiomedicalConcept_175" - }, - { - "id": 216404, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_717", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37764", - "biomedical_concept_uid": "BiomedicalConcept_175" - }, - { - "id": 216405, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_718", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37765", - "biomedical_concept_uid": "BiomedicalConcept_175" - }, - { - "id": 216406, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_719", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37766", - "biomedical_concept_uid": "BiomedicalConcept_175" - }, - { - "id": 216407, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_720", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37767", - "biomedical_concept_uid": "BiomedicalConcept_175" - }, - { - "id": 216408, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_721", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37768", - "biomedical_concept_uid": "BiomedicalConcept_176" - }, - { - "id": 216409, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_722", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37769", - "biomedical_concept_uid": "BiomedicalConcept_176" - }, - { - "id": 216410, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_723", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37770", - "biomedical_concept_uid": "BiomedicalConcept_176" - }, - { - "id": 216411, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_724", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37771", - "biomedical_concept_uid": "BiomedicalConcept_176" - }, - { - "id": 216412, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_725", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37772", - "biomedical_concept_uid": "BiomedicalConcept_176" - }, - { - "id": 216413, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_726", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37773", - "biomedical_concept_uid": "BiomedicalConcept_176" - }, - { - "id": 216414, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_727", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37774", - "biomedical_concept_uid": "BiomedicalConcept_176" - }, - { - "id": 216415, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_728", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37775", - "biomedical_concept_uid": "BiomedicalConcept_176" - }, - { - "id": 216416, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_729", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37776", - "biomedical_concept_uid": "BiomedicalConcept_177" - }, - { - "id": 216417, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_730", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37777", - "biomedical_concept_uid": "BiomedicalConcept_177" - }, - { - "id": 216418, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_731", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37778", - "biomedical_concept_uid": "BiomedicalConcept_177" - }, - { - "id": 216419, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_732", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37779", - "biomedical_concept_uid": "BiomedicalConcept_177" - }, - { - "id": 216420, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_733", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37780", - "biomedical_concept_uid": "BiomedicalConcept_177" - }, - { - "id": 216421, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_734", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37781", - "biomedical_concept_uid": "BiomedicalConcept_177" - }, - { - "id": 216422, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_735", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37782", - "biomedical_concept_uid": "BiomedicalConcept_177" - }, - { - "id": 216423, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_736", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37783", - "biomedical_concept_uid": "BiomedicalConcept_177" - }, - { - "id": 216424, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_737", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37784", - "biomedical_concept_uid": "BiomedicalConcept_178" - }, - { - "id": 216425, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_738", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37785", - "biomedical_concept_uid": "BiomedicalConcept_178" - }, - { - "id": 216426, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_739", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37786", - "biomedical_concept_uid": "BiomedicalConcept_178" - }, - { - "id": 216427, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_740", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37787", - "biomedical_concept_uid": "BiomedicalConcept_178" - }, - { - "id": 216428, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_741", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37788", - "biomedical_concept_uid": "BiomedicalConcept_178" - }, - { - "id": 216429, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_742", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37789", - "biomedical_concept_uid": "BiomedicalConcept_178" - }, - { - "id": 216430, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_743", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37790", - "biomedical_concept_uid": "BiomedicalConcept_178" - }, - { - "id": 216431, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_744", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37791", - "biomedical_concept_uid": "BiomedicalConcept_178" - }, - { - "id": 216432, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_745", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37792", - "biomedical_concept_uid": "BiomedicalConcept_179" - }, - { - "id": 216433, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_746", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37793", - "biomedical_concept_uid": "BiomedicalConcept_179" - }, - { - "id": 216434, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_747", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37794", - "biomedical_concept_uid": "BiomedicalConcept_179" - }, - { - "id": 216435, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_748", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37795", - "biomedical_concept_uid": "BiomedicalConcept_179" - }, - { - "id": 216436, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_749", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37796", - "biomedical_concept_uid": "BiomedicalConcept_179" - }, - { - "id": 216437, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_750", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37797", - "biomedical_concept_uid": "BiomedicalConcept_179" - }, - { - "id": 216438, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_751", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "decimal", - "code": "AliasCode_37798", - "biomedical_concept_uid": "BiomedicalConcept_179" - }, - { - "id": 216439, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_752", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37799", - "biomedical_concept_uid": "BiomedicalConcept_179" - }, - { - "id": 216440, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_753", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37800", - "biomedical_concept_uid": "BiomedicalConcept_180" - }, - { - "id": 216441, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_754", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37801", - "biomedical_concept_uid": "BiomedicalConcept_180" - }, - { - "id": 216442, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_755", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37802", - "biomedical_concept_uid": "BiomedicalConcept_180" - }, - { - "id": 216443, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_756", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37803", - "biomedical_concept_uid": "BiomedicalConcept_180" - }, - { - "id": 216444, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_757", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37804", - "biomedical_concept_uid": "BiomedicalConcept_180" - }, - { - "id": 216445, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_758", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37805", - "biomedical_concept_uid": "BiomedicalConcept_180" - }, - { - "id": 216446, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_759", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37806", - "biomedical_concept_uid": "BiomedicalConcept_180" - }, - { - "id": 216447, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_760", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37807", - "biomedical_concept_uid": "BiomedicalConcept_180" - }, - { - "id": 216448, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_761", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37808", - "biomedical_concept_uid": "BiomedicalConcept_181" - }, - { - "id": 216449, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_762", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37809", - "biomedical_concept_uid": "BiomedicalConcept_181" - }, - { - "id": 216450, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_763", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37810", - "biomedical_concept_uid": "BiomedicalConcept_181" - }, - { - "id": 216451, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_764", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37811", - "biomedical_concept_uid": "BiomedicalConcept_181" - }, - { - "id": 216452, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_765", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37812", - "biomedical_concept_uid": "BiomedicalConcept_181" - }, - { - "id": 216453, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_766", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37813", - "biomedical_concept_uid": "BiomedicalConcept_181" - }, - { - "id": 216454, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_767", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37814", - "biomedical_concept_uid": "BiomedicalConcept_181" - }, - { - "id": 216455, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_768", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37815", - "biomedical_concept_uid": "BiomedicalConcept_181" - }, - { - "id": 216456, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_769", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37816", - "biomedical_concept_uid": "BiomedicalConcept_182" - }, - { - "id": 216457, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_770", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37817", - "biomedical_concept_uid": "BiomedicalConcept_182" - }, - { - "id": 216458, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_771", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37818", - "biomedical_concept_uid": "BiomedicalConcept_182" - }, - { - "id": 216459, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_772", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37819", - "biomedical_concept_uid": "BiomedicalConcept_182" - }, - { - "id": 216460, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_773", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37820", - "biomedical_concept_uid": "BiomedicalConcept_182" - }, - { - "id": 216461, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_774", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37821", - "biomedical_concept_uid": "BiomedicalConcept_182" - }, - { - "id": 216462, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_775", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37822", - "biomedical_concept_uid": "BiomedicalConcept_182" - }, - { - "id": 216463, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_776", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37823", - "biomedical_concept_uid": "BiomedicalConcept_182" - }, - { - "id": 216464, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_777", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37824", - "biomedical_concept_uid": "BiomedicalConcept_183" - }, - { - "id": 216465, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_778", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37825", - "biomedical_concept_uid": "BiomedicalConcept_183" - }, - { - "id": 216466, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_779", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37826", - "biomedical_concept_uid": "BiomedicalConcept_183" - }, - { - "id": 216467, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_780", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37827", - "biomedical_concept_uid": "BiomedicalConcept_183" - }, - { - "id": 216468, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_781", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37828", - "biomedical_concept_uid": "BiomedicalConcept_183" - }, - { - "id": 216469, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_782", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37829", - "biomedical_concept_uid": "BiomedicalConcept_183" - }, - { - "id": 216470, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_783", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37830", - "biomedical_concept_uid": "BiomedicalConcept_183" - }, - { - "id": 216471, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_784", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37831", - "biomedical_concept_uid": "BiomedicalConcept_183" - }, - { - "id": 216472, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_785", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37832", - "biomedical_concept_uid": "BiomedicalConcept_184" - }, - { - "id": 216473, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_786", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37833", - "biomedical_concept_uid": "BiomedicalConcept_184" - }, - { - "id": 216474, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_787", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37834", - "biomedical_concept_uid": "BiomedicalConcept_184" - }, - { - "id": 216475, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_788", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37835", - "biomedical_concept_uid": "BiomedicalConcept_184" - }, - { - "id": 216476, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_789", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37836", - "biomedical_concept_uid": "BiomedicalConcept_184" - }, - { - "id": 216477, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_790", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37837", - "biomedical_concept_uid": "BiomedicalConcept_184" - }, - { - "id": 216478, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_791", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37838", - "biomedical_concept_uid": "BiomedicalConcept_184" - }, - { - "id": 216479, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_792", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37839", - "biomedical_concept_uid": "BiomedicalConcept_184" - }, - { - "id": 216480, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_793", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37840", - "biomedical_concept_uid": "BiomedicalConcept_185" - }, - { - "id": 216481, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_794", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37841", - "biomedical_concept_uid": "BiomedicalConcept_185" - }, - { - "id": 216482, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_795", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37842", - "biomedical_concept_uid": "BiomedicalConcept_185" - }, - { - "id": 216483, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_796", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37843", - "biomedical_concept_uid": "BiomedicalConcept_185" - }, - { - "id": 216484, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_797", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37844", - "biomedical_concept_uid": "BiomedicalConcept_185" - }, - { - "id": 216485, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_798", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37845", - "biomedical_concept_uid": "BiomedicalConcept_185" - }, - { - "id": 216486, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_799", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37846", - "biomedical_concept_uid": "BiomedicalConcept_185" - }, - { - "id": 216487, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_800", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37847", - "biomedical_concept_uid": "BiomedicalConcept_185" - }, - { - "id": 216488, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_801", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37848", - "biomedical_concept_uid": "BiomedicalConcept_186" - }, - { - "id": 216489, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_802", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37849", - "biomedical_concept_uid": "BiomedicalConcept_186" - }, - { - "id": 216490, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_803", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37850", - "biomedical_concept_uid": "BiomedicalConcept_186" - }, - { - "id": 216491, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_804", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37851", - "biomedical_concept_uid": "BiomedicalConcept_186" - }, - { - "id": 216492, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_805", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37852", - "biomedical_concept_uid": "BiomedicalConcept_186" - }, - { - "id": 216493, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_806", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37853", - "biomedical_concept_uid": "BiomedicalConcept_186" - }, - { - "id": 216494, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_807", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37854", - "biomedical_concept_uid": "BiomedicalConcept_186" - }, - { - "id": 216495, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_808", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37855", - "biomedical_concept_uid": "BiomedicalConcept_186" - }, - { - "id": 216496, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_809", - "name": "Ordinal Position", - "label": "Ordinal Position", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37856", - "biomedical_concept_uid": "BiomedicalConcept_187" - }, - { - "id": 216497, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_810", - "name": "Clinical or Research Assessment Answer", - "label": "Clinical or Research Assessment Answer", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "integer", - "code": "AliasCode_37857", - "biomedical_concept_uid": "BiomedicalConcept_187" - }, - { - "id": 216498, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_811", - "name": "Unit of Time", - "label": "Unit of Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37858", - "biomedical_concept_uid": "BiomedicalConcept_187" - }, - { - "id": 216499, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_812", - "name": "Category", - "label": "Category", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37859", - "biomedical_concept_uid": "BiomedicalConcept_187" - }, - { - "id": 216500, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_813", - "name": "Subcategory", - "label": "Subcategory", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37860", - "biomedical_concept_uid": "BiomedicalConcept_187" - }, - { - "id": 216501, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_814", - "name": "Completion Status", - "label": "Completion Status", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37861", - "biomedical_concept_uid": "BiomedicalConcept_187" - }, - { - "id": 216502, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_815", - "name": "Not-Done Reason", - "label": "Not-Done Reason", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37862", - "biomedical_concept_uid": "BiomedicalConcept_187" - }, - { - "id": 216503, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_816", - "name": "Evaluator", - "label": "Evaluator", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37863", - "biomedical_concept_uid": "BiomedicalConcept_187" - }, - { - "id": 216504, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_817", - "name": "Collection Date Time", - "label": "Collection Date Time", - "description": null, - "isRequired": 1, - "isEnabled": 1, - "datatype": "datetime", - "code": "AliasCode_37864", - "biomedical_concept_uid": "BiomedicalConcept_187" - }, - { - "id": 216505, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_818", - "name": "TSPARMCD", - "label": "TSPARMCD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37865", - "biomedical_concept_uid": "BiomedicalConcept_163" - }, - { - "id": 216506, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_819", - "name": "TSPARM", - "label": "TSPARM", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37866", - "biomedical_concept_uid": "BiomedicalConcept_163" - }, - { - "id": 216507, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_820", - "name": "TSVAL", - "label": "TSVAL", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "boolean", - "code": "AliasCode_37867", - "biomedical_concept_uid": "BiomedicalConcept_163" - }, - { - "id": 216508, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_821", - "name": "TSVALCD", - "label": "TSVALCD", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37868", - "biomedical_concept_uid": "BiomedicalConcept_163" - }, - { - "id": 216509, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_822", - "name": "TSVCDREF", - "label": "TSVCDREF", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37869", - "biomedical_concept_uid": "BiomedicalConcept_163" - }, - { - "id": 216510, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_823", - "name": "TSVCDVER", - "label": "TSVCDVER", - "description": null, - "isRequired": 0, - "isEnabled": 1, - "datatype": "string", - "code": "AliasCode_37870", - "biomedical_concept_uid": "BiomedicalConcept_163" - } - ], - "bcp_response_code": [ - { - "id": 11938, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1343", - "response_code_uid": "ResponseCode_768", - "name": "EGCTMON", - "label": "EGCTMON", - "is_enabled": 1, - "code": "AliasCode_10833" - }, - { - "id": 11939, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1344", - "response_code_uid": "ResponseCode_769", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "is_enabled": 1, - "code": "AliasCode_10835" - }, - { - "id": 11940, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1353", - "response_code_uid": "ResponseCode_770", - "name": "MRI", - "label": "MRI", - "is_enabled": 1, - "code": "AliasCode_10845" - }, - { - "id": 13355, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1134", - "response_code_uid": "ResponseCode_1647", - "name": "EGCTMON", - "label": "EGCTMON", - "is_enabled": 1, - "code": "AliasCode_19575" - }, - { - "id": 13793, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_789", - "response_code_uid": "ResponseCode_1961", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_22751" - }, - { - "id": 13816, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_965", - "response_code_uid": "ResponseCode_1983", - "name": "SITE TRANSFER", - "label": "SITE TRANSFER", - "is_enabled": 1, - "code": "AliasCode_22949" - }, - { - "id": 14111, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_965", - "response_code_uid": "ResponseCode_2171", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_25710" - }, - { - "id": 14141, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1085", - "response_code_uid": "ResponseCode_2201", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_25860" - }, - { - "id": 14145, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1118", - "response_code_uid": "ResponseCode_2205", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_25897" - }, - { - "id": 14151, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1184", - "response_code_uid": "ResponseCode_2211", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_25969" - }, - { - "id": 14152, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1187", - "response_code_uid": "ResponseCode_2212", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_25973" - }, - { - "id": 14181, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1387", - "response_code_uid": "ResponseCode_2240", - "name": "MRI", - "label": "MRI", - "is_enabled": 1, - "code": "AliasCode_26201" - }, - { - "id": 14182, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1390", - "response_code_uid": "ResponseCode_2241", - "name": "BRAIN", - "label": "BRAIN", - "is_enabled": 1, - "code": "AliasCode_26205" - }, - { - "id": 14183, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1402", - "response_code_uid": "ResponseCode_2242", - "name": "CT SCAN", - "label": "CT SCAN", - "is_enabled": 1, - "code": "AliasCode_26218" - }, - { - "id": 14418, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_770", - "response_code_uid": "ResponseCode_2347", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_27121" - }, - { - "id": 14421, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_788", - "response_code_uid": "ResponseCode_2350", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_27142" - }, - { - "id": 14661, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_217", - "response_code_uid": "ResponseCode_2457", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_28244" - }, - { - "id": 14673, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_393", - "response_code_uid": "ResponseCode_2463", - "name": "MRI", - "label": "MRI", - "is_enabled": 1, - "code": "AliasCode_28426" - }, - { - "id": 14678, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_426", - "response_code_uid": "ResponseCode_2466", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_28462" - }, - { - "id": 14685, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_440", - "response_code_uid": "ResponseCode_2469", - "name": "fL", - "label": "fL", - "is_enabled": 1, - "code": "AliasCode_28479" - }, - { - "id": 14686, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_441", - "response_code_uid": "ResponseCode_2470", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "is_enabled": 1, - "code": "AliasCode_28481" - }, - { - "id": 14687, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_446", - "response_code_uid": "ResponseCode_2471", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_28487" - }, - { - "id": 14703, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_471", - "response_code_uid": "ResponseCode_2479", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_28520" - }, - { - "id": 14706, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_481", - "response_code_uid": "ResponseCode_2481", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_28532" - }, - { - "id": 14709, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_489", - "response_code_uid": "ResponseCode_2483", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_28542" - }, - { - "id": 14711, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_493", - "response_code_uid": "ResponseCode_2484", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_28547" - }, - { - "id": 14760, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_616", - "response_code_uid": "ResponseCode_2509", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_28718" - }, - { - "id": 14800, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_790", - "response_code_uid": "ResponseCode_2541", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_28925" - }, - { - "id": 14816, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_924", - "response_code_uid": "ResponseCode_2556", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_29074" - }, - { - "id": 14817, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_930", - "response_code_uid": "ResponseCode_2557", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_29081" - }, - { - "id": 14936, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_311", - "response_code_uid": "ResponseCode_2583", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_29819" - }, - { - "id": 14945, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_341", - "response_code_uid": "ResponseCode_2592", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_29858" - }, - { - "id": 14959, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_406", - "response_code_uid": "ResponseCode_2606", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_29937" - }, - { - "id": 14960, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_411", - "response_code_uid": "ResponseCode_2607", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_29943" - }, - { - "id": 14963, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_426", - "response_code_uid": "ResponseCode_2610", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_29961" - }, - { - "id": 14966, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_441", - "response_code_uid": "ResponseCode_2613", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_29979" - }, - { - "id": 14974, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_491", - "response_code_uid": "ResponseCode_2621", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_30037" - }, - { - "id": 14996, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_623", - "response_code_uid": "ResponseCode_2643", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_30191" - }, - { - "id": 15001, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_664", - "response_code_uid": "ResponseCode_2648", - "name": "EGCTMON", - "label": "EGCTMON", - "is_enabled": 1, - "code": "AliasCode_30237" - }, - { - "id": 15002, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_665", - "response_code_uid": "ResponseCode_2649", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "is_enabled": 1, - "code": "AliasCode_30239" - }, - { - "id": 15058, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_220", - "response_code_uid": "ResponseCode_2657", - "name": "breaths/min", - "label": "breaths/min", - "is_enabled": 1, - "code": "AliasCode_30906" - }, - { - "id": 15067, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_438", - "response_code_uid": "ResponseCode_2666", - "name": "CT SCAN", - "label": "CT SCAN", - "is_enabled": 1, - "code": "AliasCode_31133" - }, - { - "id": 15068, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_441", - "response_code_uid": "ResponseCode_2667", - "name": "CHEST", - "label": "CHEST", - "is_enabled": 1, - "code": "AliasCode_31137" - }, - { - "id": 15076, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_508", - "response_code_uid": "ResponseCode_2672", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_31210" - }, - { - "id": 15081, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_517", - "response_code_uid": "ResponseCode_2674", - "name": "fL", - "label": "fL", - "is_enabled": 1, - "code": "AliasCode_31221" - }, - { - "id": 15082, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_518", - "response_code_uid": "ResponseCode_2675", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "is_enabled": 1, - "code": "AliasCode_31223" - }, - { - "id": 15098, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_543", - "response_code_uid": "ResponseCode_2683", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_31256" - }, - { - "id": 15102, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_553", - "response_code_uid": "ResponseCode_2685", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_31268" - }, - { - "id": 15106, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_562", - "response_code_uid": "ResponseCode_2687", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_31279" - }, - { - "id": 15108, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_566", - "response_code_uid": "ResponseCode_2688", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_31284" - }, - { - "id": 15110, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_570", - "response_code_uid": "ResponseCode_2689", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_31289" - }, - { - "id": 15112, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_574", - "response_code_uid": "ResponseCode_2690", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_31294" - }, - { - "id": 15118, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_588", - "response_code_uid": "ResponseCode_2693", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_31311" - }, - { - "id": 15126, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_623", - "response_code_uid": "ResponseCode_2700", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_31353" - }, - { - "id": 15134, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_663", - "response_code_uid": "ResponseCode_2708", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_31401" - }, - { - "id": 15138, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_673", - "response_code_uid": "ResponseCode_2710", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_31413" - }, - { - "id": 15142, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_683", - "response_code_uid": "ResponseCode_2712", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_31425" - }, - { - "id": 15146, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_693", - "response_code_uid": "ResponseCode_2714", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_31443" - }, - { - "id": 15148, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_699", - "response_code_uid": "ResponseCode_2715", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_31450" - }, - { - "id": 15152, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_709", - "response_code_uid": "ResponseCode_2717", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_31462" - }, - { - "id": 15154, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_714", - "response_code_uid": "ResponseCode_2718", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_31468" - }, - { - "id": 15158, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_723", - "response_code_uid": "ResponseCode_2720", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_31479" - }, - { - "id": 15162, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_733", - "response_code_uid": "ResponseCode_2722", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_31491" - }, - { - "id": 15167, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_741", - "response_code_uid": "ResponseCode_2724", - "name": "DETECTION", - "label": "DETECTION", - "is_enabled": 1, - "code": "AliasCode_31501" - }, - { - "id": 15172, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_749", - "response_code_uid": "ResponseCode_2727", - "name": "LINE PROBE ASSAY", - "label": "LINE PROBE ASSAY", - "is_enabled": 1, - "code": "AliasCode_31512" - }, - { - "id": 15178, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_769", - "response_code_uid": "ResponseCode_2732", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_31537" - }, - { - "id": 15183, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_789", - "response_code_uid": "ResponseCode_2736", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_31561" - }, - { - "id": 15186, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_799", - "response_code_uid": "ResponseCode_2738", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_31573" - }, - { - "id": 15190, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_808", - "response_code_uid": "ResponseCode_2740", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_31584" - }, - { - "id": 15196, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_838", - "response_code_uid": "ResponseCode_2743", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_31617" - }, - { - "id": 15198, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_841", - "response_code_uid": "ResponseCode_2744", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_31621" - }, - { - "id": 15202, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_847", - "response_code_uid": "ResponseCode_2746", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_31629" - }, - { - "id": 15206, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_879", - "response_code_uid": "ResponseCode_2748", - "name": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "label": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "is_enabled": 1, - "code": "AliasCode_31663" - }, - { - "id": 15210, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_889", - "response_code_uid": "ResponseCode_2750", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_31675" - }, - { - "id": 15216, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_925", - "response_code_uid": "ResponseCode_2756", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_31717" - }, - { - "id": 15217, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_931", - "response_code_uid": "ResponseCode_2757", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_31724" - }, - { - "id": 15225, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_988", - "response_code_uid": "ResponseCode_2765", - "name": "EGCTMON", - "label": "EGCTMON", - "is_enabled": 1, - "code": "AliasCode_31789" - }, - { - "id": 15226, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_989", - "response_code_uid": "ResponseCode_2766", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "is_enabled": 1, - "code": "AliasCode_31791" - }, - { - "id": 15228, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_995", - "response_code_uid": "ResponseCode_2768", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "is_enabled": 1, - "code": "AliasCode_31799" - }, - { - "id": 15326, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_228", - "response_code_uid": "ResponseCode_2777", - "name": "deg", - "label": "deg", - "is_enabled": 1, - "code": "AliasCode_32084" - }, - { - "id": 15332, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_291", - "response_code_uid": "ResponseCode_2783", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_32153" - }, - { - "id": 15334, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_301", - "response_code_uid": "ResponseCode_2785", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "is_enabled": 1, - "code": "AliasCode_32165" - }, - { - "id": 15338, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_320", - "response_code_uid": "ResponseCode_2789", - "name": "10^6/L", - "label": "10^6/L", - "is_enabled": 1, - "code": "AliasCode_32188" - }, - { - "id": 15339, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_321", - "response_code_uid": "ResponseCode_2790", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_32190" - }, - { - "id": 15340, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_331", - "response_code_uid": "ResponseCode_2791", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_32201" - }, - { - "id": 15342, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_346", - "response_code_uid": "ResponseCode_2793", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_32218" - }, - { - "id": 15345, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_362", - "response_code_uid": "ResponseCode_2796", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_32237" - }, - { - "id": 15346, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_371", - "response_code_uid": "ResponseCode_2797", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_32247" - }, - { - "id": 15347, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_376", - "response_code_uid": "ResponseCode_2798", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_32253" - }, - { - "id": 15349, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_396", - "response_code_uid": "ResponseCode_2800", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_32275" - }, - { - "id": 15351, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_421", - "response_code_uid": "ResponseCode_2802", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_32302" - }, - { - "id": 15353, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_436", - "response_code_uid": "ResponseCode_2804", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_32319" - }, - { - "id": 15354, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_457", - "response_code_uid": "ResponseCode_2805", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_32341" - }, - { - "id": 15356, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_467", - "response_code_uid": "ResponseCode_2807", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_32353" - }, - { - "id": 15360, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_508", - "response_code_uid": "ResponseCode_2811", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_32398" - }, - { - "id": 15362, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_518", - "response_code_uid": "ResponseCode_2813", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_32410" - }, - { - "id": 15367, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_542", - "response_code_uid": "ResponseCode_2818", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_32439" - }, - { - "id": 15368, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_546", - "response_code_uid": "ResponseCode_2819", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_32444" - }, - { - "id": 15370, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_572", - "response_code_uid": "ResponseCode_2821", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_32472" - }, - { - "id": 15371, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_575", - "response_code_uid": "ResponseCode_2822", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_32476" - }, - { - "id": 15374, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_613", - "response_code_uid": "ResponseCode_2825", - "name": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "label": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "is_enabled": 1, - "code": "AliasCode_33098" - }, - { - "id": 15376, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_635", - "response_code_uid": "ResponseCode_2827", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_33122" - }, - { - "id": 15381, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_683", - "response_code_uid": "ResponseCode_2832", - "name": "BRAIN", - "label": "BRAIN", - "is_enabled": 1, - "code": "AliasCode_33175" - }, - { - "id": 15430, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_9", - "response_code_uid": "ResponseCode_2841", - "name": "INFORMED CONSENT OBTAINED", - "label": "INFORMED CONSENT OBTAINED", - "is_enabled": 1, - "code": "AliasCode_33318" - }, - { - "id": 15432, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_30", - "response_code_uid": "ResponseCode_2842", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "is_enabled": 1, - "code": "AliasCode_33341" - }, - { - "id": 15434, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_66", - "response_code_uid": "ResponseCode_2843", - "name": "YEARS", - "label": "YEARS", - "is_enabled": 1, - "code": "AliasCode_33379" - }, - { - "id": 15440, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_167", - "response_code_uid": "ResponseCode_2848", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_33485" - }, - { - "id": 15442, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_173", - "response_code_uid": "ResponseCode_2849", - "name": "breaths/min", - "label": "breaths/min", - "is_enabled": 1, - "code": "AliasCode_33492" - }, - { - "id": 15445, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_28", - "response_code_uid": "ResponseCode_2850", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "is_enabled": 1, - "code": "AliasCode_33523" - }, - { - "id": 15449, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_182", - "response_code_uid": "ResponseCode_2853", - "name": "X-RAY", - "label": "X-RAY", - "is_enabled": 1, - "code": "AliasCode_33681" - }, - { - "id": 15450, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_188", - "response_code_uid": "ResponseCode_2854", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "is_enabled": 1, - "code": "AliasCode_33688" - }, - { - "id": 15453, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_226", - "response_code_uid": "ResponseCode_2855", - "name": "breaths/min", - "label": "breaths/min", - "is_enabled": 1, - "code": "AliasCode_33729" - }, - { - "id": 15456, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_454", - "response_code_uid": "ResponseCode_2858", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_33960" - }, - { - "id": 15457, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_467", - "response_code_uid": "ResponseCode_2859", - "name": "deg", - "label": "deg", - "is_enabled": 1, - "code": "AliasCode_33974" - }, - { - "id": 15462, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_516", - "response_code_uid": "ResponseCode_2864", - "name": "CT SCAN", - "label": "CT SCAN", - "is_enabled": 1, - "code": "AliasCode_34028" - }, - { - "id": 15463, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_519", - "response_code_uid": "ResponseCode_2865", - "name": "CHEST", - "label": "CHEST", - "is_enabled": 1, - "code": "AliasCode_34032" - }, - { - "id": 15464, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_541", - "response_code_uid": "ResponseCode_2866", - "name": "MRI", - "label": "MRI", - "is_enabled": 1, - "code": "AliasCode_34055" - }, - { - "id": 15465, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_544", - "response_code_uid": "ResponseCode_2867", - "name": "BRAIN", - "label": "BRAIN", - "is_enabled": 1, - "code": "AliasCode_34059" - }, - { - "id": 15470, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_589", - "response_code_uid": "ResponseCode_2872", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34109" - }, - { - "id": 15474, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_604", - "response_code_uid": "ResponseCode_2876", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34128" - }, - { - "id": 15477, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_614", - "response_code_uid": "ResponseCode_2879", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34141" - }, - { - "id": 15480, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_624", - "response_code_uid": "ResponseCode_2882", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "is_enabled": 1, - "code": "AliasCode_34154" - }, - { - "id": 15483, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_633", - "response_code_uid": "ResponseCode_2885", - "name": "fL", - "label": "fL", - "is_enabled": 1, - "code": "AliasCode_34166" - }, - { - "id": 15484, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_634", - "response_code_uid": "ResponseCode_2886", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "is_enabled": 1, - "code": "AliasCode_34168" - }, - { - "id": 15486, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_644", - "response_code_uid": "ResponseCode_2888", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34180" - }, - { - "id": 15488, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_653", - "response_code_uid": "ResponseCode_2890", - "name": "10^9/L", - "label": "10^9/L", - "is_enabled": 1, - "code": "AliasCode_34191" - }, - { - "id": 15489, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_654", - "response_code_uid": "ResponseCode_2891", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34193" - }, - { - "id": 15491, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_663", - "response_code_uid": "ResponseCode_2893", - "name": "10^6/L", - "label": "10^6/L", - "is_enabled": 1, - "code": "AliasCode_34204" - }, - { - "id": 15492, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_664", - "response_code_uid": "ResponseCode_2894", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34206" - }, - { - "id": 15494, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_673", - "response_code_uid": "ResponseCode_2896", - "name": "10^9/L", - "label": "10^9/L", - "is_enabled": 1, - "code": "AliasCode_34217" - }, - { - "id": 15495, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_674", - "response_code_uid": "ResponseCode_2897", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34219" - }, - { - "id": 15497, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_683", - "response_code_uid": "ResponseCode_2899", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34230" - }, - { - "id": 15499, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_692", - "response_code_uid": "ResponseCode_2901", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34241" - }, - { - "id": 15501, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_701", - "response_code_uid": "ResponseCode_2903", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34252" - }, - { - "id": 15503, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_710", - "response_code_uid": "ResponseCode_2905", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34263" - }, - { - "id": 15504, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_714", - "response_code_uid": "ResponseCode_2906", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34268" - }, - { - "id": 15506, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_722", - "response_code_uid": "ResponseCode_2908", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34278" - }, - { - "id": 15508, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_731", - "response_code_uid": "ResponseCode_2910", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34289" - }, - { - "id": 15510, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_740", - "response_code_uid": "ResponseCode_2912", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34300" - }, - { - "id": 15512, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_749", - "response_code_uid": "ResponseCode_2914", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34311" - }, - { - "id": 15514, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_759", - "response_code_uid": "ResponseCode_2916", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34323" - }, - { - "id": 15517, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_779", - "response_code_uid": "ResponseCode_2919", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34346" - }, - { - "id": 15519, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_799", - "response_code_uid": "ResponseCode_2921", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34368" - }, - { - "id": 15521, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_809", - "response_code_uid": "ResponseCode_2923", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34380" - }, - { - "id": 15523, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_819", - "response_code_uid": "ResponseCode_2925", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34392" - }, - { - "id": 15525, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_829", - "response_code_uid": "ResponseCode_2927", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34404" - }, - { - "id": 15527, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_839", - "response_code_uid": "ResponseCode_2929", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34416" - }, - { - "id": 15529, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_849", - "response_code_uid": "ResponseCode_2931", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34428" - }, - { - "id": 15531, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_859", - "response_code_uid": "ResponseCode_2933", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34440" - }, - { - "id": 15533, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_869", - "response_code_uid": "ResponseCode_2935", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34452" - }, - { - "id": 15535, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_880", - "response_code_uid": "ResponseCode_2937", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34465" - }, - { - "id": 15537, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_890", - "response_code_uid": "ResponseCode_2939", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34477" - }, - { - "id": 15539, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_900", - "response_code_uid": "ResponseCode_2941", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34489" - }, - { - "id": 15541, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_910", - "response_code_uid": "ResponseCode_2943", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34501" - }, - { - "id": 15544, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_926", - "response_code_uid": "ResponseCode_2946", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34520" - }, - { - "id": 15545, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_931", - "response_code_uid": "ResponseCode_2947", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34526" - }, - { - "id": 15548, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_945", - "response_code_uid": "ResponseCode_2950", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34543" - }, - { - "id": 15550, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_955", - "response_code_uid": "ResponseCode_2952", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34555" - }, - { - "id": 15552, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_969", - "response_code_uid": "ResponseCode_2954", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34571" - }, - { - "id": 15555, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_979", - "response_code_uid": "ResponseCode_2957", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34584" - }, - { - "id": 15558, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_989", - "response_code_uid": "ResponseCode_2960", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34597" - }, - { - "id": 15560, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_997", - "response_code_uid": "ResponseCode_2962", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34607" - }, - { - "id": 15564, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1014", - "response_code_uid": "ResponseCode_2966", - "name": "DETECTION", - "label": "DETECTION", - "is_enabled": 1, - "code": "AliasCode_34628" - }, - { - "id": 15565, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1016", - "response_code_uid": "ResponseCode_2967", - "name": "SERUM", - "label": "SERUM", - "is_enabled": 1, - "code": "AliasCode_34631" - }, - { - "id": 15566, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1019", - "response_code_uid": "ResponseCode_2968", - "name": "DETECTION", - "label": "DETECTION", - "is_enabled": 1, - "code": "AliasCode_34635" - }, - { - "id": 15567, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1022", - "response_code_uid": "ResponseCode_2969", - "name": "LINE PROBE ASSAY", - "label": "LINE PROBE ASSAY", - "is_enabled": 1, - "code": "AliasCode_34639" - }, - { - "id": 15570, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1035", - "response_code_uid": "ResponseCode_2972", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_34655" - }, - { - "id": 15573, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1047", - "response_code_uid": "ResponseCode_2975", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_34670" - }, - { - "id": 15574, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1052", - "response_code_uid": "ResponseCode_2976", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34676" - }, - { - "id": 15575, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1057", - "response_code_uid": "ResponseCode_2977", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_34682" - }, - { - "id": 15577, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1067", - "response_code_uid": "ResponseCode_2979", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_34694" - }, - { - "id": 15579, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1076", - "response_code_uid": "ResponseCode_2981", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_34705" - }, - { - "id": 15581, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1103", - "response_code_uid": "ResponseCode_2983", - "name": "STOOL", - "label": "STOOL", - "is_enabled": 1, - "code": "AliasCode_34734" - }, - { - "id": 15582, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1111", - "response_code_uid": "ResponseCode_2984", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_34743" - }, - { - "id": 15585, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1125", - "response_code_uid": "ResponseCode_2987", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_34760" - }, - { - "id": 15588, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1155", - "response_code_uid": "ResponseCode_2990", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_34793" - }, - { - "id": 15589, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1190", - "response_code_uid": "ResponseCode_2991", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_34829" - }, - { - "id": 15592, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1231", - "response_code_uid": "ResponseCode_2994", - "name": "SITE TRANSFER", - "label": "SITE TRANSFER", - "is_enabled": 1, - "code": "AliasCode_34873" - }, - { - "id": 15598, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1276", - "response_code_uid": "ResponseCode_3000", - "name": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "label": "WITHDRAWAL OF CONSENT FROM PROTOCOL-SPECIFIED ACTIVITY", - "is_enabled": 1, - "code": "AliasCode_34924" - }, - { - "id": 15606, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1309", - "response_code_uid": "ResponseCode_3008", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_34965" - }, - { - "id": 15607, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1325", - "response_code_uid": "ResponseCode_3009", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_34982" - }, - { - "id": 15608, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1339", - "response_code_uid": "ResponseCode_3010", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_34997" - }, - { - "id": 15609, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1345", - "response_code_uid": "ResponseCode_3011", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_35004" - }, - { - "id": 15610, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1351", - "response_code_uid": "ResponseCode_3012", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_35011" - }, - { - "id": 15611, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1357", - "response_code_uid": "ResponseCode_3013", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_35018" - }, - { - "id": 15612, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1422", - "response_code_uid": "ResponseCode_3014", - "name": "EGCTMON", - "label": "EGCTMON", - "is_enabled": 1, - "code": "AliasCode_35084" - }, - { - "id": 15613, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1423", - "response_code_uid": "ResponseCode_3015", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "is_enabled": 1, - "code": "AliasCode_35086" - }, - { - "id": 15614, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1428", - "response_code_uid": "ResponseCode_3016", - "name": "EGCTMON", - "label": "EGCTMON", - "is_enabled": 1, - "code": "AliasCode_35092" - }, - { - "id": 15615, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1429", - "response_code_uid": "ResponseCode_3017", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "is_enabled": 1, - "code": "AliasCode_35094" - }, - { - "id": 15616, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1438", - "response_code_uid": "ResponseCode_3018", - "name": "MRI", - "label": "MRI", - "is_enabled": 1, - "code": "AliasCode_35104" - }, - { - "id": 15617, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1441", - "response_code_uid": "ResponseCode_3019", - "name": "BRAIN", - "label": "BRAIN", - "is_enabled": 1, - "code": "AliasCode_35108" - }, - { - "id": 15618, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1453", - "response_code_uid": "ResponseCode_3020", - "name": "CT SCAN", - "label": "CT SCAN", - "is_enabled": 1, - "code": "AliasCode_35121" - }, - { - "id": 15677, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_1", - "response_code_uid": "ResponseCode_3021", - "name": "INFORMED CONSENT OBTAINED", - "label": "INFORMED CONSENT OBTAINED", - "is_enabled": 1, - "code": "AliasCode_35123" - }, - { - "id": 15678, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_12", - "response_code_uid": "ResponseCode_3022", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "is_enabled": 1, - "code": "AliasCode_35135" - }, - { - "id": 15679, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_29", - "response_code_uid": "ResponseCode_3023", - "name": "YEARS", - "label": "YEARS", - "is_enabled": 1, - "code": "AliasCode_35165" - }, - { - "id": 15680, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_85", - "response_code_uid": "ResponseCode_3024", - "name": "X-RAY", - "label": "X-RAY", - "is_enabled": 1, - "code": "AliasCode_35222" - }, - { - "id": 15681, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_91", - "response_code_uid": "ResponseCode_3025", - "name": "RANDOMIZED", - "label": "RANDOMIZED", - "is_enabled": 1, - "code": "AliasCode_35229" - }, - { - "id": 15682, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_105", - "response_code_uid": "ResponseCode_3026", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_35335" - }, - { - "id": 15683, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_111", - "response_code_uid": "ResponseCode_3027", - "name": "breaths/min", - "label": "breaths/min", - "is_enabled": 1, - "code": "AliasCode_35342" - }, - { - "id": 15684, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_222", - "response_code_uid": "ResponseCode_3028", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_35454" - }, - { - "id": 15685, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_251", - "response_code_uid": "ResponseCode_3029", - "name": "CT SCAN", - "label": "CT SCAN", - "is_enabled": 1, - "code": "AliasCode_35484" - }, - { - "id": 15686, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_254", - "response_code_uid": "ResponseCode_3030", - "name": "CHEST", - "label": "CHEST", - "is_enabled": 1, - "code": "AliasCode_35488" - }, - { - "id": 15687, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_258", - "response_code_uid": "ResponseCode_3031", - "name": "MRI", - "label": "MRI", - "is_enabled": 1, - "code": "AliasCode_35747" - }, - { - "id": 15688, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_261", - "response_code_uid": "ResponseCode_3032", - "name": "BRAIN", - "label": "BRAIN", - "is_enabled": 1, - "code": "AliasCode_35751" - }, - { - "id": 15689, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_286", - "response_code_uid": "ResponseCode_3033", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_35777" - }, - { - "id": 15690, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_296", - "response_code_uid": "ResponseCode_3034", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_35788" - }, - { - "id": 15691, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_305", - "response_code_uid": "ResponseCode_3035", - "name": "fL", - "label": "fL", - "is_enabled": 1, - "code": "AliasCode_35798" - }, - { - "id": 15692, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_306", - "response_code_uid": "ResponseCode_3036", - "name": "ERYTHROCYTES", - "label": "ERYTHROCYTES", - "is_enabled": 1, - "code": "AliasCode_35800" - }, - { - "id": 15693, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_315", - "response_code_uid": "ResponseCode_3037", - "name": "10^9/L", - "label": "10^9/L", - "is_enabled": 1, - "code": "AliasCode_35810" - }, - { - "id": 15694, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_316", - "response_code_uid": "ResponseCode_3038", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_35812" - }, - { - "id": 15695, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_325", - "response_code_uid": "ResponseCode_3039", - "name": "10^9/L", - "label": "10^9/L", - "is_enabled": 1, - "code": "AliasCode_35822" - }, - { - "id": 15696, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_326", - "response_code_uid": "ResponseCode_3040", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_35824" - }, - { - "id": 15697, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_336", - "response_code_uid": "ResponseCode_3041", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_35835" - }, - { - "id": 15698, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_350", - "response_code_uid": "ResponseCode_3042", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_35850" - }, - { - "id": 15699, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_354", - "response_code_uid": "ResponseCode_3043", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_35855" - }, - { - "id": 15700, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_358", - "response_code_uid": "ResponseCode_3044", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_35860" - }, - { - "id": 15701, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_366", - "response_code_uid": "ResponseCode_3045", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_35869" - }, - { - "id": 15702, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_381", - "response_code_uid": "ResponseCode_3046", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_35885" - }, - { - "id": 15703, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_386", - "response_code_uid": "ResponseCode_3047", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_35891" - }, - { - "id": 15704, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_391", - "response_code_uid": "ResponseCode_3048", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_35897" - }, - { - "id": 15705, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_401", - "response_code_uid": "ResponseCode_3049", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_35908" - }, - { - "id": 15706, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_416", - "response_code_uid": "ResponseCode_3050", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_35924" - }, - { - "id": 15707, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_431", - "response_code_uid": "ResponseCode_3051", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_35940" - }, - { - "id": 15708, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_452", - "response_code_uid": "ResponseCode_3052", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_35962" - }, - { - "id": 15709, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_462", - "response_code_uid": "ResponseCode_3053", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_35973" - }, - { - "id": 15710, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_472", - "response_code_uid": "ResponseCode_3054", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_35984" - }, - { - "id": 15711, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_476", - "response_code_uid": "ResponseCode_3055", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_35989" - }, - { - "id": 15712, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_486", - "response_code_uid": "ResponseCode_3056", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_36000" - }, - { - "id": 15713, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_494", - "response_code_uid": "ResponseCode_3057", - "name": "DETECTION", - "label": "DETECTION", - "is_enabled": 1, - "code": "AliasCode_36009" - }, - { - "id": 15714, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_496", - "response_code_uid": "ResponseCode_3058", - "name": "SERUM", - "label": "SERUM", - "is_enabled": 1, - "code": "AliasCode_36012" - }, - { - "id": 15715, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_499", - "response_code_uid": "ResponseCode_3059", - "name": "DETECTION", - "label": "DETECTION", - "is_enabled": 1, - "code": "AliasCode_36016" - }, - { - "id": 15716, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_502", - "response_code_uid": "ResponseCode_3060", - "name": "LINE PROBE ASSAY", - "label": "LINE PROBE ASSAY", - "is_enabled": 1, - "code": "AliasCode_36020" - }, - { - "id": 15717, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_505", - "response_code_uid": "ResponseCode_3061", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_36024" - }, - { - "id": 15718, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_513", - "response_code_uid": "ResponseCode_3062", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_36033" - }, - { - "id": 15719, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_523", - "response_code_uid": "ResponseCode_3063", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_36044" - }, - { - "id": 15720, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_528", - "response_code_uid": "ResponseCode_3064", - "name": "SERUM OR PLASMA", - "label": "SERUM OR PLASMA", - "is_enabled": 1, - "code": "AliasCode_36050" - }, - { - "id": 15721, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_533", - "response_code_uid": "ResponseCode_3065", - "name": "URINE", - "label": "URINE", - "is_enabled": 1, - "code": "AliasCode_36056" - }, - { - "id": 15722, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_537", - "response_code_uid": "ResponseCode_3066", - "name": "STOOL", - "label": "STOOL", - "is_enabled": 1, - "code": "AliasCode_36061" - }, - { - "id": 15723, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_550", - "response_code_uid": "ResponseCode_3067", - "name": "BLOOD", - "label": "BLOOD", - "is_enabled": 1, - "code": "AliasCode_36075" - }, - { - "id": 15724, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_578", - "response_code_uid": "ResponseCode_3068", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_36104" - }, - { - "id": 15725, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_581", - "response_code_uid": "ResponseCode_3069", - "name": "CAREGIVER", - "label": "CAREGIVER", - "is_enabled": 1, - "code": "AliasCode_36108" - }, - { - "id": 15726, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_610", - "response_code_uid": "ResponseCode_3070", - "name": "SITE TRANSFER", - "label": "SITE TRANSFER", - "is_enabled": 1, - "code": "AliasCode_36138" - }, - { - "id": 15727, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_617", - "response_code_uid": "ResponseCode_3071", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_36146" - }, - { - "id": 15728, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_629", - "response_code_uid": "ResponseCode_3072", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_36159" - }, - { - "id": 15729, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_641", - "response_code_uid": "ResponseCode_3073", - "name": "mmHg", - "label": "mmHg", - "is_enabled": 1, - "code": "AliasCode_36172" - }, - { - "id": 15730, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_647", - "response_code_uid": "ResponseCode_3074", - "name": "beats/min", - "label": "beats/min", - "is_enabled": 1, - "code": "AliasCode_36179" - }, - { - "id": 15731, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_670", - "response_code_uid": "ResponseCode_3075", - "name": "EGCTMON", - "label": "EGCTMON", - "is_enabled": 1, - "code": "AliasCode_36203" - }, - { - "id": 15732, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_671", - "response_code_uid": "ResponseCode_3076", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "is_enabled": 1, - "code": "AliasCode_36205" - }, - { - "id": 15733, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_680", - "response_code_uid": "ResponseCode_3077", - "name": "MRI", - "label": "MRI", - "is_enabled": 1, - "code": "AliasCode_36215" - }, - { - "id": 15734, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_687", - "response_code_uid": "ResponseCode_3078", - "name": "CT SCAN", - "label": "CT SCAN", - "is_enabled": 1, - "code": "AliasCode_36223" - }, - { - "id": 15772, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_674", - "response_code_uid": "ResponseCode_3079", - "name": "MRI", - "label": "MRI", - "is_enabled": 1, - "code": "AliasCode_36898" - }, - { - "id": 15773, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_677", - "response_code_uid": "ResponseCode_3080", - "name": "BRAIN", - "label": "BRAIN", - "is_enabled": 1, - "code": "AliasCode_36902" - }, - { - "id": 15774, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_681", - "response_code_uid": "ResponseCode_3081", - "name": "CT SCAN", - "label": "CT SCAN", - "is_enabled": 1, - "code": "AliasCode_36907" - }, - { - "id": 15775, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_818", - "response_code_uid": "ResponseCode_3082", - "name": "EGCTMON", - "label": "EGCTMON", - "is_enabled": 1, - "code": "AliasCode_37045" - }, - { - "id": 15776, - "soa_id": 3, - "biomedical_concept_property_uid": "BiomedicalConceptProperty_819", - "response_code_uid": "ResponseCode_3083", - "name": "ECG Continuous Monitoring", - "label": "ECG Continuous Monitoring", - "is_enabled": 1, - "code": "AliasCode_37047" - } - ], - "biomedical_concept_surrogate": [ - { - "id": 9, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_9", - "name": "MHIS-NACC / MHIS01", - "label": "Modified Hachinski Ischemic Scale (C112523)", - "description": "Modified Hachinski Ischemic Scale-NACC Version Questionnaire", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112523", - "concept_group_uid": null - }, - { - "id": 10, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_10", - "name": "MHIS0101", - "label": "Abrupt Onset (C112618)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Abrupt onset (re: cognitive status).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112618", - "concept_group_uid": null - }, - { - "id": 11, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_11", - "name": "MHIS0102", - "label": "Stepwise Deterioration (C112619)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Stepwise deterioration (re: cognitive status).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112619", - "concept_group_uid": null - }, - { - "id": 12, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_12", - "name": "MHIS0103", - "label": "Emotional Incontinence (C112620)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Emotional incontinence.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112620", - "concept_group_uid": null - }, - { - "id": 13, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_13", - "name": "MHIS0104", - "label": "History or Presence of Hypertension (C112621)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - History or presence of hypertension.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112621", - "concept_group_uid": null - }, - { - "id": 14, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_14", - "name": "MHIS0105", - "label": "History of Stroke (C112622)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - History of stroke.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112622", - "concept_group_uid": null - }, - { - "id": 15, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_15", - "name": "MHIS0106", - "label": "Focal Neurological Symptoms (C112623)", - "description": "MHIS-NACC - Focal Neurological Symptoms", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112623", - "concept_group_uid": null - }, - { - "id": 16, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_16", - "name": "MHIS0107", - "label": "Focal Neurological Signs (C112624)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Focal neurological signs.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112624", - "concept_group_uid": null - }, - { - "id": 17, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_17", - "name": "MHIS0108", - "label": "Somatic Complaints (C112813)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Somatic complaints.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112813", - "concept_group_uid": null - }, - { - "id": 18, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_18", - "name": "MHIS0109", - "label": "Total Score (C112625)", - "description": "Modified Hachinski Ischemic Scale-NACC Version - Sum all circled answers for a total score.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112625", - "concept_group_uid": null - }, - { - "id": 25, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_19", - "name": "APOE Gene", - "label": "APOE Gene (C84468)", - "description": "This gene is involved in lipid transport and metabolism.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C84468", - "concept_group_uid": null - }, - { - "id": 26, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_20", - "name": "Mini-Mental Status Exam", - "label": "Mini-Mental Status Exam (C74982)", - "description": "Mini-Mental State Examination (MMSE) (MMSE Copyright 1975, 1998, 2001 by MiniMental, LLC All rights reserved. Published 2001 by Psychological Assessment Resources, Inc. May not be reproduced in whole or in part in any form or by any means without written permission of Psychological Assessment Resources, Inc.).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C74982", - "concept_group_uid": null - }, - { - "id": 27, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_21", - "name": "MMSE - Question 1", - "label": "MMSE - Question 1 (C100542)", - "description": "The Mini-Mental State Examination (MMSE) Question 1.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100542", - "concept_group_uid": null - }, - { - "id": 28, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_22", - "name": "MMSE - Question 2", - "label": "MMSE - Question 2 (C100548)", - "description": "The Mini-Mental State Examination (MMSE) Question 2.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100548", - "concept_group_uid": null - }, - { - "id": 29, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_23", - "name": "MMSE - Question 3", - "label": "MMSE - Question 3 (C100554)", - "description": "The Mini-Mental State Examination (MMSE) Question 3.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100554", - "concept_group_uid": null - }, - { - "id": 30, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_24", - "name": "MMSE - Question 4", - "label": "MMSE - Question 4 (C100558)", - "description": "The Mini-Mental State Examination (MMSE) Question 4.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100558", - "concept_group_uid": null - }, - { - "id": 31, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_25", - "name": "MMSE - Question 6", - "label": "MMSE - Question 6 (C100575)", - "description": "The Mini-Mental State Examination (MMSE) Question 6.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100575", - "concept_group_uid": null - }, - { - "id": 32, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_26", - "name": "MMSE Functional Test Question", - "label": "MMSE Functional Test Question (C100118)", - "description": "A question associated with the MMSE functional test.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C100118", - "concept_group_uid": null - }, - { - "id": 33, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_27", - "name": "ADCS-CGIC", - "label": "ADCS-CGIC Questionnaire Question (C103490)", - "description": "A question associated with the ADCS-CGIC questionnaire.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103490", - "concept_group_uid": null - }, - { - "id": 34, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_28", - "name": "DAD", - "label": "Disability Assessment for Dementia Questionnaire (C105165)", - "description": "Disability Assessment for Dementia (DAD) (copyright 1994 by L. Gauthier I. Gelinas. All rights reserved.).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C105165", - "concept_group_uid": null - }, - { - "id": 35, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_29", - "name": "NPI - NPI Total Distress Score", - "label": "NPI - NPI Total Distress Score (C112482)", - "description": "Neuropsychiatric Inventory - Sub-total of distress score.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112482", - "concept_group_uid": "ConceptGroup_2" - }, - { - "id": 36, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_30", - "name": "NPI - Anxiety Severity", - "label": "NPI - Anxiety Severity (C103615)", - "description": "Neuropsychiatric Inventory - Severity of the anxiety.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103615", - "concept_group_uid": "ConceptGroup_2" - }, - { - "id": 37, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_31", - "name": "NPI - Disinhibition Frequency", - "label": "NPI - Disinhibition Frequency (C103623)", - "description": "Neuropsychiatric Inventory - Frequency of the disinhibition.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103623", - "concept_group_uid": "ConceptGroup_2" - }, - { - "id": 38, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_32", - "name": "NPI - Disinhibition Severity", - "label": "NPI - Disinhibition Severity (C103624)", - "description": "Neuropsychiatric Inventory - Severity of the disinhibition.", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103624", - "concept_group_uid": "ConceptGroup_2" - }, - { - "id": 39, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_33", - "name": "NPI - Disinhibition Distress", - "label": "NPI - Disinhibition Distress (C103625)", - "description": "Neuropsychiatric Inventory - How emotionally distressing do you find this behavior?", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103625", - "concept_group_uid": "ConceptGroup_2" - }, - { - "id": 40, - "soa_id": 3, - "surrogate_uid": "BiomedicalConceptSurrogate_34", - "name": "NPI - Disinhibition FxS Score", - "label": "NPI - Disinhibition FxS Score (C112476)", - "description": "Neuropsychiatric Inventory - Disinhibition: (frequency score x severity score).", - "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C112476", - "concept_group_uid": "ConceptGroup_2" - } - ], - "activity_concept": [ - { - "id": 326, - "activity_id": 3, - "concept_code": "C16735", - "concept_title": "Informed Consent", - "concept_uid": "BiomedicalConcept_1", - "activity_uid": "Activity_1", - "soa_id": 3, - "href": null, - "dss_title": "CONSENT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CONSENT", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 327, - "activity_id": 4, - "concept_code": "C25532", - "concept_title": "Inclusion Criteria", - "concept_uid": "BiomedicalConcept_2", - "activity_uid": "Activity_2", - "soa_id": 3, - "href": null, - "dss_title": "INCL01", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/INCL01", - "dss_domain": "IE", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 328, - "activity_id": 4, - "concept_code": "C83063", - "concept_title": "Inclusion Exclusion Criteria Yes No Indicator", - "concept_uid": "BiomedicalConcept_3", - "activity_uid": "Activity_2", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 329, - "activity_id": 4, - "concept_code": "C25370", - "concept_title": "Exclusion Criteria", - "concept_uid": "BiomedicalConcept_4", - "activity_uid": "Activity_2", - "soa_id": 3, - "href": null, - "dss_title": "EXCL01", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EXCL01", - "dss_domain": "IE", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 330, - "activity_id": 5, - "concept_code": "C114209", - "concept_title": "Subject is Randomized", - "concept_uid": "BiomedicalConcept_5", - "activity_uid": "Activity_3", - "soa_id": 3, - "href": null, - "dss_title": "RAND", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RAND", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 331, - "activity_id": 6, - "concept_code": "C17049", - "concept_title": "Race", - "concept_uid": "BiomedicalConcept_6", - "activity_uid": "Activity_4", - "soa_id": 3, - "href": null, - "dss_title": "RACE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RACE", - "dss_domain": "DM", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 332, - "activity_id": 6, - "concept_code": "C16564", - "concept_title": "Ethnic Group", - "concept_uid": "BiomedicalConcept_7", - "activity_uid": "Activity_4", - "soa_id": 3, - "href": null, - "dss_title": "ETHNIC", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ETHNIC", - "dss_domain": "DM", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 333, - "activity_id": 6, - "concept_code": "C69260", - "concept_title": "Subject Age", - "concept_uid": "BiomedicalConcept_8", - "activity_uid": "Activity_4", - "soa_id": 3, - "href": null, - "dss_title": "AGE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/AGE", - "dss_domain": "DM", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 334, - "activity_id": 6, - "concept_code": "C83217", - "concept_title": "Birth Date and Time", - "concept_uid": "BiomedicalConcept_9", - "activity_uid": "Activity_4", - "soa_id": 3, - "href": null, - "dss_title": "BRTHDTC", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BRTHDTC", - "dss_domain": "DM", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 335, - "activity_id": 6, - "concept_code": "C28421", - "concept_title": "Sex", - "concept_uid": "BiomedicalConcept_10", - "activity_uid": "Activity_4", - "soa_id": 3, - "href": null, - "dss_title": "SEX", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SEX", - "dss_domain": "DM", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 336, - "activity_id": 7, - "concept_code": "C17953", - "concept_title": "Education Level", - "concept_uid": "BiomedicalConcept_11", - "activity_uid": "Activity_5", - "soa_id": 3, - "href": null, - "dss_title": "EDULEVEL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EDULEVEL", - "dss_domain": "SC", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 337, - "activity_id": 7, - "concept_code": "C122393", - "concept_title": "Number of Years of Education", - "concept_uid": "BiomedicalConcept_12", - "activity_uid": "Activity_5", - "soa_id": 3, - "href": null, - "dss_title": "EDUYRNUM", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EDUYRNUM", - "dss_domain": "SC", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 339, - "activity_id": 12, - "concept_code": "C200145", - "concept_title": "Solicited Medical History", - "concept_uid": "BiomedicalConcept_14", - "activity_uid": "Activity_9", - "soa_id": 3, - "href": null, - "dss_title": "MEDHISTFREE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MEDHISTFREE", - "dss_domain": "MH", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 340, - "activity_id": 13, - "concept_code": "C81229", - "concept_title": "Alcohol Use History", - "concept_uid": "BiomedicalConcept_15", - "activity_uid": "Activity_10", - "soa_id": 3, - "href": null, - "dss_title": "ALCOHOLHX", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALCOHOLHX", - "dss_domain": "SU", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 341, - "activity_id": 13, - "concept_code": "C201990", - "concept_title": "Caffeine Use History", - "concept_uid": "BiomedicalConcept_16", - "activity_uid": "Activity_10", - "soa_id": 3, - "href": null, - "dss_title": "CAFFEINEHX", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CAFFEINEHX", - "dss_domain": "SU", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 342, - "activity_id": 13, - "concept_code": "C181760", - "concept_title": "History of Tobacco Use", - "concept_uid": "BiomedicalConcept_17", - "activity_uid": "Activity_10", - "soa_id": 3, - "href": null, - "dss_title": "CIGARETTEHX", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CIGARETTEHX", - "dss_domain": "SU", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 343, - "activity_id": 17, - "concept_code": "C38101", - "concept_title": "X-Ray Imaging", - "concept_uid": "BiomedicalConcept_18", - "activity_uid": "Activity_11", - "soa_id": 3, - "href": null, - "dss_title": "XRAYCHEST", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/XRAYCHEST", - "dss_domain": "PR", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 344, - "activity_id": 19, - "concept_code": "C114209", - "concept_title": "Subject is Randomized", - "concept_uid": "BiomedicalConcept_19", - "activity_uid": "Activity_13", - "soa_id": 3, - "href": null, - "dss_title": "RAND", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RAND", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 345, - "activity_id": 20, - "concept_code": "C174446", - "concept_title": "Body Temperature", - "concept_uid": "BiomedicalConcept_20", - "activity_uid": "Activity_14", - "soa_id": 3, - "href": null, - "dss_title": "TEMP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TEMP", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 346, - "activity_id": 20, - "concept_code": "C81328", - "concept_title": "Body Weight", - "concept_uid": "BiomedicalConcept_21", - "activity_uid": "Activity_14", - "soa_id": 3, - "href": null, - "dss_title": "WEIGHT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/WEIGHT", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 347, - "activity_id": 20, - "concept_code": "C164634", - "concept_title": "Body Height", - "concept_uid": "BiomedicalConcept_22", - "activity_uid": "Activity_14", - "soa_id": 3, - "href": null, - "dss_title": "HEIGHT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HEIGHT", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 348, - "activity_id": 20, - "concept_code": "C49676", - "concept_title": "Pulse Rate", - "concept_uid": "BiomedicalConcept_23", - "activity_uid": "Activity_14", - "soa_id": 3, - "href": null, - "dss_title": "PULSE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PULSE", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 349, - "activity_id": 20, - "concept_code": "C49678", - "concept_title": "Respiratory Rate", - "concept_uid": "BiomedicalConcept_24", - "activity_uid": "Activity_14", - "soa_id": 3, - "href": null, - "dss_title": "RESP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RESP", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 350, - "activity_id": 20, - "concept_code": "C16358", - "concept_title": "Body Mass Index", - "concept_uid": "BiomedicalConcept_25", - "activity_uid": "Activity_14", - "soa_id": 3, - "href": null, - "dss_title": "BMI", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BMI", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 351, - "activity_id": 20, - "concept_code": "C54706", - "concept_title": "Blood Pressure", - "concept_uid": "BiomedicalConcept_26", - "activity_uid": "Activity_14", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 352, - "activity_id": 23, - "concept_code": "C181655", - "concept_title": "Electrocardiogram Analysis", - "concept_uid": "BiomedicalConcept_27", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "EGINTP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EGINTP", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 353, - "activity_id": 23, - "concept_code": "C111131", - "concept_title": "Atrioventricular Conduction ECG Assessment", - "concept_uid": "BiomedicalConcept_28", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "AVCOND", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/AVCOND", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 354, - "activity_id": 23, - "concept_code": "C111132", - "concept_title": "Axis and Voltage ECG Assessment", - "concept_uid": "BiomedicalConcept_29", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "AXISVOLT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/AXISVOLT", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 355, - "activity_id": 23, - "concept_code": "C111155", - "concept_title": "Chamber Hypertrophy or Enlargement ECG Assessment", - "concept_uid": "BiomedicalConcept_30", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "CHYPTENL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CHYPTENL", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 356, - "activity_id": 23, - "concept_code": "C117807", - "concept_title": "ECG Technical Quality", - "concept_uid": "BiomedicalConcept_31", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "TECHQUAL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TECHQUAL", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 357, - "activity_id": 23, - "concept_code": "C111238", - "concept_title": "Intraventricular and Intraatrial Conduction ECG Assessment", - "concept_uid": "BiomedicalConcept_32", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "IVTIACD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/IVTIACD", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 358, - "activity_id": 23, - "concept_code": "C111280", - "concept_title": "Myocardial Infarction ECG Assessment", - "concept_uid": "BiomedicalConcept_33", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "MI", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MI", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 359, - "activity_id": 23, - "concept_code": "C111285", - "concept_title": "Pacemaker ECG Assessment", - "concept_uid": "BiomedicalConcept_34", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "PACEMAKR", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PACEMAKR", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 360, - "activity_id": 23, - "concept_code": "C111307", - "concept_title": "Rhythm Not Otherwise Specified ECG Assessment", - "concept_uid": "BiomedicalConcept_35", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "RHYNOS", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RHYNOS", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 361, - "activity_id": 23, - "concept_code": "C111363", - "concept_title": "ST Segment, T wave, and U wave ECG Assessment", - "concept_uid": "BiomedicalConcept_36", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "STSTWUW", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/STSTWUW", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 362, - "activity_id": 23, - "concept_code": "C111312", - "concept_title": "Sinus Node Rhythm and Arrhythmia ECG Assessment", - "concept_uid": "BiomedicalConcept_37", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "SNRARRY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SNRARRY", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 363, - "activity_id": 23, - "concept_code": "C111320", - "concept_title": "Supraventricular Arrhythmia ECG Assessment", - "concept_uid": "BiomedicalConcept_38", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "SPRARRY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SPRARRY", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 364, - "activity_id": 23, - "concept_code": "C111321", - "concept_title": "Supraventricular Tachyarrhythmia ECG Assessment", - "concept_uid": "BiomedicalConcept_39", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "SPRTARRY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SPRTARRY", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 365, - "activity_id": 23, - "concept_code": "C117773", - "concept_title": "Aggregate PR Interval", - "concept_uid": "BiomedicalConcept_40", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "PRAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PRAG", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 366, - "activity_id": 23, - "concept_code": "C117779", - "concept_title": "Aggregate QRS Duration", - "concept_uid": "BiomedicalConcept_41", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "QRSAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QRSAG", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 367, - "activity_id": 23, - "concept_code": "C117783", - "concept_title": "Aggregate QT Interval", - "concept_uid": "BiomedicalConcept_42", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "QTAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QTAG", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 368, - "activity_id": 23, - "concept_code": "C117784", - "concept_title": "Aggregate QTCB Interval", - "concept_uid": "BiomedicalConcept_43", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "QTCBAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QTCBAG", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 369, - "activity_id": 23, - "concept_code": "C117786", - "concept_title": "Aggregate QTCF Interval", - "concept_uid": "BiomedicalConcept_44", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "QTCFAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QTCFAG", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 370, - "activity_id": 23, - "concept_code": "C117791", - "concept_title": "Aggregate RR Interval", - "concept_uid": "BiomedicalConcept_45", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "RRAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RRAG", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 371, - "activity_id": 23, - "concept_code": "C119259", - "concept_title": "Mean Heart Rate by Electrocardiogram", - "concept_uid": "BiomedicalConcept_46", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "EGHRMN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EGHRMN", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 372, - "activity_id": 23, - "concept_code": "C118165", - "concept_title": "QRS Axis", - "concept_uid": "BiomedicalConcept_47", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "QRS_AXIS", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QRS_AXIS", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 373, - "activity_id": 23, - "concept_code": "C174285", - "concept_title": "QTc Correction Method Unspecified, Aggregate", - "concept_uid": "BiomedicalConcept_48", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "QTCUNSAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QTCUNSAG", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 374, - "activity_id": 23, - "concept_code": "C111330", - "concept_title": "Ventricular Arrhythmia ECG Assessment", - "concept_uid": "BiomedicalConcept_49", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "VTARRY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/VTARRY", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 375, - "activity_id": 23, - "concept_code": "C111331", - "concept_title": "Ventricular Tachyarrhythmia ECG Assessment", - "concept_uid": "BiomedicalConcept_50", - "activity_uid": "Activity_17", - "soa_id": 3, - "href": null, - "dss_title": "VTTARRY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/VTTARRY", - "dss_domain": "EG", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 376, - "activity_id": 25, - "concept_code": "C17204", - "concept_title": "Computed Tomography", - "concept_uid": "BiomedicalConcept_51", - "activity_uid": "Activity_19", - "soa_id": 3, - "href": null, - "dss_title": "CTSCANCHEST", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CTSCANCHEST", - "dss_domain": "PR", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 377, - "activity_id": 26, - "concept_code": "C16809", - "concept_title": "Magnetic Resonance Imaging", - "concept_uid": "BiomedicalConcept_52", - "activity_uid": "Activity_20", - "soa_id": 3, - "href": null, - "dss_title": "MRIBRAIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MRIBRAIN", - "dss_domain": "PR", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 379, - "activity_id": 28, - "concept_code": "C83056", - "concept_title": "Concomitant Medication Yes No Indicator", - "concept_uid": "BiomedicalConcept_54", - "activity_uid": "Activity_22", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 380, - "activity_id": 28, - "concept_code": "C53630", - "concept_title": "Concomitant Therapy", - "concept_uid": "BiomedicalConcept_55", - "activity_uid": "Activity_22", - "soa_id": 3, - "href": null, - "dss_title": "CMFREE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CMFREE", - "dss_domain": "CM", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 381, - "activity_id": 29, - "concept_code": "C64848", - "concept_title": "Hemoglobin Measurement", - "concept_uid": "BiomedicalConcept_56", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "HGBBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HGBBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 382, - "activity_id": 29, - "concept_code": "C64796", - "concept_title": "Hematocrit Measurement", - "concept_uid": "BiomedicalConcept_57", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "HCTBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HCTBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 383, - "activity_id": 29, - "concept_code": "C51946", - "concept_title": "Erythrocyte Count", - "concept_uid": "BiomedicalConcept_58", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "RBCBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RBCBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 384, - "activity_id": 29, - "concept_code": "C64797", - "concept_title": "Erythrocyte Mean Corpuscular Hemoglobin", - "concept_uid": "BiomedicalConcept_59", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "MCH", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MCH", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 385, - "activity_id": 29, - "concept_code": "C64799", - "concept_title": "Erythrocyte Mean Corpuscular Volume", - "concept_uid": "BiomedicalConcept_60", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "MCV", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MCV", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 386, - "activity_id": 29, - "concept_code": "C51948", - "concept_title": "Leukocyte Count", - "concept_uid": "BiomedicalConcept_61", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "WBCBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/WBCBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 387, - "activity_id": 29, - "concept_code": "C81997", - "concept_title": "Segmented Neutrophil Count", - "concept_uid": "BiomedicalConcept_62", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "NEUTSGBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NEUTSGBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 388, - "activity_id": 29, - "concept_code": "C64830", - "concept_title": "Neutrophil Band Form Count", - "concept_uid": "BiomedicalConcept_63", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "NEUTBBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NEUTBBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 389, - "activity_id": 29, - "concept_code": "C63321", - "concept_title": "Absolute Neutrophil Count", - "concept_uid": "BiomedicalConcept_64", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "NEUTBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NEUTBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 390, - "activity_id": 29, - "concept_code": "C64823", - "concept_title": "Monocyte Count", - "concept_uid": "BiomedicalConcept_65", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "MONOBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MONOBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 391, - "activity_id": 29, - "concept_code": "C64550", - "concept_title": "Eosinophil Count", - "concept_uid": "BiomedicalConcept_66", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "EOSBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EOSBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 392, - "activity_id": 29, - "concept_code": "C64470", - "concept_title": "Absolute Basophil Count", - "concept_uid": "BiomedicalConcept_67", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "BASOBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BASOBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 393, - "activity_id": 29, - "concept_code": "C51951", - "concept_title": "Platelet Count", - "concept_uid": "BiomedicalConcept_68", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "PLATBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PLATBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 394, - "activity_id": 29, - "concept_code": "C64822", - "concept_title": "Microcyte Count", - "concept_uid": "BiomedicalConcept_69", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "MICROCYBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MICROCYBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 395, - "activity_id": 29, - "concept_code": "C64821", - "concept_title": "Macrocyte Count", - "concept_uid": "BiomedicalConcept_70", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "MACROCYBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MACROCYBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 396, - "activity_id": 29, - "concept_code": "C74797", - "concept_title": "Anisocyte Measurement", - "concept_uid": "BiomedicalConcept_71", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "ANISOBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ANISOBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 397, - "activity_id": 29, - "concept_code": "C79602", - "concept_title": "Poikilocyte Measurement", - "concept_uid": "BiomedicalConcept_72", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "POIKILOBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/POIKILOBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 398, - "activity_id": 29, - "concept_code": "C64803", - "concept_title": "Polychromasia", - "concept_uid": "BiomedicalConcept_73", - "activity_uid": "Activity_23", - "soa_id": 3, - "href": null, - "dss_title": "POLYCHRBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/POLYCHRBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 399, - "activity_id": 30, - "concept_code": "C64433", - "concept_title": "Alanine Aminotransferase Measurement", - "concept_uid": "BiomedicalConcept_74", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "ALTSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 400, - "activity_id": 30, - "concept_code": "C64431", - "concept_title": "Albumin Measurement", - "concept_uid": "BiomedicalConcept_75", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "ALBSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 401, - "activity_id": 30, - "concept_code": "C64432", - "concept_title": "Alkaline Phosphatase Measurement", - "concept_uid": "BiomedicalConcept_76", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "ALPSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 402, - "activity_id": 30, - "concept_code": "C64467", - "concept_title": "Aspartate Aminotransferase Measurement", - "concept_uid": "BiomedicalConcept_77", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "ASTSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 403, - "activity_id": 30, - "concept_code": "C64547", - "concept_title": "Creatinine Measurement", - "concept_uid": "BiomedicalConcept_78", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "CREATSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 404, - "activity_id": 30, - "concept_code": "C64853", - "concept_title": "Potassium Measurement", - "concept_uid": "BiomedicalConcept_79", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "KBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/KBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 405, - "activity_id": 30, - "concept_code": "C64809", - "concept_title": "Sodium Measurement", - "concept_uid": "BiomedicalConcept_80", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "SODIUMBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 406, - "activity_id": 30, - "concept_code": "C125949", - "concept_title": "Urea Nitrogen Measurement", - "concept_uid": "BiomedicalConcept_81", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "UREANSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 407, - "activity_id": 30, - "concept_code": "C74667", - "concept_title": "Bicarbonate Measurement", - "concept_uid": "BiomedicalConcept_82", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "BICARBBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BICARBBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 408, - "activity_id": 30, - "concept_code": "C64495", - "concept_title": "Chloride Measurement", - "concept_uid": "BiomedicalConcept_83", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "CLBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CLBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 409, - "activity_id": 30, - "concept_code": "C38037", - "concept_title": "Total Bilirubin Measurement", - "concept_uid": "BiomedicalConcept_84", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "BILISERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 410, - "activity_id": 30, - "concept_code": "C64847", - "concept_title": "Gamma Glutamyl Transpeptidase Measurement", - "concept_uid": "BiomedicalConcept_85", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "GGTSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/GGTSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 411, - "activity_id": 30, - "concept_code": "C64814", - "concept_title": "Urate Measurement", - "concept_uid": "BiomedicalConcept_86", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "URATESERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/URATESERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 412, - "activity_id": 30, - "concept_code": "C64857", - "concept_title": "Phosphate Measurement", - "concept_uid": "BiomedicalConcept_87", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "PHOSSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PHOSSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 413, - "activity_id": 30, - "concept_code": "C64488", - "concept_title": "Calcium Measurement", - "concept_uid": "BiomedicalConcept_88", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "CABLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CABLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 414, - "activity_id": 30, - "concept_code": "C105585", - "concept_title": "Glucose Measurement", - "concept_uid": "BiomedicalConcept_89", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "GLUCBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 415, - "activity_id": 30, - "concept_code": "C64858", - "concept_title": "Total Protein Measurement", - "concept_uid": "BiomedicalConcept_90", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "PROTSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 416, - "activity_id": 30, - "concept_code": "C105586", - "concept_title": "Cholesterol Measurement", - "concept_uid": "BiomedicalConcept_91", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "CHOLSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 417, - "activity_id": 30, - "concept_code": "C74748", - "concept_title": "Triiodothyronine Uptake Measurement", - "concept_uid": "BiomedicalConcept_92", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "T3UPSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/T3UPSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 418, - "activity_id": 30, - "concept_code": "C74747", - "concept_title": "Triiodothyronine Measurement", - "concept_uid": "BiomedicalConcept_93", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "T3SERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/T3SERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 419, - "activity_id": 30, - "concept_code": "C74786", - "concept_title": "Free Thyroxine Measurement", - "concept_uid": "BiomedicalConcept_94", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "T4FRSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/T4FRSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 420, - "activity_id": 30, - "concept_code": "C170598", - "concept_title": "Free Thyroxine Index", - "concept_uid": "BiomedicalConcept_95", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "T4FRIDXSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/T4FRIDXSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 421, - "activity_id": 30, - "concept_code": "C64813", - "concept_title": "Thyrotropin Measurement", - "concept_uid": "BiomedicalConcept_96", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "TSHBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TSHBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 422, - "activity_id": 30, - "concept_code": "C74676", - "concept_title": "Folic Acid Measurement", - "concept_uid": "BiomedicalConcept_97", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "VITB9BLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/VITB9BLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 423, - "activity_id": 30, - "concept_code": "C64817", - "concept_title": "Vitamin B12 Measurement", - "concept_uid": "BiomedicalConcept_98", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "VITB12BLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/VITB12BLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 424, - "activity_id": 30, - "concept_code": "C132388", - "concept_title": "Treponema pallidum Antibody Measurement", - "concept_uid": "BiomedicalConcept_99", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "TPLAB", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TPLAB", - "dss_domain": "MB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 425, - "activity_id": 30, - "concept_code": "C198341", - "concept_title": "Treponema pallidum DNA Measurement", - "concept_uid": "BiomedicalConcept_100", - "activity_uid": "Activity_24", - "soa_id": 3, - "href": null, - "dss_title": "TPADNA", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TPADNA", - "dss_domain": "MB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 426, - "activity_id": 31, - "concept_code": "C64546", - "concept_title": "Color Assessment", - "concept_uid": "BiomedicalConcept_101", - "activity_uid": "Activity_25", - "soa_id": 3, - "href": null, - "dss_title": "COLORURIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/COLORURIN", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 427, - "activity_id": 31, - "concept_code": "C64832", - "concept_title": "Specific Gravity", - "concept_uid": "BiomedicalConcept_102", - "activity_uid": "Activity_25", - "soa_id": 3, - "href": null, - "dss_title": "SPGRAVURIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 428, - "activity_id": 31, - "concept_code": "C64858", - "concept_title": "Total Protein Measurement", - "concept_uid": "BiomedicalConcept_103", - "activity_uid": "Activity_25", - "soa_id": 3, - "href": null, - "dss_title": "PROTSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 429, - "activity_id": 31, - "concept_code": "C105585", - "concept_title": "Glucose Measurement", - "concept_uid": "BiomedicalConcept_104", - "activity_uid": "Activity_25", - "soa_id": 3, - "href": null, - "dss_title": "GLUCBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 430, - "activity_id": 31, - "concept_code": "C64854", - "concept_title": "Ketone Measurement", - "concept_uid": "BiomedicalConcept_105", - "activity_uid": "Activity_25", - "soa_id": 3, - "href": null, - "dss_title": "KETONESURIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/KETONESURIN", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 431, - "activity_id": 31, - "concept_code": "C38037", - "concept_title": "Total Bilirubin Measurement", - "concept_uid": "BiomedicalConcept_106", - "activity_uid": "Activity_25", - "soa_id": 3, - "href": null, - "dss_title": "BILISERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 432, - "activity_id": 31, - "concept_code": "C64816", - "concept_title": "Urobilinogen Measurement", - "concept_uid": "BiomedicalConcept_107", - "activity_uid": "Activity_25", - "soa_id": 3, - "href": null, - "dss_title": "UROBILURIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/UROBILURIN", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 433, - "activity_id": 31, - "concept_code": "C74686", - "concept_title": "Occult Blood Measurement", - "concept_uid": "BiomedicalConcept_108", - "activity_uid": "Activity_25", - "soa_id": 3, - "href": null, - "dss_title": "OCCBLDSTOOL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/OCCBLDSTOOL", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 434, - "activity_id": 31, - "concept_code": "C64810", - "concept_title": "Nitrite Measurement", - "concept_uid": "BiomedicalConcept_109", - "activity_uid": "Activity_25", - "soa_id": 3, - "href": null, - "dss_title": "NITRITEURIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NITRITEURIN", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 435, - "activity_id": 33, - "concept_code": "C64849", - "concept_title": "Hemoglobin A1C Measurement", - "concept_uid": "BiomedicalConcept_110", - "activity_uid": "Activity_27", - "soa_id": 3, - "href": null, - "dss_title": "HBA1CBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HBA1CBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 436, - "activity_id": 33, - "concept_code": "C111207", - "concept_title": "Hemoglobin A1C to Hemoglobin Ratio Measurement", - "concept_uid": "BiomedicalConcept_111", - "activity_uid": "Activity_27", - "soa_id": 3, - "href": null, - "dss_title": "HBA1CHGBBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HBA1CHGBBLD", - "dss_domain": "LB", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 437, - "activity_id": 34, - "concept_code": "C117466", - "concept_title": "Exposure as Collected Domain", - "concept_uid": "BiomedicalConcept_112", - "activity_uid": "Activity_28", - "soa_id": 3, - "href": null, - "dss_title": "EXPOSCOLL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EXPOSCOLL", - "dss_domain": "EC", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 438, - "activity_id": 35, - "concept_code": "NEW_LZZT", - "concept_title": "TTS Acceptability Survey", - "concept_uid": "BiomedicalConcept_113", - "activity_uid": "Activity_29", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 439, - "activity_id": 35, - "concept_code": "NEW_LZZT4", - "concept_title": "TTS Acceptability Survey - Patch Acceptability", - "concept_uid": "BiomedicalConcept_114", - "activity_uid": "Activity_29", - "soa_id": 3, - "href": null, - "dss_title": "PATCHSURVEYACCEPTABILITY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYACCEPTABILITY", - "dss_domain": "QS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 440, - "activity_id": 35, - "concept_code": "NEW_LZZT1", - "concept_title": "TTS Acceptability Survey - Patch Appearance", - "concept_uid": "BiomedicalConcept_115", - "activity_uid": "Activity_29", - "soa_id": 3, - "href": null, - "dss_title": "PATCHSURVEYAPPEARANCE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYAPPEARANCE", - "dss_domain": "QS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 441, - "activity_id": 35, - "concept_code": "NEW_LZZT3", - "concept_title": "TTS Acceptability Survey - Patch Durability", - "concept_uid": "BiomedicalConcept_116", - "activity_uid": "Activity_29", - "soa_id": 3, - "href": null, - "dss_title": "PATCHSURVEYDURABILITY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYDURABILITY", - "dss_domain": "QS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 442, - "activity_id": 35, - "concept_code": "NEW_LZZT2", - "concept_title": "TTS Acceptability Survey - Patch Size", - "concept_uid": "BiomedicalConcept_117", - "activity_uid": "Activity_29", - "soa_id": 3, - "href": null, - "dss_title": "PATCHSURVEYSIZE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYSIZE", - "dss_domain": "QS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 459, - "activity_id": 92, - "concept_code": "C83347", - "concept_title": "Adverse Event Yes No Indicator", - "concept_uid": "BiomedicalConcept_134", - "activity_uid": "Activity_34", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 460, - "activity_id": 92, - "concept_code": "C179175", - "concept_title": "Solicited Adverse Event", - "concept_uid": "BiomedicalConcept_135", - "activity_uid": "Activity_34", - "soa_id": 3, - "href": null, - "dss_title": "AE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/AE", - "dss_domain": "AE", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 461, - "activity_id": 94, - "concept_code": "C25250", - "concept_title": "Complete", - "concept_uid": "BiomedicalConcept_136", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "PROTCOMP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROTCOMP", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 462, - "activity_id": 94, - "concept_code": "C139236", - "concept_title": "Failure To Meet Continuation Criteria", - "concept_uid": "BiomedicalConcept_137", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "FAILCONT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/FAILCONT", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 463, - "activity_id": 94, - "concept_code": "C28554", - "concept_title": "Dead", - "concept_uid": "BiomedicalConcept_138", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "DEAD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/DEAD", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 464, - "activity_id": 94, - "concept_code": "C48226", - "concept_title": "Lack of Efficacy", - "concept_uid": "BiomedicalConcept_139", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "LACKEFFICACY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/LACKEFFICACY", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 465, - "activity_id": 94, - "concept_code": "C48227", - "concept_title": "Lost To Follow-Up", - "concept_uid": "BiomedicalConcept_140", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "LTFUP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/LTFUP", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 466, - "activity_id": 94, - "concept_code": "C41331", - "concept_title": "Adverse Event", - "concept_uid": "BiomedicalConcept_141", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "ADVEVENT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 467, - "activity_id": 94, - "concept_code": "C48250", - "concept_title": "Physician Decision", - "concept_uid": "BiomedicalConcept_142", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "PHYDECISION", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PHYDECISION", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 468, - "activity_id": 94, - "concept_code": "C191656", - "concept_title": "Pregnant Subject", - "concept_uid": "BiomedicalConcept_143", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "SUBJPREG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SUBJPREG", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 469, - "activity_id": 94, - "concept_code": "C35571", - "concept_title": "Progressive Disease", - "concept_uid": "BiomedicalConcept_144", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "PROGDISEASE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROGDISEASE", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 470, - "activity_id": 94, - "concept_code": "C50996", - "concept_title": "Protocol Deviation", - "concept_uid": "BiomedicalConcept_145", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "PROTDEV", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROTDEV", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 471, - "activity_id": 94, - "concept_code": "C186208", - "concept_title": "Study Site Transfer", - "concept_uid": "BiomedicalConcept_146", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "SITETRANSFER", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SITETRANSFER", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 472, - "activity_id": 94, - "concept_code": "C49632", - "concept_title": "Study Terminated By Sponsor", - "concept_uid": "BiomedicalConcept_147", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 473, - "activity_id": 94, - "concept_code": "C161410", - "concept_title": "Subject Removed at Sponsor Request", - "concept_uid": "BiomedicalConcept_148", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 474, - "activity_id": 94, - "concept_code": "C49628", - "concept_title": "Trial Screen Failure", - "concept_uid": "BiomedicalConcept_149", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 475, - "activity_id": 94, - "concept_code": "C106576", - "concept_title": "Trial Site Terminated by Sponsor", - "concept_uid": "BiomedicalConcept_150", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 476, - "activity_id": 94, - "concept_code": "C49634", - "concept_title": "Withdrawal by Subject", - "concept_uid": "BiomedicalConcept_151", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "SUBJWITHDRAW", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SUBJWITHDRAW", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 477, - "activity_id": 94, - "concept_code": "C170610", - "concept_title": "Withdrawal of Consent From Protocol-Specified Activity", - "concept_uid": "BiomedicalConcept_152", - "activity_uid": "Activity_36", - "soa_id": 3, - "href": null, - "dss_title": "CONSWDRL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CONSWDRL", - "dss_domain": "DS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 478, - "activity_id": 96, - "concept_code": "C25298", - "concept_title": "Systolic Blood Pressure", - "concept_uid": "BiomedicalConcept_153", - "activity_uid": "Activity_38", - "soa_id": 3, - "href": null, - "dss_title": "SYSBP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 479, - "activity_id": 96, - "concept_code": "C25299", - "concept_title": "Diastolic Blood Pressure", - "concept_uid": "BiomedicalConcept_154", - "activity_uid": "Activity_38", - "soa_id": 3, - "href": null, - "dss_title": "DIABP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/DIABP", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 480, - "activity_id": 96, - "concept_code": "C49677", - "concept_title": "Heart Rate", - "concept_uid": "BiomedicalConcept_155", - "activity_uid": "Activity_38", - "soa_id": 3, - "href": null, - "dss_title": "HR", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HR", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 484, - "activity_id": 98, - "concept_code": "C25298", - "concept_title": "Systolic Blood Pressure", - "concept_uid": "BiomedicalConcept_156", - "activity_uid": "Activity_40", - "soa_id": 3, - "href": null, - "dss_title": "SYSBP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 485, - "activity_id": 98, - "concept_code": "C25299", - "concept_title": "Diastolic Blood Pressure", - "concept_uid": "BiomedicalConcept_157", - "activity_uid": "Activity_40", - "soa_id": 3, - "href": null, - "dss_title": "DIABP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/DIABP", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 486, - "activity_id": 98, - "concept_code": "C49677", - "concept_title": "Heart Rate", - "concept_uid": "BiomedicalConcept_158", - "activity_uid": "Activity_40", - "soa_id": 3, - "href": null, - "dss_title": "HR", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HR", - "dss_domain": "VS", - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 797, - "activity_id": 10, - "concept_code": "C138967", - "concept_title": "Isometric Muscle Strength", - "concept_uid": "BiomedicalConcept_159", - "activity_uid": "Activity_8", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_1", - "bc_category_name": null - }, - { - "id": 798, - "activity_id": 10, - "concept_code": "C178017", - "concept_title": "Skeletal Muscle Mass Measurement", - "concept_uid": "BiomedicalConcept_160", - "activity_uid": "Activity_8", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_1", - "bc_category_name": null - }, - { - "id": 799, - "activity_id": 10, - "concept_code": "C181501", - "concept_title": "Muscle Endurance Measurement", - "concept_uid": "BiomedicalConcept_161", - "activity_uid": "Activity_8", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_1", - "bc_category_name": null - }, - { - "id": 800, - "activity_id": 21, - "concept_code": "C119561", - "concept_title": "ECG Continuous Monitoring Indicator", - "concept_uid": "BiomedicalConcept_162", - "activity_uid": "Activity_15", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 802, - "activity_id": 22, - "concept_code": "C119561", - "concept_title": "ECG Continuous Monitoring Indicator", - "concept_uid": "BiomedicalConcept_163", - "activity_uid": "Activity_16", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 803, - "activity_id": 24, - "concept_code": "NEW_LZZT", - "concept_title": "TTS Acceptability Survey", - "concept_uid": "BiomedicalConcept_164", - "activity_uid": "Activity_18", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 804, - "activity_id": 27, - "concept_code": "C16809", - "concept_title": "Magnetic Resonance Imaging", - "concept_uid": "BiomedicalConcept_165", - "activity_uid": "Activity_21", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 805, - "activity_id": 27, - "concept_code": "C17204", - "concept_title": "Computed Tomography", - "concept_uid": "BiomedicalConcept_166", - "activity_uid": "Activity_21", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 807, - "activity_id": 95, - "concept_code": "C49672", - "concept_title": "Vital Signs Measurement", - "concept_uid": "BiomedicalConcept_168", - "activity_uid": "Activity_37", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 808, - "activity_id": 97, - "concept_code": "C49672", - "concept_title": "Vital Signs Measurement", - "concept_uid": "BiomedicalConcept_169", - "activity_uid": "Activity_39", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 809, - "activity_id": 93, - "concept_code": "C41331", - "concept_title": "Adverse Event", - "concept_uid": "BiomedicalConcept_170", - "activity_uid": "Activity_35", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 810, - "activity_id": 93, - "concept_code": "C83347", - "concept_title": "Adverse Event Yes No Indicator", - "concept_uid": "BiomedicalConcept_171", - "activity_uid": "Activity_35", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": null, - "bc_category_name": null - }, - { - "id": 825, - "activity_id": 36, - "concept_code": "C100177", - "concept_title": "CDISC ADAS-Cog - Word Recall Average Score", - "concept_uid": "BiomedicalConcept_172", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 826, - "activity_id": 36, - "concept_code": "C100191", - "concept_title": "CDISC ADAS-Cog - Naming Objects and Fingers Summary Score", - "concept_uid": "BiomedicalConcept_173", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 827, - "activity_id": 36, - "concept_code": "C100209", - "concept_title": "CDISC ADAS-Cog - Commands Summary Score", - "concept_uid": "BiomedicalConcept_174", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 828, - "activity_id": 36, - "concept_code": "C100215", - "concept_title": "CDISC ADAS-Cog - Delayed Word Recall Summary Score", - "concept_uid": "BiomedicalConcept_175", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 829, - "activity_id": 36, - "concept_code": "C100226", - "concept_title": "CDISC ADAS-Cog - Constructional Praxis Summary Score", - "concept_uid": "BiomedicalConcept_176", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 830, - "activity_id": 36, - "concept_code": "C100232", - "concept_title": "CDISC ADAS-Cog - Ideational Praxis Summary Score", - "concept_uid": "BiomedicalConcept_177", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 831, - "activity_id": 36, - "concept_code": "C100238", - "concept_title": "CDISC ADAS-Cog - Orientation Summary Score", - "concept_uid": "BiomedicalConcept_178", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 832, - "activity_id": 36, - "concept_code": "C100247", - "concept_title": "CDISC ADAS-Cog - Word Recognition Summary Score", - "concept_uid": "BiomedicalConcept_179", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 833, - "activity_id": 36, - "concept_code": "C100275", - "concept_title": "CDISC ADAS-Cog - Remembering Test Instructions", - "concept_uid": "BiomedicalConcept_180", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 834, - "activity_id": 36, - "concept_code": "C100276", - "concept_title": "CDISC ADAS-Cog - Spoken Language Ability", - "concept_uid": "BiomedicalConcept_181", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 835, - "activity_id": 36, - "concept_code": "C100277", - "concept_title": "CDISC ADAS-Cog - Word Difficulty in Spontaneous Speech", - "concept_uid": "BiomedicalConcept_182", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 836, - "activity_id": 36, - "concept_code": "C100278", - "concept_title": "CDISC ADAS-Cog - Comprehension", - "concept_uid": "BiomedicalConcept_183", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 837, - "activity_id": 36, - "concept_code": "C100279", - "concept_title": "CDISC ADAS-Cog - Concentration/Distractibility", - "concept_uid": "BiomedicalConcept_184", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 838, - "activity_id": 36, - "concept_code": "C100280", - "concept_title": "CDISC ADAS-Cog - Number Cancellation Summary Score", - "concept_uid": "BiomedicalConcept_185", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 839, - "activity_id": 36, - "concept_code": "C100285", - "concept_title": "CDISC ADAS-Cog - Executive Function Maze: Errors", - "concept_uid": "BiomedicalConcept_186", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - }, - { - "id": 840, - "activity_id": 36, - "concept_code": "C100286", - "concept_title": "CDISC ADAS-Cog - Executive Function Maze: Time", - "concept_uid": "BiomedicalConcept_187", - "activity_uid": "Activity_30", - "soa_id": 3, - "href": null, - "dss_title": null, - "dss_href": null, - "dss_domain": null, - "concept_group_uid": "ConceptGroup_5", - "bc_category_name": null - } - ], - "activity_concept_dss": [ - { - "id": 48, - "soa_id": 3, - "activity_id": 4, - "concept_code": "C25370", - "dss_title": "EXCL01", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EXCL01", - "dss_domain": "IE", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_1" - }, - { - "id": 49, - "soa_id": 3, - "activity_id": 5, - "concept_code": "C114209", - "dss_title": "RAND", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RAND", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_2" - }, - { - "id": 51, - "soa_id": 3, - "activity_id": 6, - "concept_code": "C16564", - "dss_title": "ETHNIC", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ETHNIC", - "dss_domain": "DM", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_3" - }, - { - "id": 52, - "soa_id": 3, - "activity_id": 6, - "concept_code": "C69260", - "dss_title": "AGE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/AGE", - "dss_domain": "DM", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_4" - }, - { - "id": 53, - "soa_id": 3, - "activity_id": 6, - "concept_code": "C83217", - "dss_title": "BRTHDTC", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BRTHDTC", - "dss_domain": "DM", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_5" - }, - { - "id": 54, - "soa_id": 3, - "activity_id": 6, - "concept_code": "C28421", - "dss_title": "SEX", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SEX", - "dss_domain": "DM", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_6" - }, - { - "id": 55, - "soa_id": 3, - "activity_id": 7, - "concept_code": "C17953", - "dss_title": "EDULEVEL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EDULEVEL", - "dss_domain": "SC", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_7" - }, - { - "id": 56, - "soa_id": 3, - "activity_id": 7, - "concept_code": "C122393", - "dss_title": "EDUYRNUM", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EDUYRNUM", - "dss_domain": "SC", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_8" - }, - { - "id": 63, - "soa_id": 3, - "activity_id": 20, - "concept_code": "C174446", - "dss_title": "TEMP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TEMP", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_9" - }, - { - "id": 64, - "soa_id": 3, - "activity_id": 20, - "concept_code": "C81328", - "dss_title": "WEIGHT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/WEIGHT", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_10" - }, - { - "id": 65, - "soa_id": 3, - "activity_id": 20, - "concept_code": "C164634", - "dss_title": "HEIGHT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HEIGHT", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_11" - }, - { - "id": 66, - "soa_id": 3, - "activity_id": 20, - "concept_code": "C49676", - "dss_title": "PULSE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PULSE", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_12" - }, - { - "id": 67, - "soa_id": 3, - "activity_id": 20, - "concept_code": "C49678", - "dss_title": "RESP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RESP", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_13" - }, - { - "id": 68, - "soa_id": 3, - "activity_id": 20, - "concept_code": "C16358", - "dss_title": "BMI", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BMI", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_14" - }, - { - "id": 69, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C181655", - "dss_title": "EGINTP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EGINTP", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_15" - }, - { - "id": 70, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111131", - "dss_title": "AVCOND", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/AVCOND", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_16" - }, - { - "id": 71, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111132", - "dss_title": "AXISVOLT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/AXISVOLT", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_17" - }, - { - "id": 72, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111155", - "dss_title": "CHYPTENL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CHYPTENL", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_18" - }, - { - "id": 73, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C117807", - "dss_title": "TECHQUAL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TECHQUAL", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_19" - }, - { - "id": 74, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111238", - "dss_title": "IVTIACD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/IVTIACD", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_20" - }, - { - "id": 75, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111280", - "dss_title": "MI", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MI", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_21" - }, - { - "id": 76, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111285", - "dss_title": "PACEMAKR", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PACEMAKR", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_22" - }, - { - "id": 77, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111307", - "dss_title": "RHYNOS", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RHYNOS", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_23" - }, - { - "id": 78, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111363", - "dss_title": "STSTWUW", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/STSTWUW", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_24" - }, - { - "id": 79, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111312", - "dss_title": "SNRARRY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SNRARRY", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_25" - }, - { - "id": 80, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111320", - "dss_title": "SPRARRY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SPRARRY", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_26" - }, - { - "id": 81, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111321", - "dss_title": "SPRTARRY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SPRTARRY", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_27" - }, - { - "id": 82, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C117773", - "dss_title": "PRAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PRAG", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_28" - }, - { - "id": 83, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C117779", - "dss_title": "QRSAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QRSAG", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_29" - }, - { - "id": 84, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C117783", - "dss_title": "QTAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QTAG", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_30" - }, - { - "id": 85, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C117784", - "dss_title": "QTCBAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QTCBAG", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_31" - }, - { - "id": 86, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C117786", - "dss_title": "QTCFAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QTCFAG", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_32" - }, - { - "id": 87, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C117791", - "dss_title": "RRAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RRAG", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_33" - }, - { - "id": 88, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C119259", - "dss_title": "EGHRMN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EGHRMN", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_34" - }, - { - "id": 89, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C118165", - "dss_title": "QRS_AXIS", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QRS_AXIS", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_35" - }, - { - "id": 90, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C174285", - "dss_title": "QTCUNSAG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/QTCUNSAG", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_36" - }, - { - "id": 91, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111330", - "dss_title": "VTARRY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/VTARRY", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_37" - }, - { - "id": 92, - "soa_id": 3, - "activity_id": 23, - "concept_code": "C111331", - "dss_title": "VTTARRY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/VTTARRY", - "dss_domain": "EG", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_38" - }, - { - "id": 93, - "soa_id": 3, - "activity_id": 25, - "concept_code": "C17204", - "dss_title": "CTSCANCHEST", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CTSCANCHEST", - "dss_domain": "PR", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_39" - }, - { - "id": 94, - "soa_id": 3, - "activity_id": 26, - "concept_code": "C16809", - "dss_title": "MRIBRAIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MRIBRAIN", - "dss_domain": "PR", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_40" - }, - { - "id": 95, - "soa_id": 3, - "activity_id": 28, - "concept_code": "C53630", - "dss_title": "CMFREE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CMFREE", - "dss_domain": "CM", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_41" - }, - { - "id": 96, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C64848", - "dss_title": "HGBBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HGBBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_42" - }, - { - "id": 97, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C64796", - "dss_title": "HCTBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HCTBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_43" - }, - { - "id": 98, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C51946", - "dss_title": "RBCBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RBCBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_44" - }, - { - "id": 99, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C64797", - "dss_title": "MCH", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MCH", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_45" - }, - { - "id": 100, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C64799", - "dss_title": "MCV", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MCV", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_46" - }, - { - "id": 101, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C51948", - "dss_title": "WBCBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/WBCBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_47" - }, - { - "id": 102, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C81997", - "dss_title": "NEUTSGBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NEUTSGBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_48" - }, - { - "id": 103, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C64830", - "dss_title": "NEUTBBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NEUTBBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_49" - }, - { - "id": 104, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C63321", - "dss_title": "NEUTBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NEUTBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_50" - }, - { - "id": 105, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C64823", - "dss_title": "MONOBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MONOBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_51" - }, - { - "id": 106, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C64550", - "dss_title": "EOSBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EOSBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_52" - }, - { - "id": 107, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C64470", - "dss_title": "BASOBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BASOBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_53" - }, - { - "id": 108, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C51951", - "dss_title": "PLATBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PLATBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_54" - }, - { - "id": 109, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C64822", - "dss_title": "MICROCYBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MICROCYBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_55" - }, - { - "id": 110, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C64821", - "dss_title": "MACROCYBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MACROCYBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_56" - }, - { - "id": 111, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C74797", - "dss_title": "ANISOBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ANISOBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_57" - }, - { - "id": 112, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C79602", - "dss_title": "POIKILOBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/POIKILOBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_58" - }, - { - "id": 113, - "soa_id": 3, - "activity_id": 29, - "concept_code": "C64803", - "dss_title": "POLYCHRBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/POLYCHRBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_59" - }, - { - "id": 114, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64433", - "dss_title": "ALTSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_60" - }, - { - "id": 115, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64431", - "dss_title": "ALBSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_61" - }, - { - "id": 116, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64432", - "dss_title": "ALPSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_62" - }, - { - "id": 117, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64467", - "dss_title": "ASTSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_63" - }, - { - "id": 118, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64547", - "dss_title": "CREATSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_64" - }, - { - "id": 119, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64853", - "dss_title": "KBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/KBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_65" - }, - { - "id": 120, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64809", - "dss_title": "SODIUMBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_66" - }, - { - "id": 121, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C125949", - "dss_title": "UREANSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_67" - }, - { - "id": 122, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C74667", - "dss_title": "BICARBBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BICARBBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_68" - }, - { - "id": 123, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64495", - "dss_title": "CLBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CLBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_69" - }, - { - "id": 124, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C38037", - "dss_title": "BILISERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_70" - }, - { - "id": 125, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64847", - "dss_title": "GGTSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/GGTSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_71" - }, - { - "id": 126, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64814", - "dss_title": "URATESERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/URATESERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_72" - }, - { - "id": 127, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64857", - "dss_title": "PHOSSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PHOSSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_73" - }, - { - "id": 128, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64488", - "dss_title": "CABLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CABLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_74" - }, - { - "id": 129, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C105585", - "dss_title": "GLUCBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_75" - }, - { - "id": 130, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64858", - "dss_title": "PROTSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_76" - }, - { - "id": 131, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C105586", - "dss_title": "CHOLSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_77" - }, - { - "id": 132, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C74748", - "dss_title": "T3UPSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/T3UPSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_78" - }, - { - "id": 133, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C74747", - "dss_title": "T3SERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/T3SERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_79" - }, - { - "id": 134, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C74786", - "dss_title": "T4FRSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/T4FRSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_80" - }, - { - "id": 135, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C170598", - "dss_title": "T4FRIDXSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/T4FRIDXSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_81" - }, - { - "id": 136, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64813", - "dss_title": "TSHBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TSHBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_82" - }, - { - "id": 137, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C74676", - "dss_title": "VITB9BLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/VITB9BLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_83" - }, - { - "id": 138, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C64817", - "dss_title": "VITB12BLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/VITB12BLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_84" - }, - { - "id": 139, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C132388", - "dss_title": "TPLAB", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TPLAB", - "dss_domain": "MB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_85" - }, - { - "id": 140, - "soa_id": 3, - "activity_id": 30, - "concept_code": "C198341", - "dss_title": "TPADNA", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TPADNA", - "dss_domain": "MB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_86" - }, - { - "id": 141, - "soa_id": 3, - "activity_id": 31, - "concept_code": "C64546", - "dss_title": "COLORURIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/COLORURIN", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_87" - }, - { - "id": 142, - "soa_id": 3, - "activity_id": 31, - "concept_code": "C64832", - "dss_title": "SPGRAVURIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_88" - }, - { - "id": 143, - "soa_id": 3, - "activity_id": 31, - "concept_code": "C64858", - "dss_title": "PROTSERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_89" - }, - { - "id": 145, - "soa_id": 3, - "activity_id": 31, - "concept_code": "C64854", - "dss_title": "KETONESURIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/KETONESURIN", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_91" - }, - { - "id": 146, - "soa_id": 3, - "activity_id": 31, - "concept_code": "C38037", - "dss_title": "BILISERPL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BILISERPL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_92" - }, - { - "id": 147, - "soa_id": 3, - "activity_id": 31, - "concept_code": "C64816", - "dss_title": "UROBILURIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/UROBILURIN", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_93" - }, - { - "id": 148, - "soa_id": 3, - "activity_id": 31, - "concept_code": "C74686", - "dss_title": "OCCBLDSTOOL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/OCCBLDSTOOL", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_94" - }, - { - "id": 149, - "soa_id": 3, - "activity_id": 31, - "concept_code": "C64810", - "dss_title": "NITRITEURIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NITRITEURIN", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_95" - }, - { - "id": 150, - "soa_id": 3, - "activity_id": 33, - "concept_code": "C64849", - "dss_title": "HBA1CBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HBA1CBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_96" - }, - { - "id": 151, - "soa_id": 3, - "activity_id": 33, - "concept_code": "C111207", - "dss_title": "HBA1CHGBBLD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HBA1CHGBBLD", - "dss_domain": "LB", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_97" - }, - { - "id": 152, - "soa_id": 3, - "activity_id": 34, - "concept_code": "C117466", - "dss_title": "EXPOSCOLL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EXPOSCOLL", - "dss_domain": "EC", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_98" - }, - { - "id": 153, - "soa_id": 3, - "activity_id": 35, - "concept_code": "NEW_LZZT4", - "dss_title": "PATCHSURVEYACCEPTABILITY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYACCEPTABILITY", - "dss_domain": "QS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_99" - }, - { - "id": 154, - "soa_id": 3, - "activity_id": 35, - "concept_code": "NEW_LZZT1", - "dss_title": "PATCHSURVEYAPPEARANCE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYAPPEARANCE", - "dss_domain": "QS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_100" - }, - { - "id": 155, - "soa_id": 3, - "activity_id": 35, - "concept_code": "NEW_LZZT3", - "dss_title": "PATCHSURVEYDURABILITY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYDURABILITY", - "dss_domain": "QS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_101" - }, - { - "id": 156, - "soa_id": 3, - "activity_id": 35, - "concept_code": "NEW_LZZT2", - "dss_title": "PATCHSURVEYSIZE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PATCHSURVEYSIZE", - "dss_domain": "QS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_102" - }, - { - "id": 157, - "soa_id": 3, - "activity_id": 92, - "concept_code": "C179175", - "dss_title": "AE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/AE", - "dss_domain": "AE", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_103" - }, - { - "id": 158, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C25250", - "dss_title": "PROTCOMP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROTCOMP", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_104" - }, - { - "id": 159, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C139236", - "dss_title": "FAILCONT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/FAILCONT", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_105" - }, - { - "id": 160, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C28554", - "dss_title": "DEAD", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/DEAD", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_106" - }, - { - "id": 161, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C48226", - "dss_title": "LACKEFFICACY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/LACKEFFICACY", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_107" - }, - { - "id": 162, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C48227", - "dss_title": "LTFUP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/LTFUP", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_108" - }, - { - "id": 163, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C41331", - "dss_title": "ADVEVENT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_109" - }, - { - "id": 164, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C48250", - "dss_title": "PHYDECISION", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PHYDECISION", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_110" - }, - { - "id": 165, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C191656", - "dss_title": "SUBJPREG", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SUBJPREG", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_111" - }, - { - "id": 166, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C35571", - "dss_title": "PROGDISEASE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROGDISEASE", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_112" - }, - { - "id": 167, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C50996", - "dss_title": "PROTDEV", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROTDEV", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_113" - }, - { - "id": 168, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C186208", - "dss_title": "SITETRANSFER", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SITETRANSFER", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_114" - }, - { - "id": 169, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C49634", - "dss_title": "SUBJWITHDRAW", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SUBJWITHDRAW", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_115" - }, - { - "id": 170, - "soa_id": 3, - "activity_id": 94, - "concept_code": "C170610", - "dss_title": "CONSWDRL", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CONSWDRL", - "dss_domain": "DS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_116" - }, - { - "id": 171, - "soa_id": 3, - "activity_id": 96, - "concept_code": "C25298", - "dss_title": "SYSBP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_117" - }, - { - "id": 172, - "soa_id": 3, - "activity_id": 96, - "concept_code": "C25299", - "dss_title": "DIABP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/DIABP", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_118" - }, - { - "id": 173, - "soa_id": 3, - "activity_id": 96, - "concept_code": "C49677", - "dss_title": "HR", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HR", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_119" - }, - { - "id": 174, - "soa_id": 3, - "activity_id": 98, - "concept_code": "C25298", - "dss_title": "SYSBP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SYSBP", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_120" - }, - { - "id": 175, - "soa_id": 3, - "activity_id": 98, - "concept_code": "C25299", - "dss_title": "DIABP", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/DIABP", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_121" - }, - { - "id": 176, - "soa_id": 3, - "activity_id": 98, - "concept_code": "C49677", - "dss_title": "HR", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HR", - "dss_domain": "VS", - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_122" - }, - { - "id": 224, - "soa_id": 3, - "activity_id": 12, - "concept_code": "C200145", - "dss_title": "MEDHISTFREE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MEDHISTFREE", - "dss_domain": null, - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_123" - }, - { - "id": 225, - "soa_id": 3, - "activity_id": 12, - "concept_code": "C200145", - "dss_title": "MHALZHEIMERS", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MHALZHEIMERS", - "dss_domain": null, - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_124" - }, - { - "id": 226, - "soa_id": 3, - "activity_id": 6, - "concept_code": "C17049", - "dss_title": "RACE", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RACE", - "dss_domain": null, - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_125" - }, - { - "id": 227, - "soa_id": 3, - "activity_id": 3, - "concept_code": "C16735", - "dss_title": "CONSENT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CONSENT", - "dss_domain": null, - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_126" - }, - { - "id": 228, - "soa_id": 3, - "activity_id": 4, - "concept_code": "C25532", - "dss_title": "INCL01", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/INCL01", - "dss_domain": null, - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_127" - }, - { - "id": 230, - "soa_id": 3, - "activity_id": 12, - "concept_code": "C200145", - "dss_title": "MHVISUALHALLUCINATIONS", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MHVISUALHALLUCINATIONS", - "dss_domain": null, - "dss_display": null, - "extension_attribute_uid": "ExtensionAttribute_128" - }, - { - "id": 231, - "soa_id": 3, - "activity_id": 10, - "concept_code": "C178017", - "dss_title": "SMMASS", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SMMASS", - "dss_domain": null, - "dss_display": "Skeletal Muscle Mass", - "extension_attribute_uid": "ExtensionAttribute_129" - }, - { - "id": 233, - "soa_id": 3, - "activity_id": 13, - "concept_code": "C181760", - "dss_title": "CIGARHX", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CIGARHX", - "dss_domain": null, - "dss_display": "Cigar History", - "extension_attribute_uid": "ExtensionAttribute_130" - }, - { - "id": 234, - "soa_id": 3, - "activity_id": 13, - "concept_code": "C181760", - "dss_title": "CIGARETTEHX", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CIGARETTEHX", - "dss_domain": null, - "dss_display": "Cigarette History", - "extension_attribute_uid": "ExtensionAttribute_131" - }, - { - "id": 235, - "soa_id": 3, - "activity_id": 13, - "concept_code": "C181760", - "dss_title": "PIPEHX", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PIPEHX", - "dss_domain": null, - "dss_display": "Pipe History", - "extension_attribute_uid": "ExtensionAttribute_132" - }, - { - "id": 236, - "soa_id": 3, - "activity_id": 13, - "concept_code": "C181760", - "dss_title": "TOBACCOHX", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TOBACCOHX", - "dss_domain": null, - "dss_display": "Tobacco History", - "extension_attribute_uid": "ExtensionAttribute_133" - }, - { - "id": 239, - "soa_id": 3, - "activity_id": 13, - "concept_code": "C81229", - "dss_title": "ALCOHOLHX", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALCOHOLHX", - "dss_domain": null, - "dss_display": "Alcohol Use History", - "extension_attribute_uid": "ExtensionAttribute_134" - }, - { - "id": 240, - "soa_id": 3, - "activity_id": 13, - "concept_code": "C201990", - "dss_title": "CAFFEINEHX", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CAFFEINEHX", - "dss_domain": null, - "dss_display": "Caffeine Use History", - "extension_attribute_uid": "ExtensionAttribute_135" - }, - { - "id": 241, - "soa_id": 3, - "activity_id": 17, - "concept_code": "C38101", - "dss_title": "XRAY", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/XRAY", - "dss_domain": null, - "dss_display": "X-Ray", - "extension_attribute_uid": "ExtensionAttribute_136" - }, - { - "id": 242, - "soa_id": 3, - "activity_id": 17, - "concept_code": "C38101", - "dss_title": "XRAYCHEST", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/XRAYCHEST", - "dss_domain": null, - "dss_display": "Chest X-Ray", - "extension_attribute_uid": "ExtensionAttribute_137" - }, - { - "id": 243, - "soa_id": 3, - "activity_id": 19, - "concept_code": "C114209", - "dss_title": "RAND", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RAND", - "dss_domain": null, - "dss_display": "Randomized", - "extension_attribute_uid": "ExtensionAttribute_138" - }, - { - "id": 244, - "soa_id": 3, - "activity_id": 21, - "concept_code": "C119561", - "dss_title": "EGCTMON", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EGCTMON", - "dss_domain": null, - "dss_display": "ECG Continuous Monitoring (TS)", - "extension_attribute_uid": "ExtensionAttribute_139" - }, - { - "id": 245, - "soa_id": 3, - "activity_id": 22, - "concept_code": "C119561", - "dss_title": "EGCTMON", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EGCTMON", - "dss_domain": null, - "dss_display": "ECG Continuous Monitoring (TS)", - "extension_attribute_uid": "ExtensionAttribute_140" - }, - { - "id": 246, - "soa_id": 3, - "activity_id": 27, - "concept_code": "C16809", - "dss_title": "MRIBRAIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MRIBRAIN", - "dss_domain": null, - "dss_display": "MRI Brain", - "extension_attribute_uid": "ExtensionAttribute_141" - }, - { - "id": 247, - "soa_id": 3, - "activity_id": 27, - "concept_code": "C17204", - "dss_title": "CTSCAN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CTSCAN", - "dss_domain": null, - "dss_display": "CT Scan", - "extension_attribute_uid": "ExtensionAttribute_142" - }, - { - "id": 248, - "soa_id": 3, - "activity_id": 93, - "concept_code": "C41331", - "dss_title": "ADVEVENT", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", - "dss_domain": null, - "dss_display": "Adverse Event", - "extension_attribute_uid": "ExtensionAttribute_143" - }, - { - "id": 251, - "soa_id": 3, - "activity_id": 31, - "concept_code": "C105585", - "dss_title": "GLUCURIN", - "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/GLUCURIN", - "dss_domain": null, - "dss_display": "Glucose Concentration in Urine", - "extension_attribute_uid": "ExtensionAttribute_144" - } - ], - "activity_surrogate": [ - { - "id": 28, - "soa_id": 3, - "activity_uid": "Activity_12", - "surrogate_uid": "BiomedicalConceptSurrogate_19", - "concept_group_uid": null - }, - { - "id": 36, - "soa_id": 3, - "activity_uid": "Activity_31", - "surrogate_uid": "BiomedicalConceptSurrogate_27", - "concept_group_uid": null - }, - { - "id": 37, - "soa_id": 3, - "activity_uid": "Activity_32", - "surrogate_uid": "BiomedicalConceptSurrogate_28", - "concept_group_uid": null - }, - { - "id": 38, - "soa_id": 3, - "activity_uid": "Activity_33", - "surrogate_uid": "BiomedicalConceptSurrogate_29", - "concept_group_uid": "ConceptGroup_2" - }, - { - "id": 39, - "soa_id": 3, - "activity_uid": "Activity_33", - "surrogate_uid": "BiomedicalConceptSurrogate_30", - "concept_group_uid": "ConceptGroup_2" - }, - { - "id": 40, - "soa_id": 3, - "activity_uid": "Activity_33", - "surrogate_uid": "BiomedicalConceptSurrogate_31", - "concept_group_uid": "ConceptGroup_2" - }, - { - "id": 41, - "soa_id": 3, - "activity_uid": "Activity_33", - "surrogate_uid": "BiomedicalConceptSurrogate_32", - "concept_group_uid": "ConceptGroup_2" - }, - { - "id": 42, - "soa_id": 3, - "activity_uid": "Activity_33", - "surrogate_uid": "BiomedicalConceptSurrogate_33", - "concept_group_uid": "ConceptGroup_2" - }, - { - "id": 43, - "soa_id": 3, - "activity_uid": "Activity_33", - "surrogate_uid": "BiomedicalConceptSurrogate_34", - "concept_group_uid": "ConceptGroup_2" - }, - { - "id": 13, - "soa_id": 3, - "activity_uid": "Activity_6", - "surrogate_uid": "BiomedicalConceptSurrogate_10", - "concept_group_uid": null - }, - { - "id": 14, - "soa_id": 3, - "activity_uid": "Activity_6", - "surrogate_uid": "BiomedicalConceptSurrogate_11", - "concept_group_uid": null - }, - { - "id": 15, - "soa_id": 3, - "activity_uid": "Activity_6", - "surrogate_uid": "BiomedicalConceptSurrogate_12", - "concept_group_uid": null - }, - { - "id": 16, - "soa_id": 3, - "activity_uid": "Activity_6", - "surrogate_uid": "BiomedicalConceptSurrogate_13", - "concept_group_uid": null - }, - { - "id": 17, - "soa_id": 3, - "activity_uid": "Activity_6", - "surrogate_uid": "BiomedicalConceptSurrogate_14", - "concept_group_uid": null - }, - { - "id": 18, - "soa_id": 3, - "activity_uid": "Activity_6", - "surrogate_uid": "BiomedicalConceptSurrogate_15", - "concept_group_uid": null - }, - { - "id": 19, - "soa_id": 3, - "activity_uid": "Activity_6", - "surrogate_uid": "BiomedicalConceptSurrogate_16", - "concept_group_uid": null - }, - { - "id": 20, - "soa_id": 3, - "activity_uid": "Activity_6", - "surrogate_uid": "BiomedicalConceptSurrogate_17", - "concept_group_uid": null - }, - { - "id": 21, - "soa_id": 3, - "activity_uid": "Activity_6", - "surrogate_uid": "BiomedicalConceptSurrogate_18", - "concept_group_uid": null - }, - { - "id": 12, - "soa_id": 3, - "activity_uid": "Activity_6", - "surrogate_uid": "BiomedicalConceptSurrogate_9", - "concept_group_uid": null - }, - { - "id": 29, - "soa_id": 3, - "activity_uid": "Activity_7", - "surrogate_uid": "BiomedicalConceptSurrogate_20", - "concept_group_uid": null - }, - { - "id": 30, - "soa_id": 3, - "activity_uid": "Activity_7", - "surrogate_uid": "BiomedicalConceptSurrogate_21", - "concept_group_uid": null - }, - { - "id": 31, - "soa_id": 3, - "activity_uid": "Activity_7", - "surrogate_uid": "BiomedicalConceptSurrogate_22", - "concept_group_uid": null - }, - { - "id": 32, - "soa_id": 3, - "activity_uid": "Activity_7", - "surrogate_uid": "BiomedicalConceptSurrogate_23", - "concept_group_uid": null - }, - { - "id": 33, - "soa_id": 3, - "activity_uid": "Activity_7", - "surrogate_uid": "BiomedicalConceptSurrogate_24", - "concept_group_uid": null - }, - { - "id": 34, - "soa_id": 3, - "activity_uid": "Activity_7", - "surrogate_uid": "BiomedicalConceptSurrogate_25", - "concept_group_uid": null - }, - { - "id": 35, - "soa_id": 3, - "activity_uid": "Activity_7", - "surrogate_uid": "BiomedicalConceptSurrogate_26", - "concept_group_uid": null - } - ], - "objective": [ - { - "id": 2, - "soa_id": 3, - "objective_uid": "Objective_1", - "name": "OBJ1", - "label": "Objective 1", - "description": "Main Objective", - "text": "To determine if there is a statistically significant relationship (overall Type 1 erroralpha=0.05) between the change in both the ADAS-Cog (11) and CIBIC+ scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).", - "level_code_uid": "Code_2508", - "order_index": 1 - }, - { - "id": 3, - "soa_id": 3, - "objective_uid": "Objective_2", - "name": "OBJ2", - "label": "Objective 2", - "description": "Safety", - "text": "To document the safety profile of the xanomeline TTS.", - "level_code_uid": "Code_2509", - "order_index": 2 - }, - { - "id": 4, - "soa_id": 3, - "objective_uid": "Objective_3", - "name": "OBJ3", - "label": "Objective 3", - "description": "Behaviour", - "text": "To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.", - "level_code_uid": "Code_2510", - "order_index": 3 - }, - { - "id": 5, - "soa_id": 3, - "objective_uid": "Objective_4", - "name": "OBJ4", - "label": "Objective 4", - "description": "Improvements", - "text": "To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas (see Attachment LZZT.5).", - "level_code_uid": "Code_2511", - "order_index": 4 - }, - { - "id": 6, - "soa_id": 3, - "objective_uid": "Objective_5", - "name": "OBJ5", - "label": "Objective 5", - "description": "Improvements", - "text": "To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer's Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment (see Attachment LZZT.2).", - "level_code_uid": "Code_2512", - "order_index": 5 - }, - { - "id": 7, - "soa_id": 3, - "objective_uid": "Objective_6", - "name": "OBJ6", - "label": "Objective 6", - "description": "Response", - "text": "To assess the treatment response as a function of Apo E genotype.", - "level_code_uid": "Code_2513", - "order_index": 6 - } - ], - "endpoint": [ - { - "id": 1, - "soa_id": 3, - "endpoint_uid": "Endpoint_1", - "objective_uid": "Objective_1", - "name": "ENDPT1", - "label": "Endpoint 1", - "description": "ADAS-Cog Week 24 Endpoint", - "text": "Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] at Week 24", - "purpose": null, - "level_code_uid": "Code_2514", - "order_index": 1 - }, - { - "id": 10, - "soa_id": 3, - "endpoint_uid": "Endpoint_10", - "objective_uid": "Objective_5", - "name": "ENDPT10", - "label": "Endpoint 10", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "purpose": null, - "level_code_uid": "Code_2523", - "order_index": 10 - }, - { - "id": 11, - "soa_id": 3, - "endpoint_uid": "Endpoint_11", - "objective_uid": "Objective_6", - "name": "ENDPT11", - "label": "Endpoint 11", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "purpose": null, - "level_code_uid": "Code_2524", - "order_index": 11 - }, - { - "id": 2, - "soa_id": 3, - "endpoint_uid": "Endpoint_2", - "objective_uid": "Objective_1", - "name": "ENDPT2", - "label": "Endpoint 2", - "description": "Clinician Week 24 impression of change", - "text": "Video-referenced Clinician\\u2019s Interview-based Impression of Change (CIBIC+) at Week 24", - "purpose": null, - "level_code_uid": "Code_2515", - "order_index": 2 - }, - { - "id": 3, - "soa_id": 3, - "endpoint_uid": "Endpoint_3", - "objective_uid": "Objective_2", - "name": "ENDPT3", - "label": "Endpoint 3", - "description": "Adverse events", - "text": "Adverse events", - "purpose": null, - "level_code_uid": "Code_2516", - "order_index": 3 - }, - { - "id": 4, - "soa_id": 3, - "endpoint_uid": "Endpoint_4", - "objective_uid": "Objective_2", - "name": "ENDPT4", - "label": "Endpoint 4", - "description": "Vital Signs", - "text": "Vital signs (weight, standing and supine blood pressure, heart rate)", - "purpose": null, - "level_code_uid": "Code_2517", - "order_index": 4 - }, - { - "id": 5, - "soa_id": 3, - "endpoint_uid": "Endpoint_5", - "objective_uid": "Objective_2", - "name": "ENDPT5", - "label": "Endpoint 5", - "description": "Baseline", - "text": "The change from baseline laboratory value will be calculated as the difference between the baseline lab value and the endpoint value (i.e., the value at the specified visit) or the end of treatment observation\", \"text\": \"Laboratory evaluations (Change from Baseline)", - "purpose": null, - "level_code_uid": "Code_2518", - "order_index": 5 - }, - { - "id": 6, - "soa_id": 3, - "endpoint_uid": "Endpoint_6", - "objective_uid": "Objective_3", - "name": "ENDPT6", - "label": "Endpoint 6", - "description": "Cognitive Scale", - "text": "Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] at Weeks 8 and 16", - "purpose": null, - "level_code_uid": "Code_2519", - "order_index": 6 - }, - { - "id": 7, - "soa_id": 3, - "endpoint_uid": "Endpoint_7", - "objective_uid": "Objective_3", - "name": "ENDPT7", - "label": "Endpoint 7", - "description": "Clinician impression at Week8 and Week16", - "text": "Video-referenced Clinician\\u2019s Interview-based Impression of Change (CIBIC+) at Weeks 8 and 16", - "purpose": null, - "level_code_uid": "Code_2520", - "order_index": 7 - }, - { - "id": 8, - "soa_id": 3, - "endpoint_uid": "Endpoint_8", - "objective_uid": "Objective_3", - "name": "ENDPT8", - "label": "Endpoint 8", - "description": "NPI-X", - "text": "Mean Revised Neuropsychiatric Inventory (NPI-X) from Week 4 to Week 24", - "purpose": null, - "level_code_uid": "Code_2521", - "order_index": 8 - }, - { - "id": 9, - "soa_id": 3, - "endpoint_uid": "Endpoint_9", - "objective_uid": "Objective_4", - "name": "ENDPT9", - "label": "Endpoint 9", - "description": "UNK", - "text": "*** To be determined from protocol ***", - "purpose": null, - "level_code_uid": "Code_2522", - "order_index": 9 - } - ], - "study_title": [ - { - "id": 1, - "soa_id": 3, - "study_title_uid": "StudyTitle_1", - "text": "LZZT - Pilot", - "type_code_uid": "Code_27557", - "order_index": 1 - }, - { - "id": 2, - "soa_id": 3, - "study_title_uid": "StudyTitle_2", - "text": "Xanomeline (LY246708)", - "type_code_uid": "Code_27601", - "order_index": 2 - }, - { - "id": 3, - "soa_id": 3, - "study_title_uid": "StudyTitle_3", - "text": "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease", - "type_code_uid": "Code_27813", - "order_index": 3 - } - ], - "organization": [ - { - "id": 1, - "soa_id": 3, - "organization_uid": "Organization_1", - "name": "LILLY", - "label": "Eli Lilly", - "identifier": "00-642-1325", - "identifier_scheme": "DUNS", - "type_code_uid": "Code_28637", - "addr_text": "Lilly Corporate Ctr, Indianapolis, , IN, 4628, United States of America", - "addr_lines": "[\"Lilly Corporate Ctr\"]", - "addr_city": "Indianapolis", - "addr_district": null, - "addr_state": "IN", - "addr_postal_code": "4628", - "addr_country_code_uid": "Code_28638", - "order_index": 1 - }, - { - "id": 2, - "soa_id": 3, - "organization_uid": "Organization_2", - "name": "CT-GOV", - "label": "ClinicalTrials.gov", - "identifier": "CT-GOV", - "identifier_scheme": "USGOV", - "type_code_uid": "Code_28639", - "addr_text": "National Library of Medicine, Bethesda, 8600 Rockville Pike, MD, 20894, United States of America", - "addr_lines": "[\"National Library of Medicine\"]", - "addr_city": "Bethesda", - "addr_district": "8600 Rockville Pike", - "addr_state": "MD", - "addr_postal_code": "20894", - "addr_country_code_uid": "Code_28640", - "order_index": 2 - }, - { - "id": 5, - "soa_id": 3, - "organization_uid": "Organization_3", - "name": "MLM Medical Labs", - "label": "Central Labu", - "identifier": null, - "identifier_scheme": null, - "type_code_uid": "Code_39641", - "addr_text": null, - "addr_lines": null, - "addr_city": null, - "addr_district": null, - "addr_state": null, - "addr_postal_code": null, - "addr_country_code_uid": "Code_39642", - "order_index": 3 - } - ], - "role": [ - { - "id": 2, - "soa_id": 3, - "role_uid": "StudyRole_1", - "name": "Role 1", - "label": "Sponsor", - "description": "Study Sponsor", - "code_uid": "Code_35642", - "organization_ids": "[\"Organization_1\"]", - "masking": 1, - "order_index": 1 - }, - { - "id": 12, - "soa_id": 3, - "role_uid": "StudyRole_3", - "name": "Laboratory Contact", - "label": "Lab Primary Contact", - "description": "The primary person to contact at the Central Lab", - "code_uid": "Code_40467", - "organization_ids": "[\"Organization_3\"]", - "masking": 0, - "order_index": 2 - } - ], - "footnote": [ - { - "id": 3, - "soa_id": 3, - "footnote_uid": "Footnote_1", - "name": "Footnote 1", - "label": "Footnote 1", - "description": "This is an example of a footnote including Markup", - "text": "\r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \t\r\n \t\r\n \r\n
1Performed if patient is an insulin-dependent diabetic
2Practice only - It is recommended that a sampling of the CIBIC+, ADAS-Cog, DAD, and NPI-X be administered at Visit 1. Data from this sampling would not be considered as study data and would not be collected.
3Practice only - It is recommended that a sampling of the CIBIC+, ADAS-Cog, DAD, and NPI-X be administered at Visit 1. Data from this sampling would not be considered as study data and would not be collected.
4Practice only - It is recommended that a sampling of the CIBIC+, ADAS-Cog, DAD, and NPI-X be administered at Visit 1. Data from this sampling would not be considered as study data and would not be collected.
5Practice only - It is recommended that a sampling of the CIBIC+, ADAS-Cog, DAD, and NPI-X be administered at Visit 1. Data from this sampling would not be considered as study data and would not be collected.
", - "dictionary_uid": null - } - ], - "study_amendment": [ - { - "id": 3, - "soa_id": 3, - "freeze_id": 35, - "amendment_uid": "StudyAmendment_1", - "name": "AMEND_1", - "number": "1", - "summary": "Updated inclusion criteria", - "label": "Amendment 1", - "description": "First amendment" - } - ], - "study_amendment_reason": [ - { - "id": 5, - "soa_id": 3, - "amendment_uid": "StudyAmendment_1", - "reason_uid": "StudyAmendmentReason_1", - "role": "primary", - "code_uid": "Code_2525", - "other_reason": null - }, - { - "id": 6, - "soa_id": 3, - "amendment_uid": "StudyAmendment_1", - "reason_uid": "StudyAmendmentReason_2", - "role": "secondary", - "code_uid": "Code_2526", - "other_reason": "Fix typographical errors" - } - ], - "study_amendment_impact": [ - { - "id": 2, - "soa_id": 3, - "amendment_uid": "StudyAmendment_1", - "impact_uid": "StudyAmendmentImpact_1", - "type_code_uid": "Code_2527", - "text": "Enhance subject safety", - "is_substantial": 0 - } - ], - "study_change": [ - { - "id": 2, - "soa_id": 3, - "amendment_uid": "StudyAmendment_1", - "change_uid": "StudyChange_2", - "name": "AMEND_CHG_1", - "label": "Change 1", - "description": "Typographical errors lead to ambiguity when interpreting Inclusion Criteria", - "summary": "Fixed inclusion criteria text", - "rationale": "Subject safety" - } - ], - "document_content_reference": [ - { - "id": 2, - "soa_id": 3, - "change_uid": "StudyChange_2", - "ref_uid": "DocumentContentReference_2", - "section_number": "1.5", - "section_title": "Header 1.5", - "applies_to_id": "StudyDefinitionDocument_1" - } - ], - "amendment_geographic_scope": [ - { - "id": 1, - "soa_id": 3, - "amendment_uid": "StudyAmendment_1", - "scope_uid": "GeographicScope_1", - "type_code_uid": "Code_12462", - "location_code_uid": null - }, - { - "id": 5, - "soa_id": 3, - "amendment_uid": "StudyAmendment_1", - "scope_uid": "GeographicScope_5", - "type_code_uid": "Code_20010", - "location_code_uid": "Code_20011" - } - ], - "amendment_governance_date": [ - { - "id": 1, - "soa_id": 3, - "amendment_uid": "StudyAmendment_1", - "date_uid": "GovernanceDate_1", - "name": "Protocol Approval", - "label": null, - "description": null, - "type_code_uid": "Code_13051", - "date_value": "2006-06-01" - } - ], - "governance_date_geographic_scope": [ - { - "id": 1, - "soa_id": 3, - "date_uid": "GovernanceDate_1", - "scope_uid": "GeographicScope_1" - } - ], - "amendment_subject_enrollment": [ - { - "id": 1, - "soa_id": 3, - "amendment_uid": "StudyAmendment_1", - "enrollment_uid": "SubjectEnrollment_1", - "name": "Enrollment 1", - "label": null, - "description": null, - "quantity_value": 15.0, - "quantity_unit_code_uid": null, - "for_scope_uid": "GeographicScope_5", - "for_study_cohort_id": null, - "for_study_site_id": null - } - ] -} diff --git a/output/exports/PrE0102.soa-bundle.json b/output/exports/PrE0102.soa-bundle.json new file mode 100644 index 0000000..06aed55 --- /dev/null +++ b/output/exports/PrE0102.soa-bundle.json @@ -0,0 +1,24609 @@ +{ + "format_version": "1.0", + "exported_at": "2026-08-13T13:36:24.392754+00:00", + "soa": { + "name": "PrE0102", + "study_id": "NCT01797120", + "study_label": "Study of Fulvestrant +/\u200b- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI", + "study_description": "Post-menopausal women with hormone-receptor positive (HR+) metastatic breast cancer resistant to aromatase inhibitor (AI) therapy will be randomized to receive Fulvestrant (Faslodex) with Everolimus or Fulvestrant (Faslodex) with a placebo (no active ingredients).\r\n\r\nFulvestrant has demonstrated activity when used as first, second, or third line endocrine therapy, making it an attractive therapy for combination with other agents. In addition, it is commonly reserved for use following disease progression on AI therapy.\r\n\r\nEverolimus is an orally administered drug that blocks a signaling pathway called \"mTOR\". \"mTOR\" acts as a regulator for many processes in the body, including cell growth. Blocking this pathway may have an effect on cell growth.\r\n\r\nThe combination of a novel class of agents (mTOR inhibitors) and an established standard treatment for metastatic HR+ breast cancer may potentially increase the clinical benefit by targeting multiple different biological pathways." + }, + "code": [ + { + "id": 2562, + "soa_id": 60, + "code_uid": "Code_8", + "code": "C16735", + "code_system": "/mdr/bc/packages/2023-12-12/biomedicalconcepts", + "code_system_version": "2023-12-12", + "decode": "Informed Consent" + }, + { + "id": 2567, + "soa_id": 60, + "code_uid": "Code_13", + "code": "C132447", + "code_system": "/mdr/bc/packages/2023-12-12/biomedicalconcepts", + "code_system_version": "2023-12-12", + "decode": "Eligibility Criteria Met By Subject" + }, + { + "id": 2574, + "soa_id": 60, + "code_uid": "Code_20", + "code": "C102408", + "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", + "code_system_version": "2025-09-23", + "decode": "ECOG - Performance Status" + }, + { + "id": 2582, + "soa_id": 60, + "code_uid": "Code_28", + "code": "C83119", + "code_system": "/mdr/bc/packages/2024-04-02/biomedicalconcepts", + "code_system_version": "2024-04-02", + "decode": "Physical Examination Finding" + }, + { + "id": 2583, + "soa_id": 60, + "code_uid": "Code_29", + "code": "C25298", + "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", + "code_system_version": "2025-12-16", + "decode": "Systolic Blood Pressure" + }, + { + "id": 2595, + "soa_id": 60, + "code_uid": "Code_41", + "code": "C25299", + "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", + "code_system_version": "2025-12-16", + "decode": "Diastolic Blood Pressure" + }, + { + "id": 2607, + "soa_id": 60, + "code_uid": "Code_53", + "code": "C49677", + "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", + "code_system_version": "2025-12-16", + "decode": "Heart Rate" + }, + { + "id": 3115, + "soa_id": 60, + "code_uid": "Code_574", + "code": "C105586", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Cholesterol Measurement" + }, + { + "id": 3311, + "soa_id": 60, + "code_uid": "Code_757", + "code": "C64814", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Urate Measurement" + }, + { + "id": 21901, + "soa_id": 60, + "code_uid": "Code_807", + "code": "C64467", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Aspartate Aminotransferase Measurement" + }, + { + "id": 148797, + "soa_id": 60, + "code_uid": "Code_5767", + "code": "C174446", + "code_system": "/mdr/bc/packages/2024-12-16/biomedicalconcepts", + "code_system_version": "2024-12-16", + "decode": "Body Temperature" + }, + { + "id": 148798, + "soa_id": 60, + "code_uid": "Code_5768", + "code": "C64547", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Creatinine Measurement" + }, + { + "id": 148799, + "soa_id": 60, + "code_uid": "Code_5769", + "code": "C64431", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Albumin Measurement" + }, + { + "id": 148804, + "soa_id": 60, + "code_uid": "Code_5774", + "code": "C62656", + "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", + "code_system_version": "2025-12-16", + "decode": "Prothrombin Time" + }, + { + "id": 148805, + "soa_id": 60, + "code_uid": "Code_5775", + "code": "C64805", + "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", + "code_system_version": "2025-12-16", + "decode": "International Normalized Ratio of Prothrombin Time" + }, + { + "id": 148806, + "soa_id": 60, + "code_uid": "Code_5776", + "code": "C105587", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "High Density Lipoprotein Cholesterol Measurement" + }, + { + "id": 148807, + "soa_id": 60, + "code_uid": "Code_5777", + "code": "C51948", + "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", + "code_system_version": "2025-12-16", + "decode": "Leukocyte Count" + }, + { + "id": 148808, + "soa_id": 60, + "code_uid": "Code_5778", + "code": "C51951", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Platelet Count" + }, + { + "id": 148809, + "soa_id": 60, + "code_uid": "Code_5779", + "code": "C64853", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Potassium Measurement" + }, + { + "id": 148810, + "soa_id": 60, + "code_uid": "Code_5780", + "code": "C64809", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Sodium Measurement" + }, + { + "id": 148811, + "soa_id": 60, + "code_uid": "Code_5781", + "code": "C64495", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Chloride Measurement" + }, + { + "id": 148812, + "soa_id": 60, + "code_uid": "Code_5782", + "code": "C64545", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Carbon Dioxide Measurement" + }, + { + "id": 148813, + "soa_id": 60, + "code_uid": "Code_5783", + "code": "C64488", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Calcium Measurement" + }, + { + "id": 148814, + "soa_id": 60, + "code_uid": "Code_5784", + "code": "C125949", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Urea Nitrogen Measurement" + }, + { + "id": 148815, + "soa_id": 60, + "code_uid": "Code_5785", + "code": "C64858", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Total Protein Measurement" + }, + { + "id": 148816, + "soa_id": 60, + "code_uid": "Code_5786", + "code": "C64432", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Alkaline Phosphatase Measurement" + }, + { + "id": 164401, + "soa_id": 60, + "code_uid": "Code_7476", + "code": "C105588", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Low Density Lipoprotein Cholesterol Measurement" + }, + { + "id": 194866, + "soa_id": 60, + "code_uid": "Code_7947", + "code": "C9246", + "code_system": "http://ncithesaurus.nci.nih.gov", + "code_system_version": "24.04e", + "decode": "Hormone Receptor-Positive Breast Carcinoma" + }, + { + "id": 194867, + "soa_id": 60, + "code_uid": "Code_7948", + "code": "C7771", + "code_system": "http://ncithesaurus.nci.nih.gov", + "code_system_version": "24.04e", + "decode": "Metastatic Breast Carcinoma" + }, + { + "id": 196209, + "soa_id": 60, + "code_uid": "Code_7949", + "code": "C70793", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Clinical Study Sponsor" + }, + { + "id": 196210, + "soa_id": 60, + "code_uid": "Code_7950", + "code": "840", + "code_system": "ISO 3166 1 Numeric Code", + "code_system_version": "2026", + "decode": "United States of America" + }, + { + "id": 196993, + "soa_id": 60, + "code_uid": "Code_7951", + "code": "C25392", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Manufacturer" + }, + { + "id": 196994, + "soa_id": 60, + "code_uid": "Code_7952", + "code": "840", + "code_system": "ISO 3166 1 Numeric Code", + "code_system_version": "2026", + "decode": "United States of America" + }, + { + "id": 198377, + "soa_id": 60, + "code_uid": "Code_8489", + "code": "C70793", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Clinical Study Sponsor" + }, + { + "id": 198385, + "soa_id": 60, + "code_uid": "Code_8497", + "code": "C207616", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Official Study Title" + }, + { + "id": 223249, + "soa_id": 60, + "code_uid": "Code_9714", + "code": "C25392", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Manufacturer" + }, + { + "id": 223250, + "soa_id": 60, + "code_uid": "Code_9715", + "code": "C215673", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Pharmacovigilance Group" + }, + { + "id": 225264, + "soa_id": 60, + "code_uid": "Code_9716", + "code": "C19924", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Principal Investigator" + }, + { + "id": 225351, + "soa_id": 60, + "code_uid": "Code_9717", + "code": "C25936", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Investigator" + }, + { + "id": 225392, + "soa_id": 60, + "code_uid": "Code_9718", + "code": "C51876", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Sponsor Medical Expert" + }, + { + "id": 225435, + "soa_id": 60, + "code_uid": "Code_9719", + "code": "C51877", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Statistician" + }, + { + "id": 225620, + "soa_id": 60, + "code_uid": "Code_9720", + "code": "C51851", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Project Coordinator" + }, + { + "id": 233368, + "soa_id": 60, + "code_uid": "Code_9956", + "code": "C188863", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Regulatory Agency" + }, + { + "id": 233369, + "soa_id": 60, + "code_uid": "Code_9957", + "code": "840", + "code_system": "ISO 3166 1 Numeric Code", + "code_system_version": "2026", + "decode": "United States of America" + }, + { + "id": 233370, + "soa_id": 60, + "code_uid": "Code_9958", + "code": "C37984", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Laboratory" + }, + { + "id": 233371, + "soa_id": 60, + "code_uid": "Code_9959", + "code": "840", + "code_system": "ISO 3166 1 Numeric Code", + "code_system_version": "2026", + "decode": "United States of America" + }, + { + "id": 233373, + "soa_id": 60, + "code_uid": "Code_9961", + "code": "C37984", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Laboratory" + }, + { + "id": 233374, + "soa_id": 60, + "code_uid": "Code_9962", + "code": "840", + "code_system": "ISO 3166 1 Numeric Code", + "code_system_version": "2026", + "decode": "United States of America" + }, + { + "id": 233376, + "soa_id": 60, + "code_uid": "Code_9963", + "code": "C51851", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Project Coordinator" + }, + { + "id": 233377, + "soa_id": 60, + "code_uid": "Code_9964", + "code": "C51851", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Project Coordinator" + }, + { + "id": 233378, + "soa_id": 60, + "code_uid": "Code_9965", + "code": "C51851", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Project Coordinator" + }, + { + "id": 233379, + "soa_id": 60, + "code_uid": "Code_9966", + "code": "C51851", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Project Coordinator" + }, + { + "id": 233895, + "soa_id": 60, + "code_uid": "Code_10029", + "code": "C81328", + "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", + "code_system_version": "2025-11-18", + "decode": "Body Weight" + }, + { + "id": 233896, + "soa_id": 60, + "code_uid": "Code_10030", + "code": "C64433", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Alanine Aminotransferase Measurement" + }, + { + "id": 233920, + "soa_id": 60, + "code_uid": "Code_10032", + "code": "C25196", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Randomization" + }, + { + "id": 233926, + "soa_id": 60, + "code_uid": "Code_10033", + "code": "C41161", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Experimental Intervention" + }, + { + "id": 233927, + "soa_id": 60, + "code_uid": "Code_10034", + "code": "C54696", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-09-26", + "decode": "Combination Product" + }, + { + "id": 233929, + "soa_id": 60, + "code_uid": "Code_10036", + "code": "C68609", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Active Comparator" + }, + { + "id": 233930, + "soa_id": 60, + "code_uid": "Code_10037", + "code": "C54696", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-09-26", + "decode": "Combination Product" + }, + { + "id": 233935, + "soa_id": 60, + "code_uid": "Code_10112", + "code": "C41161", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-03-27", + "decode": "Experimental Intervention" + }, + { + "id": 233936, + "soa_id": 60, + "code_uid": "Code_10113", + "code": "C1909", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-09-26", + "decode": "Pharmacologic Substance" + }, + { + "id": 236506, + "soa_id": 60, + "code_uid": "Code_10379", + "code": "C82977", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Dictionary-derived Term" + }, + { + "id": 236507, + "soa_id": 60, + "code_uid": "Code_10380", + "code": "C16735", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "INFORMED CONSENT OBTAINED" + }, + { + "id": 236508, + "soa_id": 60, + "code_uid": "Code_10381", + "code": "C82571", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Reported Event Term" + }, + { + "id": 236509, + "soa_id": 60, + "code_uid": "Code_10382", + "code": "C82517", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Start Date Time" + }, + { + "id": 236519, + "soa_id": 60, + "code_uid": "Code_10392", + "code": "C82977", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Dictionary-derived Term" + }, + { + "id": 236520, + "soa_id": 60, + "code_uid": "Code_10393", + "code": "C132447", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "ELIGIBILITY CRITERIA MET" + }, + { + "id": 236521, + "soa_id": 60, + "code_uid": "Code_10394", + "code": "C82571", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Reported Event Term" + }, + { + "id": 236522, + "soa_id": 60, + "code_uid": "Code_10395", + "code": "C82517", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Start Date Time" + }, + { + "id": 236531, + "soa_id": 60, + "code_uid": "Code_10404", + "code": "C91106", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Clinical or Research Assessment Answer" + }, + { + "id": 236532, + "soa_id": 60, + "code_uid": "Code_10405", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236533, + "soa_id": 60, + "code_uid": "Code_10406", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236534, + "soa_id": 60, + "code_uid": "Code_10407", + "code": "C49669", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Pressure" + }, + { + "id": 236535, + "soa_id": 60, + "code_uid": "Code_10408", + "code": "C49670", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "mmHg" + }, + { + "id": 236536, + "soa_id": 60, + "code_uid": "Code_10409", + "code": "C62164", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Body Position" + }, + { + "id": 236537, + "soa_id": 60, + "code_uid": "Code_10410", + "code": "C13717", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Anatomic Site" + }, + { + "id": 236538, + "soa_id": 60, + "code_uid": "Code_10411", + "code": "C25185", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Laterality" + }, + { + "id": 236539, + "soa_id": 60, + "code_uid": "Code_10412", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236540, + "soa_id": 60, + "code_uid": "Code_10413", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236541, + "soa_id": 60, + "code_uid": "Code_10414", + "code": "C49669", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Pressure" + }, + { + "id": 236542, + "soa_id": 60, + "code_uid": "Code_10415", + "code": "C49670", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "mmHg" + }, + { + "id": 236543, + "soa_id": 60, + "code_uid": "Code_10416", + "code": "C62164", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Body Position" + }, + { + "id": 236544, + "soa_id": 60, + "code_uid": "Code_10417", + "code": "C13717", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Anatomic Site" + }, + { + "id": 236545, + "soa_id": 60, + "code_uid": "Code_10418", + "code": "C25185", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Laterality" + }, + { + "id": 236546, + "soa_id": 60, + "code_uid": "Code_10419", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236547, + "soa_id": 60, + "code_uid": "Code_10420", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236548, + "soa_id": 60, + "code_uid": "Code_10421", + "code": "C73688", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Count per Minute" + }, + { + "id": 236549, + "soa_id": 60, + "code_uid": "Code_10422", + "code": "C49673", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "beats/min" + }, + { + "id": 236550, + "soa_id": 60, + "code_uid": "Code_10423", + "code": "C62164", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Body Position" + }, + { + "id": 236551, + "soa_id": 60, + "code_uid": "Code_10424", + "code": "C13717", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Anatomic Site" + }, + { + "id": 236552, + "soa_id": 60, + "code_uid": "Code_10425", + "code": "C25185", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Laterality" + }, + { + "id": 236553, + "soa_id": 60, + "code_uid": "Code_10426", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236554, + "soa_id": 60, + "code_uid": "Code_10427", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236555, + "soa_id": 60, + "code_uid": "Code_10428", + "code": "C44276", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Temperature" + }, + { + "id": 236556, + "soa_id": 60, + "code_uid": "Code_10429", + "code": "C13717", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Anatomic Site" + }, + { + "id": 236557, + "soa_id": 60, + "code_uid": "Code_10430", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236558, + "soa_id": 60, + "code_uid": "Code_10431", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236559, + "soa_id": 60, + "code_uid": "Code_10432", + "code": "C48208", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Weight" + }, + { + "id": 236560, + "soa_id": 60, + "code_uid": "Code_10433", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236561, + "soa_id": 60, + "code_uid": "Code_10434", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236562, + "soa_id": 60, + "code_uid": "Code_10435", + "code": "C67365", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + }, + { + "id": 236563, + "soa_id": 60, + "code_uid": "Code_10436", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236564, + "soa_id": 60, + "code_uid": "Code_10437", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236565, + "soa_id": 60, + "code_uid": "Code_10438", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236566, + "soa_id": 60, + "code_uid": "Code_10439", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236567, + "soa_id": 60, + "code_uid": "Code_10440", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236568, + "soa_id": 60, + "code_uid": "Code_10441", + "code": "C67365", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + }, + { + "id": 236569, + "soa_id": 60, + "code_uid": "Code_10442", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236570, + "soa_id": 60, + "code_uid": "Code_10443", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236571, + "soa_id": 60, + "code_uid": "Code_10444", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236572, + "soa_id": 60, + "code_uid": "Code_10445", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236573, + "soa_id": 60, + "code_uid": "Code_10446", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236574, + "soa_id": 60, + "code_uid": "Code_10447", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236575, + "soa_id": 60, + "code_uid": "Code_10448", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236576, + "soa_id": 60, + "code_uid": "Code_10449", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236577, + "soa_id": 60, + "code_uid": "Code_10450", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236578, + "soa_id": 60, + "code_uid": "Code_10451", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236579, + "soa_id": 60, + "code_uid": "Code_10452", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236580, + "soa_id": 60, + "code_uid": "Code_10453", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236581, + "soa_id": 60, + "code_uid": "Code_10454", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236582, + "soa_id": 60, + "code_uid": "Code_10455", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236583, + "soa_id": 60, + "code_uid": "Code_10456", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236584, + "soa_id": 60, + "code_uid": "Code_10457", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236585, + "soa_id": 60, + "code_uid": "Code_10458", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236586, + "soa_id": 60, + "code_uid": "Code_10459", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236587, + "soa_id": 60, + "code_uid": "Code_10460", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236588, + "soa_id": 60, + "code_uid": "Code_10461", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236589, + "soa_id": 60, + "code_uid": "Code_10462", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236590, + "soa_id": 60, + "code_uid": "Code_10463", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236609, + "soa_id": 60, + "code_uid": "Code_10482", + "code": "C70902", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Agent" + }, + { + "id": 236610, + "soa_id": 60, + "code_uid": "Code_10483", + "code": "C83345", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Medication Dictionary Derived Term" + }, + { + "id": 236611, + "soa_id": 60, + "code_uid": "Code_10484", + "code": "C83219", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Medication Class" + }, + { + "id": 236612, + "soa_id": 60, + "code_uid": "Code_10485", + "code": "C83085", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Medication Use Indication" + }, + { + "id": 236613, + "soa_id": 60, + "code_uid": "Code_10486", + "code": "C83221", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Medication Dose" + }, + { + "id": 236614, + "soa_id": 60, + "code_uid": "Code_10487", + "code": "C83221", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Medication Dose" + }, + { + "id": 236615, + "soa_id": 60, + "code_uid": "Code_10488", + "code": "C83034", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Medication Dose Unit" + }, + { + "id": 236616, + "soa_id": 60, + "code_uid": "Code_10489", + "code": "C83110", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Medication Dose Form" + }, + { + "id": 236617, + "soa_id": 60, + "code_uid": "Code_10490", + "code": "C83042", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Medication Dose Frequency" + }, + { + "id": 236618, + "soa_id": 60, + "code_uid": "Code_10491", + "code": "C83120", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Medication Route of Administration" + }, + { + "id": 236619, + "soa_id": 60, + "code_uid": "Code_10492", + "code": "C83235", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Medication Use Start Date Time" + }, + { + "id": 236620, + "soa_id": 60, + "code_uid": "Code_10493", + "code": "C83225", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Concomitant Medication Use End Date Time" + }, + { + "id": 236621, + "soa_id": 60, + "code_uid": "Code_10494", + "code": "C82559", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Start Relative to Reference Period" + }, + { + "id": 236622, + "soa_id": 60, + "code_uid": "Code_10495", + "code": "C82560", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Start Relative to Reference Time Point" + }, + { + "id": 236623, + "soa_id": 60, + "code_uid": "Code_10496", + "code": "C82575", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Reference Start Time Point" + }, + { + "id": 236624, + "soa_id": 60, + "code_uid": "Code_10497", + "code": "C82557", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "End Relative to Reference Period" + }, + { + "id": 236625, + "soa_id": 60, + "code_uid": "Code_10498", + "code": "C82558", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "End Relative to Reference Time Point" + }, + { + "id": 236626, + "soa_id": 60, + "code_uid": "Code_10499", + "code": "C82574", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Reference End Time Point End" + }, + { + "id": 236627, + "soa_id": 60, + "code_uid": "Code_10500", + "code": "C83445", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Trial Summary Parameter Code" + }, + { + "id": 236628, + "soa_id": 60, + "code_uid": "Code_10501", + "code": "C25196", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "RANDOM" + }, + { + "id": 236629, + "soa_id": 60, + "code_uid": "Code_10502", + "code": "C49691", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Trial Summary Parameter" + }, + { + "id": 236630, + "soa_id": 60, + "code_uid": "Code_10503", + "code": "C25196", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Trial is Randomized" + }, + { + "id": 236631, + "soa_id": 60, + "code_uid": "Code_10504", + "code": "C83447", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Trial Summary Parameter Value" + }, + { + "id": 236632, + "soa_id": 60, + "code_uid": "Code_10505", + "code": "C117458", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Trial Summary Parameter Value Code" + }, + { + "id": 236633, + "soa_id": 60, + "code_uid": "Code_10506", + "code": "C117460", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Trial Summary Parameter Name of the Reference Terminology" + }, + { + "id": 236634, + "soa_id": 60, + "code_uid": "Code_10507", + "code": "C117461", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Trial Summary Parameter Version of the Reference Terminology" + }, + { + "id": 236635, + "soa_id": 60, + "code_uid": "Code_10508", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236636, + "soa_id": 60, + "code_uid": "Code_10509", + "code": "C42574", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Time" + }, + { + "id": 236637, + "soa_id": 60, + "code_uid": "Code_10510", + "code": "C42535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "s" + }, + { + "id": 236638, + "soa_id": 60, + "code_uid": "Code_10511", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236639, + "soa_id": 60, + "code_uid": "Code_10512", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236640, + "soa_id": 60, + "code_uid": "Code_10513", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236641, + "soa_id": 60, + "code_uid": "Code_10514", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236642, + "soa_id": 60, + "code_uid": "Code_10515", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236643, + "soa_id": 60, + "code_uid": "Code_10516", + "code": "C42574", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Time" + }, + { + "id": 236644, + "soa_id": 60, + "code_uid": "Code_10517", + "code": "C44256", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "RATIO" + }, + { + "id": 236645, + "soa_id": 60, + "code_uid": "Code_10518", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236646, + "soa_id": 60, + "code_uid": "Code_10519", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236647, + "soa_id": 60, + "code_uid": "Code_10520", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236648, + "soa_id": 60, + "code_uid": "Code_10521", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236649, + "soa_id": 60, + "code_uid": "Code_10522", + "code": "C42574", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Time" + }, + { + "id": 236650, + "soa_id": 60, + "code_uid": "Code_10523", + "code": "C42535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "s" + }, + { + "id": 236651, + "soa_id": 60, + "code_uid": "Code_10524", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236652, + "soa_id": 60, + "code_uid": "Code_10525", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236653, + "soa_id": 60, + "code_uid": "Code_10526", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236654, + "soa_id": 60, + "code_uid": "Code_10527", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236655, + "soa_id": 60, + "code_uid": "Code_10528", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236656, + "soa_id": 60, + "code_uid": "Code_10529", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236657, + "soa_id": 60, + "code_uid": "Code_10530", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236658, + "soa_id": 60, + "code_uid": "Code_10531", + "code": "C82535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Test Method" + }, + { + "id": 236659, + "soa_id": 60, + "code_uid": "Code_10532", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236660, + "soa_id": 60, + "code_uid": "Code_10533", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236661, + "soa_id": 60, + "code_uid": "Code_10534", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236662, + "soa_id": 60, + "code_uid": "Code_10535", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236663, + "soa_id": 60, + "code_uid": "Code_10536", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236664, + "soa_id": 60, + "code_uid": "Code_10537", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236665, + "soa_id": 60, + "code_uid": "Code_10538", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236666, + "soa_id": 60, + "code_uid": "Code_10539", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236667, + "soa_id": 60, + "code_uid": "Code_10540", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236668, + "soa_id": 60, + "code_uid": "Code_10541", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236669, + "soa_id": 60, + "code_uid": "Code_10542", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236670, + "soa_id": 60, + "code_uid": "Code_10543", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236671, + "soa_id": 60, + "code_uid": "Code_10544", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236672, + "soa_id": 60, + "code_uid": "Code_10545", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236673, + "soa_id": 60, + "code_uid": "Code_10546", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236674, + "soa_id": 60, + "code_uid": "Code_10547", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236675, + "soa_id": 60, + "code_uid": "Code_10548", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236676, + "soa_id": 60, + "code_uid": "Code_10549", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236677, + "soa_id": 60, + "code_uid": "Code_10550", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236678, + "soa_id": 60, + "code_uid": "Code_10551", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236679, + "soa_id": 60, + "code_uid": "Code_10552", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236680, + "soa_id": 60, + "code_uid": "Code_10553", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236681, + "soa_id": 60, + "code_uid": "Code_10554", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236682, + "soa_id": 60, + "code_uid": "Code_10555", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236683, + "soa_id": 60, + "code_uid": "Code_10556", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236684, + "soa_id": 60, + "code_uid": "Code_10557", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236685, + "soa_id": 60, + "code_uid": "Code_10558", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236686, + "soa_id": 60, + "code_uid": "Code_10559", + "code": "C67391", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Number Concentration" + }, + { + "id": 236687, + "soa_id": 60, + "code_uid": "Code_10560", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236688, + "soa_id": 60, + "code_uid": "Code_10561", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236689, + "soa_id": 60, + "code_uid": "Code_10562", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236690, + "soa_id": 60, + "code_uid": "Code_10563", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236691, + "soa_id": 60, + "code_uid": "Code_10564", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236692, + "soa_id": 60, + "code_uid": "Code_10565", + "code": "C67391", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Number Concentration" + }, + { + "id": 236693, + "soa_id": 60, + "code_uid": "Code_10566", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236694, + "soa_id": 60, + "code_uid": "Code_10567", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236695, + "soa_id": 60, + "code_uid": "Code_10568", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236696, + "soa_id": 60, + "code_uid": "Code_10569", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236697, + "soa_id": 60, + "code_uid": "Code_10570", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236698, + "soa_id": 60, + "code_uid": "Code_10571", + "code": "C67391", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Number Concentration" + }, + { + "id": 236699, + "soa_id": 60, + "code_uid": "Code_10572", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236700, + "soa_id": 60, + "code_uid": "Code_10573", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236701, + "soa_id": 60, + "code_uid": "Code_10574", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236702, + "soa_id": 60, + "code_uid": "Code_10575", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236703, + "soa_id": 60, + "code_uid": "Code_10576", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236704, + "soa_id": 60, + "code_uid": "Code_10577", + "code": "C64567", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Molarity Unit" + }, + { + "id": 236705, + "soa_id": 60, + "code_uid": "Code_10578", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236706, + "soa_id": 60, + "code_uid": "Code_10579", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236707, + "soa_id": 60, + "code_uid": "Code_10580", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236708, + "soa_id": 60, + "code_uid": "Code_10581", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236709, + "soa_id": 60, + "code_uid": "Code_10582", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236710, + "soa_id": 60, + "code_uid": "Code_10583", + "code": "C64567", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Molarity Unit" + }, + { + "id": 236711, + "soa_id": 60, + "code_uid": "Code_10584", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236712, + "soa_id": 60, + "code_uid": "Code_10585", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236713, + "soa_id": 60, + "code_uid": "Code_10586", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236714, + "soa_id": 60, + "code_uid": "Code_10587", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236715, + "soa_id": 60, + "code_uid": "Code_10588", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236716, + "soa_id": 60, + "code_uid": "Code_10589", + "code": "C64567", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Molarity Unit" + }, + { + "id": 236717, + "soa_id": 60, + "code_uid": "Code_10590", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236718, + "soa_id": 60, + "code_uid": "Code_10591", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236719, + "soa_id": 60, + "code_uid": "Code_10592", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236720, + "soa_id": 60, + "code_uid": "Code_10593", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236721, + "soa_id": 60, + "code_uid": "Code_10594", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236722, + "soa_id": 60, + "code_uid": "Code_10595", + "code": "C64567", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Molarity Unit" + }, + { + "id": 236723, + "soa_id": 60, + "code_uid": "Code_10596", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236724, + "soa_id": 60, + "code_uid": "Code_10597", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236725, + "soa_id": 60, + "code_uid": "Code_10598", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236726, + "soa_id": 60, + "code_uid": "Code_10599", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236727, + "soa_id": 60, + "code_uid": "Code_10600", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236728, + "soa_id": 60, + "code_uid": "Code_10601", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236729, + "soa_id": 60, + "code_uid": "Code_10602", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236730, + "soa_id": 60, + "code_uid": "Code_10603", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 236731, + "soa_id": 60, + "code_uid": "Code_10604", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236732, + "soa_id": 60, + "code_uid": "Code_10605", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236733, + "soa_id": 60, + "code_uid": "Code_10606", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236734, + "soa_id": 60, + "code_uid": "Code_10607", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236735, + "soa_id": 60, + "code_uid": "Code_10608", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236736, + "soa_id": 60, + "code_uid": "Code_10609", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236737, + "soa_id": 60, + "code_uid": "Code_10610", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236738, + "soa_id": 60, + "code_uid": "Code_10611", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236739, + "soa_id": 60, + "code_uid": "Code_10612", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236740, + "soa_id": 60, + "code_uid": "Code_10613", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236741, + "soa_id": 60, + "code_uid": "Code_10614", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236742, + "soa_id": 60, + "code_uid": "Code_10615", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236743, + "soa_id": 60, + "code_uid": "Code_10616", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236744, + "soa_id": 60, + "code_uid": "Code_10617", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236745, + "soa_id": 60, + "code_uid": "Code_10618", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236746, + "soa_id": 60, + "code_uid": "Code_10619", + "code": "C67365", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Catalytic Activity Concentration" + }, + { + "id": 236747, + "soa_id": 60, + "code_uid": "Code_10620", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236748, + "soa_id": 60, + "code_uid": "Code_10621", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236749, + "soa_id": 60, + "code_uid": "Code_10622", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236750, + "soa_id": 60, + "code_uid": "Code_10623", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236751, + "soa_id": 60, + "code_uid": "Code_10624", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236752, + "soa_id": 60, + "code_uid": "Code_10625", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 236753, + "soa_id": 60, + "code_uid": "Code_10626", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 236754, + "soa_id": 60, + "code_uid": "Code_10627", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 236755, + "soa_id": 60, + "code_uid": "Code_10628", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 236756, + "soa_id": 60, + "code_uid": "Code_10629", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236789, + "soa_id": 60, + "code_uid": "Code_10662", + "code": "C38037", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Total Bilirubin Measurement" + }, + { + "id": 236791, + "soa_id": 60, + "code_uid": "Code_10664", + "code": "C53630", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Concomitant Therapy" + }, + { + "id": 236792, + "soa_id": 60, + "code_uid": "Code_10665", + "code": "C38462", + "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", + "code_system_version": "2025-12-16", + "decode": "Activated Partial Thromboplastin Time" + }, + { + "id": 236793, + "soa_id": 60, + "code_uid": "Code_10666", + "code": "C105585", + "code_system": "/mdr/bc/packages/2025-09-23/biomedicalconcepts", + "code_system_version": "2025-09-23", + "decode": "Glucose Measurement" + }, + { + "id": 236794, + "soa_id": 60, + "code_uid": "Code_10667", + "code": "C64812", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Triglyceride Measurement" + }, + { + "id": 236796, + "soa_id": 60, + "code_uid": "Code_10669", + "code": "C51946", + "code_system": "/mdr/bc/packages/2025-12-16/biomedicalconcepts", + "code_system_version": "2025-12-16", + "decode": "Erythrocyte Count" + }, + { + "id": 236916, + "soa_id": 60, + "code_uid": "Code_10670", + "code": "C200145", + "code_system": "/mdr/bc/packages/2026-07-14/biomedicalconcepts", + "code_system_version": "2026-07-14", + "decode": "Solicited Medical History" + }, + { + "id": 236918, + "soa_id": 60, + "code_uid": "Code_10672", + "code": "C83119", + "code_system": "/mdr/bc/packages/2024-04-02/biomedicalconcepts", + "code_system_version": "2024-04-02", + "decode": "Physical Examination Finding" + }, + { + "id": 236919, + "soa_id": 60, + "code_uid": "Code_10673", + "code": "C83119", + "code_system": "/mdr/bc/packages/2024-04-02/biomedicalconcepts", + "code_system_version": "2024-04-02", + "decode": "Physical Examination Finding" + }, + { + "id": 236920, + "soa_id": 60, + "code_uid": "Code_10674", + "code": "C103420", + "code_system": "/mdr/bc/packages/2024-06-27/biomedicalconcepts", + "code_system_version": "2024-06-27", + "decode": "New Lesion Progression" + }, + { + "id": 236921, + "soa_id": 60, + "code_uid": "Code_10675", + "code": "C124448", + "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", + "code_system_version": "2026-05-26", + "decode": "Lymph Node State" + }, + { + "id": 236922, + "soa_id": 60, + "code_uid": "Code_10676", + "code": "C161483", + "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", + "code_system_version": "2026-05-26", + "decode": "Non-Target Indicator" + }, + { + "id": 236923, + "soa_id": 60, + "code_uid": "Code_10677", + "code": "C178053", + "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", + "code_system_version": "2026-05-26", + "decode": "Target Indicator" + }, + { + "id": 236924, + "soa_id": 60, + "code_uid": "Code_10678", + "code": "C225437", + "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", + "code_system_version": "2026-05-26", + "decode": "Confluent Tumor Masses Assessment" + }, + { + "id": 236925, + "soa_id": 60, + "code_uid": "Code_10679", + "code": "C225438", + "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", + "code_system_version": "2026-05-26", + "decode": "Tumor Fragmentation Assessment" + }, + { + "id": 236926, + "soa_id": 60, + "code_uid": "Code_10680", + "code": "C94523", + "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", + "code_system_version": "2026-05-26", + "decode": "Tumor Identification" + }, + { + "id": 236927, + "soa_id": 60, + "code_uid": "Code_10681", + "code": "C94534", + "code_system": "/mdr/bc/packages/2024-06-27/biomedicalconcepts", + "code_system_version": "2024-06-27", + "decode": "Response in Target Lesion" + }, + { + "id": 236928, + "soa_id": 60, + "code_uid": "Code_10682", + "code": "C94535", + "code_system": "/mdr/bc/packages/2024-06-27/biomedicalconcepts", + "code_system_version": "2024-06-27", + "decode": "Response in Non-Target Lesion" + }, + { + "id": 236929, + "soa_id": 60, + "code_uid": "Code_10683", + "code": "C94536", + "code_system": "/mdr/bc/packages/2024-06-27/biomedicalconcepts", + "code_system_version": "2024-06-27", + "decode": "Best Overall Response" + }, + { + "id": 236930, + "soa_id": 60, + "code_uid": "Code_10684", + "code": "C96613", + "code_system": "/mdr/bc/packages/2024-06-27/biomedicalconcepts", + "code_system_version": "2024-06-27", + "decode": "Overall Response" + }, + { + "id": 236931, + "soa_id": 60, + "code_uid": "Code_10685", + "code": "C96643", + "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", + "code_system_version": "2026-05-26", + "decode": "Tumor Status" + }, + { + "id": 236932, + "soa_id": 60, + "code_uid": "Code_10686", + "code": "C96684", + "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", + "code_system_version": "2026-05-26", + "decode": "Longest Diameter" + }, + { + "id": 236933, + "soa_id": 60, + "code_uid": "Code_10687", + "code": "C96685", + "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", + "code_system_version": "2026-05-26", + "decode": "Longest Perpendicular" + }, + { + "id": 236934, + "soa_id": 60, + "code_uid": "Code_10688", + "code": "C25372", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Category" + }, + { + "id": 236935, + "soa_id": 60, + "code_uid": "Code_10689", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Observation Result" + }, + { + "id": 236936, + "soa_id": 60, + "code_uid": "Code_10690", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Evaluator" + }, + { + "id": 236937, + "soa_id": 60, + "code_uid": "Code_10691", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Evaluator Identifier" + }, + { + "id": 236938, + "soa_id": 60, + "code_uid": "Code_10692", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Collection Date Time" + }, + { + "id": 236939, + "soa_id": 60, + "code_uid": "Code_10693", + "code": "C117413", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Link Identifier" + }, + { + "id": 236940, + "soa_id": 60, + "code_uid": "Code_10694", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 236941, + "soa_id": 60, + "code_uid": "Code_10695", + "code": "C82535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Test Method" + }, + { + "id": 236942, + "soa_id": 60, + "code_uid": "Code_10696", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236943, + "soa_id": 60, + "code_uid": "Code_10697", + "code": "C117419", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Reference Identifier" + }, + { + "id": 236944, + "soa_id": 60, + "code_uid": "Code_10698", + "code": "C117411", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Group Identifier" + }, + { + "id": 236945, + "soa_id": 60, + "code_uid": "Code_10699", + "code": "C117412", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Link Group" + }, + { + "id": 236946, + "soa_id": 60, + "code_uid": "Code_10700", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 236947, + "soa_id": 60, + "code_uid": "Code_10701", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236948, + "soa_id": 60, + "code_uid": "Code_10702", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236949, + "soa_id": 60, + "code_uid": "Code_10703", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 236950, + "soa_id": 60, + "code_uid": "Code_10704", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 236951, + "soa_id": 60, + "code_uid": "Code_10705", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236952, + "soa_id": 60, + "code_uid": "Code_10706", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236953, + "soa_id": 60, + "code_uid": "Code_10707", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 236954, + "soa_id": 60, + "code_uid": "Code_10708", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 236955, + "soa_id": 60, + "code_uid": "Code_10709", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236956, + "soa_id": 60, + "code_uid": "Code_10710", + "code": "C170500", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Result Anatomical Location" + }, + { + "id": 236957, + "soa_id": 60, + "code_uid": "Code_10711", + "code": "C117442", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Identifier Reference Identifier" + }, + { + "id": 236958, + "soa_id": 60, + "code_uid": "Code_10712", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236959, + "soa_id": 60, + "code_uid": "Code_10713", + "code": "C54215", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Directionality" + }, + { + "id": 236960, + "soa_id": 60, + "code_uid": "Code_10714", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236961, + "soa_id": 60, + "code_uid": "Code_10715", + "code": "C82535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Test Method" + }, + { + "id": 236962, + "soa_id": 60, + "code_uid": "Code_10716", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 236963, + "soa_id": 60, + "code_uid": "Code_10717", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 236964, + "soa_id": 60, + "code_uid": "Code_10718", + "code": "C25185", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Laterality" + }, + { + "id": 236965, + "soa_id": 60, + "code_uid": "Code_10719", + "code": "C117436", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Identifier Link Identifier" + }, + { + "id": 236966, + "soa_id": 60, + "code_uid": "Code_10720", + "code": "C54215", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Directionality" + }, + { + "id": 236967, + "soa_id": 60, + "code_uid": "Code_10721", + "code": "C25185", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Laterality" + }, + { + "id": 236968, + "soa_id": 60, + "code_uid": "Code_10722", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 236969, + "soa_id": 60, + "code_uid": "Code_10723", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236970, + "soa_id": 60, + "code_uid": "Code_10724", + "code": "C170500", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Result Anatomical Location" + }, + { + "id": 236971, + "soa_id": 60, + "code_uid": "Code_10725", + "code": "C82535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Test Method" + }, + { + "id": 236972, + "soa_id": 60, + "code_uid": "Code_10726", + "code": "C117436", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Identifier Link Identifier" + }, + { + "id": 236973, + "soa_id": 60, + "code_uid": "Code_10727", + "code": "C117442", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Identifier Reference Identifier" + }, + { + "id": 236974, + "soa_id": 60, + "code_uid": "Code_10728", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236975, + "soa_id": 60, + "code_uid": "Code_10729", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 236976, + "soa_id": 60, + "code_uid": "Code_10730", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236977, + "soa_id": 60, + "code_uid": "Code_10731", + "code": "C94520", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "TARGET" + }, + { + "id": 236978, + "soa_id": 60, + "code_uid": "Code_10732", + "code": "C170500", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Result Anatomical Location" + }, + { + "id": 236979, + "soa_id": 60, + "code_uid": "Code_10733", + "code": "C25185", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Laterality" + }, + { + "id": 236980, + "soa_id": 60, + "code_uid": "Code_10734", + "code": "C54215", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Directionality" + }, + { + "id": 236981, + "soa_id": 60, + "code_uid": "Code_10735", + "code": "C82535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Test Method" + }, + { + "id": 236982, + "soa_id": 60, + "code_uid": "Code_10736", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 236983, + "soa_id": 60, + "code_uid": "Code_10737", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 236984, + "soa_id": 60, + "code_uid": "Code_10738", + "code": "C117442", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Identifier Reference Identifier" + }, + { + "id": 236985, + "soa_id": 60, + "code_uid": "Code_10739", + "code": "C117436", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Identifier Link Identifier" + }, + { + "id": 236986, + "soa_id": 60, + "code_uid": "Code_10740", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236987, + "soa_id": 60, + "code_uid": "Code_10741", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236988, + "soa_id": 60, + "code_uid": "Code_10742", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 236989, + "soa_id": 60, + "code_uid": "Code_10743", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 236990, + "soa_id": 60, + "code_uid": "Code_10744", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236991, + "soa_id": 60, + "code_uid": "Code_10745", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 236992, + "soa_id": 60, + "code_uid": "Code_10746", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 236993, + "soa_id": 60, + "code_uid": "Code_10747", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 236994, + "soa_id": 60, + "code_uid": "Code_10748", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 236995, + "soa_id": 60, + "code_uid": "Code_10749", + "code": "C117394", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Disease Response Link Group" + }, + { + "id": 236996, + "soa_id": 60, + "code_uid": "Code_10750", + "code": "C25372", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Category" + }, + { + "id": 236997, + "soa_id": 60, + "code_uid": "Code_10751", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Observation Result" + }, + { + "id": 236998, + "soa_id": 60, + "code_uid": "Code_10752", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Evaluator" + }, + { + "id": 236999, + "soa_id": 60, + "code_uid": "Code_10753", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Evaluator Identifier" + }, + { + "id": 237000, + "soa_id": 60, + "code_uid": "Code_10754", + "code": "C71738", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Clinical Trial Epoch" + }, + { + "id": 237001, + "soa_id": 60, + "code_uid": "Code_10755", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2024-06-27", + "decode": "Collection Date Time" + }, + { + "id": 237002, + "soa_id": 60, + "code_uid": "Code_10756", + "code": "C117394", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Disease Response Link Group" + }, + { + "id": 237003, + "soa_id": 60, + "code_uid": "Code_10757", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237004, + "soa_id": 60, + "code_uid": "Code_10758", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 237005, + "soa_id": 60, + "code_uid": "Code_10759", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 237006, + "soa_id": 60, + "code_uid": "Code_10760", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237007, + "soa_id": 60, + "code_uid": "Code_10761", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237008, + "soa_id": 60, + "code_uid": "Code_10762", + "code": "C117411", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Group Identifier" + }, + { + "id": 237009, + "soa_id": 60, + "code_uid": "Code_10763", + "code": "C117419", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Reference Identifier" + }, + { + "id": 237010, + "soa_id": 60, + "code_uid": "Code_10764", + "code": "C117412", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Link Group" + }, + { + "id": 237011, + "soa_id": 60, + "code_uid": "Code_10765", + "code": "C117413", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Link Identifier" + }, + { + "id": 237012, + "soa_id": 60, + "code_uid": "Code_10766", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237013, + "soa_id": 60, + "code_uid": "Code_10767", + "code": "C82535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Test Method" + }, + { + "id": 237014, + "soa_id": 60, + "code_uid": "Code_10768", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 237015, + "soa_id": 60, + "code_uid": "Code_10769", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 237016, + "soa_id": 60, + "code_uid": "Code_10770", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237017, + "soa_id": 60, + "code_uid": "Code_10771", + "code": "C117411", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Group Identifier" + }, + { + "id": 237018, + "soa_id": 60, + "code_uid": "Code_10772", + "code": "C117419", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Reference Identifier" + }, + { + "id": 237019, + "soa_id": 60, + "code_uid": "Code_10773", + "code": "C117412", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Link Group" + }, + { + "id": 237020, + "soa_id": 60, + "code_uid": "Code_10774", + "code": "C117413", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Link Identifier" + }, + { + "id": 237021, + "soa_id": 60, + "code_uid": "Code_10775", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237022, + "soa_id": 60, + "code_uid": "Code_10776", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 237023, + "soa_id": 60, + "code_uid": "Code_10777", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 237024, + "soa_id": 60, + "code_uid": "Code_10778", + "code": "C82535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Test Method" + }, + { + "id": 237025, + "soa_id": 60, + "code_uid": "Code_10779", + "code": "C42578", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Length" + }, + { + "id": 237026, + "soa_id": 60, + "code_uid": "Code_10780", + "code": "C117043", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator Identifier" + }, + { + "id": 237027, + "soa_id": 60, + "code_uid": "Code_10781", + "code": "C51824", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Evaluator" + }, + { + "id": 237028, + "soa_id": 60, + "code_uid": "Code_10782", + "code": "C117419", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Reference Identifier" + }, + { + "id": 237029, + "soa_id": 60, + "code_uid": "Code_10783", + "code": "C117412", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Link Group" + }, + { + "id": 237030, + "soa_id": 60, + "code_uid": "Code_10784", + "code": "C117413", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Link Identifier" + }, + { + "id": 237031, + "soa_id": 60, + "code_uid": "Code_10785", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237032, + "soa_id": 60, + "code_uid": "Code_10786", + "code": "C42578", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Length" + }, + { + "id": 237033, + "soa_id": 60, + "code_uid": "Code_10787", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237034, + "soa_id": 60, + "code_uid": "Code_10788", + "code": "C117411", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Tumor Results Group Identifier" + }, + { + "id": 237035, + "soa_id": 60, + "code_uid": "Code_10789", + "code": "C82535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Test Method" + }, + { + "id": 237036, + "soa_id": 60, + "code_uid": "Code_10790", + "code": "C45997", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "pH" + }, + { + "id": 237037, + "soa_id": 60, + "code_uid": "Code_10791", + "code": "C64546", + "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", + "code_system_version": "2025-11-18", + "decode": "Color Assessment" + }, + { + "id": 237038, + "soa_id": 60, + "code_uid": "Code_10792", + "code": "C64832", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Specific Gravity" + }, + { + "id": 237039, + "soa_id": 60, + "code_uid": "Code_10793", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237040, + "soa_id": 60, + "code_uid": "Code_10794", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237041, + "soa_id": 60, + "code_uid": "Code_10795", + "code": "C13283", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "URINE" + }, + { + "id": 237042, + "soa_id": 60, + "code_uid": "Code_10796", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237043, + "soa_id": 60, + "code_uid": "Code_10797", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237044, + "soa_id": 60, + "code_uid": "Code_10798", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237045, + "soa_id": 60, + "code_uid": "Code_10799", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237046, + "soa_id": 60, + "code_uid": "Code_10800", + "code": "C13283", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "URINE" + }, + { + "id": 237047, + "soa_id": 60, + "code_uid": "Code_10801", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237048, + "soa_id": 60, + "code_uid": "Code_10802", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237049, + "soa_id": 60, + "code_uid": "Code_10803", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237050, + "soa_id": 60, + "code_uid": "Code_10804", + "code": "C13283", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "URINE" + }, + { + "id": 237051, + "soa_id": 60, + "code_uid": "Code_10805", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237052, + "soa_id": 60, + "code_uid": "Code_10806", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237053, + "soa_id": 60, + "code_uid": "Code_10807", + "code": "C64796", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Hematocrit Measurement" + }, + { + "id": 237054, + "soa_id": 60, + "code_uid": "Code_10808", + "code": "C64848", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Hemoglobin Measurement" + }, + { + "id": 237055, + "soa_id": 60, + "code_uid": "Code_10809", + "code": "C64797", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Erythrocyte Mean Corpuscular Hemoglobin" + }, + { + "id": 237056, + "soa_id": 60, + "code_uid": "Code_10810", + "code": "C51949", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Lymphocyte Count" + }, + { + "id": 237057, + "soa_id": 60, + "code_uid": "Code_10811", + "code": "C64823", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Monocyte Count" + }, + { + "id": 237058, + "soa_id": 60, + "code_uid": "Code_10812", + "code": "C63321", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Absolute Neutrophil Count" + }, + { + "id": 237059, + "soa_id": 60, + "code_uid": "Code_10813", + "code": "C64470", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Absolute Basophil Count" + }, + { + "id": 237060, + "soa_id": 60, + "code_uid": "Code_10814", + "code": "C64550", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Eosinophil Count" + }, + { + "id": 237061, + "soa_id": 60, + "code_uid": "Code_10815", + "code": "C64830", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Neutrophil Band Form Count" + }, + { + "id": 237062, + "soa_id": 60, + "code_uid": "Code_10816", + "code": "C111361", + "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", + "code_system_version": "2026-03-31", + "decode": "Forced Vital Capacity" + }, + { + "id": 237063, + "soa_id": 60, + "code_uid": "Code_10817", + "code": "C38084", + "code_system": "/mdr/bc/packages/2026-05-26/biomedicalconcepts", + "code_system_version": "2026-05-26", + "decode": "Forced Expiratory Volume in 1 Second" + }, + { + "id": 237064, + "soa_id": 60, + "code_uid": "Code_10818", + "code": "C47843", + "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", + "code_system_version": "2026-03-31", + "decode": "Forced Expiratory Volume in 6 Seconds" + }, + { + "id": 237065, + "soa_id": 60, + "code_uid": "Code_10819", + "code": "C41372", + "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", + "code_system_version": "2026-03-31", + "decode": "Peak Expiratory Flow" + }, + { + "id": 237066, + "soa_id": 60, + "code_uid": "Code_10820", + "code": "C111324", + "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", + "code_system_version": "2026-03-31", + "decode": "Tidal Volume" + }, + { + "id": 237067, + "soa_id": 60, + "code_uid": "Code_10821", + "code": "C111362", + "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", + "code_system_version": "2026-03-31", + "decode": "Inspiratory Capacity" + }, + { + "id": 237068, + "soa_id": 60, + "code_uid": "Code_10822", + "code": "C111200", + "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", + "code_system_version": "2026-03-31", + "decode": "Expiratory Reserve Volume" + }, + { + "id": 237069, + "soa_id": 60, + "code_uid": "Code_10823", + "code": "C111237", + "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", + "code_system_version": "2026-03-31", + "decode": "Inspiratory Reserve Volume" + }, + { + "id": 237070, + "soa_id": 60, + "code_uid": "Code_10824", + "code": "C111315", + "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", + "code_system_version": "2026-03-31", + "decode": "Slow Vital Capacity" + }, + { + "id": 237072, + "soa_id": 60, + "code_uid": "Code_10826", + "code": "C64857", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Phosphate Measurement" + }, + { + "id": 237073, + "soa_id": 60, + "code_uid": "Code_10827", + "code": "C74711", + "code_system": "/mdr/bc/packages/2026-07-14/biomedicalconcepts", + "code_system_version": "2026-07-14", + "decode": "Hepatitis B Surface Antibody Measurement" + }, + { + "id": 237074, + "soa_id": 60, + "code_uid": "Code_10828", + "code": "C142330", + "code_system": "/mdr/bc/packages/2026-07-14/biomedicalconcepts", + "code_system_version": "2026-07-14", + "decode": "Hepatitis C Virus RNA Measurement" + }, + { + "id": 237075, + "soa_id": 60, + "code_uid": "Code_10829", + "code": "C103404", + "code_system": "/mdr/bc/packages/2026-07-14/biomedicalconcepts", + "code_system_version": "2026-07-14", + "decode": "Hepatitis B DNA Measurement" + }, + { + "id": 237076, + "soa_id": 60, + "code_uid": "Code_10830", + "code": "C64799", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Erythrocyte Mean Corpuscular Volume" + }, + { + "id": 237077, + "soa_id": 60, + "code_uid": "Code_10831", + "code": "C83118", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-12-16", + "decode": "Medical History Reported Term" + }, + { + "id": 237078, + "soa_id": 60, + "code_uid": "Code_10832", + "code": "C83346", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-12-16", + "decode": "Medical History Dictionary Derived Term" + }, + { + "id": 237079, + "soa_id": 60, + "code_uid": "Code_10833", + "code": "C83338", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-12-16", + "decode": "Medical History Event Start Date Time" + }, + { + "id": 237080, + "soa_id": 60, + "code_uid": "Code_10834", + "code": "C83330", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-12-16", + "decode": "Medical History Event End Date Time" + }, + { + "id": 237081, + "soa_id": 60, + "code_uid": "Code_10835", + "code": "C82557", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-12-16", + "decode": "End Relative to Reference Period" + }, + { + "id": 237082, + "soa_id": 60, + "code_uid": "Code_10836", + "code": "C82558", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-12-16", + "decode": "End Relative to Reference Time Point" + }, + { + "id": 237083, + "soa_id": 60, + "code_uid": "Code_10837", + "code": "C82574", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-12-16", + "decode": "Reference End Time Point End" + }, + { + "id": 237109, + "soa_id": 60, + "code_uid": "Code_10863", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237110, + "soa_id": 60, + "code_uid": "Code_10864", + "code": "C69174", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volume Fraction" + }, + { + "id": 237111, + "soa_id": 60, + "code_uid": "Code_10865", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237112, + "soa_id": 60, + "code_uid": "Code_10866", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 237113, + "soa_id": 60, + "code_uid": "Code_10867", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237114, + "soa_id": 60, + "code_uid": "Code_10868", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237115, + "soa_id": 60, + "code_uid": "Code_10869", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237116, + "soa_id": 60, + "code_uid": "Code_10870", + "code": "C64571", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Mass Concentration" + }, + { + "id": 237117, + "soa_id": 60, + "code_uid": "Code_10871", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237118, + "soa_id": 60, + "code_uid": "Code_10872", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 237119, + "soa_id": 60, + "code_uid": "Code_10873", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237120, + "soa_id": 60, + "code_uid": "Code_10874", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237121, + "soa_id": 60, + "code_uid": "Code_10875", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237122, + "soa_id": 60, + "code_uid": "Code_10876", + "code": "C25709", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Measure" + }, + { + "id": 237123, + "soa_id": 60, + "code_uid": "Code_10877", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237124, + "soa_id": 60, + "code_uid": "Code_10878", + "code": "C12521", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "ERYTHROCYTES" + }, + { + "id": 237125, + "soa_id": 60, + "code_uid": "Code_10879", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237126, + "soa_id": 60, + "code_uid": "Code_10880", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237127, + "soa_id": 60, + "code_uid": "Code_10881", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237128, + "soa_id": 60, + "code_uid": "Code_10882", + "code": "C67391", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Number Concentration" + }, + { + "id": 237129, + "soa_id": 60, + "code_uid": "Code_10883", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237130, + "soa_id": 60, + "code_uid": "Code_10884", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 237131, + "soa_id": 60, + "code_uid": "Code_10885", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237132, + "soa_id": 60, + "code_uid": "Code_10886", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237133, + "soa_id": 60, + "code_uid": "Code_10887", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237134, + "soa_id": 60, + "code_uid": "Code_10888", + "code": "C67391", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Number Concentration" + }, + { + "id": 237135, + "soa_id": 60, + "code_uid": "Code_10889", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237136, + "soa_id": 60, + "code_uid": "Code_10890", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 237137, + "soa_id": 60, + "code_uid": "Code_10891", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237138, + "soa_id": 60, + "code_uid": "Code_10892", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237139, + "soa_id": 60, + "code_uid": "Code_10893", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237140, + "soa_id": 60, + "code_uid": "Code_10894", + "code": "C67391", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Number Concentration" + }, + { + "id": 237141, + "soa_id": 60, + "code_uid": "Code_10895", + "code": "C67255", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "10^9/L" + }, + { + "id": 237142, + "soa_id": 60, + "code_uid": "Code_10896", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237143, + "soa_id": 60, + "code_uid": "Code_10897", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 237144, + "soa_id": 60, + "code_uid": "Code_10898", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237145, + "soa_id": 60, + "code_uid": "Code_10899", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237146, + "soa_id": 60, + "code_uid": "Code_10900", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237147, + "soa_id": 60, + "code_uid": "Code_10901", + "code": "C67391", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Number Concentration" + }, + { + "id": 237148, + "soa_id": 60, + "code_uid": "Code_10902", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237149, + "soa_id": 60, + "code_uid": "Code_10903", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 237150, + "soa_id": 60, + "code_uid": "Code_10904", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237151, + "soa_id": 60, + "code_uid": "Code_10905", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237152, + "soa_id": 60, + "code_uid": "Code_10906", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237153, + "soa_id": 60, + "code_uid": "Code_10907", + "code": "C67391", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Number Concentration" + }, + { + "id": 237154, + "soa_id": 60, + "code_uid": "Code_10908", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237155, + "soa_id": 60, + "code_uid": "Code_10909", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 237156, + "soa_id": 60, + "code_uid": "Code_10910", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237157, + "soa_id": 60, + "code_uid": "Code_10911", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237158, + "soa_id": 60, + "code_uid": "Code_10912", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237159, + "soa_id": 60, + "code_uid": "Code_10913", + "code": "C67391", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Number Concentration" + }, + { + "id": 237160, + "soa_id": 60, + "code_uid": "Code_10914", + "code": "C67452", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "10^6/L" + }, + { + "id": 237161, + "soa_id": 60, + "code_uid": "Code_10915", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237162, + "soa_id": 60, + "code_uid": "Code_10916", + "code": "C12434", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "BLOOD" + }, + { + "id": 237163, + "soa_id": 60, + "code_uid": "Code_10917", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237164, + "soa_id": 60, + "code_uid": "Code_10918", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237165, + "soa_id": 60, + "code_uid": "Code_10919", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237166, + "soa_id": 60, + "code_uid": "Code_10920", + "code": "C44279", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volume" + }, + { + "id": 237167, + "soa_id": 60, + "code_uid": "Code_10921", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237168, + "soa_id": 60, + "code_uid": "Code_10922", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237169, + "soa_id": 60, + "code_uid": "Code_10923", + "code": "C44279", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volume" + }, + { + "id": 237170, + "soa_id": 60, + "code_uid": "Code_10924", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237171, + "soa_id": 60, + "code_uid": "Code_10925", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237172, + "soa_id": 60, + "code_uid": "Code_10926", + "code": "C44279", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volume" + }, + { + "id": 237173, + "soa_id": 60, + "code_uid": "Code_10927", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237174, + "soa_id": 60, + "code_uid": "Code_10928", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237175, + "soa_id": 60, + "code_uid": "Code_10929", + "code": "C48568", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volumetric Flow Rate" + }, + { + "id": 237176, + "soa_id": 60, + "code_uid": "Code_10930", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237177, + "soa_id": 60, + "code_uid": "Code_10931", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237178, + "soa_id": 60, + "code_uid": "Code_10932", + "code": "C44279", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volume" + }, + { + "id": 237179, + "soa_id": 60, + "code_uid": "Code_10933", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237180, + "soa_id": 60, + "code_uid": "Code_10934", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237181, + "soa_id": 60, + "code_uid": "Code_10935", + "code": "C44279", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volume" + }, + { + "id": 237182, + "soa_id": 60, + "code_uid": "Code_10936", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237183, + "soa_id": 60, + "code_uid": "Code_10937", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237184, + "soa_id": 60, + "code_uid": "Code_10938", + "code": "C44279", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volume" + }, + { + "id": 237185, + "soa_id": 60, + "code_uid": "Code_10939", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237186, + "soa_id": 60, + "code_uid": "Code_10940", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237187, + "soa_id": 60, + "code_uid": "Code_10941", + "code": "C44279", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volume" + }, + { + "id": 237188, + "soa_id": 60, + "code_uid": "Code_10942", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237189, + "soa_id": 60, + "code_uid": "Code_10943", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237190, + "soa_id": 60, + "code_uid": "Code_10944", + "code": "C44279", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volume" + }, + { + "id": 237191, + "soa_id": 60, + "code_uid": "Code_10945", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237195, + "soa_id": 60, + "code_uid": "Code_10949", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237196, + "soa_id": 60, + "code_uid": "Code_10950", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Concentration" + }, + { + "id": 237197, + "soa_id": 60, + "code_uid": "Code_10951", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237198, + "soa_id": 60, + "code_uid": "Code_10952", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "SERUM OR PLASMA" + }, + { + "id": 237199, + "soa_id": 60, + "code_uid": "Code_10953", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237200, + "soa_id": 60, + "code_uid": "Code_10954", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237201, + "soa_id": 60, + "code_uid": "Code_10955", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Collection Date Time" + }, + { + "id": 237202, + "soa_id": 60, + "code_uid": "Code_10956", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Observation Result" + }, + { + "id": 237203, + "soa_id": 60, + "code_uid": "Code_10957", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Unit of Concentration" + }, + { + "id": 237204, + "soa_id": 60, + "code_uid": "Code_10958", + "code": "C117062", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Measurement, Test or Examination Detail" + }, + { + "id": 237205, + "soa_id": 60, + "code_uid": "Code_10959", + "code": "C82535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Test Method" + }, + { + "id": 237206, + "soa_id": 60, + "code_uid": "Code_10960", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Biospecimen Type" + }, + { + "id": 237207, + "soa_id": 60, + "code_uid": "Code_10961", + "code": "C117062", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Measurement, Test or Examination Detail" + }, + { + "id": 237208, + "soa_id": 60, + "code_uid": "Code_10962", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Observation Result" + }, + { + "id": 237209, + "soa_id": 60, + "code_uid": "Code_10963", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Unit of Concentration" + }, + { + "id": 237210, + "soa_id": 60, + "code_uid": "Code_10964", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Biospecimen Type" + }, + { + "id": 237211, + "soa_id": 60, + "code_uid": "Code_10965", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "SERUM OR PLASMA" + }, + { + "id": 237212, + "soa_id": 60, + "code_uid": "Code_10966", + "code": "C82535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Test Method" + }, + { + "id": 237213, + "soa_id": 60, + "code_uid": "Code_10967", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Collection Date Time" + }, + { + "id": 237214, + "soa_id": 60, + "code_uid": "Code_10968", + "code": "C117062", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Measurement, Test or Examination Detail" + }, + { + "id": 237215, + "soa_id": 60, + "code_uid": "Code_10969", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Observation Result" + }, + { + "id": 237216, + "soa_id": 60, + "code_uid": "Code_10970", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Unit of Concentration" + }, + { + "id": 237217, + "soa_id": 60, + "code_uid": "Code_10971", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Biospecimen Type" + }, + { + "id": 237218, + "soa_id": 60, + "code_uid": "Code_10972", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "SERUM OR PLASMA" + }, + { + "id": 237219, + "soa_id": 60, + "code_uid": "Code_10973", + "code": "C82535", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Test Method" + }, + { + "id": 237220, + "soa_id": 60, + "code_uid": "Code_10974", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Collection Date Time" + }, + { + "id": 237221, + "soa_id": 60, + "code_uid": "Code_10975", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237222, + "soa_id": 60, + "code_uid": "Code_10976", + "code": "C44279", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volume" + }, + { + "id": 237223, + "soa_id": 60, + "code_uid": "Code_10977", + "code": "C64780", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "fL" + }, + { + "id": 237224, + "soa_id": 60, + "code_uid": "Code_10978", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Biospecimen Type" + }, + { + "id": 237225, + "soa_id": 60, + "code_uid": "Code_10979", + "code": "C12521", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "ERYTHROCYTES" + }, + { + "id": 237226, + "soa_id": 60, + "code_uid": "Code_10980", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Fasting Status Indicator" + }, + { + "id": 237227, + "soa_id": 60, + "code_uid": "Code_10981", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237229, + "soa_id": 60, + "code_uid": "Code_10983", + "code": "C200145", + "code_system": "/mdr/bc/packages/2026-07-14/biomedicalconcepts", + "code_system_version": "2026-07-14", + "decode": "Solicited Medical History" + }, + { + "id": 237230, + "soa_id": 60, + "code_uid": "Code_10984", + "code": "C64840", + "code_system": "/mdr/bc/packages/2026-07-14/biomedicalconcepts", + "code_system_version": "2026-07-14", + "decode": "Magnesium Measurement" + }, + { + "id": 237231, + "soa_id": 60, + "code_uid": "Code_10985", + "code": "C117466", + "code_system": "/mdr/bc/packages/2023-10-03/biomedicalconcepts", + "code_system_version": "2023-10-03", + "decode": "Exposure as Collected Domain" + }, + { + "id": 237232, + "soa_id": 60, + "code_uid": "Code_10986", + "code": "C179175", + "code_system": "/mdr/bc/packages/2025-07-01/biomedicalconcepts", + "code_system_version": "2025-07-01", + "decode": "Solicited Adverse Event" + }, + { + "id": 237233, + "soa_id": 60, + "code_uid": "Code_10987", + "code": "C164634", + "code_system": "/mdr/bc/packages/2025-11-18/biomedicalconcepts", + "code_system_version": "2025-11-18", + "decode": "Body Height" + }, + { + "id": 237234, + "soa_id": 60, + "code_uid": "Code_10988", + "code": "C38083", + "code_system": "/mdr/bc/packages/2026-03-31/biomedicalconcepts", + "code_system_version": "2026-03-31", + "decode": "Carbon Monoxide Diffusing Capability Test" + }, + { + "id": 237235, + "soa_id": 60, + "code_uid": "Code_10989", + "code": "C83118", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Medical History Reported Term" + }, + { + "id": 237236, + "soa_id": 60, + "code_uid": "Code_10990", + "code": "C83346", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Medical History Dictionary Derived Term" + }, + { + "id": 237237, + "soa_id": 60, + "code_uid": "Code_10991", + "code": "C171000", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Prespecified Event or Intervention Indicator" + }, + { + "id": 237238, + "soa_id": 60, + "code_uid": "Code_10992", + "code": "C127786", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Occurrence Indicator" + }, + { + "id": 237239, + "soa_id": 60, + "code_uid": "Code_10993", + "code": "C219752", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Medical History Event Date Type" + }, + { + "id": 237240, + "soa_id": 60, + "code_uid": "Code_10994", + "code": "C15220", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "DIAGNOSIS" + }, + { + "id": 237241, + "soa_id": 60, + "code_uid": "Code_10995", + "code": "C83338", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Medical History Event Start Date Time" + }, + { + "id": 237242, + "soa_id": 60, + "code_uid": "Code_10996", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Observation Result" + }, + { + "id": 237243, + "soa_id": 60, + "code_uid": "Code_10997", + "code": "C48207", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Unit of Concentration" + }, + { + "id": 237244, + "soa_id": 60, + "code_uid": "Code_10998", + "code": "C70713", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Biospecimen Type" + }, + { + "id": 237245, + "soa_id": 60, + "code_uid": "Code_10999", + "code": "C105706", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "SERUM OR PLASMA" + }, + { + "id": 237246, + "soa_id": 60, + "code_uid": "Code_11000", + "code": "C93566", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Fasting Status Indicator" + }, + { + "id": 237247, + "soa_id": 60, + "code_uid": "Code_11001", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-07-14", + "decode": "Collection Date Time" + }, + { + "id": 237248, + "soa_id": 60, + "code_uid": "Code_11002", + "code": "C117473", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Name of Treatment" + }, + { + "id": 237249, + "soa_id": 60, + "code_uid": "Code_11003", + "code": "C117469", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Reference Identifier" + }, + { + "id": 237250, + "soa_id": 60, + "code_uid": "Code_11004", + "code": "C117479", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Dose" + }, + { + "id": 237251, + "soa_id": 60, + "code_uid": "Code_11005", + "code": "C117480", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Dose Description" + }, + { + "id": 237252, + "soa_id": 60, + "code_uid": "Code_11006", + "code": "C117481", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Dose Units" + }, + { + "id": 237253, + "soa_id": 60, + "code_uid": "Code_11007", + "code": "C117482", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Dose Form" + }, + { + "id": 237254, + "soa_id": 60, + "code_uid": "Code_11008", + "code": "C117483", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Dosing Frequency per Interval" + }, + { + "id": 237255, + "soa_id": 60, + "code_uid": "Code_11009", + "code": "C117485", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Intended Dose Regimen" + }, + { + "id": 237256, + "soa_id": 60, + "code_uid": "Code_11010", + "code": "C117486", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Route of Administration" + }, + { + "id": 237257, + "soa_id": 60, + "code_uid": "Code_11011", + "code": "C117488", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Location" + }, + { + "id": 237258, + "soa_id": 60, + "code_uid": "Code_11012", + "code": "C117489", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Laterality" + }, + { + "id": 237259, + "soa_id": 60, + "code_uid": "Code_11013", + "code": "C117490", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Directionality" + }, + { + "id": 237260, + "soa_id": 60, + "code_uid": "Code_11014", + "code": "C117496", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected Start Date and Time of Treatment" + }, + { + "id": 237261, + "soa_id": 60, + "code_uid": "Code_11015", + "code": "C117497", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Exposure as Collected End Date and Time of Treatment" + }, + { + "id": 237262, + "soa_id": 60, + "code_uid": "Code_11016", + "code": "C78541", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Verbatim Description" + }, + { + "id": 237263, + "soa_id": 60, + "code_uid": "Code_11017", + "code": "C83344", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Dictionary Derived Term" + }, + { + "id": 237264, + "soa_id": 60, + "code_uid": "Code_11018", + "code": "C87840", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Pre-specified" + }, + { + "id": 237265, + "soa_id": 60, + "code_uid": "Code_11019", + "code": "C83205", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Location" + }, + { + "id": 237266, + "soa_id": 60, + "code_uid": "Code_11020", + "code": "C53253", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Severity of Adverse Event" + }, + { + "id": 237267, + "soa_id": 60, + "code_uid": "Code_11021", + "code": "C53252", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Seriousness of Adverse Event" + }, + { + "id": 237268, + "soa_id": 60, + "code_uid": "Code_11022", + "code": "C83013", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Action Taken with Study Treatment" + }, + { + "id": 237269, + "soa_id": 60, + "code_uid": "Code_11023", + "code": "C83109", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Other Actions taken in Response to Adverse Event" + }, + { + "id": 237270, + "soa_id": 60, + "code_uid": "Code_11024", + "code": "C41358", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Attribution to Product or Procedure" + }, + { + "id": 237271, + "soa_id": 60, + "code_uid": "Code_11025", + "code": "C83210", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Relationship to Non Study Treatment" + }, + { + "id": 237272, + "soa_id": 60, + "code_uid": "Code_11026", + "code": "C83208", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Pattern" + }, + { + "id": 237273, + "soa_id": 60, + "code_uid": "Code_11027", + "code": "C49489", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Outcome" + }, + { + "id": 237274, + "soa_id": 60, + "code_uid": "Code_11028", + "code": "C83211", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Involves Cancer" + }, + { + "id": 237275, + "soa_id": 60, + "code_uid": "Code_11029", + "code": "C83117", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Seriousness Due to Congenital Anomaly" + }, + { + "id": 237276, + "soa_id": 60, + "code_uid": "Code_11030", + "code": "C113380", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Disabling Adverse Event" + }, + { + "id": 237277, + "soa_id": 60, + "code_uid": "Code_11031", + "code": "C48275", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Death Related to Adverse Event" + }, + { + "id": 237278, + "soa_id": 60, + "code_uid": "Code_11032", + "code": "C83052", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event associated with Hospitalization" + }, + { + "id": 237279, + "soa_id": 60, + "code_uid": "Code_11033", + "code": "C84266", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Life Threatening Adverse Event" + }, + { + "id": 237280, + "soa_id": 60, + "code_uid": "Code_11034", + "code": "C83214", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Occurred with Overdose" + }, + { + "id": 237281, + "soa_id": 60, + "code_uid": "Code_11035", + "code": "C83053", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Associated with Serious Medical Event" + }, + { + "id": 237282, + "soa_id": 60, + "code_uid": "Code_11036", + "code": "C83199", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Concomitant Treatment" + }, + { + "id": 237283, + "soa_id": 60, + "code_uid": "Code_11037", + "code": "C78605", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Toxicity Grade" + }, + { + "id": 237284, + "soa_id": 60, + "code_uid": "Code_11038", + "code": "C83215", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event Start Date Time" + }, + { + "id": 237285, + "soa_id": 60, + "code_uid": "Code_11039", + "code": "C83201", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Adverse Event End Date Time" + }, + { + "id": 237286, + "soa_id": 60, + "code_uid": "Code_11040", + "code": "C82557", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "End Relative to Reference Period" + }, + { + "id": 237287, + "soa_id": 60, + "code_uid": "Code_11041", + "code": "C82558", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "End Relative to Reference Time Point" + }, + { + "id": 237288, + "soa_id": 60, + "code_uid": "Code_11042", + "code": "C82574", + "code_system": "http://www.cdisc.org", + "code_system_version": "2025-07-01", + "decode": "Reference End Time Point End" + }, + { + "id": 237289, + "soa_id": 60, + "code_uid": "Code_11043", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237290, + "soa_id": 60, + "code_uid": "Code_11044", + "code": "C168688", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Height" + }, + { + "id": 237291, + "soa_id": 60, + "code_uid": "Code_11045", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + }, + { + "id": 237292, + "soa_id": 60, + "code_uid": "Code_11046", + "code": "C70856", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Observation Result" + }, + { + "id": 237293, + "soa_id": 60, + "code_uid": "Code_11047", + "code": "C44279", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Unit of Volume" + }, + { + "id": 237294, + "soa_id": 60, + "code_uid": "Code_11048", + "code": "C82515", + "code_system": "http://www.cdisc.org", + "code_system_version": "2026-05-26", + "decode": "Collection Date Time" + } + ], + "alias_code": [ + { + "id": 2125, + "soa_id": 60, + "alias_code_uid": "AliasCode_1", + "standard_code": "Code_8" + }, + { + "id": 2130, + "soa_id": 60, + "alias_code_uid": "AliasCode_6", + "standard_code": "Code_13" + }, + { + "id": 2137, + "soa_id": 60, + "alias_code_uid": "AliasCode_13", + "standard_code": "Code_20" + }, + { + "id": 2145, + "soa_id": 60, + "alias_code_uid": "AliasCode_21", + "standard_code": "Code_28" + }, + { + "id": 2146, + "soa_id": 60, + "alias_code_uid": "AliasCode_22", + "standard_code": "Code_29" + }, + { + "id": 2158, + "soa_id": 60, + "alias_code_uid": "AliasCode_34", + "standard_code": "Code_41" + }, + { + "id": 2170, + "soa_id": 60, + "alias_code_uid": "AliasCode_46", + "standard_code": "Code_53" + }, + { + "id": 2493, + "soa_id": 60, + "alias_code_uid": "AliasCode_369", + "standard_code": "Code_376" + }, + { + "id": 2502, + "soa_id": 60, + "alias_code_uid": "AliasCode_378", + "standard_code": "Code_385" + }, + { + "id": 2556, + "soa_id": 60, + "alias_code_uid": "AliasCode_432", + "standard_code": "Code_439" + }, + { + "id": 2586, + "soa_id": 60, + "alias_code_uid": "AliasCode_462", + "standard_code": "Code_469" + }, + { + "id": 2602, + "soa_id": 60, + "alias_code_uid": "AliasCode_469", + "standard_code": "Code_509" + }, + { + "id": 2678, + "soa_id": 60, + "alias_code_uid": "AliasCode_534", + "standard_code": "Code_574" + }, + { + "id": 2691, + "soa_id": 60, + "alias_code_uid": "AliasCode_547", + "standard_code": "Code_587" + }, + { + "id": 2704, + "soa_id": 60, + "alias_code_uid": "AliasCode_560", + "standard_code": "Code_600" + }, + { + "id": 2718, + "soa_id": 60, + "alias_code_uid": "AliasCode_574", + "standard_code": "Code_614" + }, + { + "id": 2744, + "soa_id": 60, + "alias_code_uid": "AliasCode_600", + "standard_code": "Code_640" + }, + { + "id": 2770, + "soa_id": 60, + "alias_code_uid": "AliasCode_626", + "standard_code": "Code_666" + }, + { + "id": 2783, + "soa_id": 60, + "alias_code_uid": "AliasCode_639", + "standard_code": "Code_679" + }, + { + "id": 2835, + "soa_id": 60, + "alias_code_uid": "AliasCode_691", + "standard_code": "Code_731" + }, + { + "id": 2848, + "soa_id": 60, + "alias_code_uid": "AliasCode_704", + "standard_code": "Code_744" + }, + { + "id": 2874, + "soa_id": 60, + "alias_code_uid": "AliasCode_717", + "standard_code": "Code_757" + }, + { + "id": 2887, + "soa_id": 60, + "alias_code_uid": "AliasCode_730", + "standard_code": "Code_770" + }, + { + "id": 2888, + "soa_id": 60, + "alias_code_uid": "AliasCode_731", + "standard_code": "Code_771" + }, + { + "id": 2902, + "soa_id": 60, + "alias_code_uid": "AliasCode_745", + "standard_code": "Code_785" + }, + { + "id": 2911, + "soa_id": 60, + "alias_code_uid": "AliasCode_754", + "standard_code": "Code_794" + }, + { + "id": 21461, + "soa_id": 60, + "alias_code_uid": "AliasCode_764", + "standard_code": "Code_804" + }, + { + "id": 21462, + "soa_id": 60, + "alias_code_uid": "AliasCode_765", + "standard_code": "Code_805" + }, + { + "id": 21463, + "soa_id": 60, + "alias_code_uid": "AliasCode_766", + "standard_code": "Code_806" + }, + { + "id": 21464, + "soa_id": 60, + "alias_code_uid": "AliasCode_767", + "standard_code": "Code_807" + }, + { + "id": 21465, + "soa_id": 60, + "alias_code_uid": "AliasCode_768", + "standard_code": "Code_808" + }, + { + "id": 21466, + "soa_id": 60, + "alias_code_uid": "AliasCode_769", + "standard_code": "Code_809" + }, + { + "id": 21467, + "soa_id": 60, + "alias_code_uid": "AliasCode_770", + "standard_code": "Code_810" + }, + { + "id": 21468, + "soa_id": 60, + "alias_code_uid": "AliasCode_771", + "standard_code": "Code_811" + }, + { + "id": 21469, + "soa_id": 60, + "alias_code_uid": "AliasCode_772", + "standard_code": "Code_812" + }, + { + "id": 21470, + "soa_id": 60, + "alias_code_uid": "AliasCode_773", + "standard_code": "Code_813" + }, + { + "id": 21471, + "soa_id": 60, + "alias_code_uid": "AliasCode_774", + "standard_code": "Code_814" + }, + { + "id": 21472, + "soa_id": 60, + "alias_code_uid": "AliasCode_775", + "standard_code": "Code_815" + }, + { + "id": 21473, + "soa_id": 60, + "alias_code_uid": "AliasCode_776", + "standard_code": "Code_816" + }, + { + "id": 21474, + "soa_id": 60, + "alias_code_uid": "AliasCode_777", + "standard_code": "Code_817" + }, + { + "id": 21475, + "soa_id": 60, + "alias_code_uid": "AliasCode_778", + "standard_code": "Code_818" + }, + { + "id": 21476, + "soa_id": 60, + "alias_code_uid": "AliasCode_779", + "standard_code": "Code_819" + }, + { + "id": 21477, + "soa_id": 60, + "alias_code_uid": "AliasCode_780", + "standard_code": "Code_820" + }, + { + "id": 21478, + "soa_id": 60, + "alias_code_uid": "AliasCode_781", + "standard_code": "Code_821" + }, + { + "id": 21479, + "soa_id": 60, + "alias_code_uid": "AliasCode_782", + "standard_code": "Code_822" + }, + { + "id": 21480, + "soa_id": 60, + "alias_code_uid": "AliasCode_783", + "standard_code": "Code_823" + }, + { + "id": 21481, + "soa_id": 60, + "alias_code_uid": "AliasCode_784", + "standard_code": "Code_824" + }, + { + "id": 25974, + "soa_id": 60, + "alias_code_uid": "AliasCode_785", + "standard_code": "Code_825" + }, + { + "id": 30930, + "soa_id": 60, + "alias_code_uid": "AliasCode_786", + "standard_code": "Code_826" + }, + { + "id": 148347, + "soa_id": 60, + "alias_code_uid": "AliasCode_5688", + "standard_code": "Code_5767" + }, + { + "id": 148348, + "soa_id": 60, + "alias_code_uid": "AliasCode_5689", + "standard_code": "Code_5768" + }, + { + "id": 148349, + "soa_id": 60, + "alias_code_uid": "AliasCode_5690", + "standard_code": "Code_5769" + }, + { + "id": 148354, + "soa_id": 60, + "alias_code_uid": "AliasCode_5695", + "standard_code": "Code_5774" + }, + { + "id": 148355, + "soa_id": 60, + "alias_code_uid": "AliasCode_5696", + "standard_code": "Code_5775" + }, + { + "id": 148356, + "soa_id": 60, + "alias_code_uid": "AliasCode_5697", + "standard_code": "Code_5776" + }, + { + "id": 148357, + "soa_id": 60, + "alias_code_uid": "AliasCode_5698", + "standard_code": "Code_5777" + }, + { + "id": 148358, + "soa_id": 60, + "alias_code_uid": "AliasCode_5699", + "standard_code": "Code_5778" + }, + { + "id": 148359, + "soa_id": 60, + "alias_code_uid": "AliasCode_5700", + "standard_code": "Code_5779" + }, + { + "id": 148360, + "soa_id": 60, + "alias_code_uid": "AliasCode_5701", + "standard_code": "Code_5780" + }, + { + "id": 148361, + "soa_id": 60, + "alias_code_uid": "AliasCode_5702", + "standard_code": "Code_5781" + }, + { + "id": 148362, + "soa_id": 60, + "alias_code_uid": "AliasCode_5703", + "standard_code": "Code_5782" + }, + { + "id": 148363, + "soa_id": 60, + "alias_code_uid": "AliasCode_5704", + "standard_code": "Code_5783" + }, + { + "id": 148364, + "soa_id": 60, + "alias_code_uid": "AliasCode_5705", + "standard_code": "Code_5784" + }, + { + "id": 148365, + "soa_id": 60, + "alias_code_uid": "AliasCode_5706", + "standard_code": "Code_5785" + }, + { + "id": 148366, + "soa_id": 60, + "alias_code_uid": "AliasCode_5707", + "standard_code": "Code_5786" + }, + { + "id": 163876, + "soa_id": 60, + "alias_code_uid": "AliasCode_7397", + "standard_code": "Code_7476" + }, + { + "id": 233307, + "soa_id": 60, + "alias_code_uid": "AliasCode_9354", + "standard_code": "Code_10029" + }, + { + "id": 233308, + "soa_id": 60, + "alias_code_uid": "AliasCode_9355", + "standard_code": "Code_10030" + }, + { + "id": 233332, + "soa_id": 60, + "alias_code_uid": "AliasCode_9357", + "standard_code": "Code_10032" + }, + { + "id": 235907, + "soa_id": 60, + "alias_code_uid": "AliasCode_9623", + "standard_code": "Code_10379" + }, + { + "id": 235908, + "soa_id": 60, + "alias_code_uid": "AliasCode_9624", + "standard_code": "Code_10380" + }, + { + "id": 235909, + "soa_id": 60, + "alias_code_uid": "AliasCode_9625", + "standard_code": "Code_10381" + }, + { + "id": 235910, + "soa_id": 60, + "alias_code_uid": "AliasCode_9626", + "standard_code": "Code_10382" + }, + { + "id": 235920, + "soa_id": 60, + "alias_code_uid": "AliasCode_9636", + "standard_code": "Code_10392" + }, + { + "id": 235921, + "soa_id": 60, + "alias_code_uid": "AliasCode_9637", + "standard_code": "Code_10393" + }, + { + "id": 235922, + "soa_id": 60, + "alias_code_uid": "AliasCode_9638", + "standard_code": "Code_10394" + }, + { + "id": 235923, + "soa_id": 60, + "alias_code_uid": "AliasCode_9639", + "standard_code": "Code_10395" + }, + { + "id": 235932, + "soa_id": 60, + "alias_code_uid": "AliasCode_9648", + "standard_code": "Code_10404" + }, + { + "id": 235933, + "soa_id": 60, + "alias_code_uid": "AliasCode_9649", + "standard_code": "Code_10405" + }, + { + "id": 235934, + "soa_id": 60, + "alias_code_uid": "AliasCode_9650", + "standard_code": "Code_10406" + }, + { + "id": 235935, + "soa_id": 60, + "alias_code_uid": "AliasCode_9651", + "standard_code": "Code_10407" + }, + { + "id": 235936, + "soa_id": 60, + "alias_code_uid": "AliasCode_9652", + "standard_code": "Code_10408" + }, + { + "id": 235937, + "soa_id": 60, + "alias_code_uid": "AliasCode_9653", + "standard_code": "Code_10409" + }, + { + "id": 235938, + "soa_id": 60, + "alias_code_uid": "AliasCode_9654", + "standard_code": "Code_10410" + }, + { + "id": 235939, + "soa_id": 60, + "alias_code_uid": "AliasCode_9655", + "standard_code": "Code_10411" + }, + { + "id": 235940, + "soa_id": 60, + "alias_code_uid": "AliasCode_9656", + "standard_code": "Code_10412" + }, + { + "id": 235941, + "soa_id": 60, + "alias_code_uid": "AliasCode_9657", + "standard_code": "Code_10413" + }, + { + "id": 235942, + "soa_id": 60, + "alias_code_uid": "AliasCode_9658", + "standard_code": "Code_10414" + }, + { + "id": 235943, + "soa_id": 60, + "alias_code_uid": "AliasCode_9659", + "standard_code": "Code_10415" + }, + { + "id": 235944, + "soa_id": 60, + "alias_code_uid": "AliasCode_9660", + "standard_code": "Code_10416" + }, + { + "id": 235945, + "soa_id": 60, + "alias_code_uid": "AliasCode_9661", + "standard_code": "Code_10417" + }, + { + "id": 235946, + "soa_id": 60, + "alias_code_uid": "AliasCode_9662", + "standard_code": "Code_10418" + }, + { + "id": 235947, + "soa_id": 60, + "alias_code_uid": "AliasCode_9663", + "standard_code": "Code_10419" + }, + { + "id": 235948, + "soa_id": 60, + "alias_code_uid": "AliasCode_9664", + "standard_code": "Code_10420" + }, + { + "id": 235949, + "soa_id": 60, + "alias_code_uid": "AliasCode_9665", + "standard_code": "Code_10421" + }, + { + "id": 235950, + "soa_id": 60, + "alias_code_uid": "AliasCode_9666", + "standard_code": "Code_10422" + }, + { + "id": 235951, + "soa_id": 60, + "alias_code_uid": "AliasCode_9667", + "standard_code": "Code_10423" + }, + { + "id": 235952, + "soa_id": 60, + "alias_code_uid": "AliasCode_9668", + "standard_code": "Code_10424" + }, + { + "id": 235953, + "soa_id": 60, + "alias_code_uid": "AliasCode_9669", + "standard_code": "Code_10425" + }, + { + "id": 235954, + "soa_id": 60, + "alias_code_uid": "AliasCode_9670", + "standard_code": "Code_10426" + }, + { + "id": 235955, + "soa_id": 60, + "alias_code_uid": "AliasCode_9671", + "standard_code": "Code_10427" + }, + { + "id": 235956, + "soa_id": 60, + "alias_code_uid": "AliasCode_9672", + "standard_code": "Code_10428" + }, + { + "id": 235957, + "soa_id": 60, + "alias_code_uid": "AliasCode_9673", + "standard_code": "Code_10429" + }, + { + "id": 235958, + "soa_id": 60, + "alias_code_uid": "AliasCode_9674", + "standard_code": "Code_10430" + }, + { + "id": 235959, + "soa_id": 60, + "alias_code_uid": "AliasCode_9675", + "standard_code": "Code_10431" + }, + { + "id": 235960, + "soa_id": 60, + "alias_code_uid": "AliasCode_9676", + "standard_code": "Code_10432" + }, + { + "id": 235961, + "soa_id": 60, + "alias_code_uid": "AliasCode_9677", + "standard_code": "Code_10433" + }, + { + "id": 235962, + "soa_id": 60, + "alias_code_uid": "AliasCode_9678", + "standard_code": "Code_10434" + }, + { + "id": 235963, + "soa_id": 60, + "alias_code_uid": "AliasCode_9679", + "standard_code": "Code_10435" + }, + { + "id": 235964, + "soa_id": 60, + "alias_code_uid": "AliasCode_9680", + "standard_code": "Code_10436" + }, + { + "id": 235965, + "soa_id": 60, + "alias_code_uid": "AliasCode_9681", + "standard_code": "Code_10437" + }, + { + "id": 235966, + "soa_id": 60, + "alias_code_uid": "AliasCode_9682", + "standard_code": "Code_10438" + }, + { + "id": 235967, + "soa_id": 60, + "alias_code_uid": "AliasCode_9683", + "standard_code": "Code_10439" + }, + { + "id": 235968, + "soa_id": 60, + "alias_code_uid": "AliasCode_9684", + "standard_code": "Code_10440" + }, + { + "id": 235969, + "soa_id": 60, + "alias_code_uid": "AliasCode_9685", + "standard_code": "Code_10441" + }, + { + "id": 235970, + "soa_id": 60, + "alias_code_uid": "AliasCode_9686", + "standard_code": "Code_10442" + }, + { + "id": 235971, + "soa_id": 60, + "alias_code_uid": "AliasCode_9687", + "standard_code": "Code_10443" + }, + { + "id": 235972, + "soa_id": 60, + "alias_code_uid": "AliasCode_9688", + "standard_code": "Code_10444" + }, + { + "id": 235973, + "soa_id": 60, + "alias_code_uid": "AliasCode_9689", + "standard_code": "Code_10445" + }, + { + "id": 235974, + "soa_id": 60, + "alias_code_uid": "AliasCode_9690", + "standard_code": "Code_10446" + }, + { + "id": 235975, + "soa_id": 60, + "alias_code_uid": "AliasCode_9691", + "standard_code": "Code_10447" + }, + { + "id": 235976, + "soa_id": 60, + "alias_code_uid": "AliasCode_9692", + "standard_code": "Code_10448" + }, + { + "id": 235977, + "soa_id": 60, + "alias_code_uid": "AliasCode_9693", + "standard_code": "Code_10449" + }, + { + "id": 235978, + "soa_id": 60, + "alias_code_uid": "AliasCode_9694", + "standard_code": "Code_10450" + }, + { + "id": 235979, + "soa_id": 60, + "alias_code_uid": "AliasCode_9695", + "standard_code": "Code_10451" + }, + { + "id": 235980, + "soa_id": 60, + "alias_code_uid": "AliasCode_9696", + "standard_code": "Code_10452" + }, + { + "id": 235981, + "soa_id": 60, + "alias_code_uid": "AliasCode_9697", + "standard_code": "Code_10453" + }, + { + "id": 235982, + "soa_id": 60, + "alias_code_uid": "AliasCode_9698", + "standard_code": "Code_10454" + }, + { + "id": 235983, + "soa_id": 60, + "alias_code_uid": "AliasCode_9699", + "standard_code": "Code_10455" + }, + { + "id": 235984, + "soa_id": 60, + "alias_code_uid": "AliasCode_9700", + "standard_code": "Code_10456" + }, + { + "id": 235985, + "soa_id": 60, + "alias_code_uid": "AliasCode_9701", + "standard_code": "Code_10457" + }, + { + "id": 235986, + "soa_id": 60, + "alias_code_uid": "AliasCode_9702", + "standard_code": "Code_10458" + }, + { + "id": 235987, + "soa_id": 60, + "alias_code_uid": "AliasCode_9703", + "standard_code": "Code_10459" + }, + { + "id": 235988, + "soa_id": 60, + "alias_code_uid": "AliasCode_9704", + "standard_code": "Code_10460" + }, + { + "id": 235989, + "soa_id": 60, + "alias_code_uid": "AliasCode_9705", + "standard_code": "Code_10461" + }, + { + "id": 235990, + "soa_id": 60, + "alias_code_uid": "AliasCode_9706", + "standard_code": "Code_10462" + }, + { + "id": 235991, + "soa_id": 60, + "alias_code_uid": "AliasCode_9707", + "standard_code": "Code_10463" + }, + { + "id": 236010, + "soa_id": 60, + "alias_code_uid": "AliasCode_9726", + "standard_code": "Code_10482" + }, + { + "id": 236011, + "soa_id": 60, + "alias_code_uid": "AliasCode_9727", + "standard_code": "Code_10483" + }, + { + "id": 236012, + "soa_id": 60, + "alias_code_uid": "AliasCode_9728", + "standard_code": "Code_10484" + }, + { + "id": 236013, + "soa_id": 60, + "alias_code_uid": "AliasCode_9729", + "standard_code": "Code_10485" + }, + { + "id": 236014, + "soa_id": 60, + "alias_code_uid": "AliasCode_9730", + "standard_code": "Code_10486" + }, + { + "id": 236015, + "soa_id": 60, + "alias_code_uid": "AliasCode_9731", + "standard_code": "Code_10487" + }, + { + "id": 236016, + "soa_id": 60, + "alias_code_uid": "AliasCode_9732", + "standard_code": "Code_10488" + }, + { + "id": 236017, + "soa_id": 60, + "alias_code_uid": "AliasCode_9733", + "standard_code": "Code_10489" + }, + { + "id": 236018, + "soa_id": 60, + "alias_code_uid": "AliasCode_9734", + "standard_code": "Code_10490" + }, + { + "id": 236019, + "soa_id": 60, + "alias_code_uid": "AliasCode_9735", + "standard_code": "Code_10491" + }, + { + "id": 236020, + "soa_id": 60, + "alias_code_uid": "AliasCode_9736", + "standard_code": "Code_10492" + }, + { + "id": 236021, + "soa_id": 60, + "alias_code_uid": "AliasCode_9737", + "standard_code": "Code_10493" + }, + { + "id": 236022, + "soa_id": 60, + "alias_code_uid": "AliasCode_9738", + "standard_code": "Code_10494" + }, + { + "id": 236023, + "soa_id": 60, + "alias_code_uid": "AliasCode_9739", + "standard_code": "Code_10495" + }, + { + "id": 236024, + "soa_id": 60, + "alias_code_uid": "AliasCode_9740", + "standard_code": "Code_10496" + }, + { + "id": 236025, + "soa_id": 60, + "alias_code_uid": "AliasCode_9741", + "standard_code": "Code_10497" + }, + { + "id": 236026, + "soa_id": 60, + "alias_code_uid": "AliasCode_9742", + "standard_code": "Code_10498" + }, + { + "id": 236027, + "soa_id": 60, + "alias_code_uid": "AliasCode_9743", + "standard_code": "Code_10499" + }, + { + "id": 236028, + "soa_id": 60, + "alias_code_uid": "AliasCode_9744", + "standard_code": "Code_10500" + }, + { + "id": 236029, + "soa_id": 60, + "alias_code_uid": "AliasCode_9745", + "standard_code": "Code_10501" + }, + { + "id": 236030, + "soa_id": 60, + "alias_code_uid": "AliasCode_9746", + "standard_code": "Code_10502" + }, + { + "id": 236031, + "soa_id": 60, + "alias_code_uid": "AliasCode_9747", + "standard_code": "Code_10503" + }, + { + "id": 236032, + "soa_id": 60, + "alias_code_uid": "AliasCode_9748", + "standard_code": "Code_10504" + }, + { + "id": 236033, + "soa_id": 60, + "alias_code_uid": "AliasCode_9749", + "standard_code": "Code_10505" + }, + { + "id": 236034, + "soa_id": 60, + "alias_code_uid": "AliasCode_9750", + "standard_code": "Code_10506" + }, + { + "id": 236035, + "soa_id": 60, + "alias_code_uid": "AliasCode_9751", + "standard_code": "Code_10507" + }, + { + "id": 236036, + "soa_id": 60, + "alias_code_uid": "AliasCode_9752", + "standard_code": "Code_10508" + }, + { + "id": 236037, + "soa_id": 60, + "alias_code_uid": "AliasCode_9753", + "standard_code": "Code_10509" + }, + { + "id": 236038, + "soa_id": 60, + "alias_code_uid": "AliasCode_9754", + "standard_code": "Code_10510" + }, + { + "id": 236039, + "soa_id": 60, + "alias_code_uid": "AliasCode_9755", + "standard_code": "Code_10511" + }, + { + "id": 236040, + "soa_id": 60, + "alias_code_uid": "AliasCode_9756", + "standard_code": "Code_10512" + }, + { + "id": 236041, + "soa_id": 60, + "alias_code_uid": "AliasCode_9757", + "standard_code": "Code_10513" + }, + { + "id": 236042, + "soa_id": 60, + "alias_code_uid": "AliasCode_9758", + "standard_code": "Code_10514" + }, + { + "id": 236043, + "soa_id": 60, + "alias_code_uid": "AliasCode_9759", + "standard_code": "Code_10515" + }, + { + "id": 236044, + "soa_id": 60, + "alias_code_uid": "AliasCode_9760", + "standard_code": "Code_10516" + }, + { + "id": 236045, + "soa_id": 60, + "alias_code_uid": "AliasCode_9761", + "standard_code": "Code_10517" + }, + { + "id": 236046, + "soa_id": 60, + "alias_code_uid": "AliasCode_9762", + "standard_code": "Code_10518" + }, + { + "id": 236047, + "soa_id": 60, + "alias_code_uid": "AliasCode_9763", + "standard_code": "Code_10519" + }, + { + "id": 236048, + "soa_id": 60, + "alias_code_uid": "AliasCode_9764", + "standard_code": "Code_10520" + }, + { + "id": 236049, + "soa_id": 60, + "alias_code_uid": "AliasCode_9765", + "standard_code": "Code_10521" + }, + { + "id": 236050, + "soa_id": 60, + "alias_code_uid": "AliasCode_9766", + "standard_code": "Code_10522" + }, + { + "id": 236051, + "soa_id": 60, + "alias_code_uid": "AliasCode_9767", + "standard_code": "Code_10523" + }, + { + "id": 236052, + "soa_id": 60, + "alias_code_uid": "AliasCode_9768", + "standard_code": "Code_10524" + }, + { + "id": 236053, + "soa_id": 60, + "alias_code_uid": "AliasCode_9769", + "standard_code": "Code_10525" + }, + { + "id": 236054, + "soa_id": 60, + "alias_code_uid": "AliasCode_9770", + "standard_code": "Code_10526" + }, + { + "id": 236055, + "soa_id": 60, + "alias_code_uid": "AliasCode_9771", + "standard_code": "Code_10527" + }, + { + "id": 236056, + "soa_id": 60, + "alias_code_uid": "AliasCode_9772", + "standard_code": "Code_10528" + }, + { + "id": 236057, + "soa_id": 60, + "alias_code_uid": "AliasCode_9773", + "standard_code": "Code_10529" + }, + { + "id": 236058, + "soa_id": 60, + "alias_code_uid": "AliasCode_9774", + "standard_code": "Code_10530" + }, + { + "id": 236059, + "soa_id": 60, + "alias_code_uid": "AliasCode_9775", + "standard_code": "Code_10531" + }, + { + "id": 236060, + "soa_id": 60, + "alias_code_uid": "AliasCode_9776", + "standard_code": "Code_10532" + }, + { + "id": 236061, + "soa_id": 60, + "alias_code_uid": "AliasCode_9777", + "standard_code": "Code_10533" + }, + { + "id": 236062, + "soa_id": 60, + "alias_code_uid": "AliasCode_9778", + "standard_code": "Code_10534" + }, + { + "id": 236063, + "soa_id": 60, + "alias_code_uid": "AliasCode_9779", + "standard_code": "Code_10535" + }, + { + "id": 236064, + "soa_id": 60, + "alias_code_uid": "AliasCode_9780", + "standard_code": "Code_10536" + }, + { + "id": 236065, + "soa_id": 60, + "alias_code_uid": "AliasCode_9781", + "standard_code": "Code_10537" + }, + { + "id": 236066, + "soa_id": 60, + "alias_code_uid": "AliasCode_9782", + "standard_code": "Code_10538" + }, + { + "id": 236067, + "soa_id": 60, + "alias_code_uid": "AliasCode_9783", + "standard_code": "Code_10539" + }, + { + "id": 236068, + "soa_id": 60, + "alias_code_uid": "AliasCode_9784", + "standard_code": "Code_10540" + }, + { + "id": 236069, + "soa_id": 60, + "alias_code_uid": "AliasCode_9785", + "standard_code": "Code_10541" + }, + { + "id": 236070, + "soa_id": 60, + "alias_code_uid": "AliasCode_9786", + "standard_code": "Code_10542" + }, + { + "id": 236071, + "soa_id": 60, + "alias_code_uid": "AliasCode_9787", + "standard_code": "Code_10543" + }, + { + "id": 236072, + "soa_id": 60, + "alias_code_uid": "AliasCode_9788", + "standard_code": "Code_10544" + }, + { + "id": 236073, + "soa_id": 60, + "alias_code_uid": "AliasCode_9789", + "standard_code": "Code_10545" + }, + { + "id": 236074, + "soa_id": 60, + "alias_code_uid": "AliasCode_9790", + "standard_code": "Code_10546" + }, + { + "id": 236075, + "soa_id": 60, + "alias_code_uid": "AliasCode_9791", + "standard_code": "Code_10547" + }, + { + "id": 236076, + "soa_id": 60, + "alias_code_uid": "AliasCode_9792", + "standard_code": "Code_10548" + }, + { + "id": 236077, + "soa_id": 60, + "alias_code_uid": "AliasCode_9793", + "standard_code": "Code_10549" + }, + { + "id": 236078, + "soa_id": 60, + "alias_code_uid": "AliasCode_9794", + "standard_code": "Code_10550" + }, + { + "id": 236079, + "soa_id": 60, + "alias_code_uid": "AliasCode_9795", + "standard_code": "Code_10551" + }, + { + "id": 236080, + "soa_id": 60, + "alias_code_uid": "AliasCode_9796", + "standard_code": "Code_10552" + }, + { + "id": 236081, + "soa_id": 60, + "alias_code_uid": "AliasCode_9797", + "standard_code": "Code_10553" + }, + { + "id": 236082, + "soa_id": 60, + "alias_code_uid": "AliasCode_9798", + "standard_code": "Code_10554" + }, + { + "id": 236083, + "soa_id": 60, + "alias_code_uid": "AliasCode_9799", + "standard_code": "Code_10555" + }, + { + "id": 236084, + "soa_id": 60, + "alias_code_uid": "AliasCode_9800", + "standard_code": "Code_10556" + }, + { + "id": 236085, + "soa_id": 60, + "alias_code_uid": "AliasCode_9801", + "standard_code": "Code_10557" + }, + { + "id": 236086, + "soa_id": 60, + "alias_code_uid": "AliasCode_9802", + "standard_code": "Code_10558" + }, + { + "id": 236087, + "soa_id": 60, + "alias_code_uid": "AliasCode_9803", + "standard_code": "Code_10559" + }, + { + "id": 236088, + "soa_id": 60, + "alias_code_uid": "AliasCode_9804", + "standard_code": "Code_10560" + }, + { + "id": 236089, + "soa_id": 60, + "alias_code_uid": "AliasCode_9805", + "standard_code": "Code_10561" + }, + { + "id": 236090, + "soa_id": 60, + "alias_code_uid": "AliasCode_9806", + "standard_code": "Code_10562" + }, + { + "id": 236091, + "soa_id": 60, + "alias_code_uid": "AliasCode_9807", + "standard_code": "Code_10563" + }, + { + "id": 236092, + "soa_id": 60, + "alias_code_uid": "AliasCode_9808", + "standard_code": "Code_10564" + }, + { + "id": 236093, + "soa_id": 60, + "alias_code_uid": "AliasCode_9809", + "standard_code": "Code_10565" + }, + { + "id": 236094, + "soa_id": 60, + "alias_code_uid": "AliasCode_9810", + "standard_code": "Code_10566" + }, + { + "id": 236095, + "soa_id": 60, + "alias_code_uid": "AliasCode_9811", + "standard_code": "Code_10567" + }, + { + "id": 236096, + "soa_id": 60, + "alias_code_uid": "AliasCode_9812", + "standard_code": "Code_10568" + }, + { + "id": 236097, + "soa_id": 60, + "alias_code_uid": "AliasCode_9813", + "standard_code": "Code_10569" + }, + { + "id": 236098, + "soa_id": 60, + "alias_code_uid": "AliasCode_9814", + "standard_code": "Code_10570" + }, + { + "id": 236099, + "soa_id": 60, + "alias_code_uid": "AliasCode_9815", + "standard_code": "Code_10571" + }, + { + "id": 236100, + "soa_id": 60, + "alias_code_uid": "AliasCode_9816", + "standard_code": "Code_10572" + }, + { + "id": 236101, + "soa_id": 60, + "alias_code_uid": "AliasCode_9817", + "standard_code": "Code_10573" + }, + { + "id": 236102, + "soa_id": 60, + "alias_code_uid": "AliasCode_9818", + "standard_code": "Code_10574" + }, + { + "id": 236103, + "soa_id": 60, + "alias_code_uid": "AliasCode_9819", + "standard_code": "Code_10575" + }, + { + "id": 236104, + "soa_id": 60, + "alias_code_uid": "AliasCode_9820", + "standard_code": "Code_10576" + }, + { + "id": 236105, + "soa_id": 60, + "alias_code_uid": "AliasCode_9821", + "standard_code": "Code_10577" + }, + { + "id": 236106, + "soa_id": 60, + "alias_code_uid": "AliasCode_9822", + "standard_code": "Code_10578" + }, + { + "id": 236107, + "soa_id": 60, + "alias_code_uid": "AliasCode_9823", + "standard_code": "Code_10579" + }, + { + "id": 236108, + "soa_id": 60, + "alias_code_uid": "AliasCode_9824", + "standard_code": "Code_10580" + }, + { + "id": 236109, + "soa_id": 60, + "alias_code_uid": "AliasCode_9825", + "standard_code": "Code_10581" + }, + { + "id": 236110, + "soa_id": 60, + "alias_code_uid": "AliasCode_9826", + "standard_code": "Code_10582" + }, + { + "id": 236111, + "soa_id": 60, + "alias_code_uid": "AliasCode_9827", + "standard_code": "Code_10583" + }, + { + "id": 236112, + "soa_id": 60, + "alias_code_uid": "AliasCode_9828", + "standard_code": "Code_10584" + }, + { + "id": 236113, + "soa_id": 60, + "alias_code_uid": "AliasCode_9829", + "standard_code": "Code_10585" + }, + { + "id": 236114, + "soa_id": 60, + "alias_code_uid": "AliasCode_9830", + "standard_code": "Code_10586" + }, + { + "id": 236115, + "soa_id": 60, + "alias_code_uid": "AliasCode_9831", + "standard_code": "Code_10587" + }, + { + "id": 236116, + "soa_id": 60, + "alias_code_uid": "AliasCode_9832", + "standard_code": "Code_10588" + }, + { + "id": 236117, + "soa_id": 60, + "alias_code_uid": "AliasCode_9833", + "standard_code": "Code_10589" + }, + { + "id": 236118, + "soa_id": 60, + "alias_code_uid": "AliasCode_9834", + "standard_code": "Code_10590" + }, + { + "id": 236119, + "soa_id": 60, + "alias_code_uid": "AliasCode_9835", + "standard_code": "Code_10591" + }, + { + "id": 236120, + "soa_id": 60, + "alias_code_uid": "AliasCode_9836", + "standard_code": "Code_10592" + }, + { + "id": 236121, + "soa_id": 60, + "alias_code_uid": "AliasCode_9837", + "standard_code": "Code_10593" + }, + { + "id": 236122, + "soa_id": 60, + "alias_code_uid": "AliasCode_9838", + "standard_code": "Code_10594" + }, + { + "id": 236123, + "soa_id": 60, + "alias_code_uid": "AliasCode_9839", + "standard_code": "Code_10595" + }, + { + "id": 236124, + "soa_id": 60, + "alias_code_uid": "AliasCode_9840", + "standard_code": "Code_10596" + }, + { + "id": 236125, + "soa_id": 60, + "alias_code_uid": "AliasCode_9841", + "standard_code": "Code_10597" + }, + { + "id": 236126, + "soa_id": 60, + "alias_code_uid": "AliasCode_9842", + "standard_code": "Code_10598" + }, + { + "id": 236127, + "soa_id": 60, + "alias_code_uid": "AliasCode_9843", + "standard_code": "Code_10599" + }, + { + "id": 236128, + "soa_id": 60, + "alias_code_uid": "AliasCode_9844", + "standard_code": "Code_10600" + }, + { + "id": 236129, + "soa_id": 60, + "alias_code_uid": "AliasCode_9845", + "standard_code": "Code_10601" + }, + { + "id": 236130, + "soa_id": 60, + "alias_code_uid": "AliasCode_9846", + "standard_code": "Code_10602" + }, + { + "id": 236131, + "soa_id": 60, + "alias_code_uid": "AliasCode_9847", + "standard_code": "Code_10603" + }, + { + "id": 236132, + "soa_id": 60, + "alias_code_uid": "AliasCode_9848", + "standard_code": "Code_10604" + }, + { + "id": 236133, + "soa_id": 60, + "alias_code_uid": "AliasCode_9849", + "standard_code": "Code_10605" + }, + { + "id": 236134, + "soa_id": 60, + "alias_code_uid": "AliasCode_9850", + "standard_code": "Code_10606" + }, + { + "id": 236135, + "soa_id": 60, + "alias_code_uid": "AliasCode_9851", + "standard_code": "Code_10607" + }, + { + "id": 236136, + "soa_id": 60, + "alias_code_uid": "AliasCode_9852", + "standard_code": "Code_10608" + }, + { + "id": 236137, + "soa_id": 60, + "alias_code_uid": "AliasCode_9853", + "standard_code": "Code_10609" + }, + { + "id": 236138, + "soa_id": 60, + "alias_code_uid": "AliasCode_9854", + "standard_code": "Code_10610" + }, + { + "id": 236139, + "soa_id": 60, + "alias_code_uid": "AliasCode_9855", + "standard_code": "Code_10611" + }, + { + "id": 236140, + "soa_id": 60, + "alias_code_uid": "AliasCode_9856", + "standard_code": "Code_10612" + }, + { + "id": 236141, + "soa_id": 60, + "alias_code_uid": "AliasCode_9857", + "standard_code": "Code_10613" + }, + { + "id": 236142, + "soa_id": 60, + "alias_code_uid": "AliasCode_9858", + "standard_code": "Code_10614" + }, + { + "id": 236143, + "soa_id": 60, + "alias_code_uid": "AliasCode_9859", + "standard_code": "Code_10615" + }, + { + "id": 236144, + "soa_id": 60, + "alias_code_uid": "AliasCode_9860", + "standard_code": "Code_10616" + }, + { + "id": 236145, + "soa_id": 60, + "alias_code_uid": "AliasCode_9861", + "standard_code": "Code_10617" + }, + { + "id": 236146, + "soa_id": 60, + "alias_code_uid": "AliasCode_9862", + "standard_code": "Code_10618" + }, + { + "id": 236147, + "soa_id": 60, + "alias_code_uid": "AliasCode_9863", + "standard_code": "Code_10619" + }, + { + "id": 236148, + "soa_id": 60, + "alias_code_uid": "AliasCode_9864", + "standard_code": "Code_10620" + }, + { + "id": 236149, + "soa_id": 60, + "alias_code_uid": "AliasCode_9865", + "standard_code": "Code_10621" + }, + { + "id": 236150, + "soa_id": 60, + "alias_code_uid": "AliasCode_9866", + "standard_code": "Code_10622" + }, + { + "id": 236151, + "soa_id": 60, + "alias_code_uid": "AliasCode_9867", + "standard_code": "Code_10623" + }, + { + "id": 236152, + "soa_id": 60, + "alias_code_uid": "AliasCode_9868", + "standard_code": "Code_10624" + }, + { + "id": 236153, + "soa_id": 60, + "alias_code_uid": "AliasCode_9869", + "standard_code": "Code_10625" + }, + { + "id": 236154, + "soa_id": 60, + "alias_code_uid": "AliasCode_9870", + "standard_code": "Code_10626" + }, + { + "id": 236155, + "soa_id": 60, + "alias_code_uid": "AliasCode_9871", + "standard_code": "Code_10627" + }, + { + "id": 236156, + "soa_id": 60, + "alias_code_uid": "AliasCode_9872", + "standard_code": "Code_10628" + }, + { + "id": 236157, + "soa_id": 60, + "alias_code_uid": "AliasCode_9873", + "standard_code": "Code_10629" + }, + { + "id": 236190, + "soa_id": 60, + "alias_code_uid": "AliasCode_9906", + "standard_code": "Code_10662" + }, + { + "id": 236192, + "soa_id": 60, + "alias_code_uid": "AliasCode_9908", + "standard_code": "Code_10664" + }, + { + "id": 236193, + "soa_id": 60, + "alias_code_uid": "AliasCode_9909", + "standard_code": "Code_10665" + }, + { + "id": 236194, + "soa_id": 60, + "alias_code_uid": "AliasCode_9910", + "standard_code": "Code_10666" + }, + { + "id": 236195, + "soa_id": 60, + "alias_code_uid": "AliasCode_9911", + "standard_code": "Code_10667" + }, + { + "id": 236197, + "soa_id": 60, + "alias_code_uid": "AliasCode_9913", + "standard_code": "Code_10669" + }, + { + "id": 236317, + "soa_id": 60, + "alias_code_uid": "AliasCode_9914", + "standard_code": "Code_10670" + }, + { + "id": 236319, + "soa_id": 60, + "alias_code_uid": "AliasCode_9916", + "standard_code": "Code_10672" + }, + { + "id": 236320, + "soa_id": 60, + "alias_code_uid": "AliasCode_9917", + "standard_code": "Code_10673" + }, + { + "id": 236321, + "soa_id": 60, + "alias_code_uid": "AliasCode_9918", + "standard_code": "Code_10674" + }, + { + "id": 236322, + "soa_id": 60, + "alias_code_uid": "AliasCode_9919", + "standard_code": "Code_10675" + }, + { + "id": 236323, + "soa_id": 60, + "alias_code_uid": "AliasCode_9920", + "standard_code": "Code_10676" + }, + { + "id": 236324, + "soa_id": 60, + "alias_code_uid": "AliasCode_9921", + "standard_code": "Code_10677" + }, + { + "id": 236325, + "soa_id": 60, + "alias_code_uid": "AliasCode_9922", + "standard_code": "Code_10678" + }, + { + "id": 236326, + "soa_id": 60, + "alias_code_uid": "AliasCode_9923", + "standard_code": "Code_10679" + }, + { + "id": 236327, + "soa_id": 60, + "alias_code_uid": "AliasCode_9924", + "standard_code": "Code_10680" + }, + { + "id": 236328, + "soa_id": 60, + "alias_code_uid": "AliasCode_9925", + "standard_code": "Code_10681" + }, + { + "id": 236329, + "soa_id": 60, + "alias_code_uid": "AliasCode_9926", + "standard_code": "Code_10682" + }, + { + "id": 236330, + "soa_id": 60, + "alias_code_uid": "AliasCode_9927", + "standard_code": "Code_10683" + }, + { + "id": 236331, + "soa_id": 60, + "alias_code_uid": "AliasCode_9928", + "standard_code": "Code_10684" + }, + { + "id": 236332, + "soa_id": 60, + "alias_code_uid": "AliasCode_9929", + "standard_code": "Code_10685" + }, + { + "id": 236333, + "soa_id": 60, + "alias_code_uid": "AliasCode_9930", + "standard_code": "Code_10686" + }, + { + "id": 236334, + "soa_id": 60, + "alias_code_uid": "AliasCode_9931", + "standard_code": "Code_10687" + }, + { + "id": 236335, + "soa_id": 60, + "alias_code_uid": "AliasCode_9932", + "standard_code": "Code_10688" + }, + { + "id": 236336, + "soa_id": 60, + "alias_code_uid": "AliasCode_9933", + "standard_code": "Code_10689" + }, + { + "id": 236337, + "soa_id": 60, + "alias_code_uid": "AliasCode_9934", + "standard_code": "Code_10690" + }, + { + "id": 236338, + "soa_id": 60, + "alias_code_uid": "AliasCode_9935", + "standard_code": "Code_10691" + }, + { + "id": 236339, + "soa_id": 60, + "alias_code_uid": "AliasCode_9936", + "standard_code": "Code_10692" + }, + { + "id": 236340, + "soa_id": 60, + "alias_code_uid": "AliasCode_9937", + "standard_code": "Code_10693" + }, + { + "id": 236341, + "soa_id": 60, + "alias_code_uid": "AliasCode_9938", + "standard_code": "Code_10694" + }, + { + "id": 236342, + "soa_id": 60, + "alias_code_uid": "AliasCode_9939", + "standard_code": "Code_10695" + }, + { + "id": 236343, + "soa_id": 60, + "alias_code_uid": "AliasCode_9940", + "standard_code": "Code_10696" + }, + { + "id": 236344, + "soa_id": 60, + "alias_code_uid": "AliasCode_9941", + "standard_code": "Code_10697" + }, + { + "id": 236345, + "soa_id": 60, + "alias_code_uid": "AliasCode_9942", + "standard_code": "Code_10698" + }, + { + "id": 236346, + "soa_id": 60, + "alias_code_uid": "AliasCode_9943", + "standard_code": "Code_10699" + }, + { + "id": 236347, + "soa_id": 60, + "alias_code_uid": "AliasCode_9944", + "standard_code": "Code_10700" + }, + { + "id": 236348, + "soa_id": 60, + "alias_code_uid": "AliasCode_9945", + "standard_code": "Code_10701" + }, + { + "id": 236349, + "soa_id": 60, + "alias_code_uid": "AliasCode_9946", + "standard_code": "Code_10702" + }, + { + "id": 236350, + "soa_id": 60, + "alias_code_uid": "AliasCode_9947", + "standard_code": "Code_10703" + }, + { + "id": 236351, + "soa_id": 60, + "alias_code_uid": "AliasCode_9948", + "standard_code": "Code_10704" + }, + { + "id": 236352, + "soa_id": 60, + "alias_code_uid": "AliasCode_9949", + "standard_code": "Code_10705" + }, + { + "id": 236353, + "soa_id": 60, + "alias_code_uid": "AliasCode_9950", + "standard_code": "Code_10706" + }, + { + "id": 236354, + "soa_id": 60, + "alias_code_uid": "AliasCode_9951", + "standard_code": "Code_10707" + }, + { + "id": 236355, + "soa_id": 60, + "alias_code_uid": "AliasCode_9952", + "standard_code": "Code_10708" + }, + { + "id": 236356, + "soa_id": 60, + "alias_code_uid": "AliasCode_9953", + "standard_code": "Code_10709" + }, + { + "id": 236357, + "soa_id": 60, + "alias_code_uid": "AliasCode_9954", + "standard_code": "Code_10710" + }, + { + "id": 236358, + "soa_id": 60, + "alias_code_uid": "AliasCode_9955", + "standard_code": "Code_10711" + }, + { + "id": 236359, + "soa_id": 60, + "alias_code_uid": "AliasCode_9956", + "standard_code": "Code_10712" + }, + { + "id": 236360, + "soa_id": 60, + "alias_code_uid": "AliasCode_9957", + "standard_code": "Code_10713" + }, + { + "id": 236361, + "soa_id": 60, + "alias_code_uid": "AliasCode_9958", + "standard_code": "Code_10714" + }, + { + "id": 236362, + "soa_id": 60, + "alias_code_uid": "AliasCode_9959", + "standard_code": "Code_10715" + }, + { + "id": 236363, + "soa_id": 60, + "alias_code_uid": "AliasCode_9960", + "standard_code": "Code_10716" + }, + { + "id": 236364, + "soa_id": 60, + "alias_code_uid": "AliasCode_9961", + "standard_code": "Code_10717" + }, + { + "id": 236365, + "soa_id": 60, + "alias_code_uid": "AliasCode_9962", + "standard_code": "Code_10718" + }, + { + "id": 236366, + "soa_id": 60, + "alias_code_uid": "AliasCode_9963", + "standard_code": "Code_10719" + }, + { + "id": 236367, + "soa_id": 60, + "alias_code_uid": "AliasCode_9964", + "standard_code": "Code_10720" + }, + { + "id": 236368, + "soa_id": 60, + "alias_code_uid": "AliasCode_9965", + "standard_code": "Code_10721" + }, + { + "id": 236369, + "soa_id": 60, + "alias_code_uid": "AliasCode_9966", + "standard_code": "Code_10722" + }, + { + "id": 236370, + "soa_id": 60, + "alias_code_uid": "AliasCode_9967", + "standard_code": "Code_10723" + }, + { + "id": 236371, + "soa_id": 60, + "alias_code_uid": "AliasCode_9968", + "standard_code": "Code_10724" + }, + { + "id": 236372, + "soa_id": 60, + "alias_code_uid": "AliasCode_9969", + "standard_code": "Code_10725" + }, + { + "id": 236373, + "soa_id": 60, + "alias_code_uid": "AliasCode_9970", + "standard_code": "Code_10726" + }, + { + "id": 236374, + "soa_id": 60, + "alias_code_uid": "AliasCode_9971", + "standard_code": "Code_10727" + }, + { + "id": 236375, + "soa_id": 60, + "alias_code_uid": "AliasCode_9972", + "standard_code": "Code_10728" + }, + { + "id": 236376, + "soa_id": 60, + "alias_code_uid": "AliasCode_9973", + "standard_code": "Code_10729" + }, + { + "id": 236377, + "soa_id": 60, + "alias_code_uid": "AliasCode_9974", + "standard_code": "Code_10730" + }, + { + "id": 236378, + "soa_id": 60, + "alias_code_uid": "AliasCode_9975", + "standard_code": "Code_10731" + }, + { + "id": 236379, + "soa_id": 60, + "alias_code_uid": "AliasCode_9976", + "standard_code": "Code_10732" + }, + { + "id": 236380, + "soa_id": 60, + "alias_code_uid": "AliasCode_9977", + "standard_code": "Code_10733" + }, + { + "id": 236381, + "soa_id": 60, + "alias_code_uid": "AliasCode_9978", + "standard_code": "Code_10734" + }, + { + "id": 236382, + "soa_id": 60, + "alias_code_uid": "AliasCode_9979", + "standard_code": "Code_10735" + }, + { + "id": 236383, + "soa_id": 60, + "alias_code_uid": "AliasCode_9980", + "standard_code": "Code_10736" + }, + { + "id": 236384, + "soa_id": 60, + "alias_code_uid": "AliasCode_9981", + "standard_code": "Code_10737" + }, + { + "id": 236385, + "soa_id": 60, + "alias_code_uid": "AliasCode_9982", + "standard_code": "Code_10738" + }, + { + "id": 236386, + "soa_id": 60, + "alias_code_uid": "AliasCode_9983", + "standard_code": "Code_10739" + }, + { + "id": 236387, + "soa_id": 60, + "alias_code_uid": "AliasCode_9984", + "standard_code": "Code_10740" + }, + { + "id": 236388, + "soa_id": 60, + "alias_code_uid": "AliasCode_9985", + "standard_code": "Code_10741" + }, + { + "id": 236389, + "soa_id": 60, + "alias_code_uid": "AliasCode_9986", + "standard_code": "Code_10742" + }, + { + "id": 236390, + "soa_id": 60, + "alias_code_uid": "AliasCode_9987", + "standard_code": "Code_10743" + }, + { + "id": 236391, + "soa_id": 60, + "alias_code_uid": "AliasCode_9988", + "standard_code": "Code_10744" + }, + { + "id": 236392, + "soa_id": 60, + "alias_code_uid": "AliasCode_9989", + "standard_code": "Code_10745" + }, + { + "id": 236393, + "soa_id": 60, + "alias_code_uid": "AliasCode_9990", + "standard_code": "Code_10746" + }, + { + "id": 236394, + "soa_id": 60, + "alias_code_uid": "AliasCode_9991", + "standard_code": "Code_10747" + }, + { + "id": 236395, + "soa_id": 60, + "alias_code_uid": "AliasCode_9992", + "standard_code": "Code_10748" + }, + { + "id": 236396, + "soa_id": 60, + "alias_code_uid": "AliasCode_9993", + "standard_code": "Code_10749" + }, + { + "id": 236397, + "soa_id": 60, + "alias_code_uid": "AliasCode_9994", + "standard_code": "Code_10750" + }, + { + "id": 236398, + "soa_id": 60, + "alias_code_uid": "AliasCode_9995", + "standard_code": "Code_10751" + }, + { + "id": 236399, + "soa_id": 60, + "alias_code_uid": "AliasCode_9996", + "standard_code": "Code_10752" + }, + { + "id": 236400, + "soa_id": 60, + "alias_code_uid": "AliasCode_9997", + "standard_code": "Code_10753" + }, + { + "id": 236401, + "soa_id": 60, + "alias_code_uid": "AliasCode_9998", + "standard_code": "Code_10754" + }, + { + "id": 236402, + "soa_id": 60, + "alias_code_uid": "AliasCode_9999", + "standard_code": "Code_10755" + }, + { + "id": 236403, + "soa_id": 60, + "alias_code_uid": "AliasCode_10000", + "standard_code": "Code_10756" + }, + { + "id": 236404, + "soa_id": 60, + "alias_code_uid": "AliasCode_10001", + "standard_code": "Code_10757" + }, + { + "id": 236405, + "soa_id": 60, + "alias_code_uid": "AliasCode_10002", + "standard_code": "Code_10758" + }, + { + "id": 236406, + "soa_id": 60, + "alias_code_uid": "AliasCode_10003", + "standard_code": "Code_10759" + }, + { + "id": 236407, + "soa_id": 60, + "alias_code_uid": "AliasCode_10004", + "standard_code": "Code_10760" + }, + { + "id": 236408, + "soa_id": 60, + "alias_code_uid": "AliasCode_10005", + "standard_code": "Code_10761" + }, + { + "id": 236409, + "soa_id": 60, + "alias_code_uid": "AliasCode_10006", + "standard_code": "Code_10762" + }, + { + "id": 236410, + "soa_id": 60, + "alias_code_uid": "AliasCode_10007", + "standard_code": "Code_10763" + }, + { + "id": 236411, + "soa_id": 60, + "alias_code_uid": "AliasCode_10008", + "standard_code": "Code_10764" + }, + { + "id": 236412, + "soa_id": 60, + "alias_code_uid": "AliasCode_10009", + "standard_code": "Code_10765" + }, + { + "id": 236413, + "soa_id": 60, + "alias_code_uid": "AliasCode_10010", + "standard_code": "Code_10766" + }, + { + "id": 236414, + "soa_id": 60, + "alias_code_uid": "AliasCode_10011", + "standard_code": "Code_10767" + }, + { + "id": 236415, + "soa_id": 60, + "alias_code_uid": "AliasCode_10012", + "standard_code": "Code_10768" + }, + { + "id": 236416, + "soa_id": 60, + "alias_code_uid": "AliasCode_10013", + "standard_code": "Code_10769" + }, + { + "id": 236417, + "soa_id": 60, + "alias_code_uid": "AliasCode_10014", + "standard_code": "Code_10770" + }, + { + "id": 236418, + "soa_id": 60, + "alias_code_uid": "AliasCode_10015", + "standard_code": "Code_10771" + }, + { + "id": 236419, + "soa_id": 60, + "alias_code_uid": "AliasCode_10016", + "standard_code": "Code_10772" + }, + { + "id": 236420, + "soa_id": 60, + "alias_code_uid": "AliasCode_10017", + "standard_code": "Code_10773" + }, + { + "id": 236421, + "soa_id": 60, + "alias_code_uid": "AliasCode_10018", + "standard_code": "Code_10774" + }, + { + "id": 236422, + "soa_id": 60, + "alias_code_uid": "AliasCode_10019", + "standard_code": "Code_10775" + }, + { + "id": 236423, + "soa_id": 60, + "alias_code_uid": "AliasCode_10020", + "standard_code": "Code_10776" + }, + { + "id": 236424, + "soa_id": 60, + "alias_code_uid": "AliasCode_10021", + "standard_code": "Code_10777" + }, + { + "id": 236425, + "soa_id": 60, + "alias_code_uid": "AliasCode_10022", + "standard_code": "Code_10778" + }, + { + "id": 236426, + "soa_id": 60, + "alias_code_uid": "AliasCode_10023", + "standard_code": "Code_10779" + }, + { + "id": 236427, + "soa_id": 60, + "alias_code_uid": "AliasCode_10024", + "standard_code": "Code_10780" + }, + { + "id": 236428, + "soa_id": 60, + "alias_code_uid": "AliasCode_10025", + "standard_code": "Code_10781" + }, + { + "id": 236429, + "soa_id": 60, + "alias_code_uid": "AliasCode_10026", + "standard_code": "Code_10782" + }, + { + "id": 236430, + "soa_id": 60, + "alias_code_uid": "AliasCode_10027", + "standard_code": "Code_10783" + }, + { + "id": 236431, + "soa_id": 60, + "alias_code_uid": "AliasCode_10028", + "standard_code": "Code_10784" + }, + { + "id": 236432, + "soa_id": 60, + "alias_code_uid": "AliasCode_10029", + "standard_code": "Code_10785" + }, + { + "id": 236433, + "soa_id": 60, + "alias_code_uid": "AliasCode_10030", + "standard_code": "Code_10786" + }, + { + "id": 236434, + "soa_id": 60, + "alias_code_uid": "AliasCode_10031", + "standard_code": "Code_10787" + }, + { + "id": 236435, + "soa_id": 60, + "alias_code_uid": "AliasCode_10032", + "standard_code": "Code_10788" + }, + { + "id": 236436, + "soa_id": 60, + "alias_code_uid": "AliasCode_10033", + "standard_code": "Code_10789" + }, + { + "id": 236437, + "soa_id": 60, + "alias_code_uid": "AliasCode_10034", + "standard_code": "Code_10790" + }, + { + "id": 236438, + "soa_id": 60, + "alias_code_uid": "AliasCode_10035", + "standard_code": "Code_10791" + }, + { + "id": 236439, + "soa_id": 60, + "alias_code_uid": "AliasCode_10036", + "standard_code": "Code_10792" + }, + { + "id": 236440, + "soa_id": 60, + "alias_code_uid": "AliasCode_10037", + "standard_code": "Code_10793" + }, + { + "id": 236441, + "soa_id": 60, + "alias_code_uid": "AliasCode_10038", + "standard_code": "Code_10794" + }, + { + "id": 236442, + "soa_id": 60, + "alias_code_uid": "AliasCode_10039", + "standard_code": "Code_10795" + }, + { + "id": 236443, + "soa_id": 60, + "alias_code_uid": "AliasCode_10040", + "standard_code": "Code_10796" + }, + { + "id": 236444, + "soa_id": 60, + "alias_code_uid": "AliasCode_10041", + "standard_code": "Code_10797" + }, + { + "id": 236445, + "soa_id": 60, + "alias_code_uid": "AliasCode_10042", + "standard_code": "Code_10798" + }, + { + "id": 236446, + "soa_id": 60, + "alias_code_uid": "AliasCode_10043", + "standard_code": "Code_10799" + }, + { + "id": 236447, + "soa_id": 60, + "alias_code_uid": "AliasCode_10044", + "standard_code": "Code_10800" + }, + { + "id": 236448, + "soa_id": 60, + "alias_code_uid": "AliasCode_10045", + "standard_code": "Code_10801" + }, + { + "id": 236449, + "soa_id": 60, + "alias_code_uid": "AliasCode_10046", + "standard_code": "Code_10802" + }, + { + "id": 236450, + "soa_id": 60, + "alias_code_uid": "AliasCode_10047", + "standard_code": "Code_10803" + }, + { + "id": 236451, + "soa_id": 60, + "alias_code_uid": "AliasCode_10048", + "standard_code": "Code_10804" + }, + { + "id": 236452, + "soa_id": 60, + "alias_code_uid": "AliasCode_10049", + "standard_code": "Code_10805" + }, + { + "id": 236453, + "soa_id": 60, + "alias_code_uid": "AliasCode_10050", + "standard_code": "Code_10806" + }, + { + "id": 236454, + "soa_id": 60, + "alias_code_uid": "AliasCode_10051", + "standard_code": "Code_10807" + }, + { + "id": 236455, + "soa_id": 60, + "alias_code_uid": "AliasCode_10052", + "standard_code": "Code_10808" + }, + { + "id": 236456, + "soa_id": 60, + "alias_code_uid": "AliasCode_10053", + "standard_code": "Code_10809" + }, + { + "id": 236457, + "soa_id": 60, + "alias_code_uid": "AliasCode_10054", + "standard_code": "Code_10810" + }, + { + "id": 236458, + "soa_id": 60, + "alias_code_uid": "AliasCode_10055", + "standard_code": "Code_10811" + }, + { + "id": 236459, + "soa_id": 60, + "alias_code_uid": "AliasCode_10056", + "standard_code": "Code_10812" + }, + { + "id": 236460, + "soa_id": 60, + "alias_code_uid": "AliasCode_10057", + "standard_code": "Code_10813" + }, + { + "id": 236461, + "soa_id": 60, + "alias_code_uid": "AliasCode_10058", + "standard_code": "Code_10814" + }, + { + "id": 236462, + "soa_id": 60, + "alias_code_uid": "AliasCode_10059", + "standard_code": "Code_10815" + }, + { + "id": 236463, + "soa_id": 60, + "alias_code_uid": "AliasCode_10060", + "standard_code": "Code_10816" + }, + { + "id": 236464, + "soa_id": 60, + "alias_code_uid": "AliasCode_10061", + "standard_code": "Code_10817" + }, + { + "id": 236465, + "soa_id": 60, + "alias_code_uid": "AliasCode_10062", + "standard_code": "Code_10818" + }, + { + "id": 236466, + "soa_id": 60, + "alias_code_uid": "AliasCode_10063", + "standard_code": "Code_10819" + }, + { + "id": 236467, + "soa_id": 60, + "alias_code_uid": "AliasCode_10064", + "standard_code": "Code_10820" + }, + { + "id": 236468, + "soa_id": 60, + "alias_code_uid": "AliasCode_10065", + "standard_code": "Code_10821" + }, + { + "id": 236469, + "soa_id": 60, + "alias_code_uid": "AliasCode_10066", + "standard_code": "Code_10822" + }, + { + "id": 236470, + "soa_id": 60, + "alias_code_uid": "AliasCode_10067", + "standard_code": "Code_10823" + }, + { + "id": 236471, + "soa_id": 60, + "alias_code_uid": "AliasCode_10068", + "standard_code": "Code_10824" + }, + { + "id": 236473, + "soa_id": 60, + "alias_code_uid": "AliasCode_10070", + "standard_code": "Code_10826" + }, + { + "id": 236474, + "soa_id": 60, + "alias_code_uid": "AliasCode_10071", + "standard_code": "Code_10827" + }, + { + "id": 236475, + "soa_id": 60, + "alias_code_uid": "AliasCode_10072", + "standard_code": "Code_10828" + }, + { + "id": 236476, + "soa_id": 60, + "alias_code_uid": "AliasCode_10073", + "standard_code": "Code_10829" + }, + { + "id": 236477, + "soa_id": 60, + "alias_code_uid": "AliasCode_10074", + "standard_code": "Code_10830" + }, + { + "id": 236478, + "soa_id": 60, + "alias_code_uid": "AliasCode_10075", + "standard_code": "Code_10831" + }, + { + "id": 236479, + "soa_id": 60, + "alias_code_uid": "AliasCode_10076", + "standard_code": "Code_10832" + }, + { + "id": 236480, + "soa_id": 60, + "alias_code_uid": "AliasCode_10077", + "standard_code": "Code_10833" + }, + { + "id": 236481, + "soa_id": 60, + "alias_code_uid": "AliasCode_10078", + "standard_code": "Code_10834" + }, + { + "id": 236482, + "soa_id": 60, + "alias_code_uid": "AliasCode_10079", + "standard_code": "Code_10835" + }, + { + "id": 236483, + "soa_id": 60, + "alias_code_uid": "AliasCode_10080", + "standard_code": "Code_10836" + }, + { + "id": 236484, + "soa_id": 60, + "alias_code_uid": "AliasCode_10081", + "standard_code": "Code_10837" + }, + { + "id": 236510, + "soa_id": 60, + "alias_code_uid": "AliasCode_10107", + "standard_code": "Code_10863" + }, + { + "id": 236511, + "soa_id": 60, + "alias_code_uid": "AliasCode_10108", + "standard_code": "Code_10864" + }, + { + "id": 236512, + "soa_id": 60, + "alias_code_uid": "AliasCode_10109", + "standard_code": "Code_10865" + }, + { + "id": 236513, + "soa_id": 60, + "alias_code_uid": "AliasCode_10110", + "standard_code": "Code_10866" + }, + { + "id": 236514, + "soa_id": 60, + "alias_code_uid": "AliasCode_10111", + "standard_code": "Code_10867" + }, + { + "id": 236515, + "soa_id": 60, + "alias_code_uid": "AliasCode_10112", + "standard_code": "Code_10868" + }, + { + "id": 236516, + "soa_id": 60, + "alias_code_uid": "AliasCode_10113", + "standard_code": "Code_10869" + }, + { + "id": 236517, + "soa_id": 60, + "alias_code_uid": "AliasCode_10114", + "standard_code": "Code_10870" + }, + { + "id": 236518, + "soa_id": 60, + "alias_code_uid": "AliasCode_10115", + "standard_code": "Code_10871" + }, + { + "id": 236519, + "soa_id": 60, + "alias_code_uid": "AliasCode_10116", + "standard_code": "Code_10872" + }, + { + "id": 236520, + "soa_id": 60, + "alias_code_uid": "AliasCode_10117", + "standard_code": "Code_10873" + }, + { + "id": 236521, + "soa_id": 60, + "alias_code_uid": "AliasCode_10118", + "standard_code": "Code_10874" + }, + { + "id": 236522, + "soa_id": 60, + "alias_code_uid": "AliasCode_10119", + "standard_code": "Code_10875" + }, + { + "id": 236523, + "soa_id": 60, + "alias_code_uid": "AliasCode_10120", + "standard_code": "Code_10876" + }, + { + "id": 236524, + "soa_id": 60, + "alias_code_uid": "AliasCode_10121", + "standard_code": "Code_10877" + }, + { + "id": 236525, + "soa_id": 60, + "alias_code_uid": "AliasCode_10122", + "standard_code": "Code_10878" + }, + { + "id": 236526, + "soa_id": 60, + "alias_code_uid": "AliasCode_10123", + "standard_code": "Code_10879" + }, + { + "id": 236527, + "soa_id": 60, + "alias_code_uid": "AliasCode_10124", + "standard_code": "Code_10880" + }, + { + "id": 236528, + "soa_id": 60, + "alias_code_uid": "AliasCode_10125", + "standard_code": "Code_10881" + }, + { + "id": 236529, + "soa_id": 60, + "alias_code_uid": "AliasCode_10126", + "standard_code": "Code_10882" + }, + { + "id": 236530, + "soa_id": 60, + "alias_code_uid": "AliasCode_10127", + "standard_code": "Code_10883" + }, + { + "id": 236531, + "soa_id": 60, + "alias_code_uid": "AliasCode_10128", + "standard_code": "Code_10884" + }, + { + "id": 236532, + "soa_id": 60, + "alias_code_uid": "AliasCode_10129", + "standard_code": "Code_10885" + }, + { + "id": 236533, + "soa_id": 60, + "alias_code_uid": "AliasCode_10130", + "standard_code": "Code_10886" + }, + { + "id": 236534, + "soa_id": 60, + "alias_code_uid": "AliasCode_10131", + "standard_code": "Code_10887" + }, + { + "id": 236535, + "soa_id": 60, + "alias_code_uid": "AliasCode_10132", + "standard_code": "Code_10888" + }, + { + "id": 236536, + "soa_id": 60, + "alias_code_uid": "AliasCode_10133", + "standard_code": "Code_10889" + }, + { + "id": 236537, + "soa_id": 60, + "alias_code_uid": "AliasCode_10134", + "standard_code": "Code_10890" + }, + { + "id": 236538, + "soa_id": 60, + "alias_code_uid": "AliasCode_10135", + "standard_code": "Code_10891" + }, + { + "id": 236539, + "soa_id": 60, + "alias_code_uid": "AliasCode_10136", + "standard_code": "Code_10892" + }, + { + "id": 236540, + "soa_id": 60, + "alias_code_uid": "AliasCode_10137", + "standard_code": "Code_10893" + }, + { + "id": 236541, + "soa_id": 60, + "alias_code_uid": "AliasCode_10138", + "standard_code": "Code_10894" + }, + { + "id": 236542, + "soa_id": 60, + "alias_code_uid": "AliasCode_10139", + "standard_code": "Code_10895" + }, + { + "id": 236543, + "soa_id": 60, + "alias_code_uid": "AliasCode_10140", + "standard_code": "Code_10896" + }, + { + "id": 236544, + "soa_id": 60, + "alias_code_uid": "AliasCode_10141", + "standard_code": "Code_10897" + }, + { + "id": 236545, + "soa_id": 60, + "alias_code_uid": "AliasCode_10142", + "standard_code": "Code_10898" + }, + { + "id": 236546, + "soa_id": 60, + "alias_code_uid": "AliasCode_10143", + "standard_code": "Code_10899" + }, + { + "id": 236547, + "soa_id": 60, + "alias_code_uid": "AliasCode_10144", + "standard_code": "Code_10900" + }, + { + "id": 236548, + "soa_id": 60, + "alias_code_uid": "AliasCode_10145", + "standard_code": "Code_10901" + }, + { + "id": 236549, + "soa_id": 60, + "alias_code_uid": "AliasCode_10146", + "standard_code": "Code_10902" + }, + { + "id": 236550, + "soa_id": 60, + "alias_code_uid": "AliasCode_10147", + "standard_code": "Code_10903" + }, + { + "id": 236551, + "soa_id": 60, + "alias_code_uid": "AliasCode_10148", + "standard_code": "Code_10904" + }, + { + "id": 236552, + "soa_id": 60, + "alias_code_uid": "AliasCode_10149", + "standard_code": "Code_10905" + }, + { + "id": 236553, + "soa_id": 60, + "alias_code_uid": "AliasCode_10150", + "standard_code": "Code_10906" + }, + { + "id": 236554, + "soa_id": 60, + "alias_code_uid": "AliasCode_10151", + "standard_code": "Code_10907" + }, + { + "id": 236555, + "soa_id": 60, + "alias_code_uid": "AliasCode_10152", + "standard_code": "Code_10908" + }, + { + "id": 236556, + "soa_id": 60, + "alias_code_uid": "AliasCode_10153", + "standard_code": "Code_10909" + }, + { + "id": 236557, + "soa_id": 60, + "alias_code_uid": "AliasCode_10154", + "standard_code": "Code_10910" + }, + { + "id": 236558, + "soa_id": 60, + "alias_code_uid": "AliasCode_10155", + "standard_code": "Code_10911" + }, + { + "id": 236559, + "soa_id": 60, + "alias_code_uid": "AliasCode_10156", + "standard_code": "Code_10912" + }, + { + "id": 236560, + "soa_id": 60, + "alias_code_uid": "AliasCode_10157", + "standard_code": "Code_10913" + }, + { + "id": 236561, + "soa_id": 60, + "alias_code_uid": "AliasCode_10158", + "standard_code": "Code_10914" + }, + { + "id": 236562, + "soa_id": 60, + "alias_code_uid": "AliasCode_10159", + "standard_code": "Code_10915" + }, + { + "id": 236563, + "soa_id": 60, + "alias_code_uid": "AliasCode_10160", + "standard_code": "Code_10916" + }, + { + "id": 236564, + "soa_id": 60, + "alias_code_uid": "AliasCode_10161", + "standard_code": "Code_10917" + }, + { + "id": 236565, + "soa_id": 60, + "alias_code_uid": "AliasCode_10162", + "standard_code": "Code_10918" + }, + { + "id": 236566, + "soa_id": 60, + "alias_code_uid": "AliasCode_10163", + "standard_code": "Code_10919" + }, + { + "id": 236567, + "soa_id": 60, + "alias_code_uid": "AliasCode_10164", + "standard_code": "Code_10920" + }, + { + "id": 236568, + "soa_id": 60, + "alias_code_uid": "AliasCode_10165", + "standard_code": "Code_10921" + }, + { + "id": 236569, + "soa_id": 60, + "alias_code_uid": "AliasCode_10166", + "standard_code": "Code_10922" + }, + { + "id": 236570, + "soa_id": 60, + "alias_code_uid": "AliasCode_10167", + "standard_code": "Code_10923" + }, + { + "id": 236571, + "soa_id": 60, + "alias_code_uid": "AliasCode_10168", + "standard_code": "Code_10924" + }, + { + "id": 236572, + "soa_id": 60, + "alias_code_uid": "AliasCode_10169", + "standard_code": "Code_10925" + }, + { + "id": 236573, + "soa_id": 60, + "alias_code_uid": "AliasCode_10170", + "standard_code": "Code_10926" + }, + { + "id": 236574, + "soa_id": 60, + "alias_code_uid": "AliasCode_10171", + "standard_code": "Code_10927" + }, + { + "id": 236575, + "soa_id": 60, + "alias_code_uid": "AliasCode_10172", + "standard_code": "Code_10928" + }, + { + "id": 236576, + "soa_id": 60, + "alias_code_uid": "AliasCode_10173", + "standard_code": "Code_10929" + }, + { + "id": 236577, + "soa_id": 60, + "alias_code_uid": "AliasCode_10174", + "standard_code": "Code_10930" + }, + { + "id": 236578, + "soa_id": 60, + "alias_code_uid": "AliasCode_10175", + "standard_code": "Code_10931" + }, + { + "id": 236579, + "soa_id": 60, + "alias_code_uid": "AliasCode_10176", + "standard_code": "Code_10932" + }, + { + "id": 236580, + "soa_id": 60, + "alias_code_uid": "AliasCode_10177", + "standard_code": "Code_10933" + }, + { + "id": 236581, + "soa_id": 60, + "alias_code_uid": "AliasCode_10178", + "standard_code": "Code_10934" + }, + { + "id": 236582, + "soa_id": 60, + "alias_code_uid": "AliasCode_10179", + "standard_code": "Code_10935" + }, + { + "id": 236583, + "soa_id": 60, + "alias_code_uid": "AliasCode_10180", + "standard_code": "Code_10936" + }, + { + "id": 236584, + "soa_id": 60, + "alias_code_uid": "AliasCode_10181", + "standard_code": "Code_10937" + }, + { + "id": 236585, + "soa_id": 60, + "alias_code_uid": "AliasCode_10182", + "standard_code": "Code_10938" + }, + { + "id": 236586, + "soa_id": 60, + "alias_code_uid": "AliasCode_10183", + "standard_code": "Code_10939" + }, + { + "id": 236587, + "soa_id": 60, + "alias_code_uid": "AliasCode_10184", + "standard_code": "Code_10940" + }, + { + "id": 236588, + "soa_id": 60, + "alias_code_uid": "AliasCode_10185", + "standard_code": "Code_10941" + }, + { + "id": 236589, + "soa_id": 60, + "alias_code_uid": "AliasCode_10186", + "standard_code": "Code_10942" + }, + { + "id": 236590, + "soa_id": 60, + "alias_code_uid": "AliasCode_10187", + "standard_code": "Code_10943" + }, + { + "id": 236591, + "soa_id": 60, + "alias_code_uid": "AliasCode_10188", + "standard_code": "Code_10944" + }, + { + "id": 236592, + "soa_id": 60, + "alias_code_uid": "AliasCode_10189", + "standard_code": "Code_10945" + }, + { + "id": 236596, + "soa_id": 60, + "alias_code_uid": "AliasCode_10193", + "standard_code": "Code_10949" + }, + { + "id": 236597, + "soa_id": 60, + "alias_code_uid": "AliasCode_10194", + "standard_code": "Code_10950" + }, + { + "id": 236598, + "soa_id": 60, + "alias_code_uid": "AliasCode_10195", + "standard_code": "Code_10951" + }, + { + "id": 236599, + "soa_id": 60, + "alias_code_uid": "AliasCode_10196", + "standard_code": "Code_10952" + }, + { + "id": 236600, + "soa_id": 60, + "alias_code_uid": "AliasCode_10197", + "standard_code": "Code_10953" + }, + { + "id": 236601, + "soa_id": 60, + "alias_code_uid": "AliasCode_10198", + "standard_code": "Code_10954" + }, + { + "id": 236602, + "soa_id": 60, + "alias_code_uid": "AliasCode_10199", + "standard_code": "Code_10955" + }, + { + "id": 236603, + "soa_id": 60, + "alias_code_uid": "AliasCode_10200", + "standard_code": "Code_10956" + }, + { + "id": 236604, + "soa_id": 60, + "alias_code_uid": "AliasCode_10201", + "standard_code": "Code_10957" + }, + { + "id": 236605, + "soa_id": 60, + "alias_code_uid": "AliasCode_10202", + "standard_code": "Code_10958" + }, + { + "id": 236606, + "soa_id": 60, + "alias_code_uid": "AliasCode_10203", + "standard_code": "Code_10959" + }, + { + "id": 236607, + "soa_id": 60, + "alias_code_uid": "AliasCode_10204", + "standard_code": "Code_10960" + }, + { + "id": 236608, + "soa_id": 60, + "alias_code_uid": "AliasCode_10205", + "standard_code": "Code_10961" + }, + { + "id": 236609, + "soa_id": 60, + "alias_code_uid": "AliasCode_10206", + "standard_code": "Code_10962" + }, + { + "id": 236610, + "soa_id": 60, + "alias_code_uid": "AliasCode_10207", + "standard_code": "Code_10963" + }, + { + "id": 236611, + "soa_id": 60, + "alias_code_uid": "AliasCode_10208", + "standard_code": "Code_10964" + }, + { + "id": 236612, + "soa_id": 60, + "alias_code_uid": "AliasCode_10209", + "standard_code": "Code_10965" + }, + { + "id": 236613, + "soa_id": 60, + "alias_code_uid": "AliasCode_10210", + "standard_code": "Code_10966" + }, + { + "id": 236614, + "soa_id": 60, + "alias_code_uid": "AliasCode_10211", + "standard_code": "Code_10967" + }, + { + "id": 236615, + "soa_id": 60, + "alias_code_uid": "AliasCode_10212", + "standard_code": "Code_10968" + }, + { + "id": 236616, + "soa_id": 60, + "alias_code_uid": "AliasCode_10213", + "standard_code": "Code_10969" + }, + { + "id": 236617, + "soa_id": 60, + "alias_code_uid": "AliasCode_10214", + "standard_code": "Code_10970" + }, + { + "id": 236618, + "soa_id": 60, + "alias_code_uid": "AliasCode_10215", + "standard_code": "Code_10971" + }, + { + "id": 236619, + "soa_id": 60, + "alias_code_uid": "AliasCode_10216", + "standard_code": "Code_10972" + }, + { + "id": 236620, + "soa_id": 60, + "alias_code_uid": "AliasCode_10217", + "standard_code": "Code_10973" + }, + { + "id": 236621, + "soa_id": 60, + "alias_code_uid": "AliasCode_10218", + "standard_code": "Code_10974" + }, + { + "id": 236622, + "soa_id": 60, + "alias_code_uid": "AliasCode_10219", + "standard_code": "Code_10975" + }, + { + "id": 236623, + "soa_id": 60, + "alias_code_uid": "AliasCode_10220", + "standard_code": "Code_10976" + }, + { + "id": 236624, + "soa_id": 60, + "alias_code_uid": "AliasCode_10221", + "standard_code": "Code_10977" + }, + { + "id": 236625, + "soa_id": 60, + "alias_code_uid": "AliasCode_10222", + "standard_code": "Code_10978" + }, + { + "id": 236626, + "soa_id": 60, + "alias_code_uid": "AliasCode_10223", + "standard_code": "Code_10979" + }, + { + "id": 236627, + "soa_id": 60, + "alias_code_uid": "AliasCode_10224", + "standard_code": "Code_10980" + }, + { + "id": 236628, + "soa_id": 60, + "alias_code_uid": "AliasCode_10225", + "standard_code": "Code_10981" + }, + { + "id": 236630, + "soa_id": 60, + "alias_code_uid": "AliasCode_10227", + "standard_code": "Code_10983" + }, + { + "id": 236631, + "soa_id": 60, + "alias_code_uid": "AliasCode_10228", + "standard_code": "Code_10984" + }, + { + "id": 236632, + "soa_id": 60, + "alias_code_uid": "AliasCode_10229", + "standard_code": "Code_10985" + }, + { + "id": 236633, + "soa_id": 60, + "alias_code_uid": "AliasCode_10230", + "standard_code": "Code_10986" + }, + { + "id": 236634, + "soa_id": 60, + "alias_code_uid": "AliasCode_10231", + "standard_code": "Code_10987" + }, + { + "id": 236635, + "soa_id": 60, + "alias_code_uid": "AliasCode_10232", + "standard_code": "Code_10988" + }, + { + "id": 236636, + "soa_id": 60, + "alias_code_uid": "AliasCode_10233", + "standard_code": "Code_10989" + }, + { + "id": 236637, + "soa_id": 60, + "alias_code_uid": "AliasCode_10234", + "standard_code": "Code_10990" + }, + { + "id": 236638, + "soa_id": 60, + "alias_code_uid": "AliasCode_10235", + "standard_code": "Code_10991" + }, + { + "id": 236639, + "soa_id": 60, + "alias_code_uid": "AliasCode_10236", + "standard_code": "Code_10992" + }, + { + "id": 236640, + "soa_id": 60, + "alias_code_uid": "AliasCode_10237", + "standard_code": "Code_10993" + }, + { + "id": 236641, + "soa_id": 60, + "alias_code_uid": "AliasCode_10238", + "standard_code": "Code_10994" + }, + { + "id": 236642, + "soa_id": 60, + "alias_code_uid": "AliasCode_10239", + "standard_code": "Code_10995" + }, + { + "id": 236643, + "soa_id": 60, + "alias_code_uid": "AliasCode_10240", + "standard_code": "Code_10996" + }, + { + "id": 236644, + "soa_id": 60, + "alias_code_uid": "AliasCode_10241", + "standard_code": "Code_10997" + }, + { + "id": 236645, + "soa_id": 60, + "alias_code_uid": "AliasCode_10242", + "standard_code": "Code_10998" + }, + { + "id": 236646, + "soa_id": 60, + "alias_code_uid": "AliasCode_10243", + "standard_code": "Code_10999" + }, + { + "id": 236647, + "soa_id": 60, + "alias_code_uid": "AliasCode_10244", + "standard_code": "Code_11000" + }, + { + "id": 236648, + "soa_id": 60, + "alias_code_uid": "AliasCode_10245", + "standard_code": "Code_11001" + }, + { + "id": 236649, + "soa_id": 60, + "alias_code_uid": "AliasCode_10246", + "standard_code": "Code_11002" + }, + { + "id": 236650, + "soa_id": 60, + "alias_code_uid": "AliasCode_10247", + "standard_code": "Code_11003" + }, + { + "id": 236651, + "soa_id": 60, + "alias_code_uid": "AliasCode_10248", + "standard_code": "Code_11004" + }, + { + "id": 236652, + "soa_id": 60, + "alias_code_uid": "AliasCode_10249", + "standard_code": "Code_11005" + }, + { + "id": 236653, + "soa_id": 60, + "alias_code_uid": "AliasCode_10250", + "standard_code": "Code_11006" + }, + { + "id": 236654, + "soa_id": 60, + "alias_code_uid": "AliasCode_10251", + "standard_code": "Code_11007" + }, + { + "id": 236655, + "soa_id": 60, + "alias_code_uid": "AliasCode_10252", + "standard_code": "Code_11008" + }, + { + "id": 236656, + "soa_id": 60, + "alias_code_uid": "AliasCode_10253", + "standard_code": "Code_11009" + }, + { + "id": 236657, + "soa_id": 60, + "alias_code_uid": "AliasCode_10254", + "standard_code": "Code_11010" + }, + { + "id": 236658, + "soa_id": 60, + "alias_code_uid": "AliasCode_10255", + "standard_code": "Code_11011" + }, + { + "id": 236659, + "soa_id": 60, + "alias_code_uid": "AliasCode_10256", + "standard_code": "Code_11012" + }, + { + "id": 236660, + "soa_id": 60, + "alias_code_uid": "AliasCode_10257", + "standard_code": "Code_11013" + }, + { + "id": 236661, + "soa_id": 60, + "alias_code_uid": "AliasCode_10258", + "standard_code": "Code_11014" + }, + { + "id": 236662, + "soa_id": 60, + "alias_code_uid": "AliasCode_10259", + "standard_code": "Code_11015" + }, + { + "id": 236663, + "soa_id": 60, + "alias_code_uid": "AliasCode_10260", + "standard_code": "Code_11016" + }, + { + "id": 236664, + "soa_id": 60, + "alias_code_uid": "AliasCode_10261", + "standard_code": "Code_11017" + }, + { + "id": 236665, + "soa_id": 60, + "alias_code_uid": "AliasCode_10262", + "standard_code": "Code_11018" + }, + { + "id": 236666, + "soa_id": 60, + "alias_code_uid": "AliasCode_10263", + "standard_code": "Code_11019" + }, + { + "id": 236667, + "soa_id": 60, + "alias_code_uid": "AliasCode_10264", + "standard_code": "Code_11020" + }, + { + "id": 236668, + "soa_id": 60, + "alias_code_uid": "AliasCode_10265", + "standard_code": "Code_11021" + }, + { + "id": 236669, + "soa_id": 60, + "alias_code_uid": "AliasCode_10266", + "standard_code": "Code_11022" + }, + { + "id": 236670, + "soa_id": 60, + "alias_code_uid": "AliasCode_10267", + "standard_code": "Code_11023" + }, + { + "id": 236671, + "soa_id": 60, + "alias_code_uid": "AliasCode_10268", + "standard_code": "Code_11024" + }, + { + "id": 236672, + "soa_id": 60, + "alias_code_uid": "AliasCode_10269", + "standard_code": "Code_11025" + }, + { + "id": 236673, + "soa_id": 60, + "alias_code_uid": "AliasCode_10270", + "standard_code": "Code_11026" + }, + { + "id": 236674, + "soa_id": 60, + "alias_code_uid": "AliasCode_10271", + "standard_code": "Code_11027" + }, + { + "id": 236675, + "soa_id": 60, + "alias_code_uid": "AliasCode_10272", + "standard_code": "Code_11028" + }, + { + "id": 236676, + "soa_id": 60, + "alias_code_uid": "AliasCode_10273", + "standard_code": "Code_11029" + }, + { + "id": 236677, + "soa_id": 60, + "alias_code_uid": "AliasCode_10274", + "standard_code": "Code_11030" + }, + { + "id": 236678, + "soa_id": 60, + "alias_code_uid": "AliasCode_10275", + "standard_code": "Code_11031" + }, + { + "id": 236679, + "soa_id": 60, + "alias_code_uid": "AliasCode_10276", + "standard_code": "Code_11032" + }, + { + "id": 236680, + "soa_id": 60, + "alias_code_uid": "AliasCode_10277", + "standard_code": "Code_11033" + }, + { + "id": 236681, + "soa_id": 60, + "alias_code_uid": "AliasCode_10278", + "standard_code": "Code_11034" + }, + { + "id": 236682, + "soa_id": 60, + "alias_code_uid": "AliasCode_10279", + "standard_code": "Code_11035" + }, + { + "id": 236683, + "soa_id": 60, + "alias_code_uid": "AliasCode_10280", + "standard_code": "Code_11036" + }, + { + "id": 236684, + "soa_id": 60, + "alias_code_uid": "AliasCode_10281", + "standard_code": "Code_11037" + }, + { + "id": 236685, + "soa_id": 60, + "alias_code_uid": "AliasCode_10282", + "standard_code": "Code_11038" + }, + { + "id": 236686, + "soa_id": 60, + "alias_code_uid": "AliasCode_10283", + "standard_code": "Code_11039" + }, + { + "id": 236687, + "soa_id": 60, + "alias_code_uid": "AliasCode_10284", + "standard_code": "Code_11040" + }, + { + "id": 236688, + "soa_id": 60, + "alias_code_uid": "AliasCode_10285", + "standard_code": "Code_11041" + }, + { + "id": 236689, + "soa_id": 60, + "alias_code_uid": "AliasCode_10286", + "standard_code": "Code_11042" + }, + { + "id": 236690, + "soa_id": 60, + "alias_code_uid": "AliasCode_10287", + "standard_code": "Code_11043" + }, + { + "id": 236691, + "soa_id": 60, + "alias_code_uid": "AliasCode_10288", + "standard_code": "Code_11044" + }, + { + "id": 236692, + "soa_id": 60, + "alias_code_uid": "AliasCode_10289", + "standard_code": "Code_11045" + }, + { + "id": 236693, + "soa_id": 60, + "alias_code_uid": "AliasCode_10290", + "standard_code": "Code_11046" + }, + { + "id": 236694, + "soa_id": 60, + "alias_code_uid": "AliasCode_10291", + "standard_code": "Code_11047" + }, + { + "id": 236695, + "soa_id": 60, + "alias_code_uid": "AliasCode_10292", + "standard_code": "Code_11048" + } + ], + "code_association": [ + { + "id": 500, + "soa_id": 60, + "code_uid": "Code_1", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C99079", + "code": "C202487", + "decode": "C202487" + }, + { + "id": 501, + "soa_id": 60, + "code_uid": "Code_2", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C99079", + "code": "C101526", + "decode": "C101526" + }, + { + "id": 502, + "soa_id": 60, + "code_uid": "Code_3", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C99079", + "code": "C202578", + "decode": "C202578" + }, + { + "id": 503, + "soa_id": 60, + "code_uid": "Code_4", + "codelist_table": "db://protocol_terminology", + "codelist_code": "C174222", + "code": "C174266", + "decode": "Experimental Arm" + }, + { + "id": 504, + "soa_id": 60, + "code_uid": "Code_5", + "codelist_table": "db://ddf_terminology", + "codelist_code": "C188727", + "code": "C188866", + "decode": "Data Generated Within Study" + }, + { + "id": 505, + "soa_id": 60, + "code_uid": "Code_6", + "codelist_table": "db://protocol_terminology", + "codelist_code": "C174222", + "code": "C174268", + "decode": "Active Comparator Arm" + }, + { + "id": 506, + "soa_id": 60, + "code_uid": "Code_7", + "codelist_table": "db://ddf_terminology", + "codelist_code": "C188727", + "code": "C188866", + "decode": "Data Generated Within Study" + }, + { + "id": 507, + "soa_id": 60, + "code_uid": "Code_485", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 508, + "soa_id": 60, + "code_uid": "Code_486", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 509, + "soa_id": 60, + "code_uid": "Code_487", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 510, + "soa_id": 60, + "code_uid": "Code_488", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 511, + "soa_id": 60, + "code_uid": "Code_489", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 512, + "soa_id": 60, + "code_uid": "Code_490", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 513, + "soa_id": 60, + "code_uid": "Code_491", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 514, + "soa_id": 60, + "code_uid": "Code_492", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 515, + "soa_id": 60, + "code_uid": "Code_493", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 516, + "soa_id": 60, + "code_uid": "Code_494", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 517, + "soa_id": 60, + "code_uid": "Code_495", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C127262", + "code": "C18002", + "decode": "C18002" + }, + { + "id": 518, + "soa_id": 60, + "code_uid": "Code_496", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 519, + "soa_id": 60, + "code_uid": "Code_497", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 520, + "soa_id": 60, + "code_uid": "Code_498", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 521, + "soa_id": 60, + "code_uid": "Code_499", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 522, + "soa_id": 60, + "code_uid": "Code_500", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 523, + "soa_id": 60, + "code_uid": "Code_501", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 524, + "soa_id": 60, + "code_uid": "Code_502", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 525, + "soa_id": 60, + "code_uid": "Code_503", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 526, + "soa_id": 60, + "code_uid": "Code_504", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 527, + "soa_id": 60, + "code_uid": "Code_505", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 528, + "soa_id": 60, + "code_uid": "Code_506", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 529, + "soa_id": 60, + "code_uid": "Code_507", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 530, + "soa_id": 60, + "code_uid": "Code_508", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 531, + "soa_id": 60, + "code_uid": "Code_813", + "codelist_table": "/mdr/ct/packages/sdtmct-2025-09-26", + "codelist_code": "C99079", + "code": "C123452", + "decode": "C123452" + }, + { + "id": 562, + "soa_id": 60, + "code_uid": "Code_2355", + "codelist_table": "/mdr/ct/packages", + "codelist_code": "C188725", + "code": "C85826", + "decode": "Study Primary Objective" + }, + { + "id": 563, + "soa_id": 60, + "code_uid": "Code_2356", + "codelist_table": "/mdr/ct/packages", + "codelist_code": "C188726", + "code": "C94496", + "decode": "Primary Endpoint" + }, + { + "id": 564, + "soa_id": 60, + "code_uid": "Code_2357", + "codelist_table": "/mdr/ct/packages/ddfct-2026-03-27", + "codelist_code": "C188725", + "code": "C85827", + "decode": "Study Secondary Objective" + }, + { + "id": 565, + "soa_id": 60, + "code_uid": "Code_2358", + "codelist_table": "/mdr/ct/packages", + "codelist_code": "C188726", + "code": "C139173", + "decode": "Secondary Endpoint" + }, + { + "id": 566, + "soa_id": 60, + "code_uid": "Code_2359", + "codelist_table": "/mdr/ct/packages", + "codelist_code": "C188726", + "code": "C139173", + "decode": "Secondary Endpoint" + }, + { + "id": 567, + "soa_id": 60, + "code_uid": "Code_2360", + "codelist_table": "/mdr/ct/packages", + "codelist_code": "C188726", + "code": "C139173", + "decode": "Secondary Endpoint" + }, + { + "id": 568, + "soa_id": 60, + "code_uid": "Code_2361", + "codelist_table": "/mdr/ct/packages", + "codelist_code": "C188726", + "code": "C139173", + "decode": "Secondary Endpoint" + }, + { + "id": 569, + "soa_id": 60, + "code_uid": "Code_2362", + "codelist_table": "/mdr/ct/packages", + "codelist_code": "C188726", + "code": "C139173", + "decode": "Secondary Endpoint" + }, + { + "id": 1273, + "soa_id": 60, + "code_uid": "Code_10038", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1274, + "soa_id": 60, + "code_uid": "Code_10039", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1275, + "soa_id": 60, + "code_uid": "Code_10040", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1276, + "soa_id": 60, + "code_uid": "Code_10041", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1277, + "soa_id": 60, + "code_uid": "Code_10042", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1278, + "soa_id": 60, + "code_uid": "Code_10043", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1279, + "soa_id": 60, + "code_uid": "Code_10044", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1280, + "soa_id": 60, + "code_uid": "Code_10045", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1281, + "soa_id": 60, + "code_uid": "Code_10046", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1282, + "soa_id": 60, + "code_uid": "Code_10047", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1283, + "soa_id": 60, + "code_uid": "Code_10048", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1284, + "soa_id": 60, + "code_uid": "Code_10049", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1285, + "soa_id": 60, + "code_uid": "Code_10050", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1286, + "soa_id": 60, + "code_uid": "Code_10051", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1287, + "soa_id": 60, + "code_uid": "Code_10052", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1288, + "soa_id": 60, + "code_uid": "Code_10053", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1289, + "soa_id": 60, + "code_uid": "Code_10054", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1290, + "soa_id": 60, + "code_uid": "Code_10055", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1291, + "soa_id": 60, + "code_uid": "Code_10056", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1292, + "soa_id": 60, + "code_uid": "Code_10057", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1293, + "soa_id": 60, + "code_uid": "Code_10058", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1294, + "soa_id": 60, + "code_uid": "Code_10059", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1295, + "soa_id": 60, + "code_uid": "Code_10060", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1296, + "soa_id": 60, + "code_uid": "Code_10061", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1297, + "soa_id": 60, + "code_uid": "Code_10062", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1298, + "soa_id": 60, + "code_uid": "Code_10063", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1299, + "soa_id": 60, + "code_uid": "Code_10064", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1300, + "soa_id": 60, + "code_uid": "Code_10065", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1301, + "soa_id": 60, + "code_uid": "Code_10066", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1302, + "soa_id": 60, + "code_uid": "Code_10067", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1303, + "soa_id": 60, + "code_uid": "Code_10068", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1304, + "soa_id": 60, + "code_uid": "Code_10069", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1305, + "soa_id": 60, + "code_uid": "Code_10070", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1306, + "soa_id": 60, + "code_uid": "Code_10071", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1307, + "soa_id": 60, + "code_uid": "Code_10072", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1308, + "soa_id": 60, + "code_uid": "Code_10073", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1309, + "soa_id": 60, + "code_uid": "Code_10074", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1310, + "soa_id": 60, + "code_uid": "Code_10075", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1311, + "soa_id": 60, + "code_uid": "Code_10076", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1312, + "soa_id": 60, + "code_uid": "Code_10077", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C188728", + "code": "C25716", + "decode": "Visit" + }, + { + "id": 1313, + "soa_id": 60, + "code_uid": "Code_10078", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C127262", + "code": "C211570", + "decode": "C211570" + }, + { + "id": 1314, + "soa_id": 60, + "code_uid": "Code_10079", + "codelist_table": "/mdr/ct/packages/sdtmct-2026-03-27", + "codelist_code": "C171445", + "code": "C175574", + "decode": "C175574" + }, + { + "id": 1315, + "soa_id": 60, + "code_uid": "Code_10080", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201358", + "decode": "Fixed Reference" + }, + { + "id": 1316, + "soa_id": 60, + "code_uid": "Code_10081", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1317, + "soa_id": 60, + "code_uid": "Code_10082", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201357", + "decode": "Before" + }, + { + "id": 1318, + "soa_id": 60, + "code_uid": "Code_10083", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1319, + "soa_id": 60, + "code_uid": "Code_10084", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1320, + "soa_id": 60, + "code_uid": "Code_10085", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1321, + "soa_id": 60, + "code_uid": "Code_10086", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1322, + "soa_id": 60, + "code_uid": "Code_10087", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1323, + "soa_id": 60, + "code_uid": "Code_10088", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1324, + "soa_id": 60, + "code_uid": "Code_10089", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1325, + "soa_id": 60, + "code_uid": "Code_10090", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1326, + "soa_id": 60, + "code_uid": "Code_10091", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1327, + "soa_id": 60, + "code_uid": "Code_10092", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1328, + "soa_id": 60, + "code_uid": "Code_10093", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1329, + "soa_id": 60, + "code_uid": "Code_10094", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1330, + "soa_id": 60, + "code_uid": "Code_10095", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1331, + "soa_id": 60, + "code_uid": "Code_10096", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1332, + "soa_id": 60, + "code_uid": "Code_10097", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1333, + "soa_id": 60, + "code_uid": "Code_10098", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1334, + "soa_id": 60, + "code_uid": "Code_10099", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1335, + "soa_id": 60, + "code_uid": "Code_10100", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1336, + "soa_id": 60, + "code_uid": "Code_10101", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1337, + "soa_id": 60, + "code_uid": "Code_10102", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1338, + "soa_id": 60, + "code_uid": "Code_10103", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1339, + "soa_id": 60, + "code_uid": "Code_10104", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1340, + "soa_id": 60, + "code_uid": "Code_10105", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1341, + "soa_id": 60, + "code_uid": "Code_10106", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1342, + "soa_id": 60, + "code_uid": "Code_10107", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1343, + "soa_id": 60, + "code_uid": "Code_10108", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1344, + "soa_id": 60, + "code_uid": "Code_10109", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + }, + { + "id": 1345, + "soa_id": 60, + "code_uid": "Code_10110", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201264", + "code": "C201356", + "decode": "After" + }, + { + "id": 1346, + "soa_id": 60, + "code_uid": "Code_10111", + "codelist_table": "http://www.cdisc.org", + "codelist_code": "C201265", + "code": "C201355", + "decode": "Start to Start" + } + ], + "epoch": [ + { + "id": 33, + "soa_id": 60, + "name": "Pre-Study Phase", + "order_index": 1, + "epoch_seq": 1, + "epoch_label": "Pre-Study Phase", + "epoch_description": "Eligibility assessment, up to 28 days prior to C1D1", + "type": "Code_1", + "epoch_uid": "StudyEpoch_1", + "superscript": null + }, + { + "id": 34, + "soa_id": 60, + "name": "Induction Phase", + "order_index": 2, + "epoch_seq": 2, + "epoch_label": "Induction Phase", + "epoch_description": "From C1D1 until disease progression or discontinuation", + "type": "Code_2", + "epoch_uid": "StudyEpoch_2", + "superscript": null + }, + { + "id": 35, + "soa_id": 60, + "name": "Follow-up Off Therapy", + "order_index": 4, + "epoch_seq": 3, + "epoch_label": "Follow-up, off therapy", + "epoch_description": "Post-EOT survival and safety follow-up", + "type": "Code_3", + "epoch_uid": "StudyEpoch_3", + "superscript": "o" + }, + { + "id": 36, + "soa_id": 60, + "name": "Continuation Phase", + "order_index": 3, + "epoch_seq": 4, + "epoch_label": "Continuation Phase", + "epoch_description": "Continuation Phase (until progression or unacceptable toxicity", + "type": "Code_813", + "epoch_uid": "StudyEpoch_4", + "superscript": "\u00a3" + } + ], + "arm": [ + { + "id": 46, + "soa_id": 60, + "name": "ARM A", + "label": "Fulvestrant + Everolimus", + "description": "Fulvestrant 500mg IM Q28D (loading D1/D15) + Everolimus 10mg PO QD", + "order_index": 1, + "arm_uid": "StudyArm_1", + "type": "Code_4", + "data_origin_type": "Code_5" + }, + { + "id": 47, + "soa_id": 60, + "name": "ARM B", + "label": "Fulvestrant + Placebo", + "description": "Fulvestrant 500mg IM Q28D (loading D1/D15) + Placebo PO QD", + "order_index": 2, + "arm_uid": "StudyArm_2", + "type": "Code_6", + "data_origin_type": "Code_7" + } + ], + "visit": [ + { + "id": 136, + "soa_id": 60, + "name": "PRE-STUDY", + "label": "Pre-Study", + "order_index": 1, + "epoch_id": null, + "encounter_uid": "Encounter_1", + "description": "Occuring before Randomization and Treatment", + "type": "Code_485", + "environmentalSettings": "Code_486", + "contactModes": "Code_487", + "transitionStartRule": null, + "transitionEndRule": "TransitionRule_1", + "scheduledAtId": "221", + "superscript": null + }, + { + "id": 137, + "soa_id": 60, + "name": "C1D1", + "label": "Cycle 1 Day 1", + "order_index": 2, + "epoch_id": null, + "encounter_uid": "Encounter_2", + "description": "First day fulvestrant is given with everolimus/placebo; start of Induction Phase. Treatment begins within 7 working days of randomization.", + "type": "Code_488", + "environmentalSettings": "Code_489", + "contactModes": "Code_490", + "transitionStartRule": "TransitionRule_2", + "transitionEndRule": null, + "scheduledAtId": "220", + "superscript": "*" + }, + { + "id": 138, + "soa_id": 60, + "name": "C1D15", + "label": "Cycle 1 Day 15", + "order_index": 3, + "epoch_id": null, + "encounter_uid": "Encounter_3", + "description": "Second fulvestrant dose (Cycle 1 only) plus safety assessments.", + "type": "Code_491", + "environmentalSettings": "Code_492", + "contactModes": "Code_493", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "222", + "superscript": null + }, + { + "id": 277, + "soa_id": 60, + "name": "C2D1", + "label": "Cycle 2 Day 1", + "order_index": 4, + "epoch_id": null, + "encounter_uid": "Encounter_4", + "description": "Day 1 of Cycle 2 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", + "type": "Code_10038", + "environmentalSettings": "Code_10039", + "contactModes": "Code_10040", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "223", + "superscript": "*" + }, + { + "id": 278, + "soa_id": 60, + "name": "C3D1", + "label": "Cycle 3 Day 1", + "order_index": 5, + "epoch_id": null, + "encounter_uid": "Encounter_5", + "description": "Day 1 of Cycle 3 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", + "type": "Code_10041", + "environmentalSettings": "Code_10042", + "contactModes": "Code_10043", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "224", + "superscript": "*" + }, + { + "id": 279, + "soa_id": 60, + "name": "C4D1", + "label": "Cycle 4 Day 1", + "order_index": 6, + "epoch_id": null, + "encounter_uid": "Encounter_6", + "description": "Day 1 of Cycle 4 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", + "type": "Code_10044", + "environmentalSettings": "Code_10045", + "contactModes": "Code_10046", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "225", + "superscript": "*" + }, + { + "id": 280, + "soa_id": 60, + "name": "C5D1", + "label": "Cycle 5 Day 1", + "order_index": 7, + "epoch_id": null, + "encounter_uid": "Encounter_7", + "description": "Day 1 of Cycle 5 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", + "type": "Code_10047", + "environmentalSettings": "Code_10048", + "contactModes": "Code_10049", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "226", + "superscript": "*" + }, + { + "id": 281, + "soa_id": 60, + "name": "C6D1", + "label": "Cycle 6 Day 1", + "order_index": 8, + "epoch_id": null, + "encounter_uid": "Encounter_8", + "description": "Day 1 of Cycle 6 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", + "type": "Code_10050", + "environmentalSettings": "Code_10051", + "contactModes": "Code_10052", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "227", + "superscript": "*" + }, + { + "id": 282, + "soa_id": 60, + "name": "C7D1", + "label": "Cycle 7 Day 1", + "order_index": 9, + "epoch_id": null, + "encounter_uid": "Encounter_9", + "description": "Day 1 of Cycle 7 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", + "type": "Code_10053", + "environmentalSettings": "Code_10054", + "contactModes": "Code_10055", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "228", + "superscript": "*" + }, + { + "id": 283, + "soa_id": 60, + "name": "C8D1", + "label": "Cycle 8 Day 1", + "order_index": 10, + "epoch_id": null, + "encounter_uid": "Encounter_10", + "description": "Day 1 of Cycle 8 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", + "type": "Code_10056", + "environmentalSettings": "Code_10057", + "contactModes": "Code_10058", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "229", + "superscript": "*" + }, + { + "id": 284, + "soa_id": 60, + "name": "C9D1", + "label": "Cycle 9 Day 1", + "order_index": 11, + "epoch_id": null, + "encounter_uid": "Encounter_11", + "description": "Day 1 of Cycle 9 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", + "type": "Code_10059", + "environmentalSettings": "Code_10060", + "contactModes": "Code_10061", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "230", + "superscript": "*" + }, + { + "id": 285, + "soa_id": 60, + "name": "C10D1", + "label": "Cycle 10 Day 1", + "order_index": 12, + "epoch_id": null, + "encounter_uid": "Encounter_12", + "description": "Day 1 of Cycle 10 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", + "type": "Code_10062", + "environmentalSettings": "Code_10063", + "contactModes": "Code_10064", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "231", + "superscript": "*" + }, + { + "id": 286, + "soa_id": 60, + "name": "C11D1", + "label": "Cycle 11 Day 1", + "order_index": 13, + "epoch_id": null, + "encounter_uid": "Encounter_13", + "description": "Day 1 of Cycle 11 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", + "type": "Code_10065", + "environmentalSettings": "Code_10069", + "contactModes": "Code_10070", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "232", + "superscript": "*" + }, + { + "id": 287, + "soa_id": 60, + "name": "C12D1", + "label": "Cycle 12 Day 1", + "order_index": 14, + "epoch_id": null, + "encounter_uid": "Encounter_14", + "description": "Day 1 of Cycle 12 (28-day cycle): fulvestrant 500 mg IM plus everolimus/placebo (+/- 72 hour window).", + "type": "Code_10066", + "environmentalSettings": "Code_10067", + "contactModes": "Code_10068", + "transitionStartRule": null, + "transitionEndRule": null, + "scheduledAtId": "233", + "superscript": "*" + }, + { + "id": 288, + "soa_id": 60, + "name": "EOI_EOT", + "label": "End of Induction / End of Treatment", + "order_index": 15, + "epoch_id": null, + "encounter_uid": "Encounter_15", + "description": "Performed within 30 days of last fulvestrant dose, before moving to the Continuation Phase or directly to Follow-Up.", + "type": "Code_10071", + "environmentalSettings": "Code_10072", + "contactModes": "Code_10073", + "transitionStartRule": "TransitionRule_3", + "transitionEndRule": null, + "scheduledAtId": "234", + "superscript": "^" + }, + { + "id": 289, + "soa_id": 60, + "name": "CONT_CXD1", + "label": "Continuation Phase Cycle Day 1", + "order_index": 16, + "epoch_id": null, + "encounter_uid": "Encounter_16", + "description": "Day 1 of each 28-day cycle in the Continuation Phase (begins D29 after last Cycle 12 fulvestrant dose); fulvestrant +/- everolimus until progression or unacceptable toxicity. This visit repeats indefinitely - the protocol defines no fixed cycle count for the Continuation Phase, so it cannot be enumerated and is modeled as a single repeating visit.", + "type": "Code_10074", + "environmentalSettings": "Code_10075", + "contactModes": "Code_10076", + "transitionStartRule": "TransitionRule_4", + "transitionEndRule": "TransitionRule_5", + "scheduledAtId": "235", + "superscript": null + }, + { + "id": 290, + "soa_id": 60, + "name": "FU_OFF_THERAPY", + "label": "Follow-Up Off-Therapy", + "order_index": 17, + "epoch_id": null, + "encounter_uid": "Encounter_17", + "description": "Every 3 months for 3 years from randomization; disease progression, survival and new systemic therapy documented.", + "type": "Code_10077", + "environmentalSettings": "Code_10078", + "contactModes": "Code_10079", + "transitionStartRule": "TransitionRule_6", + "transitionEndRule": "TransitionRule_7", + "scheduledAtId": "236", + "superscript": null + } + ], + "activity": [ + { + "id": 138, + "soa_id": 60, + "name": "INFORMED CONSENT", + "order_index": 2, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_1", + "label": "Informed Consent", + "description": "Informed Consent collected", + "superscript": null + }, + { + "id": 139, + "soa_id": 60, + "name": "ELIGIBILITY ASSESSMENT", + "order_index": 1, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_2", + "label": "Eligibility Assessment", + "description": "Determine subject meets eligibility requirements", + "superscript": null + }, + { + "id": 140, + "soa_id": 60, + "name": "MEDICAL HISTORY", + "order_index": 4, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_3", + "label": "Medical History", + "description": "Medical History & Assessment of Baseline Signs and Symptoms", + "superscript": null + }, + { + "id": 141, + "soa_id": 60, + "name": "ECOG PERFORMANCE STATUS", + "order_index": 8, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_4", + "label": "ECOG Performance Status", + "description": "ECOG performance status", + "superscript": null + }, + { + "id": 142, + "soa_id": 60, + "name": "PHYSICAL EXAM", + "order_index": 5, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_5", + "label": "Physical Examination", + "description": "Physical Examination", + "superscript": null + }, + { + "id": 143, + "soa_id": 60, + "name": "VITAL SIGNS", + "order_index": 7, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_6", + "label": "Vital Signs", + "description": "Vital Signs (Blood Pressure, Heart Rate, Temperature) and Weight", + "superscript": null + }, + { + "id": 145, + "soa_id": 60, + "name": "CHEMISTRY LABS", + "order_index": 14, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_8", + "label": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", + "description": "Serum Creatinine, Electrolytes (K, Na, Cl, CO2), Ca, BUN, Albumin, Total Protein, Phosphorus, AST (SGOT), ALT (SGPT), Alkaline Phosphatase, Total Bilirubin, Magnesium, Uric Acid.", + "superscript": null + }, + { + "id": 147, + "soa_id": 60, + "name": "URINALYSIS", + "order_index": 12, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_10", + "label": "Urinalysis Labs", + "description": "Urinalysis Labs", + "superscript": null + }, + { + "id": 154, + "soa_id": 60, + "name": "ADVERSE EVENTS ASSESSMENTS", + "order_index": 9, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_17", + "label": "Adverse Event Assessment", + "description": "Adverse Event Assessment", + "superscript": null + }, + { + "id": 155, + "soa_id": 60, + "name": "CONCOMITANT MEDS", + "order_index": 6, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_18", + "label": "Concomitant Medications", + "description": "Concomitant Medications", + "superscript": null + }, + { + "id": 156, + "soa_id": 60, + "name": "RANDOMIZATION", + "order_index": 3, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_19", + "label": "Randomization", + "description": "Randomization", + "superscript": null + }, + { + "id": 159, + "soa_id": 60, + "name": "IMAGING SCANS", + "order_index": 10, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_22", + "label": "Imaging Scans", + "description": "Tumor imaging scans", + "superscript": null + }, + { + "id": 160, + "soa_id": 60, + "name": "PT/INR", + "order_index": 11, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_23", + "label": "PT with INR", + "description": "prothrombin time and international normalized ratio", + "superscript": null + }, + { + "id": 161, + "soa_id": 60, + "name": "CBC", + "order_index": 13, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_24", + "label": "CBC with differentials, Platelets", + "description": "CBC with differentials, Platelets", + "superscript": null + }, + { + "id": 162, + "soa_id": 60, + "name": "GLUCOSE", + "order_index": 15, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_25", + "label": "Fasting Glucose", + "description": "Fasting Glucose", + "superscript": null + }, + { + "id": 163, + "soa_id": 60, + "name": "LIPID PROFILE", + "order_index": 16, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_26", + "label": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", + "description": "Fasting serum Lipid Profile (triglycerides, total cholesterol, HDL and LDL)", + "superscript": null + }, + { + "id": 164, + "soa_id": 60, + "name": "HBV-DNA-1", + "order_index": 17, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_27", + "label": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV- RNA-PCR", + "description": "HBV-DNA, HbsAg, HBsAb, HBcAb, HCV- RNA-PCR", + "superscript": null + }, + { + "id": 165, + "soa_id": 60, + "name": "HBV-DNA-2", + "order_index": 18, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_28", + "label": "HBV DNA", + "description": "HBV DNA", + "superscript": null + }, + { + "id": 166, + "soa_id": 60, + "name": "HCV", + "order_index": 19, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_29", + "label": "HCV RNA-PCR", + "description": "HCV RNA-PCR", + "superscript": null + }, + { + "id": 167, + "soa_id": 60, + "name": "COMPLIANCE", + "order_index": 20, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_30", + "label": "Study Drug Compliance (Pill Diary)", + "description": "Study Drug Compliance (Pill Diary)", + "superscript": null + }, + { + "id": 168, + "soa_id": 60, + "name": "PFTS", + "order_index": 21, + "primary_concept_code": null, + "primary_concept_title": null, + "activity_uid": "Activity_31", + "label": "PFTs with DLCO as medically indicatedn", + "description": "PFTs with DLCO as medically indicated", + "superscript": "n" + } + ], + "element": [ + { + "id": 119, + "soa_id": 60, + "element_id": "StudyElement_1", + "name": "SCREENING_ELEMENT", + "label": "Screening", + "description": "Pre-study eligibility and baseline assessment period (within 4 weeks of randomization).", + "testrl": null, + "teenrl": "TransitionRule_1", + "order_index": 1, + "created_at": null + }, + { + "id": 120, + "soa_id": 60, + "element_id": "StudyElement_2", + "name": "INDUCTION_EVE_FUL", + "label": "Induction: Fulvestrant + Everolimus", + "description": "Induction treatment for Arm A: fulvestrant 500 mg IM (D1 & D15 of Cycle 1, then D1 each cycle) plus everolimus 10 mg PO daily, 28-day cycles, max 12 cycles.", + "testrl": "TransitionRule_2", + "teenrl": "TransitionRule_3", + "order_index": 2, + "created_at": null + }, + { + "id": 121, + "soa_id": 60, + "element_id": "StudyElement_3", + "name": "INDUCTION_PBO_FUL", + "label": "Induction: Fulvestrant + Placebo", + "description": "Induction treatment for Arm B: fulvestrant 500 mg IM (D1 & D15 of Cycle 1, then D1 each cycle) plus placebo PO daily, 28-day cycles, max 12 cycles.", + "testrl": "TransitionRule_2", + "teenrl": "TransitionRule_3", + "order_index": 3, + "created_at": null + }, + { + "id": 122, + "soa_id": 60, + "element_id": "StudyElement_4", + "name": "CONTINUATION_EVE_FUL", + "label": "Continuation: Fulvestrant + Everolimus", + "description": "Continuation treatment for patients originally randomized to everolimus: fulvestrant 500 mg IM D1 every 28-day cycle plus everolimus, until progression or unacceptable toxicity.", + "testrl": "TransitionRule_4", + "teenrl": "TransitionRule_5", + "order_index": 4, + "created_at": null + }, + { + "id": 123, + "soa_id": 60, + "element_id": "StudyElement_5", + "name": "CONTINUATION_FUL", + "label": "Continuation: Fulvestrant alone", + "description": "Continuation treatment for patients originally randomized to placebo: fulvestrant 500 mg IM D1 every 28-day cycle alone, until progression or unacceptable toxicity.", + "testrl": "TransitionRule_4", + "teenrl": "TransitionRule_5", + "order_index": 5, + "created_at": null + }, + { + "id": 124, + "soa_id": 60, + "element_id": "StudyElement_6", + "name": "FOLLOW_UP_ELEMENT", + "label": "Follow-Up Off-Therapy", + "description": "Off-therapy follow-up for disease progression and survival, every 3 months for 3 years from randomization.", + "testrl": "TransitionRule_6", + "teenrl": "TransitionRule_7", + "order_index": 6, + "created_at": null + } + ], + "study_cell": [ + { + "id": 77, + "soa_id": 60, + "study_cell_uid": "StudyCell_1", + "arm_uid": "StudyArm_1", + "epoch_uid": "StudyEpoch_1", + "element_uid": "StudyElement_1", + "order_index": 1 + }, + { + "id": 119, + "soa_id": 60, + "study_cell_uid": "StudyCell_10", + "arm_uid": "StudyArm_2", + "epoch_uid": "StudyEpoch_2", + "element_uid": "StudyElement_3", + "order_index": 6 + }, + { + "id": 120, + "soa_id": 60, + "study_cell_uid": "StudyCell_11", + "arm_uid": "StudyArm_2", + "epoch_uid": "StudyEpoch_4", + "element_uid": "StudyElement_5", + "order_index": 7 + }, + { + "id": 121, + "soa_id": 60, + "study_cell_uid": "StudyCell_12", + "arm_uid": "StudyArm_2", + "epoch_uid": "StudyEpoch_3", + "element_uid": "StudyElement_6", + "order_index": 8 + }, + { + "id": 78, + "soa_id": 60, + "study_cell_uid": "StudyCell_2", + "arm_uid": "StudyArm_1", + "epoch_uid": "StudyEpoch_2", + "element_uid": "StudyElement_2", + "order_index": 2 + }, + { + "id": 116, + "soa_id": 60, + "study_cell_uid": "StudyCell_7", + "arm_uid": "StudyArm_1", + "epoch_uid": "StudyEpoch_4", + "element_uid": "StudyElement_4", + "order_index": 3 + }, + { + "id": 117, + "soa_id": 60, + "study_cell_uid": "StudyCell_8", + "arm_uid": "StudyArm_1", + "epoch_uid": "StudyEpoch_3", + "element_uid": "StudyElement_6", + "order_index": 4 + }, + { + "id": 118, + "soa_id": 60, + "study_cell_uid": "StudyCell_9", + "arm_uid": "StudyArm_2", + "epoch_uid": "StudyEpoch_1", + "element_uid": "StudyElement_1", + "order_index": 5 + } + ], + "schedule_timelines": [ + { + "id": 34, + "soa_id": 60, + "schedule_timeline_uid": "ScheduleTimeline_1", + "name": "MAIN_TIMELINE", + "label": "PrE0102 Main Schedule of Activities Timeline", + "description": "Main timeline spanning Screening, Induction (max 12 x 28-day cycles), Continuation and Follow-Up.", + "main_timeline": 1, + "entry_condition": "Patient randomized 1:1 to Arm A (fulvestrant + everolimus) or Arm B (fulvestrant + placebo).", + "entry_id": null, + "exit_id": "ScheduleTimelineExit_1", + "order_index": 1 + } + ], + "instances": [ + { + "id": 233, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_1", + "name": "SAI_PRESTUDY", + "label": "Pre-Study", + "description": "Pre-Study", + "default_condition_uid": "ScheduledActivityInstance_2", + "epoch_uid": "StudyEpoch_1", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 1, + "encounter_uid": "Encounter_1", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 234, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_2", + "name": "SAI_C1D1", + "label": "Cycle 1 Day 1", + "description": "Cycle 1 Day 1", + "default_condition_uid": "ScheduledActivityInstance_3", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 2, + "encounter_uid": "Encounter_2", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 235, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_3", + "name": "SAI_C1D15", + "label": "Cycle 1 Day 15", + "description": "Cycle 1 Day 15", + "default_condition_uid": "ScheduledActivityInstance_4", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 3, + "encounter_uid": "Encounter_3", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 236, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_4", + "name": "SAI_C2D1", + "label": "Cycle 2 Day 1", + "description": "Cycle 2 Day 1", + "default_condition_uid": "ScheduledActivityInstance_5", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 4, + "encounter_uid": "Encounter_4", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 237, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_5", + "name": "SAI_C3D1", + "label": "Cycle 3 Day 1", + "description": "Cycle 3 Day 1", + "default_condition_uid": "ScheduledActivityInstance_6", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 5, + "encounter_uid": "Encounter_5", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 238, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_6", + "name": "SAI_C4D1", + "label": "Cycle 4 Day 1", + "description": "Cycle 4 Day 1", + "default_condition_uid": "ScheduledActivityInstance_7", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 6, + "encounter_uid": "Encounter_6", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 239, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_7", + "name": "SAI_C5D1", + "label": "Cycle 5 Day 1", + "description": "Cycle 5 Day 1", + "default_condition_uid": "ScheduledActivityInstance_8", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 7, + "encounter_uid": "Encounter_7", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 240, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_8", + "name": "SAI_C6D1", + "label": "Cycle 6 Day 1", + "description": "Cycle 6 Day 1", + "default_condition_uid": "ScheduledActivityInstance_9", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 8, + "encounter_uid": "Encounter_8", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 241, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_9", + "name": "SAI_C7D1", + "label": "Cycle 7 Day 1", + "description": "Cycle 7 Day 1", + "default_condition_uid": "ScheduledActivityInstance_10", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 9, + "encounter_uid": "Encounter_9", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 242, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_10", + "name": "SAI_C8D1", + "label": "Cycle 8 Day 1", + "description": "Cycle 8 Day 1", + "default_condition_uid": "ScheduledActivityInstance_11", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 10, + "encounter_uid": "Encounter_10", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 243, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_11", + "name": "SAI_C9D1", + "label": "Cycle 9 Day 1", + "description": "Cycle 9 Day 1", + "default_condition_uid": "ScheduledActivityInstance_12", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 11, + "encounter_uid": "Encounter_11", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 244, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_12", + "name": "SAI_C10D1", + "label": "Cycle 10 Day 1", + "description": "Cycle 10 Day 1", + "default_condition_uid": "ScheduledActivityInstance_13", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 12, + "encounter_uid": "Encounter_12", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 245, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_13", + "name": "SAI_C11D1", + "label": "Cycle 11 Day 1", + "description": "Cycle 11 Day 1", + "default_condition_uid": "ScheduledActivityInstance_14", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 13, + "encounter_uid": "Encounter_13", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 246, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_14", + "name": "SAI_C12D1", + "label": "Cycle 12 Day 1", + "description": "Cycle 12 Day 1", + "default_condition_uid": "ScheduledActivityInstance_15", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 14, + "encounter_uid": "Encounter_14", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 247, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_15", + "name": "SAI_EOI", + "label": "End of Induction / End of Treatment", + "description": "End of Induction / End of Treatment", + "default_condition_uid": "ScheduledDecisionInstance_1", + "epoch_uid": "StudyEpoch_2", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 15, + "encounter_uid": "Encounter_15", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 248, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_16", + "name": "SAI_CONT", + "label": "Continuation Phase Cycle Day 1", + "description": "Continuation Phase Cycle Day 1", + "default_condition_uid": "ScheduledDecisionInstance_2", + "epoch_uid": "StudyEpoch_4", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 16, + "encounter_uid": "Encounter_16", + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 249, + "soa_id": 60, + "instance_uid": "ScheduledActivityInstance_17", + "name": "SAI_FU", + "label": "Follow-Up Off-Therapy", + "description": "Follow-Up Off-Therapy", + "default_condition_uid": null, + "epoch_uid": "StudyEpoch_3", + "timeline_id": null, + "timeline_exit_id": null, + "order_index": 17, + "encounter_uid": "Encounter_17", + "member_of_timeline": "ScheduleTimeline_1" + } + ], + "decision_instances": [ + { + "id": 4, + "soa_id": 60, + "instance_uid": "ScheduledDecisionInstance_1", + "name": "SDI_END_INDUCTION", + "label": "Decision: End of Induction (unblinding)", + "description": "Decision: End of Induction (unblinding)", + "default_condition_uid": "ScheduledActivityInstance_17", + "epoch_uid": "StudyEpoch_2", + "member_of_timeline": "ScheduleTimeline_1", + "order_index": 1 + }, + { + "id": 5, + "soa_id": 60, + "instance_uid": "ScheduledDecisionInstance_2", + "name": "SDI_CONTINUATION", + "label": "Decision: Continuation Phase progression check", + "description": "Decision: Continuation Phase progression check", + "default_condition_uid": "ScheduledActivityInstance_16", + "epoch_uid": "StudyEpoch_4", + "member_of_timeline": "ScheduleTimeline_1", + "order_index": 2 + } + ], + "condition_assignment": [ + { + "id": 6, + "soa_id": 60, + "condition_assignment_uid": "Condition_1", + "name": "CA_1", + "label": "Condition Assignment 1", + "description": "No evidence of disease progression after 12 cycles of Induction: patient is unblinded and proceeds to the Continuation Phase.", + "condition": "No evidence of disease progression after 12 cycles of Induction: patient is unblinded and proceeds to the Continuation Phase.", + "decision_instance_uid": "ScheduledDecisionInstance_1", + "condition_target_uid": "ScheduledActivityInstance_16", + "order_index": 1 + }, + { + "id": 7, + "soa_id": 60, + "condition_assignment_uid": "Condition_2", + "name": "CA_2", + "label": "Condition Assignment 2", + "description": "Disease progression or unacceptable toxicity (or other discontinuation per Sections 5.5/5.6): patient moves to Follow-Up Off-Therapy.", + "condition": "Disease progression or unacceptable toxicity (or other discontinuation per Sections 5.5/5.6): patient moves to Follow-Up Off-Therapy.", + "decision_instance_uid": "ScheduledDecisionInstance_1", + "condition_target_uid": "ScheduledActivityInstance_17", + "order_index": 2 + }, + { + "id": 8, + "soa_id": 60, + "condition_assignment_uid": "Condition_3", + "name": "CA_3", + "label": "Condition Assignment 3", + "description": "No documented progression and no unacceptable toxicity: continue treatment with the next Continuation cycle (this visit repeats; the protocol sets no fixed Continuation cycle count).", + "condition": "No documented progression and no unacceptable toxicity: continue treatment with the next Continuation cycle (this visit repeats; the protocol sets no fixed Continuation cycle count).", + "decision_instance_uid": "ScheduledDecisionInstance_2", + "condition_target_uid": "ScheduledActivityInstance_16", + "order_index": 3 + }, + { + "id": 9, + "soa_id": 60, + "condition_assignment_uid": "Condition_4", + "name": "CA_4", + "label": "Condition Assignment 4", + "description": "Documented disease progression or unacceptable toxicity: patient moves to Follow-Up Off-Therapy.", + "condition": "Documented disease progression or unacceptable toxicity: patient moves to Follow-Up Off-Therapy.", + "decision_instance_uid": "ScheduledDecisionInstance_2", + "condition_target_uid": "ScheduledActivityInstance_17", + "order_index": 4 + } + ], + "timing": [ + { + "id": 220, + "soa_id": 60, + "timing_uid": "Timing_1", + "name": "C1D1_ANCHOR", + "label": "Cycle 1 Day 1 (anchor)", + "description": "Cycle 1 Day 1 (anchor)", + "type": "Code_10080", + "value": "P0D", + "value_label": "Day 1", + "relative_to_from": "Code_10081", + "relative_from_schedule_instance": "ScheduledActivityInstance_2", + "relative_to_schedule_instance": "ScheduledActivityInstance_2", + "window_label": null, + "window_upper": null, + "window_lower": null, + "order_index": 1, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 221, + "soa_id": 60, + "timing_uid": "Timing_2", + "name": "SCREEN_WINDOW", + "label": "Within 4 weeks before C1D1", + "description": "Within 4 weeks before C1D1", + "type": "Code_10082", + "value": "P28D", + "value_label": "Up to 28 days before", + "relative_to_from": "Code_10083", + "relative_from_schedule_instance": "ScheduledActivityInstance_2", + "relative_to_schedule_instance": "ScheduledActivityInstance_1", + "window_label": "<= 4 weeks before C1D1", + "window_upper": "P28D", + "window_lower": "P0D", + "order_index": 2, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 222, + "soa_id": 60, + "timing_uid": "Timing_3", + "name": "C1D15_OFFSET", + "label": "14 days after C1D1", + "description": "14 days after C1D1", + "type": "Code_10084", + "value": "P14D", + "value_label": "Day 15", + "relative_to_from": "Code_10085", + "relative_from_schedule_instance": "ScheduledActivityInstance_2", + "relative_to_schedule_instance": "ScheduledActivityInstance_3", + "window_label": null, + "window_upper": null, + "window_lower": null, + "order_index": 3, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 223, + "soa_id": 60, + "timing_uid": "Timing_4", + "name": "C2D1_OFFSET", + "label": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", + "description": "Cycle 2 Day 1 (28 days after Cycle 1 Day 1)", + "type": "Code_10086", + "value": "P28D", + "value_label": "28 Days", + "relative_to_from": "Code_10087", + "relative_from_schedule_instance": "ScheduledActivityInstance_2", + "relative_to_schedule_instance": "ScheduledActivityInstance_4", + "window_label": "+/- 72 hours", + "window_upper": "PT72H", + "window_lower": "-PT72H", + "order_index": 4, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 224, + "soa_id": 60, + "timing_uid": "Timing_5", + "name": "C3D1_OFFSET", + "label": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", + "description": "Cycle 3 Day 1 (28 days after Cycle 2 Day 1)", + "type": "Code_10088", + "value": "P28D", + "value_label": "28 Days", + "relative_to_from": "Code_10089", + "relative_from_schedule_instance": "ScheduledActivityInstance_4", + "relative_to_schedule_instance": "ScheduledActivityInstance_5", + "window_label": "+/- 72 hours", + "window_upper": "PT72H", + "window_lower": "-PT72H", + "order_index": 5, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 225, + "soa_id": 60, + "timing_uid": "Timing_6", + "name": "C4D1_OFFSET", + "label": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", + "description": "Cycle 4 Day 1 (28 days after Cycle 3 Day 1)", + "type": "Code_10090", + "value": "P28D", + "value_label": "28 Days", + "relative_to_from": "Code_10091", + "relative_from_schedule_instance": "ScheduledActivityInstance_5", + "relative_to_schedule_instance": "ScheduledActivityInstance_6", + "window_label": "+/- 72 hours", + "window_upper": "PT72H", + "window_lower": "-PT72H", + "order_index": 6, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 226, + "soa_id": 60, + "timing_uid": "Timing_7", + "name": "C5D1_OFFSET", + "label": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", + "description": "Cycle 5 Day 1 (28 days after Cycle 4 Day 1)", + "type": "Code_10092", + "value": "P28D", + "value_label": "28 Days", + "relative_to_from": "Code_10093", + "relative_from_schedule_instance": "ScheduledActivityInstance_6", + "relative_to_schedule_instance": "ScheduledActivityInstance_7", + "window_label": "+/- 72 hours", + "window_upper": "PT72H", + "window_lower": "-PT72H", + "order_index": 7, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 227, + "soa_id": 60, + "timing_uid": "Timing_8", + "name": "C6D1_OFFSET", + "label": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", + "description": "Cycle 6 Day 1 (28 days after Cycle 5 Day 1)", + "type": null, + "value": "P28D", + "value_label": "28 Days", + "relative_to_from": "Code_10094", + "relative_from_schedule_instance": "ScheduledActivityInstance_7", + "relative_to_schedule_instance": "ScheduledActivityInstance_8", + "window_label": "+/- 72 hours", + "window_upper": "PT72H", + "window_lower": "-PT72H", + "order_index": 8, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 228, + "soa_id": 60, + "timing_uid": "Timing_9", + "name": "C7D1_OFFSET", + "label": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", + "description": "Cycle 7 Day 1 (28 days after Cycle 6 Day 1)", + "type": null, + "value": "P28D", + "value_label": "28 Days", + "relative_to_from": "Code_10095", + "relative_from_schedule_instance": "ScheduledActivityInstance_8", + "relative_to_schedule_instance": "ScheduledActivityInstance_9", + "window_label": "+/- 72 hours", + "window_upper": "PT72H", + "window_lower": "-PT72H", + "order_index": 9, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 229, + "soa_id": 60, + "timing_uid": "Timing_10", + "name": "C8D1_OFFSET", + "label": "Cycle 8 Day 1 (28 days after Cycle 7 Day 1)", + "description": "Cycle 8 Day 1 (28 days after Cycle 7 Day 1)", + "type": "Code_10096", + "value": "P28D", + "value_label": "28 Days", + "relative_to_from": "Code_10097", + "relative_from_schedule_instance": "ScheduledActivityInstance_9", + "relative_to_schedule_instance": "ScheduledActivityInstance_10", + "window_label": "+/- 72 hours", + "window_upper": "PT72H", + "window_lower": "-PT72H", + "order_index": 10, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 230, + "soa_id": 60, + "timing_uid": "Timing_11", + "name": "C9D1_OFFSET", + "label": "Cycle 9 Day 1 (28 days after Cycle 8 Day 1)", + "description": "Cycle 9 Day 1 (28 days after Cycle 8 Day 1)", + "type": "Code_10098", + "value": "P28D", + "value_label": "28 Days", + "relative_to_from": "Code_10099", + "relative_from_schedule_instance": "ScheduledActivityInstance_10", + "relative_to_schedule_instance": "ScheduledActivityInstance_11", + "window_label": "+/- 72 hours", + "window_upper": "PT72H", + "window_lower": "-PT72H", + "order_index": 11, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 231, + "soa_id": 60, + "timing_uid": "Timing_12", + "name": "C10D1_OFFSET", + "label": "Cycle 10 Day 1 (28 days after Cycle 9 Day 1)", + "description": "Cycle 10 Day 1 (28 days after Cycle 9 Day 1)", + "type": "Code_10100", + "value": "P28D", + "value_label": "28 Days", + "relative_to_from": "Code_10101", + "relative_from_schedule_instance": "ScheduledActivityInstance_11", + "relative_to_schedule_instance": "ScheduledActivityInstance_12", + "window_label": "+/- 72 hours", + "window_upper": "PT72H", + "window_lower": "-PT72H", + "order_index": 12, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 232, + "soa_id": 60, + "timing_uid": "Timing_13", + "name": "C11D1_OFFSET", + "label": "Cycle 11 Day 1 (28 days after Cycle 10 Day 1)", + "description": "Cycle 11 Day 1 (28 days after Cycle 10 Day 1)", + "type": "Code_10102", + "value": "P28D", + "value_label": "28 Days", + "relative_to_from": "Code_10103", + "relative_from_schedule_instance": "ScheduledActivityInstance_12", + "relative_to_schedule_instance": "ScheduledActivityInstance_13", + "window_label": "+/- 72 hours", + "window_upper": "PT72H", + "window_lower": "-PT72H", + "order_index": 13, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 233, + "soa_id": 60, + "timing_uid": "Timing_14", + "name": "C12D1_OFFSET", + "label": "Cycle 12 Day 1 (28 days after Cycle 11 Day 1)", + "description": "Cycle 12 Day 1 (28 days after Cycle 11 Day 1)", + "type": "Code_10104", + "value": "P28D", + "value_label": "28 Days", + "relative_to_from": "Code_10105", + "relative_from_schedule_instance": "ScheduledActivityInstance_13", + "relative_to_schedule_instance": "ScheduledActivityInstance_14", + "window_label": "+/- 72 hours", + "window_upper": "PT72H", + "window_lower": "-PT72H", + "order_index": 14, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 234, + "soa_id": 60, + "timing_uid": "Timing_15", + "name": "EOI_OFFSET", + "label": "End of Induction", + "description": "End of Induction", + "type": "Code_10106", + "value": "P30D", + "value_label": "within 30 days of last dose", + "relative_to_from": "Code_10107", + "relative_from_schedule_instance": "ScheduledActivityInstance_14", + "relative_to_schedule_instance": "ScheduledActivityInstance_15", + "window_label": "within 30 days of last fulvestrant dose", + "window_upper": "P30D", + "window_lower": "P0D", + "order_index": 15, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 235, + "soa_id": 60, + "timing_uid": "Timing_16", + "name": "CONT_OFFSET", + "label": "Continuation Day 1", + "description": "Continuation Day 1", + "type": "Code_10108", + "value": "P28D", + "value_label": "D29 after last Cycle 12 dose", + "relative_to_from": "Code_10109", + "relative_from_schedule_instance": "ScheduledActivityInstance_14", + "relative_to_schedule_instance": "ScheduledActivityInstance_16", + "window_label": "+/- 1 week", + "window_upper": "P7D", + "window_lower": "-P7D", + "order_index": 16, + "member_of_timeline": "ScheduleTimeline_1" + }, + { + "id": 236, + "soa_id": 60, + "timing_uid": "Timing_17", + "name": "FU_OFFSET", + "label": "Every 3 months follow-up", + "description": "Every 3 months follow-up", + "type": "Code_10110", + "value": "P84D", + "value_label": "Every 3 months (12 weeks)", + "relative_to_from": "Code_10111", + "relative_from_schedule_instance": "ScheduledActivityInstance_16", + "relative_to_schedule_instance": "ScheduledActivityInstance_17", + "window_label": "+/- 1 week", + "window_upper": "P7D", + "window_lower": "-P7D", + "order_index": 17, + "member_of_timeline": "ScheduleTimeline_1" + } + ], + "transition_rule": [ + { + "id": 58, + "soa_id": 60, + "transition_rule_uid": "TransitionRule_1", + "name": "Screening Exit / Randomization", + "label": "Screening Exit / Randomization", + "description": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", + "text": "Patient meets all eligibility criteria in Section 3 and is randomized 1:1 (everolimus:placebo) via the interactive web registration (IWR) system, stratified by ECOG PS (0 vs 1), measurable disease (yes vs no) and prior chemotherapy (yes vs no). Protocol therapy must begin within 7 working days of randomization.", + "order_index": 1, + "created_at": null + }, + { + "id": 59, + "soa_id": 60, + "transition_rule_uid": "TransitionRule_2", + "name": "Induction Phase Entry", + "label": "Induction Phase Entry", + "description": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", + "text": "Cycle 1 Day 1 is the first day on which fulvestrant is given in combination with everolimus/placebo, within 7 working days of randomization.", + "order_index": 2, + "created_at": null + }, + { + "id": 60, + "soa_id": 60, + "transition_rule_uid": "TransitionRule_3", + "name": "Induction Phase Exit", + "label": "Induction Phase Exit", + "description": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "text": "Completion of a maximum of 12 28-day cycles, OR documented disease progression, OR unacceptable toxicity, whichever occurs first. End of Induction / End of Treatment assessments are performed within 30 days of the last dose of fulvestrant.", + "order_index": 3, + "created_at": null + }, + { + "id": 61, + "soa_id": 60, + "transition_rule_uid": "TransitionRule_4", + "name": "Continuation Phase Entry", + "label": "Continuation Phase Entry", + "description": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "text": "No evidence of disease progression after 12 cycles of Induction; patient is unblinded. Day 1 of the Continuation Phase begins 28 days (D29) after the last fulvestrant dose given in Cycle 12.", + "order_index": 4, + "created_at": null + }, + { + "id": 62, + "soa_id": 60, + "transition_rule_uid": "TransitionRule_5", + "name": "Continuation Phase Exit", + "label": "Continuation Phase Exit", + "description": "Documented disease progression or unacceptable toxicity.", + "text": "Documented disease progression or unacceptable toxicity.", + "order_index": 5, + "created_at": null + }, + { + "id": 63, + "soa_id": 60, + "transition_rule_uid": "TransitionRule_6", + "name": "Follow-Up Off-Therapy Entry", + "label": "Follow-Up Off-Therapy Entry", + "description": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", + "text": "Discontinuation of all protocol therapy (end of treatment for any reason per Sections 5.5/5.6).", + "order_index": 6, + "created_at": null + }, + { + "id": 64, + "soa_id": 60, + "transition_rule_uid": "TransitionRule_7", + "name": "Follow-Up Off-Therapy Exit", + "label": "Follow-Up Off-Therapy Exit", + "description": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", + "text": "Three years from the date of randomization, or death. Patients who have not progressed continue imaging every 3 months until documented progression, then are followed for survival.", + "order_index": 7, + "created_at": null + } + ], + "matrix_cells": [ + { + "id": 484, + "soa_id": 60, + "visit_id": null, + "activity_id": 138, + "status": "X", + "instance_id": 84, + "superscript": null + }, + { + "id": 485, + "soa_id": 60, + "visit_id": null, + "activity_id": 139, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 486, + "soa_id": 60, + "visit_id": null, + "activity_id": 140, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 488, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 489, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 493, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 87, + "superscript": null + }, + { + "id": 495, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 88, + "superscript": null + }, + { + "id": 500, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 87, + "superscript": null + }, + { + "id": 502, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 88, + "superscript": null + }, + { + "id": 505, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 87, + "superscript": null + }, + { + "id": 507, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 88, + "superscript": null + }, + { + "id": 509, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 512, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 87, + "superscript": null + }, + { + "id": 514, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 88, + "superscript": null + }, + { + "id": 517, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 87, + "superscript": null + }, + { + "id": 519, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 88, + "superscript": null + }, + { + "id": 535, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 87, + "superscript": null + }, + { + "id": 537, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 88, + "superscript": null + }, + { + "id": 560, + "soa_id": 60, + "visit_id": null, + "activity_id": 156, + "status": "X", + "instance_id": 93, + "superscript": null + }, + { + "id": 561, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 562, + "soa_id": 60, + "visit_id": null, + "activity_id": 159, + "status": "X", + "instance_id": 84, + "superscript": "a,i" + }, + { + "id": 563, + "soa_id": 60, + "visit_id": null, + "activity_id": 160, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 564, + "soa_id": 60, + "visit_id": null, + "activity_id": 147, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 565, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 566, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 567, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 568, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 84, + "superscript": "a" + }, + { + "id": 569, + "soa_id": 60, + "visit_id": null, + "activity_id": 164, + "status": "X", + "instance_id": 84, + "superscript": "a,f" + }, + { + "id": 570, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 85, + "superscript": "b" + }, + { + "id": 571, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 85, + "superscript": "b" + }, + { + "id": 572, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 85, + "superscript": "b" + }, + { + "id": 573, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 85, + "superscript": "b" + }, + { + "id": 574, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 85, + "superscript": "b" + }, + { + "id": 575, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 85, + "superscript": "b" + }, + { + "id": 576, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 85, + "superscript": "b" + }, + { + "id": 577, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 85, + "superscript": "b" + }, + { + "id": 579, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 85, + "superscript": "b" + }, + { + "id": 580, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 85, + "superscript": "f,g" + }, + { + "id": 581, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 85, + "superscript": "f,h" + }, + { + "id": 582, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 86, + "superscript": null + }, + { + "id": 583, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 86, + "superscript": null + }, + { + "id": 584, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 86, + "superscript": null + }, + { + "id": 585, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 86, + "superscript": null + }, + { + "id": 586, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 86, + "superscript": null + }, + { + "id": 587, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 86, + "superscript": "d" + }, + { + "id": 588, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 86, + "superscript": null + }, + { + "id": 589, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 86, + "superscript": null + }, + { + "id": 590, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 92, + "superscript": "c" + }, + { + "id": 591, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 92, + "superscript": "c" + }, + { + "id": 592, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 92, + "superscript": "c" + }, + { + "id": 594, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 92, + "superscript": "c" + }, + { + "id": 595, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 92, + "superscript": "c" + }, + { + "id": 596, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 92, + "superscript": "c,d" + }, + { + "id": 598, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 92, + "superscript": "c" + }, + { + "id": 599, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 92, + "superscript": "e" + }, + { + "id": 600, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 92, + "superscript": "e" + }, + { + "id": 601, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 92, + "superscript": "f,g" + }, + { + "id": 602, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 92, + "superscript": "f,h" + }, + { + "id": 603, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 92, + "superscript": null + }, + { + "id": 604, + "soa_id": 60, + "visit_id": null, + "activity_id": 159, + "status": "X", + "instance_id": 89, + "superscript": "i" + }, + { + "id": 605, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 89, + "superscript": "e" + }, + { + "id": 606, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 89, + "superscript": "e" + }, + { + "id": 607, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 90, + "superscript": null + }, + { + "id": 608, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 90, + "superscript": null + }, + { + "id": 609, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 90, + "superscript": null + }, + { + "id": 610, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 90, + "superscript": null + }, + { + "id": 611, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 90, + "superscript": "j" + }, + { + "id": 612, + "soa_id": 60, + "visit_id": null, + "activity_id": 159, + "status": "X", + "instance_id": 90, + "superscript": "i" + }, + { + "id": 613, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 90, + "superscript": "d" + }, + { + "id": 614, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 90, + "superscript": null + }, + { + "id": 615, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 90, + "superscript": "e" + }, + { + "id": 616, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 90, + "superscript": "e" + }, + { + "id": 617, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 90, + "superscript": null + }, + { + "id": 618, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 94, + "superscript": "j" + }, + { + "id": 619, + "soa_id": 60, + "visit_id": null, + "activity_id": 159, + "status": "X", + "instance_id": 94, + "superscript": "i" + }, + { + "id": 620, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 94, + "superscript": "k" + }, + { + "id": 621, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 94, + "superscript": "k" + }, + { + "id": 622, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 94, + "superscript": "k" + }, + { + "id": 623, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 94, + "superscript": "k" + }, + { + "id": 624, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 94, + "superscript": "k" + }, + { + "id": 625, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 94, + "superscript": "k" + }, + { + "id": 626, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 94, + "superscript": "l" + }, + { + "id": 627, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 91, + "superscript": "j" + }, + { + "id": 628, + "soa_id": 60, + "visit_id": null, + "activity_id": 159, + "status": "X", + "instance_id": 91, + "superscript": "i,m,o" + }, + { + "id": 942, + "soa_id": 60, + "visit_id": null, + "activity_id": 139, + "status": "X", + "instance_id": 233, + "superscript": "a" + }, + { + "id": 943, + "soa_id": 60, + "visit_id": null, + "activity_id": 138, + "status": "X", + "instance_id": 233, + "superscript": null + }, + { + "id": 944, + "soa_id": 60, + "visit_id": null, + "activity_id": 156, + "status": "X", + "instance_id": 233, + "superscript": null + }, + { + "id": 945, + "soa_id": 60, + "visit_id": null, + "activity_id": 140, + "status": "X", + "instance_id": 233, + "superscript": "a" + }, + { + "id": 946, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 233, + "superscript": "a" + }, + { + "id": 947, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 233, + "superscript": "a" + }, + { + "id": 948, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 233, + "superscript": "a" + }, + { + "id": 949, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 233, + "superscript": null + }, + { + "id": 950, + "soa_id": 60, + "visit_id": null, + "activity_id": 159, + "status": "X", + "instance_id": 233, + "superscript": "a,i" + }, + { + "id": 951, + "soa_id": 60, + "visit_id": null, + "activity_id": 160, + "status": "X", + "instance_id": 233, + "superscript": "a" + }, + { + "id": 952, + "soa_id": 60, + "visit_id": null, + "activity_id": 147, + "status": "X", + "instance_id": 233, + "superscript": "a" + }, + { + "id": 953, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 233, + "superscript": "a" + }, + { + "id": 954, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 233, + "superscript": "a" + }, + { + "id": 955, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 233, + "superscript": "a" + }, + { + "id": 956, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 233, + "superscript": "a" + }, + { + "id": 958, + "soa_id": 60, + "visit_id": null, + "activity_id": 164, + "status": "X", + "instance_id": 233, + "superscript": "a,f" + }, + { + "id": 959, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 234, + "superscript": "b" + }, + { + "id": 960, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 234, + "superscript": "b" + }, + { + "id": 961, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 234, + "superscript": "b" + }, + { + "id": 962, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 234, + "superscript": "b" + }, + { + "id": 963, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 234, + "superscript": "b" + }, + { + "id": 964, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 234, + "superscript": "b" + }, + { + "id": 965, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 234, + "superscript": "b" + }, + { + "id": 966, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 234, + "superscript": "b" + }, + { + "id": 967, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 234, + "superscript": "b" + }, + { + "id": 968, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 234, + "superscript": "f,g" + }, + { + "id": 969, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 234, + "superscript": "f,h" + }, + { + "id": 970, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 235, + "superscript": null + }, + { + "id": 971, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 235, + "superscript": null + }, + { + "id": 972, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 235, + "superscript": null + }, + { + "id": 973, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 235, + "superscript": null + }, + { + "id": 974, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 235, + "superscript": null + }, + { + "id": 975, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 235, + "superscript": "d" + }, + { + "id": 976, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 235, + "superscript": null + }, + { + "id": 977, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 235, + "superscript": null + }, + { + "id": 978, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 236, + "superscript": null + }, + { + "id": 979, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 237, + "superscript": null + }, + { + "id": 980, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 238, + "superscript": null + }, + { + "id": 981, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 239, + "superscript": null + }, + { + "id": 982, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 240, + "superscript": null + }, + { + "id": 983, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 241, + "superscript": null + }, + { + "id": 984, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 242, + "superscript": null + }, + { + "id": 985, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 243, + "superscript": null + }, + { + "id": 986, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 244, + "superscript": null + }, + { + "id": 987, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 245, + "superscript": null + }, + { + "id": 988, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 246, + "superscript": null + }, + { + "id": 989, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 236, + "superscript": "c" + }, + { + "id": 990, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 236, + "superscript": "c" + }, + { + "id": 991, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 236, + "superscript": "c" + }, + { + "id": 992, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 236, + "superscript": "c" + }, + { + "id": 993, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 236, + "superscript": "c" + }, + { + "id": 994, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 236, + "superscript": "c,d" + }, + { + "id": 995, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 236, + "superscript": "c" + }, + { + "id": 996, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 236, + "superscript": "e" + }, + { + "id": 997, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 236, + "superscript": "e" + }, + { + "id": 998, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 236, + "superscript": "f,g" + }, + { + "id": 999, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 236, + "superscript": "f,h" + }, + { + "id": 1000, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 237, + "superscript": "c" + }, + { + "id": 1001, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 237, + "superscript": "c" + }, + { + "id": 1002, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 237, + "superscript": "c" + }, + { + "id": 1003, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 237, + "superscript": "c" + }, + { + "id": 1004, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 237, + "superscript": "c" + }, + { + "id": 1005, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 237, + "superscript": "c,d" + }, + { + "id": 1006, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 237, + "superscript": "c" + }, + { + "id": 1007, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 237, + "superscript": "e" + }, + { + "id": 1008, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 237, + "superscript": "e" + }, + { + "id": 1009, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 237, + "superscript": "f,g" + }, + { + "id": 1011, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 237, + "superscript": "f,h" + }, + { + "id": 1012, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 238, + "superscript": "c" + }, + { + "id": 1013, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 238, + "superscript": "c" + }, + { + "id": 1014, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 238, + "superscript": "c" + }, + { + "id": 1015, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 238, + "superscript": "c" + }, + { + "id": 1016, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 238, + "superscript": "c" + }, + { + "id": 1017, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 238, + "superscript": "c,d" + }, + { + "id": 1018, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 238, + "superscript": "c" + }, + { + "id": 1019, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 238, + "superscript": "e" + }, + { + "id": 1020, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 238, + "superscript": "e" + }, + { + "id": 1021, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 238, + "superscript": "f,g" + }, + { + "id": 1022, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 238, + "superscript": "f,h" + }, + { + "id": 1023, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 239, + "superscript": "c" + }, + { + "id": 1024, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 239, + "superscript": "c" + }, + { + "id": 1025, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 239, + "superscript": "c" + }, + { + "id": 1026, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 239, + "superscript": "c" + }, + { + "id": 1027, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 239, + "superscript": "c" + }, + { + "id": 1028, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 239, + "superscript": "c,d" + }, + { + "id": 1029, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 239, + "superscript": "c" + }, + { + "id": 1030, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 239, + "superscript": "e" + }, + { + "id": 1031, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 239, + "superscript": "e" + }, + { + "id": 1032, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 239, + "superscript": "f,g" + }, + { + "id": 1033, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 239, + "superscript": "f,h" + }, + { + "id": 1034, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 240, + "superscript": "c" + }, + { + "id": 1035, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 240, + "superscript": "c" + }, + { + "id": 1036, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 240, + "superscript": "c" + }, + { + "id": 1037, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 240, + "superscript": "c" + }, + { + "id": 1038, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 240, + "superscript": "c" + }, + { + "id": 1039, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 240, + "superscript": "c,d" + }, + { + "id": 1040, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 240, + "superscript": "c" + }, + { + "id": 1041, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 240, + "superscript": "e" + }, + { + "id": 1043, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 240, + "superscript": "e" + }, + { + "id": 1044, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 240, + "superscript": "f,g" + }, + { + "id": 1045, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 240, + "superscript": "f,h" + }, + { + "id": 1046, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 241, + "superscript": "c" + }, + { + "id": 1047, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 241, + "superscript": "c" + }, + { + "id": 1048, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 241, + "superscript": "c" + }, + { + "id": 1049, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 241, + "superscript": "c" + }, + { + "id": 1050, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 241, + "superscript": "c" + }, + { + "id": 1051, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 241, + "superscript": "c,d" + }, + { + "id": 1052, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 241, + "superscript": "c" + }, + { + "id": 1053, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 241, + "superscript": "e" + }, + { + "id": 1054, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 241, + "superscript": "e" + }, + { + "id": 1055, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 241, + "superscript": "f,g" + }, + { + "id": 1056, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 241, + "superscript": "f,h" + }, + { + "id": 1057, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 242, + "superscript": "c" + }, + { + "id": 1058, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 242, + "superscript": "c" + }, + { + "id": 1059, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 242, + "superscript": "c" + }, + { + "id": 1060, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 242, + "superscript": "c" + }, + { + "id": 1061, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 242, + "superscript": "c" + }, + { + "id": 1062, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 242, + "superscript": "c,d" + }, + { + "id": 1063, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 242, + "superscript": "c" + }, + { + "id": 1064, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 242, + "superscript": "e" + }, + { + "id": 1065, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 242, + "superscript": "e" + }, + { + "id": 1066, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 242, + "superscript": "f,g" + }, + { + "id": 1067, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 242, + "superscript": "f,h" + }, + { + "id": 1068, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 243, + "superscript": "c" + }, + { + "id": 1069, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 243, + "superscript": "c" + }, + { + "id": 1070, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 243, + "superscript": "c" + }, + { + "id": 1071, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 243, + "superscript": "c" + }, + { + "id": 1073, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 243, + "superscript": "c" + }, + { + "id": 1074, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 243, + "superscript": "c,d" + }, + { + "id": 1075, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 243, + "superscript": "c" + }, + { + "id": 1076, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 243, + "superscript": "e" + }, + { + "id": 1077, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 243, + "superscript": "e" + }, + { + "id": 1078, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 243, + "superscript": "f,g" + }, + { + "id": 1079, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 243, + "superscript": "f,h" + }, + { + "id": 1080, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 244, + "superscript": "c" + }, + { + "id": 1082, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 244, + "superscript": "c" + }, + { + "id": 1083, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 244, + "superscript": "c" + }, + { + "id": 1084, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 244, + "superscript": "c" + }, + { + "id": 1085, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 244, + "superscript": "c" + }, + { + "id": 1086, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 244, + "superscript": "c,d" + }, + { + "id": 1087, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 244, + "superscript": "c" + }, + { + "id": 1088, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 244, + "superscript": "e" + }, + { + "id": 1089, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 244, + "superscript": "e" + }, + { + "id": 1090, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 244, + "superscript": "f,g" + }, + { + "id": 1091, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 244, + "superscript": "f,h" + }, + { + "id": 1092, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 245, + "superscript": "c" + }, + { + "id": 1093, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 245, + "superscript": "c" + }, + { + "id": 1094, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 245, + "superscript": "c" + }, + { + "id": 1095, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 245, + "superscript": "c" + }, + { + "id": 1096, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 245, + "superscript": "c" + }, + { + "id": 1097, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 245, + "superscript": "c,d" + }, + { + "id": 1098, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 245, + "superscript": "c" + }, + { + "id": 1099, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 245, + "superscript": "e" + }, + { + "id": 1100, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 245, + "superscript": "e" + }, + { + "id": 1101, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 245, + "superscript": "f,g" + }, + { + "id": 1102, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 245, + "superscript": "f,h" + }, + { + "id": 1103, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 246, + "superscript": "c" + }, + { + "id": 1104, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 246, + "superscript": "c" + }, + { + "id": 1106, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 246, + "superscript": "c" + }, + { + "id": 1107, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 246, + "superscript": "c" + }, + { + "id": 1108, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 246, + "superscript": "c" + }, + { + "id": 1109, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 246, + "superscript": "c,d" + }, + { + "id": 1110, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 246, + "superscript": "c" + }, + { + "id": 1111, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 246, + "superscript": "e" + }, + { + "id": 1112, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 246, + "superscript": "e" + }, + { + "id": 1113, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 246, + "superscript": "f,g" + }, + { + "id": 1114, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 246, + "superscript": "f,h" + }, + { + "id": 1115, + "soa_id": 60, + "visit_id": null, + "activity_id": 142, + "status": "X", + "instance_id": 247, + "superscript": null + }, + { + "id": 1116, + "soa_id": 60, + "visit_id": null, + "activity_id": 155, + "status": "X", + "instance_id": 247, + "superscript": null + }, + { + "id": 1117, + "soa_id": 60, + "visit_id": null, + "activity_id": 143, + "status": "X", + "instance_id": 247, + "superscript": null + }, + { + "id": 1118, + "soa_id": 60, + "visit_id": null, + "activity_id": 141, + "status": "X", + "instance_id": 247, + "superscript": null + }, + { + "id": 1119, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 247, + "superscript": "j" + }, + { + "id": 1120, + "soa_id": 60, + "visit_id": null, + "activity_id": 159, + "status": "X", + "instance_id": 247, + "superscript": "i" + }, + { + "id": 1122, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 247, + "superscript": "d" + }, + { + "id": 1123, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 247, + "superscript": null + }, + { + "id": 1124, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 247, + "superscript": "e" + }, + { + "id": 1125, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 247, + "superscript": "e" + }, + { + "id": 1126, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 247, + "superscript": null + }, + { + "id": 1127, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 248, + "superscript": "j" + }, + { + "id": 1128, + "soa_id": 60, + "visit_id": null, + "activity_id": 159, + "status": "X", + "instance_id": 248, + "superscript": "i" + }, + { + "id": 1129, + "soa_id": 60, + "visit_id": null, + "activity_id": 161, + "status": "X", + "instance_id": 248, + "superscript": "k" + }, + { + "id": 1130, + "soa_id": 60, + "visit_id": null, + "activity_id": 145, + "status": "X", + "instance_id": 248, + "superscript": "k" + }, + { + "id": 1131, + "soa_id": 60, + "visit_id": null, + "activity_id": 162, + "status": "X", + "instance_id": 248, + "superscript": "k" + }, + { + "id": 1132, + "soa_id": 60, + "visit_id": null, + "activity_id": 163, + "status": "X", + "instance_id": 248, + "superscript": "k" + }, + { + "id": 1133, + "soa_id": 60, + "visit_id": null, + "activity_id": 165, + "status": "X", + "instance_id": 248, + "superscript": "k" + }, + { + "id": 1134, + "soa_id": 60, + "visit_id": null, + "activity_id": 166, + "status": "X", + "instance_id": 248, + "superscript": "k" + }, + { + "id": 1135, + "soa_id": 60, + "visit_id": null, + "activity_id": 167, + "status": "X", + "instance_id": 248, + "superscript": "l" + }, + { + "id": 1136, + "soa_id": 60, + "visit_id": null, + "activity_id": 154, + "status": "X", + "instance_id": 249, + "superscript": "j" + }, + { + "id": 1137, + "soa_id": 60, + "visit_id": null, + "activity_id": 159, + "status": "X", + "instance_id": 249, + "superscript": "i,m,o" + } + ], + "biomedical_concept": [ + { + "id": 426, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_1", + "name": "Informed Consent", + "label": "Informed Consent", + "description": "Consent by a patient to a surgical or medical procedure or participation in a clinical study after achieving an understanding of the relevant medical facts and the risks involved.", + "code": "AliasCode_1" + }, + { + "id": 427, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_2", + "name": "Eligibility Criteria Met By Subject", + "label": "Eligibility Criteria Met By Subject", + "description": "An indication that the subject has fulfilled the criteria needed to continue to the next study period.", + "code": "AliasCode_6" + }, + { + "id": 430, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_5", + "name": "ECOG - Performance Status", + "label": "ECOG - Performance Status", + "description": "Eastern Cooperative Oncology Group (ECOG) Performance status.", + "code": "AliasCode_13" + }, + { + "id": 432, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_7", + "name": "Systolic Blood Pressure", + "label": "Systolic Blood Pressure", + "description": "The maximum pressure exerted into the systemic arterial circulation during the contraction of the left ventricle of the heart.", + "code": "AliasCode_22" + }, + { + "id": 433, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_8", + "name": "Diastolic Blood Pressure", + "label": "Diastolic Blood Pressure", + "description": "The minimum pressure exerted into the systemic arterial circulation during cardiac ventricular relaxation and filling.", + "code": "AliasCode_34" + }, + { + "id": 434, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_9", + "name": "Heart Rate", + "label": "Heart Rate", + "description": "The number of heartbeats per unit of time, usually expressed as beats per minute.", + "code": "AliasCode_46" + }, + { + "id": 435, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_10", + "name": "Body Temperature", + "label": "Body Temperature", + "description": "A measurement of the temperature of the body.", + "code": "AliasCode_5688" + }, + { + "id": 436, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_11", + "name": "Body Weight", + "label": "Body Weight", + "description": "The weight of a subject.", + "code": "AliasCode_9354" + }, + { + "id": 443, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_18", + "name": "Alanine Aminotransferase Measurement", + "label": "Alanine Aminotransferase Measurement", + "description": "A quantitative measurement of alanine aminotransferase present in a sample.", + "code": "AliasCode_9355" + }, + { + "id": 444, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_19", + "name": "Aspartate Aminotransferase Measurement", + "label": "Aspartate Aminotransferase Measurement", + "description": "A quantitative measurement of aspartate aminotransferase present in a sample.", + "code": "AliasCode_767" + }, + { + "id": 445, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_20", + "name": "Total Bilirubin Measurement", + "label": "Total Bilirubin Measurement", + "description": "The measurement of the total amount of bilirubin present in a particular substrate. The substrate most often tested is blood, but other fluids extracted from the body may be used periodically depending on the purpose of the test.", + "code": "AliasCode_9906" + }, + { + "id": 446, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_21", + "name": "Creatinine Measurement", + "label": "Creatinine Measurement", + "description": "A quantitative measurement of the amount of creatinine present in a sample.", + "code": "AliasCode_5689" + }, + { + "id": 447, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_22", + "name": "Albumin Measurement", + "label": "Albumin Measurement", + "description": "A quantitative measurement of albumin present in a sample.", + "code": "AliasCode_5690" + }, + { + "id": 475, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_50", + "name": "Concomitant Therapy", + "label": "Concomitant Therapy", + "description": "Any pharmaceutical agent, other than the primary therapy, that is administered to or used by the subject prior to or during a specified time period.", + "code": "AliasCode_9908" + }, + { + "id": 476, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_51", + "name": "Randomization", + "label": "Randomization", + "description": "The allocation of individuals to groups by chance, especially in order to control the variables in an experiment.", + "code": "AliasCode_9357" + }, + { + "id": 480, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_52", + "name": "Prothrombin Time", + "label": "Prothrombin Time", + "description": "A measurement of the clotting time of plasma recalcified in the presence of excess tissue thromboplastin; it is a measure of the extrinsic pathway of coagulation. It is used to determine the clotting tendency of blood, in the measure of warfarin dosage, liver damage and vitamin K status. Factors measured are fibrinogen, prothrombin, and factors V, VII, and X.", + "code": "AliasCode_5695" + }, + { + "id": 482, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_53", + "name": "International Normalized Ratio of Prothrombin Time", + "label": "International Normalized Ratio of Prothrombin Time", + "description": "A measure of the extrinsic pathway of coagulation. The International Normalized Ratio of Prothrombin Time (INR) is the ratio of a patient prothrombin time to a normal (control) sample raised to the power of the International Sensitivity Index (ISI) with a range of 0.8 to 1.2 seconds.", + "code": "AliasCode_5696" + }, + { + "id": 483, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_54", + "name": "Activated Partial Thromboplastin Time", + "label": "Activated Partial Thromboplastin Time", + "description": "A measurement of the length of time that it takes for clotting to occur when activating reagents are added to a plasma specimen. The test is partial due to the absence of tissue factor (Factor III) from the reaction mixture.", + "code": "AliasCode_9909" + }, + { + "id": 484, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_55", + "name": "Glucose Measurement", + "label": "Glucose Measurement", + "description": "The determination of the amount of glucose present in a sample.", + "code": "AliasCode_9910" + }, + { + "id": 485, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_56", + "name": "Triglyceride Measurement", + "label": "Triglyceride Measurement", + "description": "A quantitative measurement of the amount of triglyceride present in a sample.", + "code": "AliasCode_9911" + }, + { + "id": 486, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_57", + "name": "Cholesterol Measurement", + "label": "Cholesterol Measurement", + "description": "The determination of the amount of total cholesterol present in a sample.", + "code": "AliasCode_534" + }, + { + "id": 487, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_58", + "name": "High Density Lipoprotein Cholesterol Measurement", + "label": "High Density Lipoprotein Cholesterol Measurement", + "description": "The determination of the amount of high-density lipoprotein cholesterol present in a sample.", + "code": "AliasCode_5697" + }, + { + "id": 488, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_59", + "name": "Low Density Lipoprotein Cholesterol Measurement", + "label": "Low Density Lipoprotein Cholesterol Measurement", + "description": "The determination of the amount of low-density lipoprotein cholesterol present in a sample.", + "code": "AliasCode_7397" + }, + { + "id": 490, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_61", + "name": "Leukocyte Count", + "label": "Leukocyte Count", + "description": "A test to determine the number of leukocytes in a biospecimen.", + "code": "AliasCode_5698" + }, + { + "id": 491, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_62", + "name": "Erythrocyte Count", + "label": "Erythrocyte Count", + "description": "The determination of the number of erythrocytes in a biospecimen.", + "code": "AliasCode_9913" + }, + { + "id": 492, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_63", + "name": "Platelet Count", + "label": "Platelet Count", + "description": "The determination of the number of platelets in a biospecimen.", + "code": "AliasCode_5699" + }, + { + "id": 493, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_64", + "name": "Potassium Measurement", + "label": "Potassium Measurement", + "description": "A quantitative measurement of the amount of potassium present in a sample.", + "code": "AliasCode_5700" + }, + { + "id": 494, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_65", + "name": "Sodium Measurement", + "label": "Sodium Measurement", + "description": "A quantitative measurement of the amount of sodium present in a sample.", + "code": "AliasCode_5701" + }, + { + "id": 495, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_66", + "name": "Chloride Measurement", + "label": "Chloride Measurement", + "description": "A quantitative measurement of the amount of chloride present in a sample.", + "code": "AliasCode_5702" + }, + { + "id": 496, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_67", + "name": "Carbon Dioxide Measurement", + "label": "Carbon Dioxide Measurement", + "description": "A quantitative measurement of the gas carbon dioxide present in a sample.", + "code": "AliasCode_5703" + }, + { + "id": 497, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_68", + "name": "Calcium Measurement", + "label": "Calcium Measurement", + "description": "A quantitative measurement of the amount of calcium present in a sample.", + "code": "AliasCode_5704" + }, + { + "id": 498, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_69", + "name": "Urea Nitrogen Measurement", + "label": "Urea Nitrogen Measurement", + "description": "The determination of the amount of urea nitrogen present in a sample.", + "code": "AliasCode_5705" + }, + { + "id": 499, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_70", + "name": "Total Protein Measurement", + "label": "Total Protein Measurement", + "description": "A quantitative measurement of the amount of total protein present in a sample.", + "code": "AliasCode_5706" + }, + { + "id": 500, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_71", + "name": "Alkaline Phosphatase Measurement", + "label": "Alkaline Phosphatase Measurement", + "description": "A quantitative measurement of alkaline phosphatase present in a sample.", + "code": "AliasCode_5707" + }, + { + "id": 502, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_72", + "name": "Urate Measurement", + "label": "Urate Measurement", + "description": "A quantitative measurement of the amount of urate present in a sample.", + "code": "AliasCode_717" + }, + { + "id": 894, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_78", + "name": "Solicited Medical History", + "label": "Solicited Medical History", + "description": "Information about an individual's personal medical history that is reported by a healthcare professional, consumer, or patient through an organized data collection system.", + "code": "AliasCode_9914" + }, + { + "id": 896, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_80", + "name": "Physical Examination Finding", + "label": "Physical Examination Finding", + "description": "The result of an evaluation of the body and its functions using visual inspection, palpation, percussion, or auscultation that is performed to determine the presence, absence, or degree of a condition.", + "code": "AliasCode_9916" + }, + { + "id": 897, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_81", + "name": "Physical Examination Finding", + "label": "Physical Examination Finding", + "description": "The result of an evaluation of the body and its functions using visual inspection, palpation, percussion, or auscultation that is performed to determine the presence, absence, or degree of a condition.", + "code": "AliasCode_9917" + }, + { + "id": 898, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_82", + "name": "New Lesion Progression", + "label": "New Lesion Progression", + "description": "An assessment of the equivocality of disease progression based on a newly identified lesion.", + "code": "AliasCode_9918" + }, + { + "id": 899, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_83", + "name": "Lymph Node State", + "label": "Lymph Node State", + "description": "A condition or state of a lymph node at a particular time.", + "code": "AliasCode_9919" + }, + { + "id": 900, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_84", + "name": "Non-Target Indicator", + "label": "Non-Target Indicator", + "description": "An indication as to whether a non-target tumor, lesion, or site of disease is present.", + "code": "AliasCode_9920" + }, + { + "id": 901, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_85", + "name": "Target Indicator", + "label": "Target Indicator", + "description": "An indication as to whether a target tumor, lesion, or site of disease is present.", + "code": "AliasCode_9921" + }, + { + "id": 902, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_86", + "name": "Confluent Tumor Masses Assessment", + "label": "Confluent Tumor Masses Assessment", + "description": "An assessment as to whether multiple tumors have coalesced into one tumor.", + "code": "AliasCode_9922" + }, + { + "id": 903, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_87", + "name": "Tumor Fragmentation Assessment", + "label": "Tumor Fragmentation Assessment", + "description": "An assessment as to whether a single tumor has divided into two or more tumors.", + "code": "AliasCode_9923" + }, + { + "id": 904, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_88", + "name": "Tumor Identification", + "label": "Tumor Identification", + "description": "A diagnostic procedure to localize and characterize a tumor.", + "code": "AliasCode_9924" + }, + { + "id": 905, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_89", + "name": "Response in Target Lesion", + "label": "Response in Target Lesion", + "description": "A qualitative or quantitative measurement of the response of a target lesion(s) to the therapy.", + "code": "AliasCode_9925" + }, + { + "id": 906, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_90", + "name": "Response in Non-Target Lesion", + "label": "Response in Non-Target Lesion", + "description": "A qualitative or quantitative measurement of the response of a non-target lesion(s) to the therapy.", + "code": "AliasCode_9926" + }, + { + "id": 907, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_91", + "name": "Best Overall Response", + "label": "Best Overall Response", + "description": "The most clinically favorable response recorded from the start of the study treatment until the end of treatment.", + "code": "AliasCode_9927" + }, + { + "id": 908, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_92", + "name": "Overall Response", + "label": "Overall Response", + "description": "An assessment of the overall response of the disease to the therapy.", + "code": "AliasCode_9928" + }, + { + "id": 909, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_93", + "name": "Tumor Status", + "label": "Tumor Status", + "description": "The condition or state of the tumor at a particular time.", + "code": "AliasCode_9929" + }, + { + "id": 910, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_94", + "name": "Longest Diameter", + "label": "Longest Diameter", + "description": "The longest possible length of a straight line passing through the center of a circular or spheroid object that connects two points on the circumference.", + "code": "AliasCode_9930" + }, + { + "id": 911, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_95", + "name": "Longest Perpendicular", + "label": "Longest Perpendicular", + "description": "The longest possible straight line or plane through a body or figure that is at a right angle to a given line or plane.", + "code": "AliasCode_9931" + }, + { + "id": 912, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_96", + "name": "pH", + "label": "pH", + "description": "Quantity of dimension one used to express on a scale from 0 to 14 the amount-of-substance concentration of hydrogen ion of dilute aqueous solution, calculated as the logarithm of the reciprocal of hydrogen-ion concentration in gram atoms per liter.", + "code": "AliasCode_10034" + }, + { + "id": 913, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_97", + "name": "Color Assessment", + "label": "Color Assessment", + "description": "A qualitative assessment of the color of a biological specimen.", + "code": "AliasCode_10035" + }, + { + "id": 914, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_98", + "name": "Specific Gravity", + "label": "Specific Gravity", + "description": "The density (mass per unit volume) of any material divided by that of water at a standard temperature.", + "code": "AliasCode_10036" + }, + { + "id": 915, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_99", + "name": "Hematocrit Measurement", + "label": "Hematocrit Measurement", + "description": "A measure of the volume of red blood cells expressed as a percentage of the total blood volume. Normal in males is 43-49%, in females 37-43%.", + "code": "AliasCode_10051" + }, + { + "id": 916, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_100", + "name": "Hemoglobin Measurement", + "label": "Hemoglobin Measurement", + "description": "A quantitative measurement of the amount of hemoglobin present in a biospecimen.", + "code": "AliasCode_10052" + }, + { + "id": 917, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_101", + "name": "Erythrocyte Mean Corpuscular Hemoglobin", + "label": "Erythrocyte Mean Corpuscular Hemoglobin", + "description": "The mean cell hemoglobin (MCH), which is the average amount of hemoglobin in the average red cell. The MCH is a calculated value derived from the measurement of hemoglobin and the red cell count.", + "code": "AliasCode_10053" + }, + { + "id": 918, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_102", + "name": "Lymphocyte Count", + "label": "Lymphocyte Count", + "description": "The determination of the number of lymphocytes in a blood sample.", + "code": "AliasCode_10054" + }, + { + "id": 919, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_103", + "name": "Monocyte Count", + "label": "Monocyte Count", + "description": "The determination of the number of monocytes in a blood sample.", + "code": "AliasCode_10055" + }, + { + "id": 920, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_104", + "name": "Absolute Neutrophil Count", + "label": "Absolute Neutrophil Count", + "description": "The real number of white blood cells (WBC) that are neutrophils. It is derived by multiplying the WBC count by the percent of neutrophils in the differential WBC count. The normal range for ANC is 1.5 to 8.0 (1,500 to 8,000/mm3).", + "code": "AliasCode_10056" + }, + { + "id": 921, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_105", + "name": "Absolute Basophil Count", + "label": "Absolute Basophil Count", + "description": "The total number of white blood cells that are basophils. It is calculated by multiplying the white blood cell count by the percent of basophils in the differential white blood cell count.", + "code": "AliasCode_10057" + }, + { + "id": 922, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_106", + "name": "Eosinophil Count", + "label": "Eosinophil Count", + "description": "The determination of the number of eosinophils in a blood sample.", + "code": "AliasCode_10058" + }, + { + "id": 923, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_107", + "name": "Neutrophil Band Form Count", + "label": "Neutrophil Band Form Count", + "description": "The determination of the number of band neutrophils in a blood sample.", + "code": "AliasCode_10059" + }, + { + "id": 924, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_108", + "name": "Forced Vital Capacity", + "label": "Forced Vital Capacity", + "description": "The maximum volume of air that can be exhaled after forced maximum inhalation.", + "code": "AliasCode_10060" + }, + { + "id": 925, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_109", + "name": "Forced Expiratory Volume in 1 Second", + "label": "Forced Expiratory Volume in 1 Second", + "description": "A test of lung function, the FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. It is the most frequently used index for assessing bronchoconstriction or bronchodilatation.", + "code": "AliasCode_10061" + }, + { + "id": 926, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_110", + "name": "Forced Expiratory Volume in 6 Seconds", + "label": "Forced Expiratory Volume in 6 Seconds", + "description": "A test of lung function, the FEV6 is the volume exhaled during six seconds of a forced expiratory maneuver started from the level of total lung capacity.", + "code": "AliasCode_10062" + }, + { + "id": 927, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_111", + "name": "Peak Expiratory Flow", + "label": "Peak Expiratory Flow", + "description": "The maximum rate of gas flow, beginning at the point of peak inspiratory capacity, that can be sustained during forced exhalation for a defined period of time. This test is most often used in combination with other studies of lung function to diagnose and monitor obstructive and restrictive lung disease(s).", + "code": "AliasCode_10063" + }, + { + "id": 928, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_112", + "name": "Tidal Volume", + "label": "Tidal Volume", + "description": "The volume of air moved into and out of the lungs during breathing at rest.", + "code": "AliasCode_10064" + }, + { + "id": 929, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_113", + "name": "Inspiratory Capacity", + "label": "Inspiratory Capacity", + "description": "The maximum volume of air a subject can inhale into the lungs after a tidal exhalation (IRV plus TV).", + "code": "AliasCode_10065" + }, + { + "id": 930, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_114", + "name": "Expiratory Reserve Volume", + "label": "Expiratory Reserve Volume", + "description": "The maximum volume of air a subject can exhale from the lungs after a tidal exhalation.", + "code": "AliasCode_10066" + }, + { + "id": 931, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_115", + "name": "Inspiratory Reserve Volume", + "label": "Inspiratory Reserve Volume", + "description": "The maximum volume of air a subject can inhale into the lungs after a tidal inhalation.", + "code": "AliasCode_10067" + }, + { + "id": 932, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_116", + "name": "Slow Vital Capacity", + "label": "Slow Vital Capacity", + "description": "The maximum volume of air that can be exhaled after slow maximum inhalation.", + "code": "AliasCode_10068" + }, + { + "id": 934, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_118", + "name": "Phosphate Measurement", + "label": "Phosphate Measurement", + "description": "A quantitative measurement of the amount of phosphate present in a sample.", + "code": "AliasCode_10070" + }, + { + "id": 935, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_119", + "name": "Hepatitis B Surface Antibody Measurement", + "label": "Hepatitis B Surface Antibody Measurement", + "description": "The determination of the surface antibody reaction of a sample to the Hepatitis B virus.", + "code": "AliasCode_10071" + }, + { + "id": 936, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_120", + "name": "Hepatitis C Virus RNA Measurement", + "label": "Hepatitis C Virus RNA Measurement", + "description": "The determination of the amount of hepatitis C virus RNA present in a sample.", + "code": "AliasCode_10072" + }, + { + "id": 937, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_121", + "name": "Hepatitis B DNA Measurement", + "label": "Hepatitis B DNA Measurement", + "description": "The determination of the amount of hepatitis B virus DNA in a sample.", + "code": "AliasCode_10073" + }, + { + "id": 938, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_122", + "name": "Erythrocyte Mean Corpuscular Volume", + "label": "Erythrocyte Mean Corpuscular Volume", + "description": "The mean cell volume is the average volume of a red blood cell. This is a calculated value derived from the hematocrit and the red cell count.", + "code": "AliasCode_10074" + }, + { + "id": 940, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_124", + "name": "Solicited Medical History", + "label": "Solicited Medical History", + "description": "Information about an individual's personal medical history that is reported by a healthcare professional, consumer, or patient through an organized data collection system.", + "code": "AliasCode_10227" + }, + { + "id": 941, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_125", + "name": "Magnesium Measurement", + "label": "Magnesium Measurement", + "description": "A quantitative measurement of the amount of magnesium present in a sample.", + "code": "AliasCode_10228" + }, + { + "id": 942, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_126", + "name": "Exposure as Collected Domain", + "label": "Exposure as Collected Domain", + "description": "This interventions domain model reflects protocol-specified study treatment administrations, as collected.", + "code": "AliasCode_10229" + }, + { + "id": 943, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_127", + "name": "Solicited Adverse Event", + "label": "Solicited Adverse Event", + "description": "An adverse event that is reported by a healthcare professional, consumer, or patient through an organized data collection system.", + "code": "AliasCode_10230" + }, + { + "id": 944, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_128", + "name": "Body Height", + "label": "Body Height", + "description": "The vertical measurement or distance from the base to the top of a subject or participant.", + "code": "AliasCode_10231" + }, + { + "id": 945, + "soa_id": 60, + "biomedical_concept_uid": "BiomedicalConcept_129", + "name": "Carbon Monoxide Diffusing Capability Test", + "label": "Carbon Monoxide Diffusing Capability Test", + "description": "A measurement of carbon monoxide (CO) transfer from inspired gas to pulmonary capillary blood. During the test, the subject inspires a gas containing CO and one or more tracer gases to allow determination of the gas exchanging capability of the lungs.", + "code": "AliasCode_10232" + } + ], + "biomedical_concept_property": [ + { + "id": 219973, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_227", + "name": "DSDECOD", + "label": "DSDECOD", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9623", + "biomedical_concept_uid": "BiomedicalConcept_1" + }, + { + "id": 219974, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_228", + "name": "DSTERM", + "label": "DSTERM", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9625", + "biomedical_concept_uid": "BiomedicalConcept_1" + }, + { + "id": 219975, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_229", + "name": "DSSTDTC", + "label": "DSSTDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9626", + "biomedical_concept_uid": "BiomedicalConcept_1" + }, + { + "id": 219985, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_239", + "name": "DSDECOD", + "label": "DSDECOD", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9636", + "biomedical_concept_uid": "BiomedicalConcept_2" + }, + { + "id": 219986, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_240", + "name": "DSTERM", + "label": "DSTERM", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9638", + "biomedical_concept_uid": "BiomedicalConcept_2" + }, + { + "id": 219987, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_241", + "name": "DSSTDTC", + "label": "DSSTDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9639", + "biomedical_concept_uid": "BiomedicalConcept_2" + }, + { + "id": 219996, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_250", + "name": "RSORRES", + "label": "RSORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9648", + "biomedical_concept_uid": "BiomedicalConcept_5" + }, + { + "id": 219997, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_251", + "name": "RSDTC", + "label": "RSDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9649", + "biomedical_concept_uid": "BiomedicalConcept_5" + }, + { + "id": 219998, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_252", + "name": "VSORRES", + "label": "VSORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "integer", + "code": "AliasCode_9650", + "biomedical_concept_uid": "BiomedicalConcept_7" + }, + { + "id": 219999, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_253", + "name": "VSORRESU", + "label": "VSORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9651", + "biomedical_concept_uid": "BiomedicalConcept_7" + }, + { + "id": 220000, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_254", + "name": "VSPOS", + "label": "VSPOS", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9653", + "biomedical_concept_uid": "BiomedicalConcept_7" + }, + { + "id": 220001, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_255", + "name": "VSLOC", + "label": "VSLOC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9654", + "biomedical_concept_uid": "BiomedicalConcept_7" + }, + { + "id": 220002, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_256", + "name": "VSLAT", + "label": "VSLAT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9655", + "biomedical_concept_uid": "BiomedicalConcept_7" + }, + { + "id": 220003, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_257", + "name": "VSDTC", + "label": "VSDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9656", + "biomedical_concept_uid": "BiomedicalConcept_7" + }, + { + "id": 220004, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_258", + "name": "VSORRES", + "label": "VSORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "integer", + "code": "AliasCode_9657", + "biomedical_concept_uid": "BiomedicalConcept_8" + }, + { + "id": 220005, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_259", + "name": "VSORRESU", + "label": "VSORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9658", + "biomedical_concept_uid": "BiomedicalConcept_8" + }, + { + "id": 220006, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_260", + "name": "VSPOS", + "label": "VSPOS", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9660", + "biomedical_concept_uid": "BiomedicalConcept_8" + }, + { + "id": 220007, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_261", + "name": "VSLOC", + "label": "VSLOC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9661", + "biomedical_concept_uid": "BiomedicalConcept_8" + }, + { + "id": 220008, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_262", + "name": "VSLAT", + "label": "VSLAT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9662", + "biomedical_concept_uid": "BiomedicalConcept_8" + }, + { + "id": 220009, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_263", + "name": "VSDTC", + "label": "VSDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9663", + "biomedical_concept_uid": "BiomedicalConcept_8" + }, + { + "id": 220010, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_264", + "name": "VSORRES", + "label": "VSORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "integer", + "code": "AliasCode_9664", + "biomedical_concept_uid": "BiomedicalConcept_9" + }, + { + "id": 220011, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_265", + "name": "VSORRESU", + "label": "VSORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9665", + "biomedical_concept_uid": "BiomedicalConcept_9" + }, + { + "id": 220012, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_266", + "name": "VSPOS", + "label": "VSPOS", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9667", + "biomedical_concept_uid": "BiomedicalConcept_9" + }, + { + "id": 220013, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_267", + "name": "VSLOC", + "label": "VSLOC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9668", + "biomedical_concept_uid": "BiomedicalConcept_9" + }, + { + "id": 220014, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_268", + "name": "VSLAT", + "label": "VSLAT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9669", + "biomedical_concept_uid": "BiomedicalConcept_9" + }, + { + "id": 220015, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_269", + "name": "VSDTC", + "label": "VSDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9670", + "biomedical_concept_uid": "BiomedicalConcept_9" + }, + { + "id": 220016, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_270", + "name": "VSORRES", + "label": "VSORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9671", + "biomedical_concept_uid": "BiomedicalConcept_10" + }, + { + "id": 220017, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_271", + "name": "VSORRESU", + "label": "VSORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9672", + "biomedical_concept_uid": "BiomedicalConcept_10" + }, + { + "id": 220018, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_272", + "name": "VSLOC", + "label": "VSLOC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9673", + "biomedical_concept_uid": "BiomedicalConcept_10" + }, + { + "id": 220019, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_273", + "name": "VSDTC", + "label": "VSDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9674", + "biomedical_concept_uid": "BiomedicalConcept_10" + }, + { + "id": 220020, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_274", + "name": "VSORRES", + "label": "VSORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9675", + "biomedical_concept_uid": "BiomedicalConcept_11" + }, + { + "id": 220021, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_275", + "name": "VSORRESU", + "label": "VSORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9676", + "biomedical_concept_uid": "BiomedicalConcept_11" + }, + { + "id": 220022, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_276", + "name": "VSDTC", + "label": "VSDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9677", + "biomedical_concept_uid": "BiomedicalConcept_11" + }, + { + "id": 220023, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_277", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9678", + "biomedical_concept_uid": "BiomedicalConcept_18" + }, + { + "id": 220024, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_278", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9679", + "biomedical_concept_uid": "BiomedicalConcept_18" + }, + { + "id": 220025, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_279", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9680", + "biomedical_concept_uid": "BiomedicalConcept_18" + }, + { + "id": 220026, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_280", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9682", + "biomedical_concept_uid": "BiomedicalConcept_18" + }, + { + "id": 220027, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_281", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9683", + "biomedical_concept_uid": "BiomedicalConcept_18" + }, + { + "id": 220028, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_282", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9684", + "biomedical_concept_uid": "BiomedicalConcept_19" + }, + { + "id": 220029, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_283", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9685", + "biomedical_concept_uid": "BiomedicalConcept_19" + }, + { + "id": 220030, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_284", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9686", + "biomedical_concept_uid": "BiomedicalConcept_19" + }, + { + "id": 220031, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_285", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9688", + "biomedical_concept_uid": "BiomedicalConcept_19" + }, + { + "id": 220032, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_286", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9689", + "biomedical_concept_uid": "BiomedicalConcept_19" + }, + { + "id": 220033, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_287", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9690", + "biomedical_concept_uid": "BiomedicalConcept_20" + }, + { + "id": 220034, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_288", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9691", + "biomedical_concept_uid": "BiomedicalConcept_20" + }, + { + "id": 220035, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_289", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9692", + "biomedical_concept_uid": "BiomedicalConcept_20" + }, + { + "id": 220036, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_290", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9694", + "biomedical_concept_uid": "BiomedicalConcept_20" + }, + { + "id": 220037, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_291", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9695", + "biomedical_concept_uid": "BiomedicalConcept_20" + }, + { + "id": 220038, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_292", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9696", + "biomedical_concept_uid": "BiomedicalConcept_21" + }, + { + "id": 220039, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_293", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9697", + "biomedical_concept_uid": "BiomedicalConcept_21" + }, + { + "id": 220040, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_294", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9698", + "biomedical_concept_uid": "BiomedicalConcept_21" + }, + { + "id": 220041, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_295", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9700", + "biomedical_concept_uid": "BiomedicalConcept_21" + }, + { + "id": 220042, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_296", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9701", + "biomedical_concept_uid": "BiomedicalConcept_21" + }, + { + "id": 220043, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_297", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9702", + "biomedical_concept_uid": "BiomedicalConcept_22" + }, + { + "id": 220044, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_298", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9703", + "biomedical_concept_uid": "BiomedicalConcept_22" + }, + { + "id": 220045, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_299", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9704", + "biomedical_concept_uid": "BiomedicalConcept_22" + }, + { + "id": 220046, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_300", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9706", + "biomedical_concept_uid": "BiomedicalConcept_22" + }, + { + "id": 220047, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_301", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9707", + "biomedical_concept_uid": "BiomedicalConcept_22" + }, + { + "id": 220063, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_317", + "name": "CMTRT", + "label": "CMTRT", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9726", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220064, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_318", + "name": "CMDECOD", + "label": "CMDECOD", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9727", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220065, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_319", + "name": "CMCLAS", + "label": "CMCLAS", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9728", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220066, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_320", + "name": "CMINDC", + "label": "CMINDC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9729", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220067, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_321", + "name": "CMDOSE", + "label": "CMDOSE", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9730", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220068, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_322", + "name": "CMDOSTXT", + "label": "CMDOSTXT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9731", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220069, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_323", + "name": "CMDOSU", + "label": "CMDOSU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9732", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220070, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_324", + "name": "CMDOSFRM", + "label": "CMDOSFRM", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9733", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220071, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_325", + "name": "CMDOSFRQ", + "label": "CMDOSFRQ", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9734", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220072, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_326", + "name": "CMROUTE", + "label": "CMROUTE", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9735", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220073, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_327", + "name": "CMSTDTC", + "label": "CMSTDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9736", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220074, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_328", + "name": "CMENDTC", + "label": "CMENDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9737", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220075, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_329", + "name": "CMSTRF", + "label": "CMSTRF", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9738", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220076, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_330", + "name": "CMSTRTPT", + "label": "CMSTRTPT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9739", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220077, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_331", + "name": "CMSTTPT", + "label": "CMSTTPT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9740", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220078, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_332", + "name": "CMENRF", + "label": "CMENRF", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9741", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220079, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_333", + "name": "CMENRTPT", + "label": "CMENRTPT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9742", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220080, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_334", + "name": "CMENTPT", + "label": "CMENTPT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9743", + "biomedical_concept_uid": "BiomedicalConcept_50" + }, + { + "id": 220081, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_335", + "name": "TSPARMCD", + "label": "TSPARMCD", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9744", + "biomedical_concept_uid": "BiomedicalConcept_51" + }, + { + "id": 220082, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_336", + "name": "TSPARM", + "label": "TSPARM", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9746", + "biomedical_concept_uid": "BiomedicalConcept_51" + }, + { + "id": 220083, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_337", + "name": "TSVAL", + "label": "TSVAL", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9748", + "biomedical_concept_uid": "BiomedicalConcept_51" + }, + { + "id": 220084, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_338", + "name": "TSVALCD", + "label": "TSVALCD", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9749", + "biomedical_concept_uid": "BiomedicalConcept_51" + }, + { + "id": 220085, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_339", + "name": "TSVCDREF", + "label": "TSVCDREF", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9750", + "biomedical_concept_uid": "BiomedicalConcept_51" + }, + { + "id": 220086, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_340", + "name": "TSVCDVER", + "label": "TSVCDVER", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9751", + "biomedical_concept_uid": "BiomedicalConcept_51" + }, + { + "id": 220087, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_341", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9752", + "biomedical_concept_uid": "BiomedicalConcept_52" + }, + { + "id": 220088, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_342", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9753", + "biomedical_concept_uid": "BiomedicalConcept_52" + }, + { + "id": 220089, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_343", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9755", + "biomedical_concept_uid": "BiomedicalConcept_52" + }, + { + "id": 220090, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_344", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9757", + "biomedical_concept_uid": "BiomedicalConcept_52" + }, + { + "id": 220091, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_345", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9758", + "biomedical_concept_uid": "BiomedicalConcept_52" + }, + { + "id": 220092, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_346", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "integer", + "code": "AliasCode_9759", + "biomedical_concept_uid": "BiomedicalConcept_53" + }, + { + "id": 220093, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_347", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9760", + "biomedical_concept_uid": "BiomedicalConcept_53" + }, + { + "id": 220094, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_348", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9762", + "biomedical_concept_uid": "BiomedicalConcept_53" + }, + { + "id": 220095, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_349", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9764", + "biomedical_concept_uid": "BiomedicalConcept_53" + }, + { + "id": 220096, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_350", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "integer", + "code": "AliasCode_9765", + "biomedical_concept_uid": "BiomedicalConcept_54" + }, + { + "id": 220097, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_351", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9766", + "biomedical_concept_uid": "BiomedicalConcept_54" + }, + { + "id": 220098, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_352", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9768", + "biomedical_concept_uid": "BiomedicalConcept_54" + }, + { + "id": 220099, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_353", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9770", + "biomedical_concept_uid": "BiomedicalConcept_54" + }, + { + "id": 220100, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_354", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9771", + "biomedical_concept_uid": "BiomedicalConcept_55" + }, + { + "id": 220101, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_355", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9772", + "biomedical_concept_uid": "BiomedicalConcept_55" + }, + { + "id": 220102, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_356", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9773", + "biomedical_concept_uid": "BiomedicalConcept_55" + }, + { + "id": 220103, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_357", + "name": "LBMETHOD", + "label": "LBMETHOD", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9775", + "biomedical_concept_uid": "BiomedicalConcept_55" + }, + { + "id": 220104, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_358", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9776", + "biomedical_concept_uid": "BiomedicalConcept_55" + }, + { + "id": 220105, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_359", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9777", + "biomedical_concept_uid": "BiomedicalConcept_55" + }, + { + "id": 220106, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_360", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9778", + "biomedical_concept_uid": "BiomedicalConcept_56" + }, + { + "id": 220107, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_361", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9779", + "biomedical_concept_uid": "BiomedicalConcept_56" + }, + { + "id": 220108, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_362", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9780", + "biomedical_concept_uid": "BiomedicalConcept_56" + }, + { + "id": 220109, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_363", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9782", + "biomedical_concept_uid": "BiomedicalConcept_56" + }, + { + "id": 220110, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_364", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9783", + "biomedical_concept_uid": "BiomedicalConcept_56" + }, + { + "id": 220111, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_365", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9784", + "biomedical_concept_uid": "BiomedicalConcept_57" + }, + { + "id": 220112, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_366", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9785", + "biomedical_concept_uid": "BiomedicalConcept_57" + }, + { + "id": 220113, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_367", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9786", + "biomedical_concept_uid": "BiomedicalConcept_57" + }, + { + "id": 220114, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_368", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9788", + "biomedical_concept_uid": "BiomedicalConcept_57" + }, + { + "id": 220115, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_369", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9789", + "biomedical_concept_uid": "BiomedicalConcept_57" + }, + { + "id": 220116, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_370", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9790", + "biomedical_concept_uid": "BiomedicalConcept_58" + }, + { + "id": 220117, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_371", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9791", + "biomedical_concept_uid": "BiomedicalConcept_58" + }, + { + "id": 220118, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_372", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9792", + "biomedical_concept_uid": "BiomedicalConcept_58" + }, + { + "id": 220119, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_373", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9794", + "biomedical_concept_uid": "BiomedicalConcept_58" + }, + { + "id": 220120, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_374", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9795", + "biomedical_concept_uid": "BiomedicalConcept_58" + }, + { + "id": 220121, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_375", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9796", + "biomedical_concept_uid": "BiomedicalConcept_59" + }, + { + "id": 220122, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_376", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9797", + "biomedical_concept_uid": "BiomedicalConcept_59" + }, + { + "id": 220123, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_377", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9798", + "biomedical_concept_uid": "BiomedicalConcept_59" + }, + { + "id": 220124, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_378", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9800", + "biomedical_concept_uid": "BiomedicalConcept_59" + }, + { + "id": 220125, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_379", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9801", + "biomedical_concept_uid": "BiomedicalConcept_59" + }, + { + "id": 220126, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_380", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9802", + "biomedical_concept_uid": "BiomedicalConcept_61" + }, + { + "id": 220127, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_381", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9803", + "biomedical_concept_uid": "BiomedicalConcept_61" + }, + { + "id": 220128, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_382", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9804", + "biomedical_concept_uid": "BiomedicalConcept_61" + }, + { + "id": 220129, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_383", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9806", + "biomedical_concept_uid": "BiomedicalConcept_61" + }, + { + "id": 220130, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_384", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9807", + "biomedical_concept_uid": "BiomedicalConcept_61" + }, + { + "id": 220131, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_385", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9808", + "biomedical_concept_uid": "BiomedicalConcept_62" + }, + { + "id": 220132, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_386", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9809", + "biomedical_concept_uid": "BiomedicalConcept_62" + }, + { + "id": 220133, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_387", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9810", + "biomedical_concept_uid": "BiomedicalConcept_62" + }, + { + "id": 220134, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_388", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9812", + "biomedical_concept_uid": "BiomedicalConcept_62" + }, + { + "id": 220135, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_389", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9813", + "biomedical_concept_uid": "BiomedicalConcept_62" + }, + { + "id": 220136, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_390", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9814", + "biomedical_concept_uid": "BiomedicalConcept_63" + }, + { + "id": 220137, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_391", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9815", + "biomedical_concept_uid": "BiomedicalConcept_63" + }, + { + "id": 220138, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_392", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9816", + "biomedical_concept_uid": "BiomedicalConcept_63" + }, + { + "id": 220139, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_393", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9818", + "biomedical_concept_uid": "BiomedicalConcept_63" + }, + { + "id": 220140, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_394", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9819", + "biomedical_concept_uid": "BiomedicalConcept_63" + }, + { + "id": 220141, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_395", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9820", + "biomedical_concept_uid": "BiomedicalConcept_64" + }, + { + "id": 220142, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_396", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9821", + "biomedical_concept_uid": "BiomedicalConcept_64" + }, + { + "id": 220143, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_397", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9822", + "biomedical_concept_uid": "BiomedicalConcept_64" + }, + { + "id": 220144, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_398", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9824", + "biomedical_concept_uid": "BiomedicalConcept_64" + }, + { + "id": 220145, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_399", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9825", + "biomedical_concept_uid": "BiomedicalConcept_64" + }, + { + "id": 220146, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_400", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9826", + "biomedical_concept_uid": "BiomedicalConcept_65" + }, + { + "id": 220147, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_401", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9827", + "biomedical_concept_uid": "BiomedicalConcept_65" + }, + { + "id": 220148, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_402", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9828", + "biomedical_concept_uid": "BiomedicalConcept_65" + }, + { + "id": 220149, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_403", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9830", + "biomedical_concept_uid": "BiomedicalConcept_65" + }, + { + "id": 220150, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_404", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9831", + "biomedical_concept_uid": "BiomedicalConcept_65" + }, + { + "id": 220151, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_405", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9832", + "biomedical_concept_uid": "BiomedicalConcept_66" + }, + { + "id": 220152, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_406", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9833", + "biomedical_concept_uid": "BiomedicalConcept_66" + }, + { + "id": 220153, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_407", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9834", + "biomedical_concept_uid": "BiomedicalConcept_66" + }, + { + "id": 220154, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_408", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9836", + "biomedical_concept_uid": "BiomedicalConcept_66" + }, + { + "id": 220155, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_409", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9837", + "biomedical_concept_uid": "BiomedicalConcept_66" + }, + { + "id": 220156, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_410", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9838", + "biomedical_concept_uid": "BiomedicalConcept_67" + }, + { + "id": 220157, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_411", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9839", + "biomedical_concept_uid": "BiomedicalConcept_67" + }, + { + "id": 220158, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_412", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9840", + "biomedical_concept_uid": "BiomedicalConcept_67" + }, + { + "id": 220159, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_413", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9842", + "biomedical_concept_uid": "BiomedicalConcept_67" + }, + { + "id": 220160, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_414", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9843", + "biomedical_concept_uid": "BiomedicalConcept_67" + }, + { + "id": 220161, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_415", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9844", + "biomedical_concept_uid": "BiomedicalConcept_68" + }, + { + "id": 220162, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_416", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9845", + "biomedical_concept_uid": "BiomedicalConcept_68" + }, + { + "id": 220163, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_417", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9846", + "biomedical_concept_uid": "BiomedicalConcept_68" + }, + { + "id": 220164, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_418", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9848", + "biomedical_concept_uid": "BiomedicalConcept_68" + }, + { + "id": 220165, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_419", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9849", + "biomedical_concept_uid": "BiomedicalConcept_68" + }, + { + "id": 220166, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_420", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9850", + "biomedical_concept_uid": "BiomedicalConcept_69" + }, + { + "id": 220167, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_421", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9851", + "biomedical_concept_uid": "BiomedicalConcept_69" + }, + { + "id": 220168, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_422", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9852", + "biomedical_concept_uid": "BiomedicalConcept_69" + }, + { + "id": 220169, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_423", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9854", + "biomedical_concept_uid": "BiomedicalConcept_69" + }, + { + "id": 220170, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_424", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9855", + "biomedical_concept_uid": "BiomedicalConcept_69" + }, + { + "id": 220171, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_425", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9856", + "biomedical_concept_uid": "BiomedicalConcept_70" + }, + { + "id": 220172, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_426", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9857", + "biomedical_concept_uid": "BiomedicalConcept_70" + }, + { + "id": 220173, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_427", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9858", + "biomedical_concept_uid": "BiomedicalConcept_70" + }, + { + "id": 220174, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_428", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9860", + "biomedical_concept_uid": "BiomedicalConcept_70" + }, + { + "id": 220175, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_429", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9861", + "biomedical_concept_uid": "BiomedicalConcept_70" + }, + { + "id": 220176, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_430", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9862", + "biomedical_concept_uid": "BiomedicalConcept_71" + }, + { + "id": 220177, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_431", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9863", + "biomedical_concept_uid": "BiomedicalConcept_71" + }, + { + "id": 220178, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_432", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9864", + "biomedical_concept_uid": "BiomedicalConcept_71" + }, + { + "id": 220179, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_433", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9866", + "biomedical_concept_uid": "BiomedicalConcept_71" + }, + { + "id": 220180, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_434", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9867", + "biomedical_concept_uid": "BiomedicalConcept_71" + }, + { + "id": 220181, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_435", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_9868", + "biomedical_concept_uid": "BiomedicalConcept_72" + }, + { + "id": 220182, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_436", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9869", + "biomedical_concept_uid": "BiomedicalConcept_72" + }, + { + "id": 220183, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_437", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9870", + "biomedical_concept_uid": "BiomedicalConcept_72" + }, + { + "id": 220184, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_438", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_9872", + "biomedical_concept_uid": "BiomedicalConcept_72" + }, + { + "id": 220185, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_439", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9873", + "biomedical_concept_uid": "BiomedicalConcept_72" + }, + { + "id": 220299, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_440", + "name": "Category", + "label": "Category", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9932", + "biomedical_concept_uid": "BiomedicalConcept_82" + }, + { + "id": 220300, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_441", + "name": "Observation Result", + "label": "Observation Result", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9933", + "biomedical_concept_uid": "BiomedicalConcept_82" + }, + { + "id": 220301, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_442", + "name": "Evaluator", + "label": "Evaluator", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9934", + "biomedical_concept_uid": "BiomedicalConcept_82" + }, + { + "id": 220302, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_443", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9935", + "biomedical_concept_uid": "BiomedicalConcept_82" + }, + { + "id": 220303, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_444", + "name": "Collection Date Time", + "label": "Collection Date Time", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9936", + "biomedical_concept_uid": "BiomedicalConcept_82" + }, + { + "id": 220304, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_445", + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9937", + "biomedical_concept_uid": "BiomedicalConcept_83" + }, + { + "id": 220305, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_446", + "name": "Evaluator", + "label": "Evaluator", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9938", + "biomedical_concept_uid": "BiomedicalConcept_83" + }, + { + "id": 220306, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_447", + "name": "Test Method", + "label": "Test Method", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9939", + "biomedical_concept_uid": "BiomedicalConcept_83" + }, + { + "id": 220307, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_448", + "name": "Observation Result", + "label": "Observation Result", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9940", + "biomedical_concept_uid": "BiomedicalConcept_83" + }, + { + "id": 220308, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_449", + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9941", + "biomedical_concept_uid": "BiomedicalConcept_83" + }, + { + "id": 220309, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_450", + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9942", + "biomedical_concept_uid": "BiomedicalConcept_83" + }, + { + "id": 220310, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_451", + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9943", + "biomedical_concept_uid": "BiomedicalConcept_83" + }, + { + "id": 220311, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_452", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9944", + "biomedical_concept_uid": "BiomedicalConcept_83" + }, + { + "id": 220312, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_453", + "name": "Collection Date Time", + "label": "Collection Date Time", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9945", + "biomedical_concept_uid": "BiomedicalConcept_83" + }, + { + "id": 220313, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_454", + "name": "Observation Result", + "label": "Observation Result", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9946", + "biomedical_concept_uid": "BiomedicalConcept_84" + }, + { + "id": 220314, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_455", + "name": "Evaluator", + "label": "Evaluator", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9947", + "biomedical_concept_uid": "BiomedicalConcept_84" + }, + { + "id": 220315, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_456", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9948", + "biomedical_concept_uid": "BiomedicalConcept_84" + }, + { + "id": 220316, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_457", + "name": "Collection Date Time", + "label": "Collection Date Time", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9949", + "biomedical_concept_uid": "BiomedicalConcept_84" + }, + { + "id": 220317, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_458", + "name": "Collection Date Time", + "label": "Collection Date Time", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9950", + "biomedical_concept_uid": "BiomedicalConcept_85" + }, + { + "id": 220318, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_459", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9951", + "biomedical_concept_uid": "BiomedicalConcept_85" + }, + { + "id": 220319, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_460", + "name": "Evaluator", + "label": "Evaluator", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9952", + "biomedical_concept_uid": "BiomedicalConcept_85" + }, + { + "id": 220320, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_461", + "name": "Observation Result", + "label": "Observation Result", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9953", + "biomedical_concept_uid": "BiomedicalConcept_85" + }, + { + "id": 220321, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_462", + "name": "Result Anatomical Location", + "label": "Result Anatomical Location", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9954", + "biomedical_concept_uid": "BiomedicalConcept_86" + }, + { + "id": 220322, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_463", + "name": "Tumor Identifier Reference Identifier", + "label": "Tumor Identifier Reference Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9955", + "biomedical_concept_uid": "BiomedicalConcept_86" + }, + { + "id": 220323, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_464", + "name": "Collection Date Time", + "label": "Collection Date Time", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9956", + "biomedical_concept_uid": "BiomedicalConcept_86" + }, + { + "id": 220324, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_465", + "name": "Directionality", + "label": "Directionality", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9957", + "biomedical_concept_uid": "BiomedicalConcept_86" + }, + { + "id": 220325, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_466", + "name": "Observation Result", + "label": "Observation Result", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9958", + "biomedical_concept_uid": "BiomedicalConcept_86" + }, + { + "id": 220326, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_467", + "name": "Test Method", + "label": "Test Method", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9959", + "biomedical_concept_uid": "BiomedicalConcept_86" + }, + { + "id": 220327, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_468", + "name": "Evaluator", + "label": "Evaluator", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9960", + "biomedical_concept_uid": "BiomedicalConcept_86" + }, + { + "id": 220328, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_469", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9961", + "biomedical_concept_uid": "BiomedicalConcept_86" + }, + { + "id": 220329, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_470", + "name": "Laterality", + "label": "Laterality", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9962", + "biomedical_concept_uid": "BiomedicalConcept_86" + }, + { + "id": 220330, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_471", + "name": "Tumor Identifier Link Identifier", + "label": "Tumor Identifier Link Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9963", + "biomedical_concept_uid": "BiomedicalConcept_86" + }, + { + "id": 220331, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_472", + "name": "Directionality", + "label": "Directionality", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9964", + "biomedical_concept_uid": "BiomedicalConcept_87" + }, + { + "id": 220332, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_473", + "name": "Laterality", + "label": "Laterality", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9965", + "biomedical_concept_uid": "BiomedicalConcept_87" + }, + { + "id": 220333, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_474", + "name": "Evaluator", + "label": "Evaluator", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9966", + "biomedical_concept_uid": "BiomedicalConcept_87" + }, + { + "id": 220334, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_475", + "name": "Observation Result", + "label": "Observation Result", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9967", + "biomedical_concept_uid": "BiomedicalConcept_87" + }, + { + "id": 220335, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_476", + "name": "Result Anatomical Location", + "label": "Result Anatomical Location", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9968", + "biomedical_concept_uid": "BiomedicalConcept_87" + }, + { + "id": 220336, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_477", + "name": "Test Method", + "label": "Test Method", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9969", + "biomedical_concept_uid": "BiomedicalConcept_87" + }, + { + "id": 220337, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_478", + "name": "Tumor Identifier Link Identifier", + "label": "Tumor Identifier Link Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9970", + "biomedical_concept_uid": "BiomedicalConcept_87" + }, + { + "id": 220338, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_479", + "name": "Tumor Identifier Reference Identifier", + "label": "Tumor Identifier Reference Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9971", + "biomedical_concept_uid": "BiomedicalConcept_87" + }, + { + "id": 220339, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_480", + "name": "Collection Date Time", + "label": "Collection Date Time", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9972", + "biomedical_concept_uid": "BiomedicalConcept_87" + }, + { + "id": 220340, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_481", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9973", + "biomedical_concept_uid": "BiomedicalConcept_87" + }, + { + "id": 220341, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_482", + "name": "TUORRES", + "label": "TUORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9974", + "biomedical_concept_uid": "BiomedicalConcept_88" + }, + { + "id": 220342, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_483", + "name": "TULOC", + "label": "TULOC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9976", + "biomedical_concept_uid": "BiomedicalConcept_88" + }, + { + "id": 220343, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_484", + "name": "TULAT", + "label": "TULAT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9977", + "biomedical_concept_uid": "BiomedicalConcept_88" + }, + { + "id": 220344, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_485", + "name": "TUDIR", + "label": "TUDIR", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9978", + "biomedical_concept_uid": "BiomedicalConcept_88" + }, + { + "id": 220345, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_486", + "name": "TUMETHOD", + "label": "TUMETHOD", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9979", + "biomedical_concept_uid": "BiomedicalConcept_88" + }, + { + "id": 220346, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_487", + "name": "TUEVAL", + "label": "TUEVAL", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9980", + "biomedical_concept_uid": "BiomedicalConcept_88" + }, + { + "id": 220347, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_488", + "name": "TUEVALID", + "label": "TUEVALID", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9981", + "biomedical_concept_uid": "BiomedicalConcept_88" + }, + { + "id": 220348, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_489", + "name": "TUREFID", + "label": "TUREFID", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9982", + "biomedical_concept_uid": "BiomedicalConcept_88" + }, + { + "id": 220349, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_490", + "name": "TULNKID", + "label": "TULNKID", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9983", + "biomedical_concept_uid": "BiomedicalConcept_88" + }, + { + "id": 220350, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_491", + "name": "TUDTC", + "label": "TUDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9984", + "biomedical_concept_uid": "BiomedicalConcept_88" + }, + { + "id": 220351, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_492", + "name": "RSORRES", + "label": "RSORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9985", + "biomedical_concept_uid": "BiomedicalConcept_89" + }, + { + "id": 220352, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_493", + "name": "RSEVAL", + "label": "RSEVAL", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9986", + "biomedical_concept_uid": "BiomedicalConcept_89" + }, + { + "id": 220353, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_494", + "name": "RSEVALID", + "label": "RSEVALID", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9987", + "biomedical_concept_uid": "BiomedicalConcept_89" + }, + { + "id": 220354, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_495", + "name": "RSDTC", + "label": "RSDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9988", + "biomedical_concept_uid": "BiomedicalConcept_89" + }, + { + "id": 220355, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_496", + "name": "RSORRES", + "label": "RSORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_9989", + "biomedical_concept_uid": "BiomedicalConcept_90" + }, + { + "id": 220356, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_497", + "name": "RSEVAL", + "label": "RSEVAL", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9990", + "biomedical_concept_uid": "BiomedicalConcept_90" + }, + { + "id": 220357, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_498", + "name": "RSEVALID", + "label": "RSEVALID", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9991", + "biomedical_concept_uid": "BiomedicalConcept_90" + }, + { + "id": 220358, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_499", + "name": "RSDTC", + "label": "RSDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9992", + "biomedical_concept_uid": "BiomedicalConcept_90" + }, + { + "id": 220359, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_500", + "name": "Disease Response Link Group", + "label": "Disease Response Link Group", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9993", + "biomedical_concept_uid": "BiomedicalConcept_91" + }, + { + "id": 220360, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_501", + "name": "Category", + "label": "Category", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9994", + "biomedical_concept_uid": "BiomedicalConcept_91" + }, + { + "id": 220361, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_502", + "name": "Observation Result", + "label": "Observation Result", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9995", + "biomedical_concept_uid": "BiomedicalConcept_91" + }, + { + "id": 220362, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_503", + "name": "Evaluator", + "label": "Evaluator", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9996", + "biomedical_concept_uid": "BiomedicalConcept_91" + }, + { + "id": 220363, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_504", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9997", + "biomedical_concept_uid": "BiomedicalConcept_91" + }, + { + "id": 220364, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_505", + "name": "Clinical Trial Epoch", + "label": "Clinical Trial Epoch", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_9998", + "biomedical_concept_uid": "BiomedicalConcept_91" + }, + { + "id": 220365, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_506", + "name": "Collection Date Time", + "label": "Collection Date Time", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_9999", + "biomedical_concept_uid": "BiomedicalConcept_91" + }, + { + "id": 220366, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_507", + "name": "RSLNKGRP", + "label": "RSLNKGRP", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10000", + "biomedical_concept_uid": "BiomedicalConcept_92" + }, + { + "id": 220367, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_508", + "name": "RSORRES", + "label": "RSORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10001", + "biomedical_concept_uid": "BiomedicalConcept_92" + }, + { + "id": 220368, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_509", + "name": "RSEVAL", + "label": "RSEVAL", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10002", + "biomedical_concept_uid": "BiomedicalConcept_92" + }, + { + "id": 220369, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_510", + "name": "RSEVALID", + "label": "RSEVALID", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10003", + "biomedical_concept_uid": "BiomedicalConcept_92" + }, + { + "id": 220370, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_511", + "name": "RSDTC", + "label": "RSDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10004", + "biomedical_concept_uid": "BiomedicalConcept_92" + }, + { + "id": 220371, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_512", + "name": "Collection Date Time", + "label": "Collection Date Time", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10005", + "biomedical_concept_uid": "BiomedicalConcept_93" + }, + { + "id": 220372, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_513", + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10006", + "biomedical_concept_uid": "BiomedicalConcept_93" + }, + { + "id": 220373, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_514", + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10007", + "biomedical_concept_uid": "BiomedicalConcept_93" + }, + { + "id": 220374, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_515", + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10008", + "biomedical_concept_uid": "BiomedicalConcept_93" + }, + { + "id": 220375, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_516", + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10009", + "biomedical_concept_uid": "BiomedicalConcept_93" + }, + { + "id": 220376, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_517", + "name": "Observation Result", + "label": "Observation Result", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10010", + "biomedical_concept_uid": "BiomedicalConcept_93" + }, + { + "id": 220377, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_518", + "name": "Test Method", + "label": "Test Method", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10011", + "biomedical_concept_uid": "BiomedicalConcept_93" + }, + { + "id": 220378, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_519", + "name": "Evaluator", + "label": "Evaluator", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10012", + "biomedical_concept_uid": "BiomedicalConcept_93" + }, + { + "id": 220379, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_520", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10013", + "biomedical_concept_uid": "BiomedicalConcept_93" + }, + { + "id": 220380, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_521", + "name": "Observation Result", + "label": "Observation Result", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10014", + "biomedical_concept_uid": "BiomedicalConcept_94" + }, + { + "id": 220381, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_522", + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10015", + "biomedical_concept_uid": "BiomedicalConcept_94" + }, + { + "id": 220382, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_523", + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10016", + "biomedical_concept_uid": "BiomedicalConcept_94" + }, + { + "id": 220383, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_524", + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10017", + "biomedical_concept_uid": "BiomedicalConcept_94" + }, + { + "id": 220384, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_525", + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10018", + "biomedical_concept_uid": "BiomedicalConcept_94" + }, + { + "id": 220385, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_526", + "name": "Collection Date Time", + "label": "Collection Date Time", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10019", + "biomedical_concept_uid": "BiomedicalConcept_94" + }, + { + "id": 220386, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_527", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10020", + "biomedical_concept_uid": "BiomedicalConcept_94" + }, + { + "id": 220387, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_528", + "name": "Evaluator", + "label": "Evaluator", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10021", + "biomedical_concept_uid": "BiomedicalConcept_94" + }, + { + "id": 220388, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_529", + "name": "Test Method", + "label": "Test Method", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10022", + "biomedical_concept_uid": "BiomedicalConcept_94" + }, + { + "id": 220389, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_530", + "name": "Unit of Length", + "label": "Unit of Length", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10023", + "biomedical_concept_uid": "BiomedicalConcept_94" + }, + { + "id": 220390, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_531", + "name": "Evaluator Identifier", + "label": "Evaluator Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10024", + "biomedical_concept_uid": "BiomedicalConcept_95" + }, + { + "id": 220391, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_532", + "name": "Evaluator", + "label": "Evaluator", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10025", + "biomedical_concept_uid": "BiomedicalConcept_95" + }, + { + "id": 220392, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_533", + "name": "Tumor Results Reference Identifier", + "label": "Tumor Results Reference Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10026", + "biomedical_concept_uid": "BiomedicalConcept_95" + }, + { + "id": 220393, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_534", + "name": "Tumor Results Link Group", + "label": "Tumor Results Link Group", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10027", + "biomedical_concept_uid": "BiomedicalConcept_95" + }, + { + "id": 220394, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_535", + "name": "Tumor Results Link Identifier", + "label": "Tumor Results Link Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10028", + "biomedical_concept_uid": "BiomedicalConcept_95" + }, + { + "id": 220395, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_536", + "name": "Observation Result", + "label": "Observation Result", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10029", + "biomedical_concept_uid": "BiomedicalConcept_95" + }, + { + "id": 220396, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_537", + "name": "Unit of Length", + "label": "Unit of Length", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10030", + "biomedical_concept_uid": "BiomedicalConcept_95" + }, + { + "id": 220397, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_538", + "name": "Collection Date Time", + "label": "Collection Date Time", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10031", + "biomedical_concept_uid": "BiomedicalConcept_95" + }, + { + "id": 220398, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_539", + "name": "Tumor Results Group Identifier", + "label": "Tumor Results Group Identifier", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10032", + "biomedical_concept_uid": "BiomedicalConcept_95" + }, + { + "id": 220399, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_540", + "name": "Test Method", + "label": "Test Method", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10033", + "biomedical_concept_uid": "BiomedicalConcept_95" + }, + { + "id": 220400, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_541", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10037", + "biomedical_concept_uid": "BiomedicalConcept_96" + }, + { + "id": 220401, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_542", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10038", + "biomedical_concept_uid": "BiomedicalConcept_96" + }, + { + "id": 220402, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_543", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10040", + "biomedical_concept_uid": "BiomedicalConcept_96" + }, + { + "id": 220403, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_544", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10041", + "biomedical_concept_uid": "BiomedicalConcept_96" + }, + { + "id": 220404, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_545", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10042", + "biomedical_concept_uid": "BiomedicalConcept_97" + }, + { + "id": 220405, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_546", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10043", + "biomedical_concept_uid": "BiomedicalConcept_97" + }, + { + "id": 220406, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_547", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10045", + "biomedical_concept_uid": "BiomedicalConcept_97" + }, + { + "id": 220407, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_548", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10046", + "biomedical_concept_uid": "BiomedicalConcept_98" + }, + { + "id": 220408, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_549", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10047", + "biomedical_concept_uid": "BiomedicalConcept_98" + }, + { + "id": 220409, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_550", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10049", + "biomedical_concept_uid": "BiomedicalConcept_98" + }, + { + "id": 220410, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_551", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10050", + "biomedical_concept_uid": "BiomedicalConcept_98" + }, + { + "id": 220411, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_552", + "name": "MHTERM", + "label": "MHTERM", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10075", + "biomedical_concept_uid": "BiomedicalConcept_78" + }, + { + "id": 220412, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_553", + "name": "MHDECOD", + "label": "MHDECOD", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10076", + "biomedical_concept_uid": "BiomedicalConcept_78" + }, + { + "id": 220413, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_554", + "name": "MHSTDTC", + "label": "MHSTDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10077", + "biomedical_concept_uid": "BiomedicalConcept_78" + }, + { + "id": 220414, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_555", + "name": "MHENDTC", + "label": "MHENDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10078", + "biomedical_concept_uid": "BiomedicalConcept_78" + }, + { + "id": 220415, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_556", + "name": "MHENRF", + "label": "MHENRF", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10079", + "biomedical_concept_uid": "BiomedicalConcept_78" + }, + { + "id": 220416, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_557", + "name": "MHENRTPT", + "label": "MHENRTPT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10080", + "biomedical_concept_uid": "BiomedicalConcept_78" + }, + { + "id": 220417, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_558", + "name": "MHENTPT", + "label": "MHENTPT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10081", + "biomedical_concept_uid": "BiomedicalConcept_78" + }, + { + "id": 220443, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_584", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10107", + "biomedical_concept_uid": "BiomedicalConcept_99" + }, + { + "id": 220444, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_585", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10108", + "biomedical_concept_uid": "BiomedicalConcept_99" + }, + { + "id": 220445, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_586", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10109", + "biomedical_concept_uid": "BiomedicalConcept_99" + }, + { + "id": 220446, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_587", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10111", + "biomedical_concept_uid": "BiomedicalConcept_99" + }, + { + "id": 220447, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_588", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10112", + "biomedical_concept_uid": "BiomedicalConcept_99" + }, + { + "id": 220448, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_589", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10113", + "biomedical_concept_uid": "BiomedicalConcept_100" + }, + { + "id": 220449, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_590", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10114", + "biomedical_concept_uid": "BiomedicalConcept_100" + }, + { + "id": 220450, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_591", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10115", + "biomedical_concept_uid": "BiomedicalConcept_100" + }, + { + "id": 220451, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_592", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10117", + "biomedical_concept_uid": "BiomedicalConcept_100" + }, + { + "id": 220452, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_593", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10118", + "biomedical_concept_uid": "BiomedicalConcept_100" + }, + { + "id": 220453, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_594", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10119", + "biomedical_concept_uid": "BiomedicalConcept_101" + }, + { + "id": 220454, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_595", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10120", + "biomedical_concept_uid": "BiomedicalConcept_101" + }, + { + "id": 220455, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_596", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10121", + "biomedical_concept_uid": "BiomedicalConcept_101" + }, + { + "id": 220456, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_597", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10123", + "biomedical_concept_uid": "BiomedicalConcept_101" + }, + { + "id": 220457, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_598", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10124", + "biomedical_concept_uid": "BiomedicalConcept_101" + }, + { + "id": 220458, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_599", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10125", + "biomedical_concept_uid": "BiomedicalConcept_102" + }, + { + "id": 220459, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_600", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10126", + "biomedical_concept_uid": "BiomedicalConcept_102" + }, + { + "id": 220460, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_601", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10127", + "biomedical_concept_uid": "BiomedicalConcept_102" + }, + { + "id": 220461, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_602", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10129", + "biomedical_concept_uid": "BiomedicalConcept_102" + }, + { + "id": 220462, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_603", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10130", + "biomedical_concept_uid": "BiomedicalConcept_102" + }, + { + "id": 220463, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_604", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10131", + "biomedical_concept_uid": "BiomedicalConcept_103" + }, + { + "id": 220464, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_605", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10132", + "biomedical_concept_uid": "BiomedicalConcept_103" + }, + { + "id": 220465, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_606", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10133", + "biomedical_concept_uid": "BiomedicalConcept_103" + }, + { + "id": 220466, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_607", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10135", + "biomedical_concept_uid": "BiomedicalConcept_103" + }, + { + "id": 220467, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_608", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10136", + "biomedical_concept_uid": "BiomedicalConcept_103" + }, + { + "id": 220468, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_609", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10137", + "biomedical_concept_uid": "BiomedicalConcept_104" + }, + { + "id": 220469, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_610", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10138", + "biomedical_concept_uid": "BiomedicalConcept_104" + }, + { + "id": 220470, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_611", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10140", + "biomedical_concept_uid": "BiomedicalConcept_104" + }, + { + "id": 220471, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_612", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10142", + "biomedical_concept_uid": "BiomedicalConcept_104" + }, + { + "id": 220472, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_613", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10143", + "biomedical_concept_uid": "BiomedicalConcept_104" + }, + { + "id": 220473, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_614", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10144", + "biomedical_concept_uid": "BiomedicalConcept_105" + }, + { + "id": 220474, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_615", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10145", + "biomedical_concept_uid": "BiomedicalConcept_105" + }, + { + "id": 220475, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_616", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10146", + "biomedical_concept_uid": "BiomedicalConcept_105" + }, + { + "id": 220476, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_617", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10148", + "biomedical_concept_uid": "BiomedicalConcept_105" + }, + { + "id": 220477, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_618", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10149", + "biomedical_concept_uid": "BiomedicalConcept_105" + }, + { + "id": 220478, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_619", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10150", + "biomedical_concept_uid": "BiomedicalConcept_106" + }, + { + "id": 220479, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_620", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10151", + "biomedical_concept_uid": "BiomedicalConcept_106" + }, + { + "id": 220480, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_621", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10152", + "biomedical_concept_uid": "BiomedicalConcept_106" + }, + { + "id": 220481, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_622", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10154", + "biomedical_concept_uid": "BiomedicalConcept_106" + }, + { + "id": 220482, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_623", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10155", + "biomedical_concept_uid": "BiomedicalConcept_106" + }, + { + "id": 220483, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_624", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10156", + "biomedical_concept_uid": "BiomedicalConcept_107" + }, + { + "id": 220484, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_625", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10157", + "biomedical_concept_uid": "BiomedicalConcept_107" + }, + { + "id": 220485, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_626", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10159", + "biomedical_concept_uid": "BiomedicalConcept_107" + }, + { + "id": 220486, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_627", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10161", + "biomedical_concept_uid": "BiomedicalConcept_107" + }, + { + "id": 220487, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_628", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10162", + "biomedical_concept_uid": "BiomedicalConcept_107" + }, + { + "id": 220488, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_629", + "name": "REORRES", + "label": "REORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10163", + "biomedical_concept_uid": "BiomedicalConcept_108" + }, + { + "id": 220489, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_630", + "name": "REORRESU", + "label": "REORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10164", + "biomedical_concept_uid": "BiomedicalConcept_108" + }, + { + "id": 220490, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_631", + "name": "REDTC", + "label": "REDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10165", + "biomedical_concept_uid": "BiomedicalConcept_108" + }, + { + "id": 220491, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_632", + "name": "REORRES", + "label": "REORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10166", + "biomedical_concept_uid": "BiomedicalConcept_109" + }, + { + "id": 220492, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_633", + "name": "REORRESU", + "label": "REORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10167", + "biomedical_concept_uid": "BiomedicalConcept_109" + }, + { + "id": 220493, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_634", + "name": "REDTC", + "label": "REDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10168", + "biomedical_concept_uid": "BiomedicalConcept_109" + }, + { + "id": 220494, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_635", + "name": "REORRES", + "label": "REORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10169", + "biomedical_concept_uid": "BiomedicalConcept_110" + }, + { + "id": 220495, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_636", + "name": "REORRESU", + "label": "REORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10170", + "biomedical_concept_uid": "BiomedicalConcept_110" + }, + { + "id": 220496, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_637", + "name": "REDTC", + "label": "REDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10171", + "biomedical_concept_uid": "BiomedicalConcept_110" + }, + { + "id": 220497, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_638", + "name": "REORRES", + "label": "REORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10172", + "biomedical_concept_uid": "BiomedicalConcept_111" + }, + { + "id": 220498, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_639", + "name": "REORRESU", + "label": "REORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10173", + "biomedical_concept_uid": "BiomedicalConcept_111" + }, + { + "id": 220499, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_640", + "name": "REDTC", + "label": "REDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10174", + "biomedical_concept_uid": "BiomedicalConcept_111" + }, + { + "id": 220500, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_641", + "name": "REORRES", + "label": "REORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10175", + "biomedical_concept_uid": "BiomedicalConcept_112" + }, + { + "id": 220501, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_642", + "name": "REORRESU", + "label": "REORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10176", + "biomedical_concept_uid": "BiomedicalConcept_112" + }, + { + "id": 220502, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_643", + "name": "REDTC", + "label": "REDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10177", + "biomedical_concept_uid": "BiomedicalConcept_112" + }, + { + "id": 220503, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_644", + "name": "REORRES", + "label": "REORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10178", + "biomedical_concept_uid": "BiomedicalConcept_113" + }, + { + "id": 220504, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_645", + "name": "REORRESU", + "label": "REORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10179", + "biomedical_concept_uid": "BiomedicalConcept_113" + }, + { + "id": 220505, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_646", + "name": "REDTC", + "label": "REDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10180", + "biomedical_concept_uid": "BiomedicalConcept_113" + }, + { + "id": 220506, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_647", + "name": "REORRES", + "label": "REORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10181", + "biomedical_concept_uid": "BiomedicalConcept_114" + }, + { + "id": 220507, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_648", + "name": "REORRESU", + "label": "REORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10182", + "biomedical_concept_uid": "BiomedicalConcept_114" + }, + { + "id": 220508, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_649", + "name": "REDTC", + "label": "REDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10183", + "biomedical_concept_uid": "BiomedicalConcept_114" + }, + { + "id": 220509, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_650", + "name": "REORRES", + "label": "REORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10184", + "biomedical_concept_uid": "BiomedicalConcept_115" + }, + { + "id": 220510, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_651", + "name": "REORRESU", + "label": "REORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10185", + "biomedical_concept_uid": "BiomedicalConcept_115" + }, + { + "id": 220511, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_652", + "name": "REDTC", + "label": "REDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10186", + "biomedical_concept_uid": "BiomedicalConcept_115" + }, + { + "id": 220512, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_653", + "name": "REORRES", + "label": "REORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10187", + "biomedical_concept_uid": "BiomedicalConcept_116" + }, + { + "id": 220513, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_654", + "name": "REORRESU", + "label": "REORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10188", + "biomedical_concept_uid": "BiomedicalConcept_116" + }, + { + "id": 220514, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_655", + "name": "REDTC", + "label": "REDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10189", + "biomedical_concept_uid": "BiomedicalConcept_116" + }, + { + "id": 220518, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_659", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10193", + "biomedical_concept_uid": "BiomedicalConcept_118" + }, + { + "id": 220519, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_660", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10194", + "biomedical_concept_uid": "BiomedicalConcept_118" + }, + { + "id": 220520, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_661", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10195", + "biomedical_concept_uid": "BiomedicalConcept_118" + }, + { + "id": 220521, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_662", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10197", + "biomedical_concept_uid": "BiomedicalConcept_118" + }, + { + "id": 220522, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_663", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10198", + "biomedical_concept_uid": "BiomedicalConcept_118" + }, + { + "id": 220523, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_664", + "name": "Collection Date Time", + "label": "Collection Date Time", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10199", + "biomedical_concept_uid": "BiomedicalConcept_119" + }, + { + "id": 220524, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_665", + "name": "Observation Result", + "label": "Observation Result", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10200", + "biomedical_concept_uid": "BiomedicalConcept_119" + }, + { + "id": 220525, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_666", + "name": "Unit of Concentration", + "label": "Unit of Concentration", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10201", + "biomedical_concept_uid": "BiomedicalConcept_119" + }, + { + "id": 220526, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_667", + "name": "Measurement, Test or Examination Detail", + "label": "Measurement, Test or Examination Detail", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10202", + "biomedical_concept_uid": "BiomedicalConcept_119" + }, + { + "id": 220527, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_668", + "name": "Test Method", + "label": "Test Method", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10203", + "biomedical_concept_uid": "BiomedicalConcept_119" + }, + { + "id": 220528, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_669", + "name": "Biospecimen Type", + "label": "Biospecimen Type", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10204", + "biomedical_concept_uid": "BiomedicalConcept_119" + }, + { + "id": 220529, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_670", + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10205", + "biomedical_concept_uid": "BiomedicalConcept_120" + }, + { + "id": 220530, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_671", + "name": "MBORRES", + "label": "MBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10206", + "biomedical_concept_uid": "BiomedicalConcept_120" + }, + { + "id": 220531, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_672", + "name": "MBORRESU", + "label": "MBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10207", + "biomedical_concept_uid": "BiomedicalConcept_120" + }, + { + "id": 220532, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_673", + "name": "MBSPEC", + "label": "MBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10208", + "biomedical_concept_uid": "BiomedicalConcept_120" + }, + { + "id": 220533, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_674", + "name": "MBMETHOD", + "label": "MBMETHOD", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10210", + "biomedical_concept_uid": "BiomedicalConcept_120" + }, + { + "id": 220534, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_675", + "name": "MBDTC", + "label": "MBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10211", + "biomedical_concept_uid": "BiomedicalConcept_120" + }, + { + "id": 220535, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_676", + "name": "MBTSTDTL", + "label": "MBTSTDTL", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10212", + "biomedical_concept_uid": "BiomedicalConcept_121" + }, + { + "id": 220536, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_677", + "name": "MBORRES", + "label": "MBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10213", + "biomedical_concept_uid": "BiomedicalConcept_121" + }, + { + "id": 220537, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_678", + "name": "MBORRESU", + "label": "MBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10214", + "biomedical_concept_uid": "BiomedicalConcept_121" + }, + { + "id": 220538, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_679", + "name": "MBSPEC", + "label": "MBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10215", + "biomedical_concept_uid": "BiomedicalConcept_121" + }, + { + "id": 220539, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_680", + "name": "MBMETHOD", + "label": "MBMETHOD", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10217", + "biomedical_concept_uid": "BiomedicalConcept_121" + }, + { + "id": 220540, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_681", + "name": "MBDTC", + "label": "MBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10218", + "biomedical_concept_uid": "BiomedicalConcept_121" + }, + { + "id": 220541, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_682", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10219", + "biomedical_concept_uid": "BiomedicalConcept_122" + }, + { + "id": 220542, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_683", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10220", + "biomedical_concept_uid": "BiomedicalConcept_122" + }, + { + "id": 220543, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_684", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10222", + "biomedical_concept_uid": "BiomedicalConcept_122" + }, + { + "id": 220544, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_685", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10224", + "biomedical_concept_uid": "BiomedicalConcept_122" + }, + { + "id": 220545, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_686", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10225", + "biomedical_concept_uid": "BiomedicalConcept_122" + }, + { + "id": 220546, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_687", + "name": "MHTERM", + "label": "MHTERM", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10233", + "biomedical_concept_uid": "BiomedicalConcept_124" + }, + { + "id": 220547, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_688", + "name": "MHDECOD", + "label": "MHDECOD", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10234", + "biomedical_concept_uid": "BiomedicalConcept_124" + }, + { + "id": 220548, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_689", + "name": "MHPRESP", + "label": "MHPRESP", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10235", + "biomedical_concept_uid": "BiomedicalConcept_124" + }, + { + "id": 220549, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_690", + "name": "MHOCCUR", + "label": "MHOCCUR", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10236", + "biomedical_concept_uid": "BiomedicalConcept_124" + }, + { + "id": 220550, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_691", + "name": "MHEVTTYP", + "label": "MHEVTTYP", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10237", + "biomedical_concept_uid": "BiomedicalConcept_124" + }, + { + "id": 220551, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_692", + "name": "MHSTDTC", + "label": "MHSTDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10239", + "biomedical_concept_uid": "BiomedicalConcept_124" + }, + { + "id": 220552, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_693", + "name": "LBORRES", + "label": "LBORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10240", + "biomedical_concept_uid": "BiomedicalConcept_125" + }, + { + "id": 220553, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_694", + "name": "LBORRESU", + "label": "LBORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10241", + "biomedical_concept_uid": "BiomedicalConcept_125" + }, + { + "id": 220554, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_695", + "name": "LBSPEC", + "label": "LBSPEC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10242", + "biomedical_concept_uid": "BiomedicalConcept_125" + }, + { + "id": 220555, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_696", + "name": "LBFAST", + "label": "LBFAST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "boolean", + "code": "AliasCode_10244", + "biomedical_concept_uid": "BiomedicalConcept_125" + }, + { + "id": 220556, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_697", + "name": "LBDTC", + "label": "LBDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10245", + "biomedical_concept_uid": "BiomedicalConcept_125" + }, + { + "id": 220557, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_698", + "name": "ECTRT", + "label": "ECTRT", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10246", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220558, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_699", + "name": "ECREFID", + "label": "ECREFID", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10247", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220559, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_700", + "name": "ECDOSE", + "label": "ECDOSE", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "integer", + "code": "AliasCode_10248", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220560, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_701", + "name": "ECDOSTXT", + "label": "ECDOSTXT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10249", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220561, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_702", + "name": "ECDOSU", + "label": "ECDOSU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10250", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220562, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_703", + "name": "ECDOSFRM", + "label": "ECDOSFRM", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10251", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220563, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_704", + "name": "ECDOSFRQ", + "label": "ECDOSFRQ", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10252", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220564, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_705", + "name": "ECDOSRGM", + "label": "ECDOSRGM", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10253", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220565, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_706", + "name": "ECROUTE", + "label": "ECROUTE", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10254", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220566, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_707", + "name": "ECLOC", + "label": "ECLOC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10255", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220567, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_708", + "name": "ECLAT", + "label": "ECLAT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10256", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220568, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_709", + "name": "ECDIR", + "label": "ECDIR", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "string", + "code": "AliasCode_10257", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220569, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_710", + "name": "ECSTDTC", + "label": "ECSTDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10258", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220570, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_711", + "name": "ECENDTC", + "label": "ECENDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10259", + "biomedical_concept_uid": "BiomedicalConcept_126" + }, + { + "id": 220571, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_712", + "name": "AETERM", + "label": "AETERM", + "description": null, + "isRequired": 1, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10260", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220572, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_713", + "name": "AEDECOD", + "label": "AEDECOD", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10261", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220573, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_714", + "name": "AEPRESP", + "label": "AEPRESP", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10262", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220574, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_715", + "name": "AELOC", + "label": "AELOC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10263", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220575, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_716", + "name": "AESEV", + "label": "AESEV", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10264", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220576, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_717", + "name": "AESER", + "label": "AESER", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10265", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220577, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_718", + "name": "AEACN", + "label": "AEACN", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10266", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220578, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_719", + "name": "AEACNOTH", + "label": "AEACNOTH", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10267", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220579, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_720", + "name": "AEREL", + "label": "AEREL", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10268", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220580, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_721", + "name": "AERELNST", + "label": "AERELNST", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10269", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220581, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_722", + "name": "AEPATT", + "label": "AEPATT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10270", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220582, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_723", + "name": "AEOUT", + "label": "AEOUT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10271", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220583, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_724", + "name": "AESCAN", + "label": "AESCAN", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10272", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220584, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_725", + "name": "AESCONG", + "label": "AESCONG", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10273", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220585, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_726", + "name": "AESDISAB", + "label": "AESDISAB", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10274", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220586, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_727", + "name": "AESDTH", + "label": "AESDTH", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10275", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220587, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_728", + "name": "AESHOSP", + "label": "AESHOSP", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10276", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220588, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_729", + "name": "AESLIFE", + "label": "AESLIFE", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10277", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220589, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_730", + "name": "AESOD", + "label": "AESOD", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10278", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220590, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_731", + "name": "AESMIE", + "label": "AESMIE", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10279", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220591, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_732", + "name": "AECONTRT", + "label": "AECONTRT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10280", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220592, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_733", + "name": "AETOXGR", + "label": "AETOXGR", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10281", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220593, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_734", + "name": "AESTDTC", + "label": "AESTDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10282", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220594, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_735", + "name": "AEENDTC", + "label": "AEENDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10283", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220595, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_736", + "name": "AEENRF", + "label": "AEENRF", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10284", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220596, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_737", + "name": "AEENRTPT", + "label": "AEENRTPT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10285", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220597, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_738", + "name": "AEENTPT", + "label": "AEENTPT", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10286", + "biomedical_concept_uid": "BiomedicalConcept_127" + }, + { + "id": 220598, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_739", + "name": "VSORRES", + "label": "VSORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10287", + "biomedical_concept_uid": "BiomedicalConcept_128" + }, + { + "id": 220599, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_740", + "name": "VSORRESU", + "label": "VSORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10288", + "biomedical_concept_uid": "BiomedicalConcept_128" + }, + { + "id": 220600, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_741", + "name": "VSDTC", + "label": "VSDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10289", + "biomedical_concept_uid": "BiomedicalConcept_128" + }, + { + "id": 220601, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_742", + "name": "REORRES", + "label": "REORRES", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "float", + "code": "AliasCode_10290", + "biomedical_concept_uid": "BiomedicalConcept_129" + }, + { + "id": 220602, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_743", + "name": "REORRESU", + "label": "REORRESU", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "text", + "code": "AliasCode_10291", + "biomedical_concept_uid": "BiomedicalConcept_129" + }, + { + "id": 220603, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_744", + "name": "REDTC", + "label": "REDTC", + "description": null, + "isRequired": 0, + "isEnabled": 1, + "datatype": "datetime", + "code": "AliasCode_10292", + "biomedical_concept_uid": "BiomedicalConcept_129" + } + ], + "bcp_response_code": [ + { + "id": 16019, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_227", + "response_code_uid": "ResponseCode_40", + "name": "INFORMED CONSENT OBTAINED", + "label": "INFORMED CONSENT OBTAINED", + "is_enabled": 1, + "code": "AliasCode_9624" + }, + { + "id": 16020, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_239", + "response_code_uid": "ResponseCode_41", + "name": "ELIGIBILITY CRITERIA MET", + "label": "ELIGIBILITY CRITERIA MET", + "is_enabled": 1, + "code": "AliasCode_9637" + }, + { + "id": 16021, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_253", + "response_code_uid": "ResponseCode_42", + "name": "mmHg", + "label": "mmHg", + "is_enabled": 1, + "code": "AliasCode_9652" + }, + { + "id": 16022, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_259", + "response_code_uid": "ResponseCode_43", + "name": "mmHg", + "label": "mmHg", + "is_enabled": 1, + "code": "AliasCode_9659" + }, + { + "id": 16023, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_265", + "response_code_uid": "ResponseCode_44", + "name": "beats/min", + "label": "beats/min", + "is_enabled": 1, + "code": "AliasCode_9666" + }, + { + "id": 16024, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_279", + "response_code_uid": "ResponseCode_45", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9681" + }, + { + "id": 16025, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_284", + "response_code_uid": "ResponseCode_46", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9687" + }, + { + "id": 16026, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_289", + "response_code_uid": "ResponseCode_47", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9693" + }, + { + "id": 16027, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_294", + "response_code_uid": "ResponseCode_48", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9699" + }, + { + "id": 16028, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_299", + "response_code_uid": "ResponseCode_49", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9705" + }, + { + "id": 16032, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_335", + "response_code_uid": "ResponseCode_53", + "name": "RANDOM", + "label": "RANDOM", + "is_enabled": 1, + "code": "AliasCode_9745" + }, + { + "id": 16033, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_336", + "response_code_uid": "ResponseCode_54", + "name": "Trial is Randomized", + "label": "Trial is Randomized", + "is_enabled": 1, + "code": "AliasCode_9747" + }, + { + "id": 16034, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_342", + "response_code_uid": "ResponseCode_55", + "name": "s", + "label": "s", + "is_enabled": 1, + "code": "AliasCode_9754" + }, + { + "id": 16035, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_343", + "response_code_uid": "ResponseCode_56", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9756" + }, + { + "id": 16036, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_347", + "response_code_uid": "ResponseCode_57", + "name": "RATIO", + "label": "RATIO", + "is_enabled": 1, + "code": "AliasCode_9761" + }, + { + "id": 16037, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_348", + "response_code_uid": "ResponseCode_58", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9763" + }, + { + "id": 16038, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_351", + "response_code_uid": "ResponseCode_59", + "name": "s", + "label": "s", + "is_enabled": 1, + "code": "AliasCode_9767" + }, + { + "id": 16039, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_352", + "response_code_uid": "ResponseCode_60", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9769" + }, + { + "id": 16040, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_356", + "response_code_uid": "ResponseCode_61", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9774" + }, + { + "id": 16041, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_362", + "response_code_uid": "ResponseCode_62", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9781" + }, + { + "id": 16042, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_367", + "response_code_uid": "ResponseCode_63", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9787" + }, + { + "id": 16043, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_372", + "response_code_uid": "ResponseCode_64", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9793" + }, + { + "id": 16044, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_377", + "response_code_uid": "ResponseCode_65", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9799" + }, + { + "id": 16045, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_382", + "response_code_uid": "ResponseCode_66", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9805" + }, + { + "id": 16046, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_387", + "response_code_uid": "ResponseCode_67", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9811" + }, + { + "id": 16047, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_392", + "response_code_uid": "ResponseCode_68", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9817" + }, + { + "id": 16048, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_397", + "response_code_uid": "ResponseCode_69", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9823" + }, + { + "id": 16049, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_402", + "response_code_uid": "ResponseCode_70", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9829" + }, + { + "id": 16050, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_407", + "response_code_uid": "ResponseCode_71", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9835" + }, + { + "id": 16051, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_412", + "response_code_uid": "ResponseCode_72", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9841" + }, + { + "id": 16052, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_417", + "response_code_uid": "ResponseCode_73", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_9847" + }, + { + "id": 16053, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_422", + "response_code_uid": "ResponseCode_74", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9853" + }, + { + "id": 16054, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_427", + "response_code_uid": "ResponseCode_75", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9859" + }, + { + "id": 16055, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_432", + "response_code_uid": "ResponseCode_76", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9865" + }, + { + "id": 16056, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_437", + "response_code_uid": "ResponseCode_77", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_9871" + }, + { + "id": 16058, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_482", + "response_code_uid": "ResponseCode_78", + "name": "TARGET", + "label": "TARGET", + "is_enabled": 1, + "code": "AliasCode_9975" + }, + { + "id": 16059, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_542", + "response_code_uid": "ResponseCode_79", + "name": "URINE", + "label": "URINE", + "is_enabled": 1, + "code": "AliasCode_10039" + }, + { + "id": 16060, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_546", + "response_code_uid": "ResponseCode_80", + "name": "URINE", + "label": "URINE", + "is_enabled": 1, + "code": "AliasCode_10044" + }, + { + "id": 16061, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_549", + "response_code_uid": "ResponseCode_81", + "name": "URINE", + "label": "URINE", + "is_enabled": 1, + "code": "AliasCode_10048" + }, + { + "id": 16062, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_586", + "response_code_uid": "ResponseCode_82", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_10110" + }, + { + "id": 16063, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_591", + "response_code_uid": "ResponseCode_83", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_10116" + }, + { + "id": 16064, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_596", + "response_code_uid": "ResponseCode_84", + "name": "ERYTHROCYTES", + "label": "ERYTHROCYTES", + "is_enabled": 1, + "code": "AliasCode_10122" + }, + { + "id": 16065, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_601", + "response_code_uid": "ResponseCode_85", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_10128" + }, + { + "id": 16066, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_606", + "response_code_uid": "ResponseCode_86", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_10134" + }, + { + "id": 16067, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_610", + "response_code_uid": "ResponseCode_87", + "name": "10^9/L", + "label": "10^9/L", + "is_enabled": 1, + "code": "AliasCode_10139" + }, + { + "id": 16068, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_611", + "response_code_uid": "ResponseCode_88", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_10141" + }, + { + "id": 16069, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_616", + "response_code_uid": "ResponseCode_89", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_10147" + }, + { + "id": 16070, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_621", + "response_code_uid": "ResponseCode_90", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_10153" + }, + { + "id": 16071, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_625", + "response_code_uid": "ResponseCode_91", + "name": "10^6/L", + "label": "10^6/L", + "is_enabled": 1, + "code": "AliasCode_10158" + }, + { + "id": 16072, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_626", + "response_code_uid": "ResponseCode_92", + "name": "BLOOD", + "label": "BLOOD", + "is_enabled": 1, + "code": "AliasCode_10160" + }, + { + "id": 16073, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_661", + "response_code_uid": "ResponseCode_93", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_10196" + }, + { + "id": 16074, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_673", + "response_code_uid": "ResponseCode_94", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_10209" + }, + { + "id": 16075, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_679", + "response_code_uid": "ResponseCode_95", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_10216" + }, + { + "id": 16076, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_683", + "response_code_uid": "ResponseCode_96", + "name": "fL", + "label": "fL", + "is_enabled": 1, + "code": "AliasCode_10221" + }, + { + "id": 16077, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_684", + "response_code_uid": "ResponseCode_97", + "name": "ERYTHROCYTES", + "label": "ERYTHROCYTES", + "is_enabled": 1, + "code": "AliasCode_10223" + }, + { + "id": 16078, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_691", + "response_code_uid": "ResponseCode_98", + "name": "DIAGNOSIS", + "label": "DIAGNOSIS", + "is_enabled": 1, + "code": "AliasCode_10238" + }, + { + "id": 16079, + "soa_id": 60, + "biomedical_concept_property_uid": "BiomedicalConceptProperty_695", + "response_code_uid": "ResponseCode_99", + "name": "SERUM OR PLASMA", + "label": "SERUM OR PLASMA", + "is_enabled": 1, + "code": "AliasCode_10243" + } + ], + "biomedical_concept_surrogate": [ + { + "id": 1, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_1", + "name": "Magnesium Measurement", + "label": "Magnesium Measurement (C64840)", + "description": "A quantitative measurement of the amount of magnesium present in a sample.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64840", + "concept_group_uid": null + }, + { + "id": 2, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_2", + "name": "Hepatitis B DNA Measurement", + "label": "Hepatitis B DNA Measurement (C103404)", + "description": "A measurement of the Hepatitis B virus DNA in a biological specimen", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C103404", + "concept_group_uid": null + }, + { + "id": 3, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_3", + "name": "Hepatitis B Surface Antigen", + "label": "Hepatitis B Virus Surface Antigen Measurement (C64850)", + "description": "A measurement of the surface antigen reaction of a biological specimen to the Hepatitis B virus.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C64850", + "concept_group_uid": null + }, + { + "id": 4, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_4", + "name": "HBsAb+", + "label": "Hepatitis B Surface Antibody Positive (C153243)", + "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have been detected in a sample.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153243", + "concept_group_uid": null + }, + { + "id": 5, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_5", + "name": "HBsAb-", + "label": "Hepatitis B Surface Antibody Negative (C153244)", + "description": "An indication that antibodies that recognize a hepatitis B virus surface protein have not been detected in a sample.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C153244", + "concept_group_uid": null + }, + { + "id": 6, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_6", + "name": "HCV RNA Positive", + "label": "HCV RNA Positive (C162042)", + "description": "An indication that hepatitis C RNA has been detected in a sample.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C162042", + "concept_group_uid": null + }, + { + "id": 7, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_7", + "name": "PFTs with DLCO", + "label": "Pulmonary function tests (PFTs) that include DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) (C38081)", + "description": "A broad range of tests that are performed to assess how well lungs inhale and exhale air and how efficiently they transfer oxygen into the blood.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38081", + "concept_group_uid": null + }, + { + "id": 8, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_8", + "name": "Dietary Phosphorus Measurement", + "label": "Dietary Phosphorus Measurement (C184481)", + "description": "A determination of the phosphorus in a nutritional product or meal, or a portion thereof.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C184481", + "concept_group_uid": null + }, + { + "id": 19, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_19", + "name": "Adherence", + "label": "Adherence (C25729)", + "description": "The act of abiding by a stated treatment plan or protocol.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C25729", + "concept_group_uid": null + }, + { + "id": 20, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_20", + "name": "Patient Compliance", + "label": "Patient Compliance (C39490)", + "description": "The extent to which a patient conforms to medical advice regarding prescribed regimen, lifestyle, dietary changes, follow-up schedule and other recommendations.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C39490", + "concept_group_uid": null + }, + { + "id": 21, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_21", + "name": "Compliance Monitoring", + "label": "Compliance Monitoring (C62737)", + "description": "The act of continuously assessing whether an individual is adhering to their treatment plan.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C62737", + "concept_group_uid": null + }, + { + "id": 22, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_22", + "name": "Non-Compliance With Study Drug", + "label": "Non-Compliance With Study Drug (C49631)", + "description": "An indication that a subject has not agreed with or followed the instructions related to the study medication. (NCI)", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C49631", + "concept_group_uid": null + }, + { + "id": 23, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_23", + "name": "Non-Compliance with Study Product", + "label": "Non-Compliance with Study Product (C210354)", + "description": "An indication that a subject has not agreed with or followed the instructions related to the study product.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C210354", + "concept_group_uid": null + }, + { + "id": 24, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_24", + "name": "Trial Compliance", + "label": "Trial Compliance (C142734)", + "description": "Adherence to clinical trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. (ICH)", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C142734", + "concept_group_uid": null + }, + { + "id": 41, + "soa_id": 60, + "surrogate_uid": "BiomedicalConceptSurrogate_25", + "name": "DLCO", + "label": "DLCO (C38083)", + "description": "The volume of the carbon monoxide that is transferred from inspired air into the pulmonary capillary blood.", + "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C38083", + "concept_group_uid": null + } + ], + "activity_concept": [ + { + "id": 491, + "activity_id": 138, + "concept_code": "C16735", + "concept_title": "Informed Consent", + "concept_uid": "BiomedicalConcept_1", + "activity_uid": "Activity_1", + "soa_id": 60, + "href": null, + "dss_title": "CONSENT", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CONSENT", + "dss_domain": "DS", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 492, + "activity_id": 139, + "concept_code": "C132447", + "concept_title": "Eligibility Criteria Met By Subject", + "concept_uid": "BiomedicalConcept_2", + "activity_uid": "Activity_2", + "soa_id": 60, + "href": null, + "dss_title": "ELIGMET", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ELIGMET", + "dss_domain": "DS", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 495, + "activity_id": 141, + "concept_code": "C102408", + "concept_title": "ECOG - Performance Status", + "concept_uid": "BiomedicalConcept_5", + "activity_uid": "Activity_4", + "soa_id": 60, + "href": null, + "dss_title": "ECOG101", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ECOG101", + "dss_domain": "RS", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 497, + "activity_id": 143, + "concept_code": "C25298", + "concept_title": "Systolic Blood Pressure", + "concept_uid": "BiomedicalConcept_7", + "activity_uid": "Activity_6", + "soa_id": 60, + "href": null, + "dss_title": "SYSBP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SYSBP", + "dss_domain": "VS", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 498, + "activity_id": 143, + "concept_code": "C25299", + "concept_title": "Diastolic Blood Pressure", + "concept_uid": "BiomedicalConcept_8", + "activity_uid": "Activity_6", + "soa_id": 60, + "href": null, + "dss_title": "DIABP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/DIABP", + "dss_domain": "VS", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 499, + "activity_id": 143, + "concept_code": "C49677", + "concept_title": "Heart Rate", + "concept_uid": "BiomedicalConcept_9", + "activity_uid": "Activity_6", + "soa_id": 60, + "href": null, + "dss_title": "HR", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HR", + "dss_domain": "VS", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 500, + "activity_id": 143, + "concept_code": "C174446", + "concept_title": "Body Temperature", + "concept_uid": "BiomedicalConcept_10", + "activity_uid": "Activity_6", + "soa_id": 60, + "href": null, + "dss_title": "TEMP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TEMP", + "dss_domain": "VS", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 501, + "activity_id": 143, + "concept_code": "C81328", + "concept_title": "Body Weight", + "concept_uid": "BiomedicalConcept_11", + "activity_uid": "Activity_6", + "soa_id": 60, + "href": null, + "dss_title": "WEIGHT", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/WEIGHT", + "dss_domain": "VS", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 508, + "activity_id": 145, + "concept_code": "C64433", + "concept_title": "Alanine Aminotransferase Measurement", + "concept_uid": "BiomedicalConcept_18", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "ALTSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 509, + "activity_id": 145, + "concept_code": "C64467", + "concept_title": "Aspartate Aminotransferase Measurement", + "concept_uid": "BiomedicalConcept_19", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "ASTSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 510, + "activity_id": 145, + "concept_code": "C38037", + "concept_title": "Total Bilirubin Measurement", + "concept_uid": "BiomedicalConcept_20", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "BILISERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BILISERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 511, + "activity_id": 145, + "concept_code": "C64547", + "concept_title": "Creatinine Measurement", + "concept_uid": "BiomedicalConcept_21", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "CREATSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 512, + "activity_id": 145, + "concept_code": "C64431", + "concept_title": "Albumin Measurement", + "concept_uid": "BiomedicalConcept_22", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "ALBSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 540, + "activity_id": 155, + "concept_code": "C53630", + "concept_title": "Concomitant Therapy", + "concept_uid": "BiomedicalConcept_50", + "activity_uid": "Activity_18", + "soa_id": 60, + "href": null, + "dss_title": "CMFREE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CMFREE", + "dss_domain": "CM", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 541, + "activity_id": 156, + "concept_code": "C25196", + "concept_title": "Randomization", + "concept_uid": "BiomedicalConcept_51", + "activity_uid": "Activity_19", + "soa_id": 60, + "href": null, + "dss_title": "RANDOM", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RANDOM", + "dss_domain": "TS", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 545, + "activity_id": 160, + "concept_code": "C62656", + "concept_title": "Prothrombin Time", + "concept_uid": "BiomedicalConcept_52", + "activity_uid": "Activity_23", + "soa_id": 60, + "href": null, + "dss_title": "PTBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PTBLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 547, + "activity_id": 160, + "concept_code": "C64805", + "concept_title": "International Normalized Ratio of Prothrombin Time", + "concept_uid": "BiomedicalConcept_53", + "activity_uid": "Activity_23", + "soa_id": 60, + "href": null, + "dss_title": "INRBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/INRBLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 548, + "activity_id": 160, + "concept_code": "C38462", + "concept_title": "Activated Partial Thromboplastin Time", + "concept_uid": "BiomedicalConcept_54", + "activity_uid": "Activity_23", + "soa_id": 60, + "href": null, + "dss_title": "APTTBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/APTTBLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 549, + "activity_id": 162, + "concept_code": "C105585", + "concept_title": "Glucose Measurement", + "concept_uid": "BiomedicalConcept_55", + "activity_uid": "Activity_25", + "soa_id": 60, + "href": null, + "dss_title": "GLUCBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 550, + "activity_id": 163, + "concept_code": "C64812", + "concept_title": "Triglyceride Measurement", + "concept_uid": "BiomedicalConcept_56", + "activity_uid": "Activity_26", + "soa_id": 60, + "href": null, + "dss_title": "TRIGSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TRIGSERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 551, + "activity_id": 163, + "concept_code": "C105586", + "concept_title": "Cholesterol Measurement", + "concept_uid": "BiomedicalConcept_57", + "activity_uid": "Activity_26", + "soa_id": 60, + "href": null, + "dss_title": "CHOLSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 552, + "activity_id": 163, + "concept_code": "C105587", + "concept_title": "High Density Lipoprotein Cholesterol Measurement", + "concept_uid": "BiomedicalConcept_58", + "activity_uid": "Activity_26", + "soa_id": 60, + "href": null, + "dss_title": "HDLSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HDLSERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 553, + "activity_id": 163, + "concept_code": "C105588", + "concept_title": "Low Density Lipoprotein Cholesterol Measurement", + "concept_uid": "BiomedicalConcept_59", + "activity_uid": "Activity_26", + "soa_id": 60, + "href": null, + "dss_title": "LDLSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/LDLSERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 555, + "activity_id": 161, + "concept_code": "C51948", + "concept_title": "Leukocyte Count", + "concept_uid": "BiomedicalConcept_61", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": "WBCBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/WBCBLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 556, + "activity_id": 161, + "concept_code": "C51946", + "concept_title": "Erythrocyte Count", + "concept_uid": "BiomedicalConcept_62", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": "RBCBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RBCBLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 557, + "activity_id": 161, + "concept_code": "C51951", + "concept_title": "Platelet Count", + "concept_uid": "BiomedicalConcept_63", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": "PLATBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PLATBLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 558, + "activity_id": 145, + "concept_code": "C64853", + "concept_title": "Potassium Measurement", + "concept_uid": "BiomedicalConcept_64", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "KBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/KBLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 559, + "activity_id": 145, + "concept_code": "C64809", + "concept_title": "Sodium Measurement", + "concept_uid": "BiomedicalConcept_65", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "SODIUMBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 560, + "activity_id": 145, + "concept_code": "C64495", + "concept_title": "Chloride Measurement", + "concept_uid": "BiomedicalConcept_66", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "CLBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CLBLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 561, + "activity_id": 145, + "concept_code": "C64545", + "concept_title": "Carbon Dioxide Measurement", + "concept_uid": "BiomedicalConcept_67", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "CO2BLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CO2BLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 562, + "activity_id": 145, + "concept_code": "C64488", + "concept_title": "Calcium Measurement", + "concept_uid": "BiomedicalConcept_68", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "CABLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CABLD", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 563, + "activity_id": 145, + "concept_code": "C125949", + "concept_title": "Urea Nitrogen Measurement", + "concept_uid": "BiomedicalConcept_69", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "UREANSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 564, + "activity_id": 145, + "concept_code": "C64858", + "concept_title": "Total Protein Measurement", + "concept_uid": "BiomedicalConcept_70", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "PROTSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 565, + "activity_id": 145, + "concept_code": "C64432", + "concept_title": "Alkaline Phosphatase Measurement", + "concept_uid": "BiomedicalConcept_71", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "ALPSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 567, + "activity_id": 145, + "concept_code": "C64814", + "concept_title": "Urate Measurement", + "concept_uid": "BiomedicalConcept_72", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": "URATESERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/URATESERPL", + "dss_domain": "LB", + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1112, + "activity_id": 140, + "concept_code": "C200145", + "concept_title": "Solicited Medical History", + "concept_uid": "BiomedicalConcept_78", + "activity_uid": "Activity_3", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1114, + "activity_id": 140, + "concept_code": "C83119", + "concept_title": "Physical Examination Finding", + "concept_uid": "BiomedicalConcept_80", + "activity_uid": "Activity_3", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1115, + "activity_id": 154, + "concept_code": "C83119", + "concept_title": "Physical Examination Finding", + "concept_uid": "BiomedicalConcept_81", + "activity_uid": "Activity_17", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1116, + "activity_id": 159, + "concept_code": "C103420", + "concept_title": "New Lesion Progression", + "concept_uid": "BiomedicalConcept_82", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1117, + "activity_id": 159, + "concept_code": "C124448", + "concept_title": "Lymph Node State", + "concept_uid": "BiomedicalConcept_83", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1118, + "activity_id": 159, + "concept_code": "C161483", + "concept_title": "Non-Target Indicator", + "concept_uid": "BiomedicalConcept_84", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1119, + "activity_id": 159, + "concept_code": "C178053", + "concept_title": "Target Indicator", + "concept_uid": "BiomedicalConcept_85", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1120, + "activity_id": 159, + "concept_code": "C225437", + "concept_title": "Confluent Tumor Masses Assessment", + "concept_uid": "BiomedicalConcept_86", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1121, + "activity_id": 159, + "concept_code": "C225438", + "concept_title": "Tumor Fragmentation Assessment", + "concept_uid": "BiomedicalConcept_87", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1122, + "activity_id": 159, + "concept_code": "C94523", + "concept_title": "Tumor Identification", + "concept_uid": "BiomedicalConcept_88", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1123, + "activity_id": 159, + "concept_code": "C94534", + "concept_title": "Response in Target Lesion", + "concept_uid": "BiomedicalConcept_89", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1124, + "activity_id": 159, + "concept_code": "C94535", + "concept_title": "Response in Non-Target Lesion", + "concept_uid": "BiomedicalConcept_90", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1125, + "activity_id": 159, + "concept_code": "C94536", + "concept_title": "Best Overall Response", + "concept_uid": "BiomedicalConcept_91", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1126, + "activity_id": 159, + "concept_code": "C96613", + "concept_title": "Overall Response", + "concept_uid": "BiomedicalConcept_92", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1127, + "activity_id": 159, + "concept_code": "C96643", + "concept_title": "Tumor Status", + "concept_uid": "BiomedicalConcept_93", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1128, + "activity_id": 159, + "concept_code": "C96684", + "concept_title": "Longest Diameter", + "concept_uid": "BiomedicalConcept_94", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1129, + "activity_id": 159, + "concept_code": "C96685", + "concept_title": "Longest Perpendicular", + "concept_uid": "BiomedicalConcept_95", + "activity_uid": "Activity_22", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_recist_1_1", + "bc_category_name": null + }, + { + "id": 1130, + "activity_id": 147, + "concept_code": "C45997", + "concept_title": "pH", + "concept_uid": "BiomedicalConcept_96", + "activity_uid": "Activity_10", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_urinalysis", + "bc_category_name": null + }, + { + "id": 1131, + "activity_id": 147, + "concept_code": "C64546", + "concept_title": "Color Assessment", + "concept_uid": "BiomedicalConcept_97", + "activity_uid": "Activity_10", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_urinalysis", + "bc_category_name": null + }, + { + "id": 1132, + "activity_id": 147, + "concept_code": "C64832", + "concept_title": "Specific Gravity", + "concept_uid": "BiomedicalConcept_98", + "activity_uid": "Activity_10", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": "cdisc:concept_group:cg_urinalysis", + "bc_category_name": null + }, + { + "id": 1133, + "activity_id": 161, + "concept_code": "C64796", + "concept_title": "Hematocrit Measurement", + "concept_uid": "BiomedicalConcept_99", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1134, + "activity_id": 161, + "concept_code": "C64848", + "concept_title": "Hemoglobin Measurement", + "concept_uid": "BiomedicalConcept_100", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1135, + "activity_id": 161, + "concept_code": "C64797", + "concept_title": "Erythrocyte Mean Corpuscular Hemoglobin", + "concept_uid": "BiomedicalConcept_101", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1136, + "activity_id": 161, + "concept_code": "C51949", + "concept_title": "Lymphocyte Count", + "concept_uid": "BiomedicalConcept_102", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1137, + "activity_id": 161, + "concept_code": "C64823", + "concept_title": "Monocyte Count", + "concept_uid": "BiomedicalConcept_103", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1138, + "activity_id": 161, + "concept_code": "C63321", + "concept_title": "Absolute Neutrophil Count", + "concept_uid": "BiomedicalConcept_104", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1139, + "activity_id": 161, + "concept_code": "C64470", + "concept_title": "Absolute Basophil Count", + "concept_uid": "BiomedicalConcept_105", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1140, + "activity_id": 161, + "concept_code": "C64550", + "concept_title": "Eosinophil Count", + "concept_uid": "BiomedicalConcept_106", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1141, + "activity_id": 161, + "concept_code": "C64830", + "concept_title": "Neutrophil Band Form Count", + "concept_uid": "BiomedicalConcept_107", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1142, + "activity_id": 168, + "concept_code": "C111361", + "concept_title": "Forced Vital Capacity", + "concept_uid": "BiomedicalConcept_108", + "activity_uid": "Activity_31", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1143, + "activity_id": 168, + "concept_code": "C38084", + "concept_title": "Forced Expiratory Volume in 1 Second", + "concept_uid": "BiomedicalConcept_109", + "activity_uid": "Activity_31", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1144, + "activity_id": 168, + "concept_code": "C47843", + "concept_title": "Forced Expiratory Volume in 6 Seconds", + "concept_uid": "BiomedicalConcept_110", + "activity_uid": "Activity_31", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1145, + "activity_id": 168, + "concept_code": "C41372", + "concept_title": "Peak Expiratory Flow", + "concept_uid": "BiomedicalConcept_111", + "activity_uid": "Activity_31", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1146, + "activity_id": 168, + "concept_code": "C111324", + "concept_title": "Tidal Volume", + "concept_uid": "BiomedicalConcept_112", + "activity_uid": "Activity_31", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1147, + "activity_id": 168, + "concept_code": "C111362", + "concept_title": "Inspiratory Capacity", + "concept_uid": "BiomedicalConcept_113", + "activity_uid": "Activity_31", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1148, + "activity_id": 168, + "concept_code": "C111200", + "concept_title": "Expiratory Reserve Volume", + "concept_uid": "BiomedicalConcept_114", + "activity_uid": "Activity_31", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1149, + "activity_id": 168, + "concept_code": "C111237", + "concept_title": "Inspiratory Reserve Volume", + "concept_uid": "BiomedicalConcept_115", + "activity_uid": "Activity_31", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1150, + "activity_id": 168, + "concept_code": "C111315", + "concept_title": "Slow Vital Capacity", + "concept_uid": "BiomedicalConcept_116", + "activity_uid": "Activity_31", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1152, + "activity_id": 145, + "concept_code": "C64857", + "concept_title": "Phosphate Measurement", + "concept_uid": "BiomedicalConcept_118", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1153, + "activity_id": 164, + "concept_code": "C74711", + "concept_title": "Hepatitis B Surface Antibody Measurement", + "concept_uid": "BiomedicalConcept_119", + "activity_uid": "Activity_27", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1154, + "activity_id": 166, + "concept_code": "C142330", + "concept_title": "Hepatitis C Virus RNA Measurement", + "concept_uid": "BiomedicalConcept_120", + "activity_uid": "Activity_29", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1155, + "activity_id": 165, + "concept_code": "C103404", + "concept_title": "Hepatitis B DNA Measurement", + "concept_uid": "BiomedicalConcept_121", + "activity_uid": "Activity_28", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1156, + "activity_id": 161, + "concept_code": "C64799", + "concept_title": "Erythrocyte Mean Corpuscular Volume", + "concept_uid": "BiomedicalConcept_122", + "activity_uid": "Activity_24", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1158, + "activity_id": 142, + "concept_code": "C200145", + "concept_title": "Solicited Medical History", + "concept_uid": "BiomedicalConcept_124", + "activity_uid": "Activity_5", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1159, + "activity_id": 145, + "concept_code": "C64840", + "concept_title": "Magnesium Measurement", + "concept_uid": "BiomedicalConcept_125", + "activity_uid": "Activity_8", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1160, + "activity_id": 167, + "concept_code": "C117466", + "concept_title": "Exposure as Collected Domain", + "concept_uid": "BiomedicalConcept_126", + "activity_uid": "Activity_30", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1161, + "activity_id": 154, + "concept_code": "C179175", + "concept_title": "Solicited Adverse Event", + "concept_uid": "BiomedicalConcept_127", + "activity_uid": "Activity_17", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1162, + "activity_id": 143, + "concept_code": "C164634", + "concept_title": "Body Height", + "concept_uid": "BiomedicalConcept_128", + "activity_uid": "Activity_6", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + }, + { + "id": 1163, + "activity_id": 168, + "concept_code": "C38083", + "concept_title": "Carbon Monoxide Diffusing Capability Test", + "concept_uid": "BiomedicalConcept_129", + "activity_uid": "Activity_31", + "soa_id": 60, + "href": null, + "dss_title": null, + "dss_href": null, + "dss_domain": null, + "concept_group_uid": null, + "bc_category_name": null + } + ], + "activity_concept_dss": [ + { + "id": 181, + "soa_id": 60, + "activity_id": 138, + "concept_code": "C16735", + "dss_title": "CONSENT", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CONSENT", + "dss_domain": "DS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_1" + }, + { + "id": 182, + "soa_id": 60, + "activity_id": 139, + "concept_code": "C132447", + "dss_title": "ELIGMET", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ELIGMET", + "dss_domain": "DS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_2" + }, + { + "id": 183, + "soa_id": 60, + "activity_id": 141, + "concept_code": "C102408", + "dss_title": "ECOG101", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ECOG101", + "dss_domain": "RS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_3" + }, + { + "id": 184, + "soa_id": 60, + "activity_id": 143, + "concept_code": "C25298", + "dss_title": "SYSBP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SYSBP", + "dss_domain": "VS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_4" + }, + { + "id": 185, + "soa_id": 60, + "activity_id": 143, + "concept_code": "C25299", + "dss_title": "DIABP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/DIABP", + "dss_domain": "VS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_5" + }, + { + "id": 186, + "soa_id": 60, + "activity_id": 143, + "concept_code": "C49677", + "dss_title": "HR", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HR", + "dss_domain": "VS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_6" + }, + { + "id": 187, + "soa_id": 60, + "activity_id": 143, + "concept_code": "C174446", + "dss_title": "TEMP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TEMP", + "dss_domain": "VS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_7" + }, + { + "id": 188, + "soa_id": 60, + "activity_id": 143, + "concept_code": "C81328", + "dss_title": "WEIGHT", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/WEIGHT", + "dss_domain": "VS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_8" + }, + { + "id": 189, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64433", + "dss_title": "ALTSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALTSERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_9" + }, + { + "id": 190, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64467", + "dss_title": "ASTSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ASTSERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_10" + }, + { + "id": 191, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C38037", + "dss_title": "BILISERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BILISERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_11" + }, + { + "id": 192, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64547", + "dss_title": "CREATSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CREATSERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_12" + }, + { + "id": 193, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64431", + "dss_title": "ALBSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALBSERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_13" + }, + { + "id": 194, + "soa_id": 60, + "activity_id": 147, + "concept_code": "C45997", + "dss_title": "PHURIN", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PHURIN", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_14" + }, + { + "id": 195, + "soa_id": 60, + "activity_id": 147, + "concept_code": "C64546", + "dss_title": "COLORURIN", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/COLORURIN", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_15" + }, + { + "id": 196, + "soa_id": 60, + "activity_id": 147, + "concept_code": "C64832", + "dss_title": "SPGRAVURIN", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SPGRAVURIN", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_16" + }, + { + "id": 197, + "soa_id": 60, + "activity_id": 154, + "concept_code": "C41331", + "dss_title": "ADVEVENT", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ADVEVENT", + "dss_domain": "DS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_17" + }, + { + "id": 199, + "soa_id": 60, + "activity_id": 156, + "concept_code": "C25196", + "dss_title": "RANDOM", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RANDOM", + "dss_domain": "TS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_19" + }, + { + "id": 200, + "soa_id": 60, + "activity_id": 160, + "concept_code": "C62656", + "dss_title": "PTBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PTBLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_20" + }, + { + "id": 201, + "soa_id": 60, + "activity_id": 160, + "concept_code": "C64805", + "dss_title": "INRBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/INRBLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_21" + }, + { + "id": 202, + "soa_id": 60, + "activity_id": 160, + "concept_code": "C38462", + "dss_title": "APTTBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/APTTBLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_22" + }, + { + "id": 203, + "soa_id": 60, + "activity_id": 162, + "concept_code": "C105585", + "dss_title": "GLUCBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/GLUCBLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_23" + }, + { + "id": 204, + "soa_id": 60, + "activity_id": 163, + "concept_code": "C64812", + "dss_title": "TRIGSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TRIGSERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_24" + }, + { + "id": 205, + "soa_id": 60, + "activity_id": 163, + "concept_code": "C105586", + "dss_title": "CHOLSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CHOLSERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_25" + }, + { + "id": 206, + "soa_id": 60, + "activity_id": 163, + "concept_code": "C105587", + "dss_title": "HDLSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HDLSERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_26" + }, + { + "id": 207, + "soa_id": 60, + "activity_id": 163, + "concept_code": "C105588", + "dss_title": "LDLSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/LDLSERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_27" + }, + { + "id": 208, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C51948", + "dss_title": "WBCBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/WBCBLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_28" + }, + { + "id": 209, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C51946", + "dss_title": "RBCBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/RBCBLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_29" + }, + { + "id": 210, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C51951", + "dss_title": "PLATBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PLATBLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_30" + }, + { + "id": 211, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64853", + "dss_title": "KBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/KBLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_31" + }, + { + "id": 212, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64809", + "dss_title": "SODIUMBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SODIUMBLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_32" + }, + { + "id": 213, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64495", + "dss_title": "CLBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CLBLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_33" + }, + { + "id": 214, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64545", + "dss_title": "CO2BLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CO2BLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_34" + }, + { + "id": 215, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64488", + "dss_title": "CABLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CABLD", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_35" + }, + { + "id": 216, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C125949", + "dss_title": "UREANSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/UREANSERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_36" + }, + { + "id": 217, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64858", + "dss_title": "PROTSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PROTSERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_37" + }, + { + "id": 218, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64432", + "dss_title": "ALPSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ALPSERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_38" + }, + { + "id": 219, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64814", + "dss_title": "URATESERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/URATESERPL", + "dss_domain": "LB", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_39" + }, + { + "id": 221, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C94535", + "dss_title": "NTRGRESP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NTRGRESP", + "dss_domain": "RS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_41" + }, + { + "id": 222, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C94534", + "dss_title": "TRGRESP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TRGRESP", + "dss_domain": "RS", + "dss_display": null, + "extension_attribute_uid": "ExtensionAttribute_42" + }, + { + "id": 331, + "soa_id": 60, + "activity_id": 140, + "concept_code": "C200145", + "dss_title": "MEDHISTFREE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MEDHISTFREE", + "dss_domain": null, + "dss_display": "Medical History Free Text Format", + "extension_attribute_uid": "ExtensionAttribute_43" + }, + { + "id": 332, + "soa_id": 60, + "activity_id": 155, + "concept_code": "C53630", + "dss_title": "CMPRESP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CMPRESP", + "dss_domain": null, + "dss_display": "Concomitant Medication Prespecified", + "extension_attribute_uid": "ExtensionAttribute_44" + }, + { + "id": 333, + "soa_id": 60, + "activity_id": 155, + "concept_code": "C53630", + "dss_title": "CMPRIORBREASTCANCER", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CMPRIORBREASTCANCER", + "dss_domain": null, + "dss_display": "Concomitant Therapy Breast Cancer Prior Treatment", + "extension_attribute_uid": "ExtensionAttribute_45" + }, + { + "id": 334, + "soa_id": 60, + "activity_id": 155, + "concept_code": "C53630", + "dss_title": "CMPRIORCANCER", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CMPRIORCANCER", + "dss_domain": null, + "dss_display": "Prior Anti-Cancer Therapy", + "extension_attribute_uid": "ExtensionAttribute_46" + }, + { + "id": 335, + "soa_id": 60, + "activity_id": 155, + "concept_code": "C53630", + "dss_title": "CMFREE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/CMFREE", + "dss_domain": null, + "dss_display": "Concomitant Medication Free Text Format", + "extension_attribute_uid": "ExtensionAttribute_47" + }, + { + "id": 336, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C103420", + "dss_title": "NEWLPROG", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NEWLPROG", + "dss_domain": null, + "dss_display": "New Lesion Progression (RECIST 1.1)", + "extension_attribute_uid": "ExtensionAttribute_48" + }, + { + "id": 337, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C124448", + "dss_title": "LNSTATE_RECIST1_1", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/LNSTATE_RECIST1_1", + "dss_domain": null, + "dss_display": "Lymph Node State (RECIST 1.1 Classification)", + "extension_attribute_uid": "ExtensionAttribute_49" + }, + { + "id": 338, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C161483", + "dss_title": "NTIND_RECIST1_1", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NTIND_RECIST1_1", + "dss_domain": null, + "dss_display": "Non-Target Indicator (RECIST 1.1 Classification)", + "extension_attribute_uid": "ExtensionAttribute_50" + }, + { + "id": 339, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C178053", + "dss_title": "TIND_RECIST1_1", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TIND_RECIST1_1", + "dss_domain": null, + "dss_display": "Target Indicator (RECIST 1.1 Classification)", + "extension_attribute_uid": "ExtensionAttribute_51" + }, + { + "id": 340, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C225437", + "dss_title": "TUMERGE_RECIST1_1", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TUMERGE_RECIST1_1", + "dss_domain": null, + "dss_display": "Tumor Merged (RECIST 1.1 Classification)", + "extension_attribute_uid": "ExtensionAttribute_52" + }, + { + "id": 341, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C225438", + "dss_title": "TUSPLIT_RECIST1_1", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TUSPLIT_RECIST1_1", + "dss_domain": null, + "dss_display": "Tumor Split (RECIST 1.1 Classification)", + "extension_attribute_uid": "ExtensionAttribute_53" + }, + { + "id": 342, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C94523", + "dss_title": "TUMIDENT_RECIST1_1", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TUMIDENT_RECIST1_1", + "dss_domain": null, + "dss_display": "Tumor Identification (RECIST 1.1 Classification)", + "extension_attribute_uid": "ExtensionAttribute_54" + }, + { + "id": 343, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C94536", + "dss_title": "BESTRESP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BESTRESP", + "dss_domain": null, + "dss_display": "Best Overall Response (RECIST 1.1)", + "extension_attribute_uid": "ExtensionAttribute_55" + }, + { + "id": 345, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C96643", + "dss_title": "NEW_TUMSTATE_RECIST1_1", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NEW_TUMSTATE_RECIST1_1", + "dss_domain": null, + "dss_display": "New Tumor State (RECIST 1.1 Classification)", + "extension_attribute_uid": "ExtensionAttribute_57" + }, + { + "id": 346, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C96684", + "dss_title": "LDIAM_RECIST1_1", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/LDIAM_RECIST1_1", + "dss_domain": null, + "dss_display": "Longest Diameter (RECIST 1.1 Classification)", + "extension_attribute_uid": "ExtensionAttribute_58" + }, + { + "id": 347, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C96685", + "dss_title": "LPERP_RECIST1_1", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/LPERP_RECIST1_1", + "dss_domain": null, + "dss_display": "Longest Perpendicular (RECIST 1.1 Classification)", + "extension_attribute_uid": "ExtensionAttribute_59" + }, + { + "id": 348, + "soa_id": 60, + "activity_id": 140, + "concept_code": "C200145", + "dss_title": "MHBRCADIAG", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MHBRCADIAG", + "dss_domain": null, + "dss_display": "Medical History Prespecified: Breast Cancer Diagnosis", + "extension_attribute_uid": "ExtensionAttribute_60" + }, + { + "id": 349, + "soa_id": 60, + "activity_id": 140, + "concept_code": "C200145", + "dss_title": "MHBRCARELAPSE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MHBRCARELAPSE", + "dss_domain": null, + "dss_display": "Medical History Prespecified: Breast Cancer Disease Relapse", + "extension_attribute_uid": "ExtensionAttribute_61" + }, + { + "id": 350, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C64796", + "dss_title": "HCTBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HCTBLD", + "dss_domain": null, + "dss_display": "Hematocrit of Blood", + "extension_attribute_uid": "ExtensionAttribute_62" + }, + { + "id": 351, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C64848", + "dss_title": "HGBBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HGBBLD", + "dss_domain": null, + "dss_display": "Hemoglobin Concentration in Blood", + "extension_attribute_uid": "ExtensionAttribute_63" + }, + { + "id": 352, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C64797", + "dss_title": "MCH", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MCH", + "dss_domain": null, + "dss_display": "Erythrocyte Mean Corpuscular Hemoglobin", + "extension_attribute_uid": "ExtensionAttribute_64" + }, + { + "id": 353, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C51949", + "dss_title": "LYMPHBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/LYMPHBLD", + "dss_domain": null, + "dss_display": "Lymphocyte Count in Blood", + "extension_attribute_uid": "ExtensionAttribute_65" + }, + { + "id": 354, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C64823", + "dss_title": "MONOBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MONOBLD", + "dss_domain": null, + "dss_display": "Monocyte Count in Blood", + "extension_attribute_uid": "ExtensionAttribute_66" + }, + { + "id": 355, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C63321", + "dss_title": "NEUTBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NEUTBLD", + "dss_domain": null, + "dss_display": "Neutrophils in Blood", + "extension_attribute_uid": "ExtensionAttribute_67" + }, + { + "id": 356, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C64470", + "dss_title": "BASOBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/BASOBLD", + "dss_domain": null, + "dss_display": "Basophil Count in Blood", + "extension_attribute_uid": "ExtensionAttribute_68" + }, + { + "id": 357, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C64550", + "dss_title": "EOSBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EOSBLD", + "dss_domain": null, + "dss_display": "Eosinophil Count in Blood", + "extension_attribute_uid": "ExtensionAttribute_69" + }, + { + "id": 358, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C64830", + "dss_title": "NEUTBBLD", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/NEUTBBLD", + "dss_domain": null, + "dss_display": "Neutrophils Band Form in Blood", + "extension_attribute_uid": "ExtensionAttribute_70" + }, + { + "id": 359, + "soa_id": 60, + "activity_id": 161, + "concept_code": "C64799", + "dss_title": "MCV", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MCV", + "dss_domain": null, + "dss_display": "Erythrocyte Mean Corpuscular Volume", + "extension_attribute_uid": "ExtensionAttribute_71" + }, + { + "id": 360, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64857", + "dss_title": "PHOSSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PHOSSERPL", + "dss_domain": null, + "dss_display": "Phosphate Concentration in Serum or Plasma", + "extension_attribute_uid": "ExtensionAttribute_72" + }, + { + "id": 361, + "soa_id": 60, + "activity_id": 165, + "concept_code": "C103404", + "dss_title": "HBDNASERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HBDNASERPL", + "dss_domain": null, + "dss_display": "Hepatitis B Virus DNA Concentration in Serum or Plasma", + "extension_attribute_uid": "ExtensionAttribute_73" + }, + { + "id": 362, + "soa_id": 60, + "activity_id": 166, + "concept_code": "C142330", + "dss_title": "HCRNASERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HCRNASERPL", + "dss_domain": null, + "dss_display": "Hepatitis C Virus RNA Concentration in Serum or Plasma", + "extension_attribute_uid": "ExtensionAttribute_74" + }, + { + "id": 363, + "soa_id": 60, + "activity_id": 168, + "concept_code": "C111361", + "dss_title": "FVC_RE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/FVC_RE", + "dss_domain": null, + "dss_display": "Forced Vital Capacity (RE)", + "extension_attribute_uid": "ExtensionAttribute_75" + }, + { + "id": 364, + "soa_id": 60, + "activity_id": 168, + "concept_code": "C38084", + "dss_title": "FEV1_RE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/FEV1_RE", + "dss_domain": null, + "dss_display": "Forced Expiratory Volume in 1 Second (RE)", + "extension_attribute_uid": "ExtensionAttribute_76" + }, + { + "id": 365, + "soa_id": 60, + "activity_id": 168, + "concept_code": "C47843", + "dss_title": "FEV6_RE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/FEV6_RE", + "dss_domain": null, + "dss_display": "Forced Expiratory Volume in 6 Seconds (RE)", + "extension_attribute_uid": "ExtensionAttribute_77" + }, + { + "id": 366, + "soa_id": 60, + "activity_id": 168, + "concept_code": "C41372", + "dss_title": "PEF_RE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/PEF_RE", + "dss_domain": null, + "dss_display": "Peak Expiratory Flow (RE)", + "extension_attribute_uid": "ExtensionAttribute_78" + }, + { + "id": 367, + "soa_id": 60, + "activity_id": 168, + "concept_code": "C111324", + "dss_title": "TV_RE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/TV_RE", + "dss_domain": null, + "dss_display": "Tidal Volume (RE)", + "extension_attribute_uid": "ExtensionAttribute_79" + }, + { + "id": 368, + "soa_id": 60, + "activity_id": 168, + "concept_code": "C111362", + "dss_title": "IC_RE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/IC_RE", + "dss_domain": null, + "dss_display": "Inspiratory Capacity (RE)", + "extension_attribute_uid": "ExtensionAttribute_80" + }, + { + "id": 369, + "soa_id": 60, + "activity_id": 168, + "concept_code": "C111200", + "dss_title": "ERV_RE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/ERV_RE", + "dss_domain": null, + "dss_display": "Expiratory Reserve Volume (RE)", + "extension_attribute_uid": "ExtensionAttribute_81" + }, + { + "id": 370, + "soa_id": 60, + "activity_id": 168, + "concept_code": "C111237", + "dss_title": "IRV_RE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/IRV_RE", + "dss_domain": null, + "dss_display": "Inspiratory Reserve Volume (RE)", + "extension_attribute_uid": "ExtensionAttribute_82" + }, + { + "id": 371, + "soa_id": 60, + "activity_id": 168, + "concept_code": "C111315", + "dss_title": "SVC_RE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/SVC_RE", + "dss_domain": null, + "dss_display": "Slow Vital Capacity (RE)", + "extension_attribute_uid": "ExtensionAttribute_83" + }, + { + "id": 372, + "soa_id": 60, + "activity_id": 168, + "concept_code": "C120830", + "dss_title": "DLCOVA_RE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/DLCOVA_RE", + "dss_domain": null, + "dss_display": "DLCO/VA (RE)", + "extension_attribute_uid": "ExtensionAttribute_84" + }, + { + "id": 373, + "soa_id": 60, + "activity_id": 142, + "concept_code": "C200145", + "dss_title": "MHBRCADIAG", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MHBRCADIAG", + "dss_domain": null, + "dss_display": "Medical History Prespecified: Breast Cancer Diagnosis", + "extension_attribute_uid": "ExtensionAttribute_90" + }, + { + "id": 374, + "soa_id": 60, + "activity_id": 142, + "concept_code": "C200145", + "dss_title": "MHBRCARELAPSE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MHBRCARELAPSE", + "dss_domain": null, + "dss_display": "Medical History Prespecified: Breast Cancer Disease Relapse", + "extension_attribute_uid": "ExtensionAttribute_91" + }, + { + "id": 375, + "soa_id": 60, + "activity_id": 145, + "concept_code": "C64840", + "dss_title": "MGSERPL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/MGSERPL", + "dss_domain": null, + "dss_display": "Magnesium in Serum or Plasma", + "extension_attribute_uid": "ExtensionAttribute_92" + }, + { + "id": 376, + "soa_id": 60, + "activity_id": 167, + "concept_code": "C117466", + "dss_title": "EXPOSCOLL", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/EXPOSCOLL", + "dss_domain": null, + "dss_display": "Exposure as Collected Name of Treatment", + "extension_attribute_uid": "ExtensionAttribute_93" + }, + { + "id": 377, + "soa_id": 60, + "activity_id": 154, + "concept_code": "C179175", + "dss_title": "AEPRESP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/AEPRESP", + "dss_domain": null, + "dss_display": "Adverse Event Prespecified", + "extension_attribute_uid": "ExtensionAttribute_94" + }, + { + "id": 378, + "soa_id": 60, + "activity_id": 154, + "concept_code": "C179175", + "dss_title": "AE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/AE", + "dss_domain": null, + "dss_display": "Adverse Event Free Text Format", + "extension_attribute_uid": "ExtensionAttribute_95" + }, + { + "id": 379, + "soa_id": 60, + "activity_id": 159, + "concept_code": "C96613", + "dss_title": "OVRLRESP", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/OVRLRESP", + "dss_domain": null, + "dss_display": "Overall Response (RECIST 1.1)", + "extension_attribute_uid": "ExtensionAttribute_96" + }, + { + "id": 380, + "soa_id": 60, + "activity_id": 143, + "concept_code": "C164634", + "dss_title": "HEIGHT", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/HEIGHT", + "dss_domain": null, + "dss_display": "Height", + "extension_attribute_uid": "ExtensionAttribute_97" + }, + { + "id": 381, + "soa_id": 60, + "activity_id": 168, + "concept_code": "C38083", + "dss_title": "DLCO_RE", + "dss_href": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/DLCO_RE", + "dss_domain": null, + "dss_display": "Diffusion Capacity of Lung for CO (RE)", + "extension_attribute_uid": "ExtensionAttribute_98" + } + ], + "activity_surrogate": [], + "objective": [ + { + "id": 9, + "soa_id": 60, + "objective_uid": "Objective_1", + "name": "Primary Objective", + "label": "Primary Objective", + "description": "To assess progression-free survival in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone.", + "text": null, + "level_code_uid": "Code_2355", + "order_index": 1 + }, + { + "id": 10, + "soa_id": 60, + "objective_uid": "Objective_2", + "name": "Secondary Objective", + "label": "Secondary Objective", + "description": "To describe the safety profile, objective response rate, time to progression, and overall survival in this patient population.", + "text": null, + "level_code_uid": "Code_2357", + "order_index": 2 + } + ], + "endpoint": [ + { + "id": 13, + "soa_id": 60, + "endpoint_uid": "Endpoint_1", + "objective_uid": "Objective_1", + "name": "Progression-Free Survival (PFS)", + "label": "Progression-Free Survival (PFS)", + "description": "Time from randomization to documented disease progression or death, whichever occurs first. Subjects who have neither progressed nor died are censored at the date of last tumor assessment. Disease progression assessed per RECIST v1.1.", + "text": null, + "purpose": "To demonstrate that the addition of everolimus to fulvestrant improves PFS compared to fulvestrant plus placebo (hypothesized median PFS improvement from 5.4 to 9.2 months; HR \u2248 0.59).", + "level_code_uid": "Code_2356", + "order_index": 1 + }, + { + "id": 14, + "soa_id": 60, + "endpoint_uid": "Endpoint_2", + "objective_uid": "Objective_2", + "name": "Overall Survival (OS)", + "label": "Overall Survival (OS)", + "description": "Time from randomization until death from any cause. Subjects alive at the time of analysis are censored at the date of last follow-up.", + "text": null, + "purpose": "To characterize overall survival in the two treatment arms.", + "level_code_uid": "Code_2358", + "order_index": 2 + }, + { + "id": 15, + "soa_id": 60, + "endpoint_uid": "Endpoint_3", + "objective_uid": "Objective_2", + "name": "Time to Progression (TTP)", + "label": "Time to Progression (TTP)", + "description": "Time from randomization until objective disease progression per RECIST v1.1. Unlike PFS, deaths without prior progression are not counted as events (subjects are censored at time of death).", + "text": null, + "purpose": "To estimate and compare median time to disease progression between treatment arms.", + "level_code_uid": "Code_2359", + "order_index": 3 + }, + { + "id": 16, + "soa_id": 60, + "endpoint_uid": "Endpoint_4", + "objective_uid": "Objective_2", + "name": "Objective Response Rate (ORR)", + "label": "Objective Response Rate (ORR)", + "description": "Proportion of patients with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1. Assessed in patients with measurable disease at baseline.", + "text": null, + "purpose": "To compare the proportion of patients achieving an objective tumor response between treatment arms.", + "level_code_uid": "Code_2360", + "order_index": 4 + }, + { + "id": 17, + "soa_id": 60, + "endpoint_uid": "Endpoint_5", + "objective_uid": "Objective_2", + "name": "Clinical Benefit Rate (CBR)", + "label": "Clinical Benefit Rate (CBR)", + "description": "Proportion of patients with stable disease (SD) for \u22656 months, partial response (PR), or complete response (CR) \u2014 i.e., CR + PR + SD \u2265 6 months \u2014 per RECIST v1.1.", + "text": null, + "purpose": "To compare the proportion of patients deriving clinical benefit (response or prolonged stable disease) between treatment arms.", + "level_code_uid": "Code_2361", + "order_index": 5 + }, + { + "id": 18, + "soa_id": 60, + "endpoint_uid": "Endpoint_6", + "objective_uid": "Objective_2", + "name": "Safety and Tolerability", + "label": "Safety and Tolerability", + "description": "Incidence, severity (CTCAE v4.0 grade), and type of adverse events, including overall toxicity, grade 3\u20134 toxicities, serious adverse events (SAEs), and second primary cancers. Assessed in all patients who received at least one dose of study treatment.", + "text": null, + "purpose": "To characterize and compare the safety profile of fulvestrant plus everolimus versus fulvestrant plus placebo.", + "level_code_uid": "Code_2362", + "order_index": 6 + } + ], + "study_title": [ + { + "id": 4, + "soa_id": 60, + "study_title_uid": "StudyTitle_1", + "text": "Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy", + "type_code_uid": "Code_8497", + "order_index": 1 + } + ], + "organization": [ + { + "id": 3, + "soa_id": 60, + "organization_uid": "Organization_1", + "name": "PrECOG, LLC", + "label": "PrECOG", + "identifier": null, + "identifier_scheme": null, + "type_code_uid": "Code_7949", + "addr_text": "PrECOG, LLC, 1818 Market Street, Suite 1100, Philadelphia, PA 19103", + "addr_lines": "[\"1818 Market Street\", \"Suite 1100\"]", + "addr_city": "Philadelphia", + "addr_district": null, + "addr_state": "PA", + "addr_postal_code": "19103", + "addr_country_code_uid": "Code_7950", + "order_index": 1 + }, + { + "id": 4, + "soa_id": 60, + "organization_uid": "Organization_2", + "name": "Novartis Pharmaceuticals Corporation", + "label": "Novartis", + "identifier": null, + "identifier_scheme": null, + "type_code_uid": "Code_7951", + "addr_text": null, + "addr_lines": null, + "addr_city": null, + "addr_district": null, + "addr_state": null, + "addr_postal_code": null, + "addr_country_code_uid": "Code_7952", + "order_index": 2 + }, + { + "id": 7, + "soa_id": 60, + "organization_uid": "Organization_3", + "name": "clinicaltrials.gov", + "label": "clinicaltrials.gov", + "identifier": null, + "identifier_scheme": null, + "type_code_uid": "Code_9956", + "addr_text": "National Library of Medicine\n8600 Rockville Pike, Bethesda, MD 20894", + "addr_lines": "[\"National Library of Medicine\", \"8600 Rockville Pike\"]", + "addr_city": "Bethesda", + "addr_district": null, + "addr_state": "MD", + "addr_postal_code": "20894", + "addr_country_code_uid": "Code_9957", + "order_index": 3 + }, + { + "id": 8, + "soa_id": 60, + "organization_uid": "Organization_4", + "name": "VendorLab1", + "label": "Vendor1", + "identifier": null, + "identifier_scheme": null, + "type_code_uid": "Code_9958", + "addr_text": null, + "addr_lines": null, + "addr_city": null, + "addr_district": null, + "addr_state": null, + "addr_postal_code": null, + "addr_country_code_uid": "Code_9959", + "order_index": 4 + }, + { + "id": 9, + "soa_id": 60, + "organization_uid": "Organization_5", + "name": "VendorLab2", + "label": "Vendor2", + "identifier": null, + "identifier_scheme": null, + "type_code_uid": "Code_9961", + "addr_text": null, + "addr_lines": null, + "addr_city": null, + "addr_district": null, + "addr_state": null, + "addr_postal_code": null, + "addr_country_code_uid": "Code_9962", + "order_index": 5 + } + ], + "role": [ + { + "id": 3, + "soa_id": 60, + "role_uid": "StudyRole_1", + "name": "Clinical Study Sponsor", + "label": "Clinical Study Sponsor", + "description": "PrECOG, LLC serves as the clinical study sponsor and coordinating group for this investigator-initiated trial.", + "code_uid": "Code_8489", + "organization_ids": "[\"Organization_1\"]", + "masking": 0, + "order_index": 1 + }, + { + "id": 14, + "soa_id": 60, + "role_uid": "StudyRole_10", + "name": "Secondary Data Manager", + "label": "Secondary Data Manager", + "description": null, + "code_uid": "Code_9964", + "organization_ids": "[\"Organization_1\"]", + "masking": 0, + "order_index": 10 + }, + { + "id": 15, + "soa_id": 60, + "role_uid": "StudyRole_11", + "name": "Data Acquisition Lead", + "label": "Data Acquisition Lead", + "description": null, + "code_uid": "Code_9965", + "organization_ids": "[\"Organization_4\"]", + "masking": 0, + "order_index": 11 + }, + { + "id": 16, + "soa_id": 60, + "role_uid": "StudyRole_12", + "name": "Data Acquisition Lead", + "label": "Data Acquisition Lead", + "description": null, + "code_uid": "Code_9966", + "organization_ids": "[\"Organization_5\"]", + "masking": 0, + "order_index": 12 + }, + { + "id": 4, + "soa_id": 60, + "role_uid": "StudyRole_2", + "name": "Study Chair", + "label": "Study Chair", + "description": null, + "code_uid": "Code_9716", + "organization_ids": "[\"Organization_1\"]", + "masking": 0, + "order_index": 2 + }, + { + "id": 5, + "soa_id": 60, + "role_uid": "StudyRole_3", + "name": "Study Co-Chair", + "label": "Study Co-Chair", + "description": null, + "code_uid": "Code_9717", + "organization_ids": "[\"Organization_1\"]", + "masking": 0, + "order_index": 3 + }, + { + "id": 6, + "soa_id": 60, + "role_uid": "StudyRole_4", + "name": "Medical Monitor", + "label": "Medical Monitor", + "description": null, + "code_uid": "Code_9718", + "organization_ids": "[\"Organization_1\"]", + "masking": 0, + "order_index": 4 + }, + { + "id": 7, + "soa_id": 60, + "role_uid": "StudyRole_5", + "name": "Study Statistician", + "label": "Study Statistician", + "description": null, + "code_uid": "Code_9719", + "organization_ids": "[\"Organization_1\"]", + "masking": 0, + "order_index": 5 + }, + { + "id": 8, + "soa_id": 60, + "role_uid": "StudyRole_6", + "name": "Study Contact", + "label": "Study Contact", + "description": null, + "code_uid": "Code_9720", + "organization_ids": "[\"Organization_1\"]", + "masking": 0, + "order_index": 6 + }, + { + "id": 9, + "soa_id": 60, + "role_uid": "StudyRole_7", + "name": "Investigational Product Manufacturer", + "label": "Investigational Product Manufacturer", + "description": "Novartis Pharmaceuticals Corporation supplies everolimus and matching placebo for the study.", + "code_uid": "Code_9714", + "organization_ids": "[\"Organization_2\"]", + "masking": 0, + "order_index": 7 + }, + { + "id": 10, + "soa_id": 60, + "role_uid": "StudyRole_8", + "name": "Pharmacovigilance Group", + "label": "Pharmacovigilance Group", + "description": "Novartis Pharmaceuticals Drug Safety and Epidemiology Department (DS&E). Receives SAE notifications from PrECOG within 24 hours of awareness date.", + "code_uid": "Code_9715", + "organization_ids": "[\"Organization_2\"]", + "masking": 0, + "order_index": 8 + }, + { + "id": 13, + "soa_id": 60, + "role_uid": "StudyRole_9", + "name": "Primary Data Manager", + "label": "Primary Data Manager", + "description": null, + "code_uid": "Code_9963", + "organization_ids": "[\"Organization_1\"]", + "masking": 0, + "order_index": 9 + } + ], + "footnote": [ + { + "id": 1, + "soa_id": 60, + "footnote_uid": "Footnote_1", + "name": "NCT01797120_Footnote_1", + "label": "Footnote 1 for the NCT01797120 study", + "description": "Simple description", + "text": "\r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n \r\n
a:\u2264 4 weeks of randomization; if assessments required \u2264 7 days of Cycle 1 Day 1 (C1D1), they do not need to be repeated (includes labs).
b:\u2264 7 days prior to the start of C1D1.
c:+/- 72 hour window allowed prior to D1 of each subsequent cycle after the first cycle for scheduled therapy/tests/visits. Delay due to holidays, weekends,\r\nbad weather or other unforeseen circumstances will be permitted.
d:In the event of grade 3 or 4 hematologic toxicity, CBC with differential and platelet count will be obtained every 1-3 days until there is evidence of\r\nhematologic recovery.
e:+/- 72 hours prior to Cycle 2 Day 1 then approximately every 12 weeks during treatment (and more frequently as clinically indicated), and at end of\r\ntreatment.
f:All patients should be screened for hepatitis risk factors and any past illnesses of hepatitis B and hepatitis C infection (see Section 7.1.1). All patients with a\r\npositive medical history per Section 7.1.1 need hepatitis testing as noted on above table. It is highly recommended that patients positive for HBV-DNA or\r\nHBsAg are treated prophylactically with an antiviral (e.g., Lamivudine) for 1-2 weeks prior to receiving study drug (see Table 5-3). The antiviral treatment\r\nshould continue throughout the entire study period and for at least 4 weeks after the last dose of everolimus.\r\n
g:Patients on antiviral prophylaxis treatment or positive HBV antibodies should be tested for HBV-DNA \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior\r\nto D1 of each subsequent cycle to monitor for reactivation. See Table 5-4 for reactivation instructions.
h:Patients with positive HCV RNA-PCR results at screening and/or a history of past infection (even if treated and considered \u2018cured\u2019) should have HCV RNA-\r\nPCR testing performed on \u2264 7 days prior to the start of C1D1 and +/- 72 hrs prior to D1 of each subsequent cycle to monitor for flare. Everolimus must be\r\ndiscontinued if HCV flare is confirmed according to the guidance in Table 5-5.
i:Tumor measurements may be made using physical examination, CT Scans or MRI. Tumor assessments will be performed every 12 weeks, +/- 1 week\r\n(every 3 months). Imaging will include chest and abdomen. Bone Scans and Brain CT/MRI may be performed as clinically indicated. Scans do not have to be\r\nrepeated once disease progression is documented.
j:Adverse events related to fulvestrant and/or everolimus/placebo will be followed for 30 days after the last dose of study therapy (fulvestrant and/or\r\neverolimus/placebo) or until \u2264 grade 1 or if the grade is >1, the event must be permanent and stable. Please note- Serious adverse events >30 days after last\r\ndose of fulvestrant and/or everolimus/placebo are not reported unless the event may be related to everolimus/placebo.
k:CBC and chemistry may be used to assess ongoing toxicity but are not required in the Continuation Phase for patients who receive fulvestrant alone.\r\nPatients who continue fulvestrant with everolimus should periodically have CBC, chemistries, fasting glucose, fasting lipids, HBV DNA, HCV RNA-PCR per\r\nlabeling guidelines.
l:Study Drug Compliance (Pill Diary) for those patients who receive everolimus in the Continuation Phase.
m:All patients including those that discontinue protocol therapy will be followed for 3 years from the time of randomization. Patients that have not progressed\r\nduring the Induction or Continuation Phase will continue to have imaging scans completed every 12 weeks, +/- 1 week (every 3 months) until documented\r\nprogression.
n:PFTs with DLCO as medically indicated only, (PFTs are not otherwise required during course of study).
o:Follow every 3 months for disease progression and survival. Initiation of any new systemic therapy will also be documented
", + "dictionary_uid": null + }, + { + "id": 2, + "soa_id": 60, + "footnote_uid": "Footnote_2", + "name": "NCT01797120_Footnote_2", + "label": "Footnote 2 for the NCT01797120 study", + "description": null, + "text": "\r\n\t\r\n\t\t\r\n\t\t\r\n\t\r\n\t\r\n\t\t\r\n\t\t\r\n\t\r\n\t\r\n\t\t\r\n\t\t\r\n\t\r\n
*Cycle 1, Day 1 is defined as the first day on which fulvestrant is given in combination with placebo/everolimus (the second fulvestrant dose is given on day 15\r\nof the first cycle only). Day 1 of each additional cycle is defined as the day in which fulvestrant is given in combination with everolimus/placebo.
^End of Induction/End of Treatment should be performed within 30 days of last dose of fulvestrant.
\u00a3Continuation Phase: Patients in the Continuation Phase should continue to receive fulvestrant alone (if originally randomized to placebo) or in combination\r\nwith everolimus (if originally randomized to everolimus) at the same dose and schedule (+/- 1 week window for scheduled therapy/tests/visits; delays due to\r\nholidays, weekends, bad weather or other unforeseen circumstances will be permitted) until disease progression or unacceptable toxicity.
", + "dictionary_uid": null + } + ], + "study_amendment": [], + "study_amendment_reason": [], + "study_amendment_impact": [], + "study_change": [], + "document_content_reference": [], + "amendment_geographic_scope": [], + "amendment_governance_date": [], + "governance_date_geographic_scope": [], + "amendment_subject_enrollment": [] +} From c3825d02d37949dd60b45883f194bfb0ecd2b05b Mon Sep 17 00:00:00 2001 From: pendingintent <3921919+pendingintent@users.noreply.github.com> Date: Thu, 13 Aug 2026 09:52:06 -0400 Subject: [PATCH 4/4] Added id-token to claude workflows. --- .github/workflows/claude-comment-review.yml | 1 + .github/workflows/claude-test-analysis.yml | 1 + 2 files changed, 2 insertions(+) diff --git a/.github/workflows/claude-comment-review.yml b/.github/workflows/claude-comment-review.yml index 100416b..f2b5c1e 100644 --- a/.github/workflows/claude-comment-review.yml +++ b/.github/workflows/claude-comment-review.yml @@ -10,6 +10,7 @@ on: permissions: contents: read pull-requests: write + id-token: write jobs: review: diff --git a/.github/workflows/claude-test-analysis.yml b/.github/workflows/claude-test-analysis.yml index d5beeb6..6862ecb 100644 --- a/.github/workflows/claude-test-analysis.yml +++ b/.github/workflows/claude-test-analysis.yml @@ -14,6 +14,7 @@ jobs: contents: read issues: write pull-requests: write + id-token: write steps: - uses: actions/checkout@v4